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Also known as: Naloxone hcl, 357-08-4, Narcan, Narcanti, Naloxone (hydrochloride), Evzio
Molecular Formula
C19H22ClNO4
Molecular Weight
363.8  g/mol
InChI Key
RGPDIGOSVORSAK-STHHAXOLSA-N
FDA UNII
F850569PQR

Naloxone Hydrochloride
A specific opiate antagonist that has no agonist activity. It is a competitive antagonist at mu, delta, and kappa opioid receptors.
1 2D Structure

Naloxone Hydrochloride

2 Identification
2.1 Computed Descriptors
2.1.1 IUPAC Name
(4R,4aS,7aR,12bS)-4a,9-dihydroxy-3-prop-2-enyl-2,4,5,6,7a,13-hexahydro-1H-4,12-methanobenzofuro[3,2-e]isoquinolin-7-one;hydrochloride
2.1.2 InChI
InChI=1S/C19H21NO4.ClH/c1-2-8-20-9-7-18-15-11-3-4-12(21)16(15)24-17(18)13(22)5-6-19(18,23)14(20)10-11;/h2-4,14,17,21,23H,1,5-10H2;1H/t14-,17+,18+,19-;/m1./s1
2.1.3 InChI Key
RGPDIGOSVORSAK-STHHAXOLSA-N
2.1.4 Canonical SMILES
C=CCN1CCC23C4C(=O)CCC2(C1CC5=C3C(=C(C=C5)O)O4)O.Cl
2.1.5 Isomeric SMILES
C=CCN1CC[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
F850569PQR
2.3 Synonyms
2.3.1 MeSH Synonyms

1. Abello, Naloxone

2. Curamed, Naloxon

3. Dihydride, Naloxone Hydrochloride

4. Hydrobromide, Naloxone

5. Hydrochloride Dihydride, Naloxone

6. Hydrochloride, Naloxone

7. Mrz 2593

8. Mrz 2593 Br

9. Mrz 2593-br

10. Mrz 2593br

11. Mrz-2593

12. Mrz2593

13. Nalone

14. Naloxon Curamed

15. Naloxon Ratiopharm

16. Naloxon-ratiopharm

17. Naloxone

18. Naloxone Abello

19. Naloxone Hydrobromide

20. Naloxone Hydrochloride Dihydride

21. Naloxone Hydrochloride, (5 Beta,9 Alpha,13 Alpha,14 Alpha)-isomer

22. Naloxone, (5 Beta,9 Alpha,13 Alpha,14 Alpha)-isomer

23. Narcan

24. Narcanti

2.3.2 Depositor-Supplied Synonyms

1. Naloxone Hcl

2. 357-08-4

3. Narcan

4. Narcanti

5. Naloxone (hydrochloride)

6. Evzio

7. Nih 7890

8. En-15304

9. Anhydrous Naloxone Hydrochloride

10. Chebi:31892

11. F850569pqr

12. Nsc-757109

13. (-)-n-allyl-14-hydroxynordihydromorphinone Hydrochloride

14. 357-08-4 (hcl)

15. 17-allyl-4,5alpha-epoxy-3,14-dihydroxymorphinan-6-one Hydrochloride

16. (5alpha)-17-allyl-4,5-epoxy-3,14-dihydroxymorphinan-6-one Hydrochloride

17. (4r,4as,7ar,12bs)-3-allyl-4a,9-dihydroxy-2,3,4,4a,5,6-hexahydro-1h-4,12-methanobenzofuro[3,2-e]isoquinolin-7(7ah)-one Hydrochloride

