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Chemistry

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Also known as: 71-68-1, Hydromorphone hcl, Dilaudid, Palladone, Hymorphan, Exalgo
Molecular Formula
C17H20ClNO3
Molecular Weight
321.8  g/mol
InChI Key
XHILEZUETWRSHC-NRGUFEMZSA-N
FDA UNII
L960UP2KRW

Hydromorphone Hydrochloride
An opioid analgesic made from MORPHINE and used mainly as an analgesic. It has a shorter duration of action than morphine.
1 2D Structure

Hydromorphone Hydrochloride

2 Identification
2.1 Computed Descriptors
2.1.1 IUPAC Name
(4R,4aR,7aR,12bS)-9-hydroxy-3-methyl-1,2,4,4a,5,6,7a,13-octahydro-4,12-methanobenzofuro[3,2-e]isoquinolin-7-one;hydrochloride
2.1.2 InChI
InChI=1S/C17H19NO3.ClH/c1-18-7-6-17-10-3-5-13(20)16(17)21-15-12(19)4-2-9(14(15)17)8-11(10)18;/h2,4,10-11,16,19H,3,5-8H2,1H3;1H/t10-,11+,16-,17-;/m0./s1
2.1.3 InChI Key
XHILEZUETWRSHC-NRGUFEMZSA-N
2.1.4 Canonical SMILES
CN1CCC23C4C1CC5=C2C(=C(C=C5)O)OC3C(=O)CC4.Cl
2.1.5 Isomeric SMILES
CN1CC[C@]23[C@@H]4[C@H]1CC5=C2C(=C(C=C5)O)O[C@H]3C(=O)CC4.Cl
2.2 Other Identifiers
2.2.1 UNII
L960UP2KRW
2.3 Synonyms
2.3.1 MeSH Synonyms

1. Dihydromorphinone

2. Dilaudid

3. Hydromorphon

4. Hydromorphone

5. Laudacon

6. Palladone

2.3.2 Depositor-Supplied Synonyms

1. 71-68-1

2. Hydromorphone Hcl

3. Dilaudid

4. Palladone

5. Hymorphan

6. Exalgo

7. Dihydromorphinone Hydrochloride

8. Dilaudid-hp

9. L960up2krw

10. Hydromorphone Hydrochloride Cii

11. Nsc-117862

12. Dea No. 9150

13. (4r,4ar,7ar,12bs)-9-hydroxy-3-methyl-1,2,4,4a,5,6,7a,13-octahydro-4,12-methanobenzofuro[3,2-e]isoquinolin-7-one;hydrochloride

14. 4,5-alpha-epoxy-3-hydroxy-17-methylmorphinan-6-one Hydrochloride

15. Chebi:5791

16. Morphinone, Dihydro-, Hydrochloride

17. Einecs 200-762-6

18. Unii-l960up2krw

19. Nsc 117862

20. Hydromorphone Hydrochloride [usp]

21. Palladone (tn)

22. Dilaudid (tn)

23. (4r,4ar,7ar,12bs)-9-hydroxy-3-methyl-1,2,4,4a,5,6,7a,13-octahydro-4,12-methanobenzofuro[3,2-e]isoquinoline-7-one;hydrochloride

