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Opana ER

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ACTIVE PHARMA INGREDIENTS

11 API Suppliers, 8 USDMF, 4 NDC API, 6 Listed Suppliers

11 API Suppliers
8 USDMF
4 NDC API
6 Listed Suppliers

FINISHED DOSAGE FORMULATIONS

75 FDF Dossiers, 75 FDA Orange Book

75 FDF Dossiers
75 FDA Orange Book

DRUG PRODUCT COMPOSITIONS

INJECTABLE;INJECTION - 1MG/ML, TABLET, EXTENDED RELEASE;ORAL - 10MG, TABLET, EXTENDED RELEASE;ORAL - 15MG, TABLET, EXTENDED RELEASE;ORAL - 20MG, TABLET, EXTENDED RELEASE;ORAL - 30MG, TABLET, EXTENDED RELEASE;ORAL - 40MG, TABLET, EXTENDED RELEASE;ORAL - 5MG, TABLET, EXTENDED RELEASE;ORAL - 7.5MG, TABLET, EXTENDED RELEASE;ORAL - 10MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**, TABLET, EXTENDED RELEASE;ORAL - 15MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**, TABLET, EXTENDED RELEASE;ORAL - 20MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**, TABLET, EXTENDED RELEASE;ORAL - 30MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**, TABLET, EXTENDED RELEASE;ORAL - 40MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**, TABLET, EXTENDED RELEASE;ORAL - 5MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**, TABLET, EXTENDED RELEASE;ORAL - 7.5MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**, TABLET;ORAL - 10MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**, TABLET;ORAL - 5MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**

drugProductComposition
INJECTABLE;INJECTION - 1MG/ML
TABLET, EXTENDED RELEASE;ORAL - 10MG
TABLET, EXTENDED RELEASE;ORAL - 15MG
TABLET, EXTENDED RELEASE;ORAL - 20MG
TABLET, EXTENDED RELEASE;ORAL - 30MG
TABLET, EXTENDED RELEASE;ORAL - 40MG
TABLET, EXTENDED RELEASE;ORAL - 5MG
TABLET, EXTENDED RELEASE;ORAL - 7.5MG
TABLET, EXTENDED RELEASE;ORAL - 10MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**
TABLET, EXTENDED RELEASE;ORAL - 15MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**
TABLET, EXTENDED RELEASE;ORAL - 20MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**
TABLET, EXTENDED RELEASE;ORAL - 30MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**
TABLET, EXTENDED RELEASE;ORAL - 40MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**
TABLET, EXTENDED RELEASE;ORAL - 5MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**
TABLET, EXTENDED RELEASE;ORAL - 7.5MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**
TABLET;ORAL - 10MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**
TABLET;ORAL - 5MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**

DIGITAL CONTENT

3 DATA COMPILATION #PharmaFlow, 15 NEWS #PharmaBuzz

media
3 DATA COMPILATION #PharmaFlow
15 NEWS #PharmaBuzz

GLOBAL SALES INFORMATION

1 US Medicaid Prescriptions, 17 Finished Drug Prices

globalSalesInformation
1 US Medicaid Prescriptions
17 Finished Drug Prices

PATENTS & EXCLUSIVITIES

49 US Patents

patents
49 US Patents

REF. STANDARDS & IMPURITIES

2 Others

otherSolutions
2 Others

Synopsis

ACTIVE PHARMA INGREDIENTS

API Suppliers

USDMF

CEP/COS

JDMF

EU WC

KDMF

NDC API

VMF

Listed Suppliers

API REF. PRICE (USD/KG)

$ 0

MARKET PLACE

API

FDF

0INTERMEDIATES

FINISHED DOSAGE FORMULATIONS

FDF Dossiers

FDA Orange Book

Europe

Canada

Australia

South Africa

Listed Dossiers

0 DRUGS IN DEVELOPMENT

DRUG PRODUCT COMPOSITIONS

REF. STANDARDS OR IMPURITIES

EDQM

USP

Others

PATENTS & EXCLUSIVITIES

US Patents

US Exclusivities

Health Canada Patents

DIGITAL CONTENT

Data Compilation #PharmaFlow

Stock Recap #PipelineProspector

Weekly News Recap #Phispers

News #PharmaBuzz

GLOBAL SALES INFORMATION

US Medicaid (USD)

3,317,622

Annual Reports (USD Million)

Finished Drug Prices

0RELATED EXCIPIENT COMPANIES

0EXCIPIENTS BY APPLICATIONS

Chemistry

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Also known as: Oxymorphone hcl, 357-07-3, Opana er, Oxymorphone hydrochloride [usp], 5y2ei94nbc, Oxymorphone hcl narcotic analgesic