18. Nalonee

19. Mls000069540

20. Naloxonehydrochloride

21. Smr000058766

22. Unii-f850569pqr

23. Prestwick_879

24. Einecs 206-611-0

25. Mfcd00069322

26. Narcan (tn)

27. Kloxxado

28. Evzio (tn)

29. Nafoxone Hydrochloride

30. Nal-oxon Hydrochloride

31. Naloxone Hydrochloride [usan:usp:jan]

32. En 15304

33. Chembl1718

34. C19h21no4.hcl

35. Schembl41390

36. L-n-allyl-14-hydroxynordihydromorphinone Hydrochloride

37. Naloxone Hydrochloride Anhydrous

38. Dtxsid70957097

39. Hms1568g04

40. Naloxone Hydrochloride [mi]

41. Act02626

42. Naloxone Hydrochloride (jp17/usp)

43. Naloxone Hydrochloride [jan]

44. (5a)-17-allyl-4,5-epoxy-3,14-dihydroxymorphinan-6-one Hydrochloride

45. 17-allyl-4,5-alpha-epoxy-3,14-dihydroxymorphinan-6-one Hydrochloride

46. Naloxone Hydrochloride [usan]

47. Normorphinone, N-allyl-7,8-dihydro-14-hydroxy-, Hydrochloride, (-)-

48. S3066

49. Naloxone Hydrochloride [vandf]

50. Akos024418753

51. Morphinan-6-one, 17-allyl-4,5-alpha-epoxy-3,14-dihydroxy-, Hydrochloride

52. Naloxone Hydrochloride [mart.]

53. Ccg-220111

54. Cs-1335

55. Ks-5379

56. Naloxone Hydrochloride [who-dd]

57. Nc00587

58. Nsc 757109

59. Morphinan-6-one, 4,5-epoxy-3,14-dihydroxy-17-(2-propenyl)-, Hydrochloride, (5.alpha.)-

60. Hy-17417

61. Naloxone Hydrochloride [green Book]

62. Naloxone Hydrochloride [orange Book]

63. Sw197001-3

64. Naloxone Hydrochloride [usp Monograph]

65. D01340

66. Suboxone Component Naloxone Hydrochloride

67. Targiniq Component Naloxone Hydrochloride

68. Naloxone Hydrochloride Anhydrous [who-ip]

69. Talwin Nx Component Naloxone Hydrochloride

70. 357n084

71. Naloxone Hydrochloride Component Of Suboxone

72. Naloxone Hydrochloride Component Of Targiniq

73. Sr-01000597918

74. Sr-01000737374

75. Naloxone Hydrochloride Component Of Talwin Nx

76. Sr-01000597918-1

77. Sr-01000737374-3

78. W-106655

79. Q27114711

80. Naloxoni Hydrochloridum Anhydrous [who-ip Latin]

81. (5alpha)-17-allyl-3,14-dihydroxy-4,5-epoxymorphinan-6-one Hydrochloride

82. 17-allyl-3,14-dihydroxy-4,5alpha-epoxymorphinan-6-one Hydrochloride

83. (17r)-17-allyl-3,14-dihydroxy-6-oxo-4,5alpha-epoxymorphinan-17-ium Chloride

84. (5?)-4,5-epoxy-3,14-dihydro-17-(2-propenyl)morphinan-6-one Hydrochloride

85. (5a)-4,5-epoxy-3,14-dihydroxy-17-(2-propen-1-yl)-morphinan-6-one Hydrochloride

86. (5alpha)-4,5-epoxy-3,14-dihydroxy-17-(2-propen-1-yl)morphinan-6-one Hydrochloride (1:1)

87. (5alpha,17r)-17-allyl-3,14-dihydroxy-6-oxo-4,5-epoxymorphinan-17-ium Chloride

88. 17-allyl-4,5.alpha.-epoxy-3,14-dihydroxymorphinan-6-one Hydrochloride

89. Morphinan-6-one, 4,5-epoxy-3,14-dihydroxy-17-(2-propenyl)-, Hydrochloride, (5alpha)-

90. (4r,4as,12bs)-4a,9-dihydroxy-3-prop-2-enyl-2,4,5,6,7a,13-hexahydro-1h-4,12-methanobenzofuro[3,2-e]isoquinolin-7-one;hydrochloride

91. (4r,4as,7ar,12bs)-4a,9-dihydroxy-3-prop-2-enyl-2,4,5,6,7a,13-hexahydro-1h-4,12-methanobenzofuro[3,2-e]isoquinolin-7-one;hydrochloride

92. (5alpha)-4,5-epoxy-3,14-dihydro-17-(2-pr Openyl)morphinan-6-one Hydrochloride

2.4 Create Date
2005-08-08
3 Chemical and Physical Properties
Molecular Weight 363.8 g/mol
Molecular Formula C19H22ClNO4
Hydrogen Bond Donor Count3
Hydrogen Bond Acceptor Count5
Rotatable Bond Count2
Exact Mass363.1237359 g/mol
Monoisotopic Mass363.1237359 g/mol
Topological Polar Surface Area70 Ų
Heavy Atom Count25
Formal Charge0
Complexity594
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 NameEvzio
PubMed HealthNaloxone (Injection)
Drug ClassesToxicology-Antidote Agent
Drug LabelEVZIO (naloxone hydrochloride injection, USP) is a pre-filled, single-use auto-injector. EVZIO is not made with natural rubber latex. Chemically, naloxone hydrochloride is the hydrochloride salt of 17-Allyl-4,5-epoxy-3,14-dihydroxymorphinan-6-one h...
Active IngredientNaloxone hydrochloride
Dosage FormSolution
RouteIntramuscular, subcutaneous
Strength0.4mg/0.4ml
Market StatusPrescription
CompanyKaleo