24. Exalgo (tn)

25. 4,5alpha-epoxy-3-hydroxy-17-methylmorphinan-6-one Hydrochloride

26. Schembl30521

27. Hydromorphone Hydrochloride Usp

28. Chembl1237055

29. Dtxsid90991291

30. Morphinan-6-one, 4,5alpha-epoxy-3-hydroxy-17-methyl-, Hydrochloride

31. Hydromorphone Hydrochloride (jan/usp)

32. Morphinan-6-one, 4,5-epoxy-3-hydroxy-17-methyl-, Hydrochloride, (5alpha)-

33. Hydromorphone Hydrochloride [mi]

34. Morphinan-6-one, 4,5-alpha-epoxy-3-hydroxy-17-methyl-, Hydrochloride, (5'-alpha)-

35. Hydromorphone Hydrochloride [jan]

36. Hydromorphone Hydrochloride [mart.]

37. Hydromorphone Hydrochloride [vandf]

38. Hydromorphone Hydrochloride [who-dd]

39. D00839

40. Hydromorphone Hydrochloride [orange Book]

41. Hydromorphone Hydrochloride Cii [usp-rs]

42. Hydromorphone Hydrochloride [ep Monograph]

43. Hydromorphone Hydrochloride [usp Monograph]

44. Q27106892

45. 4,5.alpha.-epoxy-3-hydroxy-17-methylmorphinan-6-one Hydrochloride

46. Hydromorphone Hydrochloride Solution, Drug Standard, 1.0 Mg/ml In Methanol

47. Hydromorphone Hydrochloride, European Pharmacopoeia (ep) Reference Standard

48. Hydromorphone Hydrochloride, United States Pharmacopeia (usp) Reference Standard

49. Morphinan-6-one, 4,5-epoxy-3-hydroxy-17-methyl-, Hydrochloride (1:1), (5.alpha.)

50. Morphinan-6-one, 4,5-epoxy-3-hydroxy-17-methyl-, Hydrochloride, (5.alpha.)-

2.4 Create Date
2005-06-24
3 Chemical and Physical Properties
Molecular Weight 321.8 g/mol
Molecular Formula C17H20ClNO3
Hydrogen Bond Donor Count2
Hydrogen Bond Acceptor Count4
Rotatable Bond Count0
Exact Mass321.1131712 g/mol
Monoisotopic Mass321.1131712 g/mol
Topological Polar Surface Area49.8 Ų
Heavy Atom Count22
Formal Charge0
Complexity494
Isotope Atom Count0
Defined Atom Stereocenter Count4
Undefined Atom Stereocenter Count0
Defined Bond Stereocenter Count0
Undefined Bond Stereocenter Count0
Covalently Bonded Unit Count2
4 Drug and Medication Information
4.1 Drug Information
1 of 4  
Drug NameExalgo
Drug LabelEXALGO tablets contain hydromorphone hydrochloride, a mu-opioid agonist.Hydromorphone hydrochloride USP is 4,5-epoxy-3-hydroxy-17-methlymorphinan-6-one hydrochloride. Hydromorphone hydrochloride is a white or almost white crystalline powder that...
Active IngredientHydromorphone hydrochloride
Dosage FormTablet, extended release
RouteOral
Strength32mg; 12mg; 16mg; 8mg
Market StatusPrescription
CompanyMallinckrodt

2 of 4  
Drug NameHydromorphone hydrochloride
PubMed HealthHydromorphone
Drug ClassesAnalgesic, Anesthetic Adjunct, Central Nervous System Agent
Drug LabelHydromorphone Hydrochloride Tablets USP, 2 mg, 4 mg, and 8 mg are supplied in tablet form for oral administration.Hydromorphone hydrochloride, a hydrogenated ketone of morphine, is an opioid analgesic.The chemical name of hydromorphone hydrochloride...
Active IngredientHydromorphone hydrochloride
Dosage FormTablet, extended release; Tablet; Injectable; Solution
RouteInjection; Oral
Strength2mg/ml; 1mg/ml; 8mg; 10mg/ml; 4mg; 4mg/ml; 12mg; 2mg; 16mg; 5mg/5ml
Market StatusPrescription
CompanyHospira; Actavis Labs Fl; Mallinckrodt; Roxane; Lannett; Elite Labs; Akorn; Barr

3 of 4  
Drug NameExalgo
Drug LabelEXALGO tablets contain hydromorphone hydrochloride, a mu-opioid agonist.Hydromorphone hydrochloride USP is 4,5-epoxy-3-hydroxy-17-methlymorphinan-6-one hydrochloride. Hydromorphone hydrochloride is a white or almost white crystalline powder that...
Active IngredientHydromorphone hydrochloride
Dosage FormTablet, extended release
RouteOral
Strength32mg; 12mg; 16mg; 8mg
Market StatusPrescription
CompanyMallinckrodt