Molecular Formula

C₁₇H₂₀ClNO₄

Molecular Weight

337.8 g/mol

InChI Key

BCGJBQBWUGVESK-KCTCKCTRSA-N

FDA UNII

5Y2EI94NBC

An opioid analgesic with actions and uses similar to those of MORPHINE, apart from an absence of cough suppressant activity. It is used in the treatment of moderate to severe pain, including pain in obstetrics. It may also be used as an adjunct to anesthesia. (From Martindale, The Extra Pharmacopoeia, 30th ed, p1092)

1 2D Structure

Oxymorphone Hydrochloride

2 Identification

2.1 Computed Descriptors

2.1.1 IUPAC Name

(4R,4aS,7aR,12bS)-4a,9-dihydroxy-3-methyl-2,4,5,6,7a,13-hexahydro-1H-4,12-methanobenzofuro[3,2-e]isoquinolin-7-one;hydrochloride

2.1.2 InChI

InChI=1S/C17H19NO4.ClH/c1-18-7-6-16-13-9-2-3-10(19)14(13)22-15(16)11(20)4-5-17(16,21)12(18)8-9;/h2-3,12,15,19,21H,4-8H2,1H3;1H/t12-,15+,16+,17-;/m1./s1

2.1.3 InChI Key

BCGJBQBWUGVESK-KCTCKCTRSA-N

2.1.4 Canonical SMILES

CN1CCC23C4C(=O)CCC2(C1CC5=C3C(=C(C=C5)O)O4)O.Cl

2.1.5 Isomeric SMILES

CN1CC[C@]23[C@@H]4C(=O)CC[C@]2([C@H]1CC5=C3C(=C(C=C5)O)O4)O.Cl

2.2 Other Identifiers

2.2.1 UNII

5Y2EI94NBC

2.3 Synonyms

2.3.1 MeSH Synonyms

1. Numorphan

2. Opana

3. Oxymorphone

4. Oxymorphone Hcl

2.3.2 Depositor-Supplied Synonyms

1. Oxymorphone Hcl

2. 357-07-3

3. Opana Er

4. Oxymorphone Hydrochloride [usp]

5. 5y2ei94nbc

6. Oxymorphone Hcl Narcotic Analgesic

7. Oxymorphone Hydrochloride (usp)

8. Oxymorphinone Hydrochloride

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

10. Einecs 206-610-5

11. Unii-5y2ei94nbc

12. Numorphan (tn)

13. Opana (tn)

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

15. 4,5alpha-epoxy-3,14-dihydroxy-17-methylmorphinan-6-one Hydrochloride

16. Schembl41770

17. Chebi:7866

18. Chembl1200794

19. Dtxsid10189214

20. Oxymorphone Hydrochloride [mi]

21. (5alpha)-4,5-epoxy-3,14-dihydroxy-17-methylmorphinan-6-one Hydrochloride

22. Morphinan-6-one, 3,14-dihydroxy-4,5-alpha-epoxy-17-methyl-, Hydrochloride

23. Morphinan-6-one, 4,5-epoxy-3,14-dihydroxy-17-methyl-, Hydrochloride, (5alpha)-

24. Oxymorphone Hydrochloride [mart.]

25. Oxymorphone Hydrochloride [vandf]

26. Oxymorphone Hydrochloride [who-dd]

27. Oxymorphone Hydrochloride [green Book]

28. D00844

29. Oxymorphone Hydrochloride [orange Book]

30. Oxymorphone Hydrochloride [usp Monograph]

31. Q27263031

32. 4,5.alpha.-epoxy-3,14-dihydroxy-17-methylmorphinan-6-one Hydrochloride

33. Morphinan-6-one, 4,5-epoxy-3,14-dihydroxy-17-methyl-, Hydrochloride, (5.alpha.)-

2.4 Create Date

2005-06-24

3 Chemical and Physical Properties

Molecular Formula	C₁₇H₂₀ClNO₄
Molecular Weight	337.8 g/mol
Hydrogen Bond Donor Count	3
Hydrogen Bond Acceptor Count	5
Rotatable Bond Count	0
Exact Mass	337.1080858 g/mol
Monoisotopic Mass	337.1080858 g/mol
Topological Polar Surface Area	70 Å²
Heavy Atom Count	23
Formal Charge	0
Complexity	539
Isotope Atom Count	0
Defined Atom Stereocenter Count	4
Undefined Atom Stereocenter Count	0
Defined Bond Stereocenter Count	0
Undefined Bond Stereocenter Count	0
Covalently Bonded Unit Count	2