2 of 4  
Drug NameNaloxone hydrochloride
Drug LabelAmpul, Fliptop Vial, Opioid AntagonistProtect from light.RxNaloxone Hydrochloride Injection, USP is a sterile, nonpyrogenic solution of naloxone hydrochloride in water for injection. Each milliliter (mL) contains 0.4 mg naloxone hydrochloride and sod...
Active IngredientNaloxone hydrochloride
Dosage FormInjectable
RouteInjection
Strength1mg/ml; 0.4mg/ml
Market StatusPrescription
CompanyHospira; Intl Medication; Mylan Institutional

3 of 4  
Drug NameEvzio
PubMed HealthNaloxone (Injection)
Drug ClassesToxicology-Antidote Agent
Drug LabelEVZIO (naloxone hydrochloride injection, USP) is a pre-filled, single-use auto-injector. EVZIO is not made with natural rubber latex. Chemically, naloxone hydrochloride is the hydrochloride salt of 17-Allyl-4,5-epoxy-3,14-dihydroxymorphinan-6-one h...
Active IngredientNaloxone hydrochloride
Dosage FormSolution
RouteIntramuscular, subcutaneous
Strength0.4mg/0.4ml
Market StatusPrescription
CompanyKaleo

4 of 4  
Drug NameNaloxone hydrochloride
Drug LabelAmpul, Fliptop Vial, Opioid AntagonistProtect from light.RxNaloxone Hydrochloride Injection, USP is a sterile, nonpyrogenic solution of naloxone hydrochloride in water for injection. Each milliliter (mL) contains 0.4 mg naloxone hydrochloride and sod...
Active IngredientNaloxone hydrochloride
Dosage FormInjectable
RouteInjection
Strength1mg/ml; 0.4mg/ml
Market StatusPrescription
CompanyHospira; Intl Medication; Mylan Institutional

4.2 Drug Indication

Treatment of opioid-induced constipation


5 Pharmacology and Biochemistry
5.1 MeSH Pharmacological Classification

Narcotic Antagonists

Agents inhibiting the effect of narcotics on the central nervous system. (See all compounds classified as Narcotic Antagonists.)