4 of 4  
Drug NameHydromorphone hydrochloride
PubMed HealthHydromorphone
Drug ClassesAnalgesic, Anesthetic Adjunct, Central Nervous System Agent
Drug LabelHydromorphone Hydrochloride Tablets USP, 2 mg, 4 mg, and 8 mg are supplied in tablet form for oral administration.Hydromorphone hydrochloride, a hydrogenated ketone of morphine, is an opioid analgesic.The chemical name of hydromorphone hydrochloride...
Active IngredientHydromorphone hydrochloride
Dosage FormTablet, extended release; Tablet; Injectable; Solution
RouteInjection; Oral
Strength2mg/ml; 1mg/ml; 8mg; 10mg/ml; 4mg; 4mg/ml; 12mg; 2mg; 16mg; 5mg/5ml
Market StatusPrescription
CompanyHospira; Actavis Labs Fl; Mallinckrodt; Roxane; Lannett; Elite Labs; Akorn; Barr

5 Pharmacology and Biochemistry
5.1 MeSH Pharmacological Classification

Analgesics, Opioid

Compounds with activity like OPIATE ALKALOIDS, acting at OPIOID RECEPTORS. Properties include induction of ANALGESIA or NARCOSIS. (See all compounds classified as Analgesics, Opioid.)


Narcotics

Agents that induce NARCOSIS. Narcotics include agents that cause somnolence or induced sleep (STUPOR); natural or synthetic derivatives of OPIUM or MORPHINE or any substance that has such effects. They are potent inducers of ANALGESIA and OPIOID-RELATED DISORDERS. (See all compounds classified as Narcotics.)


5.2 FDA Pharmacological Classification
5.2.1 Pharmacological Classes
Opioid Agonist [EPC]; Full Opioid Agonists [MoA]

API SUPPLIERS

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R1-CEP 2004-265 - Rev 02
Valid
Chemical
2017-02-27
2099
Veranova

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Certificate Number : R1-CEP 2004-265 - Rev 02

Status : Valid

Issue Date : 2017-02-27

Type : Chemical

Substance Number : 2099

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R1-CEP 2006-169 - Rev 04
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2021-03-25
2099
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Certificate Number : R1-CEP 2006-169 - Rev 04

Status : Valid

Issue Date : 2021-03-25

Type : Chemical

Substance Number : 2099

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Certificate Number : R1-CEP 2010-117 - Rev 02

Status : Valid

Issue Date : 2022-08-04

Type : Chemical

Substance Number : 2099

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Certificate Number : R1-CEP 2008-079 - Rev 02

Status : Valid

Issue Date : 2021-12-02

Type : Chemical

Substance Number : 2099

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R0-CEP 2016-118 - Rev 00
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2017-06-14
2022-06-14
2099
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Certificate Number : R0-CEP 2016-118 - Rev 00

Status : Withdrawn by Holder

Issue Date : 2017-06-14

Type : Chemical

Substance Number : 2099

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Certificate Number : CEP 2017-123 - Rev 01

Status : Valid

Issue Date : 2023-10-26

Type : Chemical

Substance Number : 2099

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Veranova

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Hydromorphone Hydrochloride

About the Company : Veranova is a global leader in the development and manufacturing of specialist and complex APIs for pharma and biotech customers. We have over 50 years of experience navigating the...

Veranova is a global leader in the development and manufacturing of specialist and complex APIs for pharma and biotech customers. We have over 50 years of experience navigating the challenges of the global healthcare industry, and nurturing long-standing, trusted customer relationships. Operating within two divisions, Generics and Originators, we deliver a differentiated service offering to pharma and biotech customers for every stage in the drug development lifecycle. Macfarlan Smith Limited is trading as Veranova in the United Kingdom.
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Rusan Pharma

India
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Hydromorphone Hydrochloride

About the Company : Rusan Pharma is a fully integrated global pharmaceutical company specializing in the treatment of addiction & pain management. We manufacture & market a wide range of APIs & formul...