4 Drug and Medication Information

4.1 Drug Information

1 of 6
Drug Name	Opana
PubMed Health	Oxymorphone (Injection)
Drug Classes	Analgesic, Anesthetic Adjunct
Drug Label	OPANA ER (oxymorphone hydrochloride) extended-release, is a semi-synthetic opioid analgesic supplied in 5 mg, 10 mg, 20 mg, and 40 mg tablet strengths for oral administration. The tablet strength describes the amount of oxymorphone hydrochloride per...
Active Ingredient	Oxymorphone hydrochloride
Dosage Form	Tablet; Injectable
Route	Injection; Oral
Strength	1mg/ml; 5mg; 10mg
Market Status	Prescription
Company	Endo Pharms

2 of 6
Drug Name	Opana er
PubMed Health	Oxymorphone (By mouth)
Drug Classes	Analgesic
Drug Label	OPANA ER (oxymorphone hydrochloride) extended-release is a semi-synthetic opioid analgesic supplied in 5 mg, 7.5 mg, 10 mg, 15 mg, 20 mg, 30 mg, and 40 mg tablet strengths for oral administration. The tablet strength describes the amount of oxymorpho...
Active Ingredient	Oxymorphone hydrochloride
Dosage Form	Tablet, extended release
Route	Oral
Strength	7.5mg; 30mg; 15mg; 5mg; 10mg; 40mg; 20mg
Market Status	Prescription
Company	Endo Pharms

3 of 6
Drug Name	Oxymorphone hydrochloride
Drug Label	OPANA ER (oxymorphone hydrochloride) extended-release, is a semi-synthetic opioid analgesic supplied in 5 mg, 10 mg, 20 mg, and 40 mg tablet strengths for oral administration. The tablet strength describes the amount of oxymorphone hydrochloride per...
Active Ingredient	Oxymorphone hydrochloride
Dosage Form	Tablet, extended release; Tablet
Route	Oral
Strength	7.5mg; 30mg; 15mg; 5mg; 10mg; 40mg; 20mg
Market Status	Prescription
Company	Avanthi; Teva; Mallinckrodt; Roxane; Actavis Elizabeth; Impax Labs

4 of 6
Drug Name	Opana
PubMed Health	Oxymorphone (Injection)
Drug Classes	Analgesic, Anesthetic Adjunct
Drug Label	OPANA ER (oxymorphone hydrochloride) extended-release, is a semi-synthetic opioid analgesic supplied in 5 mg, 10 mg, 20 mg, and 40 mg tablet strengths for oral administration. The tablet strength describes the amount of oxymorphone hydrochloride per...
Active Ingredient	Oxymorphone hydrochloride
Dosage Form	Tablet; Injectable
Route	Injection; Oral
Strength	1mg/ml; 5mg; 10mg
Market Status	Prescription
Company	Endo Pharms

5 of 6
Drug Name	Opana er
PubMed Health	Oxymorphone (By mouth)
Drug Classes	Analgesic
Drug Label	OPANA ER (oxymorphone hydrochloride) extended-release is a semi-synthetic opioid analgesic supplied in 5 mg, 7.5 mg, 10 mg, 15 mg, 20 mg, 30 mg, and 40 mg tablet strengths for oral administration. The tablet strength describes the amount of oxymorpho...
Active Ingredient	Oxymorphone hydrochloride
Dosage Form	Tablet, extended release
Route	Oral
Strength	7.5mg; 30mg; 15mg; 5mg; 10mg; 40mg; 20mg
Market Status	Prescription
Company	Endo Pharms

6 of 6
Drug Name	Oxymorphone hydrochloride
Drug Label	OPANA ER (oxymorphone hydrochloride) extended-release, is a semi-synthetic opioid analgesic supplied in 5 mg, 10 mg, 20 mg, and 40 mg tablet strengths for oral administration. The tablet strength describes the amount of oxymorphone hydrochloride per...
Active Ingredient	Oxymorphone hydrochloride
Dosage Form	Tablet, extended release; Tablet
Route	Oral
Strength	7.5mg; 30mg; 15mg; 5mg; 10mg; 40mg; 20mg
Market Status	Prescription
Company	Avanthi; Teva; Mallinckrodt; Roxane; Actavis Elizabeth; Impax Labs

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.)

Adjuvants, Anesthesia

Agents that are administered in association with anesthetics to increase effectiveness, improve delivery, or decrease required dosage. (See all compounds classified as Adjuvants, Anesthesia.)

5.2 FDA Pharmacological Classification

5.2.1 Pharmacological Classes

Opioid Agonist [EPC]; Full Opioid Agonists [MoA]

API SUPPLIERS

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USDMF

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NDC API

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Listed Suppliers

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FDF Dossiers

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FDA Orange Book

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DRUG PRODUCT COMPOSITIONS

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