5.2 FDA Pharmacological Classification
5.2.1 Pharmacological Classes
Opioid Antagonists [MoA]; Opioid Antagonist [EPC]

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IV, Extension in IP, Pasham","city":"HYDERABAD","supplier":"M\/S.FRANCOPIA","supplierCountry":"FRANCE","foreign_port":"NA","customer":"GLAND PHARMA LIMITED","customerCountry":"INDIA","quantity":"1.60","actualQuantity":"1.6","unit":"KGS","unitRateFc":"9200","totalValueFC":"18143.6","currency":"EUR","unitRateINR":"925467.7","date":"10-Nov-2022","totalValueINR":"1480748.28","totalValueInUsd":"18143.6","indian_port":"HYDERABAD AIR","hs_no":"29335990","bill_no":"3242691","productDescription":"API","marketType":"REGULATED MARKET","country":"FRANCE","selfForZScoreResived":"Pharma Grade","supplierPort":"NA","supplierAddress":"","customerAddress":"Part of Plot No.11 & 87, Sy No.119 Phase - IV, Extension in IP, Pasham"},{"dataSource":"API Import","activeIngredients":"","year":"2023","qtr":"Q3","strtotime":1691778600,"product":"NALOXONE HYDROCHLORIDE DIHYDRATE,MILLED","address":"MSN HOUSE,PLOT NO.C-24,INDUSTRIAL, ESTATE, SANATH NAGAR,","city":"HYDERABAD","supplier":"WELDING GMBH & CO.KG","supplierCountry":"GERMANY","foreign_port":"NA","customer":"MSN LABORATORIES","customerCountry":"INDIA","quantity":"40.50","actualQuantity":"40.5","unit":"KGS","unitRateFc":"5950","totalValueFC":"267869.9","currency":"EUR","unitRateINR":"542406.5","date":"12-Aug-2023","totalValueINR":"22189358.62","totalValueInUsd":"267869.9","indian_port":"CHENNAI AIR","hs_no":"29349990","bill_no":"0","productDescription":"API","marketType":"REGULATED MARKET","country":"GERMANY","selfForZScoreResived":"Pharma Grade","supplierPort":"NA","supplierAddress":"","customerAddress":"MSN HOUSE,PLOT NO.C-24,INDUSTRIAL, ESTATE, SANATH NAGAR,"},{"dataSource":"API Import","activeIngredients":"","year":"2023","qtr":"Q3","strtotime":1691778600,"product":"NALOXONE HYDROCHLORIDE USP DIHYDRATE STANDARD","address":"NO 53, ALEAP INDUSTRIAL ESTATE, ,GAJULARAMARAM BEHIND PRAGATHINAGARKUKATPALLY","city":"HYDERABAD","supplier":"MALLINCKRODT PHARMACEUTICALS","supplierCountry":"UNITED STATES","foreign_port":"NA","customer":"ORBICULAR PHARMACEUTICAL TECHNOLOGIES ","customerCountry":"INDIA","quantity":"0.25","actualQuantity":"0.25","unit":"KGS","unitRateFc":"20000","totalValueFC":"5092.7","currency":"USD","unitRateINR":"1670554.9","date":"12-Aug-2023","totalValueINR":"421857.304","totalValueInUsd":"5092.7","indian_port":"HYDERABAD AIR","hs_no":"29391900","bill_no":"0","productDescription":"API","marketType":"REGULATED MARKET","country":"UNITED STATES","selfForZScoreResived":"Pharma Grade","supplierPort":"NA","supplierAddress":"","customerAddress":"NO 53, ALEAP INDUSTRIAL ESTATE, ,GAJULARAMARAM BEHIND PRAGATHINAGARKUKATPALLY"},{"dataSource":"API Import","activeIngredients":"","year":"2023","qtr":"Q3","strtotime":1691778600,"product":"NALOXONE HYDROCHLORIDE USP DIHYDRATE STANDARD FOC","address":"NO 53, ALEAP INDUSTRIAL ESTATE, ,GAJULARAMARAM BEHIND PRAGATHINAGARKUKATPALLY","city":"HYDERABAD","supplier":"MALLINCKRODT PHARMACEUTICALS","supplierCountry":"UNITED STATES","foreign_port":"NA","customer":"ORBICULAR PHARMACEUTICAL TECHNOLOGIES ","customerCountry":"INDIA","quantity":"0.10","actualQuantity":"0.1","unit":"KGS","unitRateFc":"4600","totalValueFC":"460.1","currency":"USD","unitRateINR":"377304.5","date":"12-Aug-2023","totalValueINR":"38111.568","totalValueInUsd":"460.1","indian_port":"HYDERABAD AIR","hs_no":"29391900","bill_no":"0","productDescription":"API","marketType":"REGULATED MARKET","country":"UNITED STATES","selfForZScoreResived":"Pharma Grade","supplierPort":"NA","supplierAddress":"","customerAddress":"NO 53, ALEAP INDUSTRIAL ESTATE, ,GAJULARAMARAM BEHIND PRAGATHINAGARKUKATPALLY"},{"dataSource":"API Import","activeIngredients":"","year":"2023","qtr":"Q4","strtotime":1701714600,"product":"NALOXONE HCL HP USP (QTY:900 GRAMS X 10000 EUR\/KG)","address":"PLOT NO.2, MAITRIVIHAR,","city":"HYDERABAD\/ANDHRA PRADESH","supplier":"FRANCOPIA","supplierCountry":"FRANCE","foreign_port":"PARIS - CHARLES DE G","customer":"AUROBINDO PHARMA LIMITED","customerCountry":"INDIA","quantity":"0.90","actualQuantity":"0.9","unit":"KGS","unitRateFc":"10000","totalValueFC":"9919.7","currency":"EUR","unitRateINR":"917500","date":"05-Dec-2023","totalValueINR":"825750","totalValueInUsd":"9919.7","indian_port":"Hyderabad