Rusan Pharma is a fully integrated global pharmaceutical company specializing in the treatment of addiction & pain management. We manufacture & market a wide range of APIs & formulations, in the area of controlled substances. Our facilities are GMP-approved by Health Canada, EU, TGA, ANVISA, PIC/S, WHO, Russia & SAHPRA. We have CEP approval for various APIs such as Buprenorphine, Fentanyl, Naltrexone, Methadone, Bisoprolol & we also manufacture Naloxone, Nalbuphine, Nalmefene, Apomorphine, Efflornithine & Sodium Oxybate. We also develop & manufacture various transdermal patches & long-acting formulations such as depot injections & Implants.
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Noramco

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Hydromorphone Hydrochloride

About the Company : Founded in 1979, Noramco specializes in the development and manufacturing of APIs for both opioid and non-opioid products. With expertise in controlled substance development and ma...

Founded in 1979, Noramco specializes in the development and manufacturing of APIs for both opioid and non-opioid products. With expertise in controlled substance development and manufacturing, Noramco offers services like supply-chain integration for high-purity controlled substances, efficient routes to APIs, analytical data, stability studies, regulatory help, formulation-friendly particle size grades, extended technical packages, DEA-compliant security and production capacity from kilos to multi-ton supply. Noramco also offers world-class supply security for controlled substances, from Schedule I to Schedule III.
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Hydromorphone Hydrochloride

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Hydromorphone Hydrochloride

About the Company : Mallinckrodt Pharmaceuticals is a multibillion dollar specialty biopharmaceutical company focused on our mission: Managing Complexity. Improving Lives. We provide medicines to addr...

Mallinckrodt Pharmaceuticals is a multibillion dollar specialty biopharmaceutical company focused on our mission: Managing Complexity. Improving Lives. We provide medicines to address unmet patient needs, steming from nearly 150 years of using our unique strengths, experience and expertise to help improve people’s lives. Discover how our rich history of innovation and patient-centered solutions has helped influence our vision for the future. Our strong ability to master and manage complexity is the key component in making high-quality products that provide value for patients.
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Hydromorphone Hydrochloride

About the Company : Mallinckrodt Pharmaceuticals is a multibillion dollar specialty biopharmaceutical company focused on our mission: Managing Complexity. Improving Lives. We provide medicines to addr...

Mallinckrodt Pharmaceuticals is a multibillion dollar specialty biopharmaceutical company focused on our mission: Managing Complexity. Improving Lives. We provide medicines to address unmet patient needs, steming from nearly 150 years of using our unique strengths, experience and expertise to help improve people’s lives. Discover how our rich history of innovation and patient-centered solutions has helped influence our vision for the future. Our strong ability to master and manage complexity is the key component in making high-quality products that provide value for patients.
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OmnisMed Pharmaceuticals

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Hydromorphone Hydrochloride

About the Company : OmnisMed Pharmaceuticals believes that good healthcare must be accessible to everyone; That is the core of our philosophy. We are experts in providing a wide range of high-quality ...

OmnisMed Pharmaceuticals believes that good healthcare must be accessible to everyone; That is the core of our philosophy. We are experts in providing a wide range of high-quality pharmaceutical products, highly tested and approved controlled drugs, and fully certifiable medical devices. All our suppliers hold several GMPs and certifications which are readily accepted by developed and developing markets. The high daily manufacturing capacity of our facilities and our distribution network allows us to quickly fulfill large orders and ensure our manufacturing process is cost-effective.
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Hydromorphone Hydrochloride

About the Company : We are the largest pharmaceutical company in Slovakia with site originally established in the 1940s. Our multi-purpose headquarters is easily reachable from all central European hu...

We are the largest pharmaceutical company in Slovakia with site originally established in the 1940s. Our multi-purpose headquarters is easily reachable from all central European hubs like Vienna, Prague and Budapest. We, at Saneca, carry on the tradition of commitments to quality and customer service level. Everything that we do we approach from the customer perspective.
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Hydromorphone Hydrochloride

Brand Name : Jurnista

Dosage Form : Hydromorphone 64Mg 14 Joined' Oral Use Rp

Dosage Strength : 14 CPR 64 mg prolonged release

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Registration Country : Italy

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Mundipharma AB

Germany
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hydromorphone

Brand Name : Palladon

Dosage Form : PROLONGED-RELEASE CAPSULE, HARD

Dosage Strength : 8 MG

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Registration Country : Sweden

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Mundipharma AB

Germany
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Mundipharma AB

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hydromorphone

Brand Name : Palladon

Dosage Form : HARD CAPSULES

Dosage Strength : 1.3 MG

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Registration Country : Sweden

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Mundipharma AB

Germany
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Mundipharma AB

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hydromorphone

Brand Name : Palladon

Dosage Form : INJECTION / INFUSION

Dosage Strength : 2 MG / ML

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Registration Country : Sweden

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Mundipharma AS

Germany
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Mundipharma AS

Germany
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Hydromorphone Hydrochloride

Brand Name : Palladon

Dosage Form : Capsule, hard

Dosage Strength : 1.3 mg

Packaging : Blister

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Registration Country : Norway

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Mundipharma AS

Germany
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Mundipharma AS

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Hydromorphone Hydrochloride

Brand Name : Palladon

Dosage Form : Injection/infusion fluid, resolution

Dosage Strength : 10 mg/ml

Packaging : Ampoule

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Application Number :

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Registration Country : Norway

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Mundipharma AS

Germany
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Mundipharma AS

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Hydromorphone Hydrochloride

Brand Name : Palladon

Dosage Form : Injection/infusion fluid, resolution

Dosage Strength : 20 mg/ml

Packaging : Ampoule

Approval Date :

Application Number :

Regulatory Info :

Registration Country : Norway

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Mundipharma AS

Germany
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Mundipharma AS

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Hydromorphone Hydrochloride

Brand Name : Palladon

Dosage Form : Injection/infusion fluid, resolution

Dosage Strength : 50 mg/ml

Packaging : Ampoule

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Regulatory Info :

Registration Country : Norway

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Hydromorphoni hydrochloridum

Brand Name : Palladon

Dosage Form : Ret Kaps

Dosage Strength : 16mg

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Registration Country : Switzerland

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Hydromorphoni hydrochloridum

Brand Name : Palladon

Dosage Form : Ret Kaps

Dosage Strength : 16mg

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Registration Country : Switzerland

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HYDROMORPHONE HCL

Brand Name : Dilaudid

Dosage Form : Tablet

Dosage Strength : 2MG

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Registration Country : U.S.A

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HYDROMORPHONE HCL

Dosage : Tablet

Dosage Strength : 2MG

Brand Name : Dilaudid

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Registration Country : U.S.A

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Farbe Firma

India
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Farbe Firma

India
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Hydromorphone Hydrochloride

Brand Name :

Dosage Form : Injection

Dosage Strength : 10MG/ML

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Registration Country : India

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Farbe Firma

India
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Farbe Firma

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Hydromorphone Hydrochloride

Dosage : Injection

Dosage Strength : 10MG/ML

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Registration Country : India

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G.L. Pharma

Austria
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G.L. Pharma

Austria
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Hydromorphone Hydrochloride

Brand Name :

Dosage Form : Solution for Injection

Dosage Strength : 10MG/ML

Packaging :

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Application Number :

Regulatory Info : Dossier Availability- Q2 2017

Registration Country : Austria

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G.L. Pharma

Austria
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G.L. Pharma

Austria
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Hydromorphone Hydrochloride

Dosage : Solution for Injection

Dosage Strength : 10MG/ML

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Registration Country : Austria

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Hana Pharm Co Ltd

South Korea
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Hana Pharm Co Ltd

South Korea
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Hydromorphone

Brand Name : Dilid

Dosage Form : INJECTION

Dosage Strength : 1MG

Packaging : 1mL x 10A

Approval Date :

Application Number :

Regulatory Info : Generic

Registration Country : South Korea

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04

Hana Pharm Co Ltd

South Korea
Medlab Asia & Asia Health
Not Confirmed
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Hana Pharm Co Ltd

South Korea
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Medlab Asia & Asia Health
Not Confirmed