Air","hs_no":"29391900","bill_no":"9078089","productDescription":"API","marketType":"REGULATED MARKET","country":"FRANCE","selfForZScoreResived":"Pharma Grade","supplierPort":"PARIS - CHARLES DE G","supplierAddress":"15 RUE TRAVERSIERE 75012 PAIRSSDNFSDNF France","customerAddress":"PLOT NO.2, MAITRIVIHAR,"},{"dataSource":"API Import","activeIngredients":"","year":"2024","qtr":"Q1","strtotime":1706812200,"product":"NALOXONE HYDROCHLORIDE USP (100% EOU)","address":"PLOT NO.B3,B4&B5 PT SIPCOT,INDUSTR","city":"SRIPERUMPUDUR,TAMIL NADU","supplier":"MALLINCKRODT PHARMACEUTICALS","supplierCountry":"UNITED STATES","foreign_port":"CHICAGO O\\'HARE INT\\'L","customer":"PFIZER INC","customerCountry":"INDIA","quantity":"0.15","actualQuantity":"0.15","unit":"KGS","unitRateFc":"11075","totalValueFC":"1699.7","currency":"USD","unitRateINR":"940205.9","date":"02-Feb-2024","totalValueINR":"141030.88","totalValueInUsd":"1699.7","indian_port":"Madras Air","hs_no":"29391900","bill_no":"9949111","productDescription":"API","marketType":"REGULATED MARKET","country":"UNITED STATES","selfForZScoreResived":"Pharma Grade","supplierPort":"CHICAGO O\\'HARE INT\\'L","supplierAddress":"PERTH HOUSE MILLENNIUM WAY DUNSTON,CHESTERFIELD DERBYSHIRE,S41 8ND USA UNITED STATES","customerAddress":"PLOT NO.B3,B4&B5 PT SIPCOT,INDUSTR"},{"dataSource":"API Import","activeIngredients":"","year":"2024","qtr":"Q2","strtotime":1717785000,"product":"395474 NALOXONE HCL HP USP (NALOXONE HYDROCHLORIDE USP)","address":"208, OKHLA INDUSTRIAL ESTATE,,PHAS","city":"NEW DELHI,DELHI","supplier":"FRANCOPIA","supplierCountry":"FRANCE","foreign_port":"PARIS","customer":"MANKIND PHARMA","customerCountry":"INDIA","quantity":"0.50","actualQuantity":"500","unit":"GMS","unitRateFc":"12.5","totalValueFC":"6921.6","currency":"EUR","unitRateINR":"1155.6","date":"08-Jun-2024","totalValueINR":"577812.5","totalValueInUsd":"6921.6","indian_port":"Delhi Air","hs_no":"29391900","bill_no":"3895431","productDescription":"API","marketType":"REGULATED MARKET","country":"FRANCE","selfForZScoreResived":"Pharma Grade","supplierPort":"PARIS","supplierAddress":"15, RUE TRAVERSIERE75012 PARISSDNF FRANCE","customerAddress":"208, OKHLA INDUSTRIAL ESTATE,,PHAS"},{"dataSource":"API Import","activeIngredients":"","year":"2024","qtr":"Q3","strtotime":1720204200,"product":"NALOXONE HYDROCHLORIDE- UNMILLED","address":"PLOT NO.C-24, MSN HOUSE, INDUSTRIAL","city":"HYDERABAD, AP","supplier":"NORAMCO","supplierCountry":"UNITED KINGDOM","foreign_port":"NEWCASTLE","customer":"MSN LABORATORIES","customerCountry":"INDIA","quantity":"49.75","actualQuantity":"49.75","unit":"KGS","unitRateFc":"6500","totalValueFC":"326697.8","currency":"USD","unitRateINR":"548925","date":"06-Jul-2024","totalValueINR":"27309018.75","totalValueInUsd":"326697.8","indian_port":"Madras Air","hs_no":"29391900","bill_no":"4361922","productDescription":"API","marketType":"REGULATED MARKET","country":"UNITED KINGDOM","selfForZScoreResived":"Pharma Grade","supplierPort":"NEWCASTLE","supplierAddress":"500 SWEDEN LANDING ROADWILMINGTONDE19801 GB","customerAddress":"PLOT NO.C-24, MSN HOUSE, INDUSTRIAL"},{"dataSource":"API Import","activeIngredients":"","year":"2024","qtr":"Q3","strtotime":1722623400,"product":"NALOXONE HCL DIHYDRATE API (TEST & ANALYSIS) (FREE OF CHARGESAMPLE) (100%EOU)","address":"PLOT NO.B3,B4&B5 PT SIPCOT,INDUSTR","city":"SRIPERUMPUDUR,TAMIL NADU","supplier":"PFIZER INC","supplierCountry":"UNITED STATES","foreign_port":"CHICAGO O\\'HARE INT\\'L","customer":"PFIZER INC","customerCountry":"INDIA","quantity":"0.39","actualQuantity":"394.7","unit":"GMS","unitRateFc":"11.3","totalValueFC":"4565.2","currency":"USD","unitRateINR":"970.2","date":"03-Aug-2024","totalValueINR":"382921.08","totalValueInUsd":"4565.2","indian_port":"Madras Air","hs_no":"29391900","bill_no":"4857122","productDescription":"API","marketType":"REGULATED MARKET","country":"UNITED STATES","selfForZScoreResived":"Pharma Grade","supplierPort":"CHICAGO O\\'HARE INT\\'L","supplierAddress":"275 N. FIELD DR. LAKE FOREST, IL 60045 , UNITED STATESSDNF UNITED STATES","customerAddress":"PLOT NO.B3,B4&B5 PT SIPCOT,INDUSTR"}]
18-Jan-2021
19-Sep-2024
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DRUG PRODUCT COMPOSITIONS