Hydromorphone

Dosage : INJECTION

Dosage Strength : 1MG

Brand Name : Dilid

Approval Date :

Application Number :

Registration Country : South Korea

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05

Hana Pharm Co Ltd

South Korea
Medlab Asia & Asia Health
Not Confirmed
arrow

Hana Pharm Co Ltd

South Korea
arrow
Medlab Asia & Asia Health
Not Confirmed

Hydromorphone

Brand Name : Dilid

Dosage Form : INJECTION

Dosage Strength : 2MG

Packaging : 2mL x 10A

Approval Date :

Application Number :

Regulatory Info : Generic

Registration Country : South Korea

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05

Hana Pharm Co Ltd

South Korea
Medlab Asia & Asia Health
Not Confirmed
arrow

Hana Pharm Co Ltd

South Korea
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Medlab Asia & Asia Health
Not Confirmed

Hydromorphone

Dosage : INJECTION

Dosage Strength : 2MG

Brand Name : Dilid

Approval Date :

Application Number :

Registration Country : South Korea

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06

Medlab Asia & Asia Health
Not Confirmed
arrow
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Medlab Asia & Asia Health
Not Confirmed

Hydromorphone Hydrochloride

Brand Name :

Dosage Form : Tablet

Dosage Strength : 2MG

Packaging : Size: 100s

Approval Date :

Application Number :

Regulatory Info :

Registration Country : U.S.A

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06

Medlab Asia & Asia Health
Not Confirmed
arrow
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Medlab Asia & Asia Health
Not Confirmed

Hydromorphone Hydrochloride

Dosage : Tablet

Dosage Strength : 2MG

Brand Name :

Approval Date :

Application Number :

Registration Country : U.S.A

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07

Medlab Asia & Asia Health
Not Confirmed
arrow
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Medlab Asia & Asia Health
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Hydromorphone Hydrochloride

Brand Name :

Dosage Form : Tablet

Dosage Strength : 4MG

Packaging : Size: 100s

Approval Date :

Application Number :

Regulatory Info :

Registration Country : U.S.A

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07

Medlab Asia & Asia Health
Not Confirmed
arrow
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Medlab Asia & Asia Health
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Hydromorphone Hydrochloride

Dosage : Tablet

Dosage Strength : 4MG

Brand Name :

Approval Date :

Application Number :

Registration Country : U.S.A

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08

Medlab Asia & Asia Health
Not Confirmed
arrow
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Medlab Asia & Asia Health
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Hydromorphone Hydrochloride

Brand Name :

Dosage Form : Tablet

Dosage Strength : 8MG

Packaging : Size: 100s

Approval Date :

Application Number :

Regulatory Info :

Registration Country : U.S.A

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08

Medlab Asia & Asia Health
Not Confirmed
arrow
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Medlab Asia & Asia Health
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Hydromorphone Hydrochloride

Dosage : Tablet

Dosage Strength : 8MG

Brand Name :

Approval Date :

Application Number :

Registration Country : U.S.A

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09

Medlab Asia & Asia Health
Not Confirmed
arrow
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Medlab Asia & Asia Health
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Hydromorphone Hydrochloride

Brand Name :

Dosage Form : Extended Release Table...

Dosage Strength : 16MG

Packaging : Size: 100s

Approval Date :

Application Number :

Regulatory Info :

Registration Country : U.S.A

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09

Medlab Asia & Asia Health
Not Confirmed
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Medlab Asia & Asia Health
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Hydromorphone Hydrochloride

Dosage : Extended Release Table...

Dosage Strength : 16MG

Brand Name :

Approval Date :

Application Number :

Registration Country : U.S.A

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10

Medlab Asia & Asia Health
Not Confirmed
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Medlab Asia & Asia Health
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Hydromorphone Hydrochloride

Brand Name :

Dosage Form : Extended Release Table...

Dosage Strength : 32MG

Packaging : Size: 100s

Approval Date :

Application Number :

Regulatory Info :

Registration Country : U.S.A

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10

Medlab Asia & Asia Health
Not Confirmed
arrow
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Medlab Asia & Asia Health
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Hydromorphone Hydrochloride

Dosage : Extended Release Table...