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DOSAGE - FILM;BUCCAL - EQ 2.1MG BASE;EQ 0.3MG...DOSAGE - FILM;BUCCAL - EQ 2.1MG BASE;EQ 0.3MG BASE

USFDA APPLICATION NUMBER - 205637

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DOSAGE - FILM;BUCCAL - EQ 4.2MG BASE;EQ 0.7MG...DOSAGE - FILM;BUCCAL - EQ 4.2MG BASE;EQ 0.7MG BASE

USFDA APPLICATION NUMBER - 205637

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DOSAGE - FILM;BUCCAL - EQ 6.3MG BASE;EQ 1MG B...DOSAGE - FILM;BUCCAL - EQ 6.3MG BASE;EQ 1MG BASE

USFDA APPLICATION NUMBER - 205637

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DOSAGE - SOLUTION;INTRAMUSCULAR, SUBCUTANEOUS...DOSAGE - SOLUTION;INTRAMUSCULAR, SUBCUTANEOUS - 0.4MG/0.4ML (0.4MG/0.4ML)

USFDA APPLICATION NUMBER - 205787

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DOSAGE - TABLET;SUBLINGUAL - EQ 2MG BASE;EQ 0...DOSAGE - TABLET;SUBLINGUAL - EQ 2MG BASE;EQ 0.5MG BASE **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**

USFDA APPLICATION NUMBER - 20733

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DOSAGE - TABLET;SUBLINGUAL - EQ 8MG BASE;EQ 2...DOSAGE - TABLET;SUBLINGUAL - EQ 8MG BASE;EQ 2MG BASE **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**

USFDA APPLICATION NUMBER - 20733

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DOSAGE - SOLUTION;INTRAMUSCULAR, SUBCUTANEOUS...DOSAGE - SOLUTION;INTRAMUSCULAR, SUBCUTANEOUS - 2MG/0.4ML (2MG/0.4ML)

USFDA APPLICATION NUMBER - 209862

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DOSAGE - FILM;BUCCAL, SUBLINGUAL - EQ 12MG BA...DOSAGE - FILM;BUCCAL, SUBLINGUAL - EQ 12MG BASE;EQ 3MG BASE

USFDA APPLICATION NUMBER - 22410

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DOSAGE - FILM;BUCCAL, SUBLINGUAL - EQ 2MG BAS...DOSAGE - FILM;BUCCAL, SUBLINGUAL - EQ 2MG BASE;EQ 0.5MG BASE

USFDA APPLICATION NUMBER - 22410

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DOSAGE - FILM;BUCCAL, SUBLINGUAL - EQ 4MG BAS...DOSAGE - FILM;BUCCAL, SUBLINGUAL - EQ 4MG BASE;EQ 1MG BASE

USFDA APPLICATION NUMBER - 22410

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DOSAGE - FILM;BUCCAL, SUBLINGUAL - EQ 8MG BAS...DOSAGE - FILM;BUCCAL, SUBLINGUAL - EQ 8MG BASE;EQ 2MG BASE

USFDA APPLICATION NUMBER - 22410

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ABOUT THIS PAGE

Naloxone Hydrochloride Dihydrate Manufacturers

A Naloxone Hydrochloride Dihydrate manufacturer is defined as any person or entity involved in the manufacture, preparation, processing, compounding or propagation of Naloxone Hydrochloride Dihydrate, including repackagers and relabelers. The FDA regulates Naloxone Hydrochloride Dihydrate manufacturers to ensure that their products comply with relevant laws and regulations and are safe and effective to use. Naloxone Hydrochloride Dihydrate API Manufacturers are required to adhere to Good Manufacturing Practices (GMP) to ensure that their products are consistently manufactured to meet established quality criteria.

click here to find a list of Naloxone Hydrochloride Dihydrate manufacturers with USDMF, JDMF, KDMF, CEP, GMP, COA and API Price related information on PhamaCompass.

Naloxone Hydrochloride Dihydrate Suppliers

A Naloxone Hydrochloride Dihydrate supplier is an individual or a company that provides Naloxone Hydrochloride Dihydrate active pharmaceutical ingredient (API) or Naloxone Hydrochloride Dihydrate finished formulations upon request. The Naloxone Hydrochloride Dihydrate suppliers may include Naloxone Hydrochloride Dihydrate API manufacturers, exporters, distributors and traders.

click here to find a list of Naloxone Hydrochloride Dihydrate suppliers with USDMF, JDMF, KDMF, CEP, GMP, COA and API Price related information on PharmaCompass.

Naloxone Hydrochloride Dihydrate USDMF

A Naloxone Hydrochloride Dihydrate DMF (Drug Master File) is a document detailing the whole manufacturing process of Naloxone Hydrochloride Dihydrate active pharmaceutical ingredient (API) in detail. Different forms of Naloxone Hydrochloride Dihydrate DMFs exist exist since differing nations have different regulations, such as Naloxone Hydrochloride Dihydrate USDMF, ASMF (EDMF), JDMF, CDMF, etc.

A Naloxone Hydrochloride Dihydrate DMF submitted to regulatory agencies in the US is known as a USDMF. Naloxone Hydrochloride Dihydrate USDMF includes data on Naloxone Hydrochloride Dihydrate's chemical properties, information on the facilities and procedures used, and details about packaging and storage. The Naloxone Hydrochloride Dihydrate USDMF is kept confidential to protect the manufacturer’s intellectual property.

click here to find a list of Naloxone Hydrochloride Dihydrate suppliers with USDMF on PharmaCompass.

Naloxone Hydrochloride Dihydrate JDMF

The Pharmaceuticals and Medical Devices Agency (PMDA) established the Japan Drug Master File (JDMF), also known as the Master File (MF), to permit Japanese and foreign manufacturers of drug substances, intermediates, excipients, raw materials, and packaging materials (‘Products’) to voluntarily register confidential information about the production and management of their products in Japan.

The Naloxone Hydrochloride Dihydrate Drug Master File in Japan (Naloxone Hydrochloride Dihydrate JDMF) empowers Naloxone Hydrochloride Dihydrate API manufacturers to present comprehensive information (e.g., production methods, data, etc.) to the review authority, i.e., PMDA (Pharmaceuticals & Medical Devices Agency).

PMDA reviews the Naloxone Hydrochloride Dihydrate JDMF during the approval evaluation for pharmaceutical products. At the time of Naloxone Hydrochloride Dihydrate JDMF registration, PMDA checks if the format is accurate, if the necessary items have been included (application), and if data has been attached.

click here to find a list of Naloxone Hydrochloride Dihydrate suppliers with JDMF on PharmaCompass.

Naloxone Hydrochloride Dihydrate KDMF

In Korea, the Ministry of Food and Drug Safety (MFDS) is in charge of regulating pharmaceutical products and services.

Pharmaceutical companies submit a Naloxone Hydrochloride Dihydrate Drug Master File in Korea (Naloxone Hydrochloride Dihydrate KDMF) to the MFDS, which includes comprehensive information about the production, processing, facilities, materials, packaging, and testing of Naloxone Hydrochloride Dihydrate. The MFDS reviews the Naloxone Hydrochloride Dihydrate KDMF as part of the drug registration process and uses the information provided in the Naloxone Hydrochloride Dihydrate KDMF to evaluate the safety and efficacy of the drug.

After submitting a Naloxone Hydrochloride Dihydrate KDMF to the MFDS, the registered manufacturer can provide importers or distributors with the registration number without revealing confidential information to Korean business partners. Applicants seeking to register their Naloxone Hydrochloride Dihydrate API can apply through the Korea Drug Master File (KDMF).

click here to find a list of Naloxone Hydrochloride Dihydrate suppliers with KDMF on PharmaCompass.