Dosage Strength : 32MG

Brand Name :

Approval Date :

Application Number :

Registration Country : U.S.A

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DRUG PRODUCT COMPOSITIONS

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DOSAGE - INJECTABLE;INJECTION - 0.2MG/ML

USFDA APPLICATION NUMBER - 19034

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DOSAGE - INJECTABLE;INJECTION - 0.5MG/0.5ML

USFDA APPLICATION NUMBER - 19034

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DOSAGE - INJECTABLE;INJECTION - 10MG/ML

USFDA APPLICATION NUMBER - 19034

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DOSAGE - INJECTABLE;INJECTION - 1MG/ML

USFDA APPLICATION NUMBER - 19034

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DOSAGE - INJECTABLE;INJECTION - 2MG/ML

USFDA APPLICATION NUMBER - 19034

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DOSAGE - INJECTABLE;INJECTION - 4MG/ML

USFDA APPLICATION NUMBER - 19034

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DOSAGE - SOLUTION;ORAL - 5MG/5ML

USFDA APPLICATION NUMBER - 19891

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DOSAGE - TABLET;ORAL - 2MG

USFDA APPLICATION NUMBER - 19892

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DOSAGE - TABLET;ORAL - 4MG

USFDA APPLICATION NUMBER - 19892

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DOSAGE - TABLET;ORAL - 8MG

USFDA APPLICATION NUMBER - 19892

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DOSAGE - TABLET, EXTENDED RELEASE;ORAL - 12MG...DOSAGE - TABLET, EXTENDED RELEASE;ORAL - 12MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**

USFDA APPLICATION NUMBER - 21217

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DOSAGE - TABLET, EXTENDED RELEASE;ORAL - 16MG...DOSAGE - TABLET, EXTENDED RELEASE;ORAL - 16MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**

USFDA APPLICATION NUMBER - 21217

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DOSAGE - TABLET, EXTENDED RELEASE;ORAL - 32MG...DOSAGE - TABLET, EXTENDED RELEASE;ORAL - 32MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**

USFDA APPLICATION NUMBER - 21217

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DOSAGE - TABLET, EXTENDED RELEASE;ORAL - 8MG ...DOSAGE - TABLET, EXTENDED RELEASE;ORAL - 8MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**

USFDA APPLICATION NUMBER - 21217

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Evonik

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Virtual BoothEvonik's CDMO solutions for APIs and HPAPIs: It specializes where the client needs it most!

Grade : Oral

Category : Controlled & Modified Release, Solubilizers

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BASF

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Parenteral

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Global Sales Information

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Finished Drug Prices

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Brand Name : Palladon

Germany
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Not Confirmed

Brand Name : Palladon

Germany
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Hydromorphone Hydrochloride

Dosage Form : Capsule, hard

Dosage Strength : 1.3 mg

Price Per Pack (Euro) : 48.708

Published in :

Country : Norway

RX/OTC/DISCN :

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02

Brand Name : Palladon

Germany
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Medlab Asia & Asia Health
Not Confirmed

Brand Name : Palladon

Germany
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Not Confirmed

Hydromorphone Hydrochloride

Dosage Form : Capsule, hard

Dosage Strength : 2.6 mg

Price Per Pack (Euro) : 41.822

Published in :

Country : Norway

RX/OTC/DISCN :

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03

Brand Name : Jurnista

Italy
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Medlab Asia & Asia Health
Not Confirmed

Brand Name : Jurnista

Italy
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Hydromorphone Hydrochloride

Dosage Form : Hydromorphone 16Mg 14 Joined' Or...

Dosage Strength : 14 CPR 16 mg prolonged release

Price Per Pack (Euro) : 53.17

Published in :

Country : Italy

RX/OTC/DISCN : Class A

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04

Brand Name : Jurnista

Italy
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Medlab Asia & Asia Health
Not Confirmed

Brand Name : Jurnista

Italy
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Medlab Asia & Asia Health
Not Confirmed

Hydromorphone Hydrochloride

Dosage Form : Hydromorphone 32Mg 14 Joined' Or...

Dosage Strength : 14 CPR 32 mg prolonged release

Price Per Pack (Euro) : 90.51

Published in :

Country : Italy

RX/OTC/DISCN : Class A

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05

Brand Name : Jurnista

Italy
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Medlab Asia & Asia Health
Not Confirmed

Brand Name : Jurnista

Italy
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Hydromorphone Hydrochloride

Dosage Form : Hydromorphone 4Mg 14 Joined' Ora...

Dosage Strength : 14 CPR 4 mg prolonged release

Price Per Pack (Euro) : 15.64

Published in :

Country : Italy

RX/OTC/DISCN : Class A

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06

Brand Name : Jurnista

Italy
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Not Confirmed

Brand Name : Jurnista

Italy
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Not Confirmed

Hydromorphone Hydrochloride

Dosage Form : Hydromorphone 64Mg 14 Joined' Or...

Dosage Strength : 14 CPR 64 mg prolonged release

Price Per Pack (Euro) : 154.73

Published in :

Country : Italy

RX/OTC/DISCN : Class A

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07

Brand Name : Jurnista

Italy
arrow
Medlab Asia & Asia Health
Not Confirmed

Brand Name : Jurnista

Italy
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Medlab Asia & Asia Health
Not Confirmed

Hydromorphone Hydrochloride

Dosage Form : Hydromorphone 8Mg 14 Joined' Ora...

Dosage Strength : 14 CPR 8 mg prolonged release

Price Per Pack (Euro) : 31.28

Published in :

Country : Italy

RX/OTC/DISCN : Class A

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08

Brand Name : Palladon

Germany
arrow
Medlab Asia & Asia Health
Not Confirmed

Brand Name : Palladon

Germany
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Medlab Asia & Asia Health
Not Confirmed

Hydromorphone Hydrochloride

Dosage Form : Injection/infusion fluid, resolu...

Dosage Strength : 10 mg/ml

Price Per Pack (Euro) : 57.651

Published in :

Country : Norway

RX/OTC/DISCN :

blank

09

Brand Name : Palladon

Germany
arrow
Medlab Asia & Asia Health
Not Confirmed

Brand Name : Palladon

Germany
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Medlab Asia & Asia Health
Not Confirmed

Hydromorphone Hydrochloride

Dosage Form : Injection/infusion fluid, resolu...

Dosage Strength : 2 mg/ml

Price Per Pack (Euro) : 30.217

Published in :

Country : Norway

RX/OTC/DISCN :

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10

Brand Name : Palladon

Germany
arrow
Medlab Asia & Asia Health
Not Confirmed

Brand Name : Palladon

Germany
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Medlab Asia & Asia Health
Not Confirmed

Hydromorphone Hydrochloride

Dosage Form : Injection/infusion fluid, resolu...

Dosage Strength : 20 mg/ml

Price Per Pack (Euro) : 101.178

Published in :

Country : Norway

RX/OTC/DISCN :

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FDF DOSSIERS

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Patents & EXCLUSIVITIES

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REF. STANDARDS & IMPURITIES

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USP

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01

USP

U.S.A
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Not Confirmed

02

USP

U.S.A
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Not Confirmed

USP

U.S.A
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Not Confirmed

Hydromorphone N-Oxide Hydrochloride CII (15 m...

CAS Number : 109648-80-8 (base)

Quantity Per Vial :

Price ($) : 730

Catalog Number : 1323019

Current Lot : F1I331

Previous Lot : F0I331 (31-MAY-2018)

NDC Code : 00216080401

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03

USP

U.S.A
arrow
Medlab Asia & Asia Health
Not Confirmed

USP

U.S.A
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Medlab Asia & Asia Health
Not Confirmed

Hydromorphone Hydrochloride CII (50 mg)

CAS Number : 71-68-1

Quantity Per Vial :

Price ($) : 305

Catalog Number : 1323000

Current Lot : K0I330

Previous Lot : J0C372 (28-FEB-2011)

NDC Code : 00216080202

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