Naloxone Hydrochloride Dihydrate CEP

A Naloxone Hydrochloride Dihydrate CEP of the European Pharmacopoeia monograph is often referred to as a Naloxone Hydrochloride Dihydrate Certificate of Suitability (COS). The purpose of a Naloxone Hydrochloride Dihydrate CEP is to show that the European Pharmacopoeia monograph adequately controls the purity of Naloxone Hydrochloride Dihydrate EP produced by a given manufacturer. Suppliers of raw materials can prove the suitability of Naloxone Hydrochloride Dihydrate to their clients by showing that a Naloxone Hydrochloride Dihydrate CEP has been issued for it. The manufacturer submits a Naloxone Hydrochloride Dihydrate CEP (COS) as part of the market authorization procedure, and it takes on the role of a Naloxone Hydrochloride Dihydrate CEP holder for the record. Additionally, the data presented in the Naloxone Hydrochloride Dihydrate CEP (COS) is managed confidentially and offers a centralized system acknowledged by numerous nations, exactly like the Naloxone Hydrochloride Dihydrate DMF.

A Naloxone Hydrochloride Dihydrate CEP (COS) is recognised by all 36 nations that make up the European Pharmacopoeia Convention. Naloxone Hydrochloride Dihydrate CEPs may be accepted in nations that are not members of the Ph. Eur. at the discretion of the authorities there.

click here to find a list of Naloxone Hydrochloride Dihydrate suppliers with CEP (COS) on PharmaCompass.

Naloxone Hydrochloride Dihydrate WC

A Naloxone Hydrochloride Dihydrate written confirmation (Naloxone Hydrochloride Dihydrate WC) is an official document issued by a regulatory agency to a Naloxone Hydrochloride Dihydrate manufacturer, verifying that the manufacturing facility of a Naloxone Hydrochloride Dihydrate active pharmaceutical ingredient (API) adheres to the Good Manufacturing Practices (GMP) regulations of the importing country. When exporting Naloxone Hydrochloride Dihydrate APIs or Naloxone Hydrochloride Dihydrate finished pharmaceutical products to another nation, regulatory agencies frequently require a Naloxone Hydrochloride Dihydrate WC (written confirmation) as part of the regulatory process.

click here to find a list of Naloxone Hydrochloride Dihydrate suppliers with Written Confirmation (WC) on PharmaCompass.

Naloxone Hydrochloride Dihydrate NDC

National Drug Code is a comprehensive database maintained by the FDA that contains information on all drugs marketed in the US. This directory includes information about finished drug products, unfinished drug products, and compounded drug products, including those containing Naloxone Hydrochloride Dihydrate as an active pharmaceutical ingredient (API).

Finished drug products

The FDA updates the NDC directory daily. The NDC numbers for Naloxone Hydrochloride Dihydrate API and other APIs are published in this directory by the FDA.

Unfinished drugs

The NDC unfinished drugs database includes product listing information submitted for all unfinished drugs, such as active pharmaceutical ingredients (APIs), drugs intended for further processing and bulk drug substances for compounding.

Pharmaceutical companies that manufacture Naloxone Hydrochloride Dihydrate as an active pharmaceutical ingredient (API) must furnish the FDA with an updated record of all drugs that they produce, prepare, propagate, compound, or process for commercial distribution in the US at their facilities.

Compounded drug products

The NDC directory also contains data on finished compounded human drug products that contain Naloxone Hydrochloride Dihydrate and are produced by outsourcing facilities. While these outsourcing facilities are not mandated to assign a Naloxone Hydrochloride Dihydrate NDC to their finished compounded human drug products, they may choose to do so.

click here to find a list of Naloxone Hydrochloride Dihydrate suppliers with NDC on PharmaCompass.

Naloxone Hydrochloride Dihydrate GMP

Naloxone Hydrochloride Dihydrate Active pharmaceutical ingredient (API) is produced in GMP-certified manufacturing facility.

GMP stands for Good Manufacturing Practices, which is a system used in the pharmaceutical industry to make sure that goods are regularly produced and monitored in accordance with quality standards. The FDA’s current Good Manufacturing Practices requirements are referred to as cGMP or current GMP which indicates that the company follows the most recent GMP specifications. The World Health Organization (WHO) has its own set of GMP guidelines, called the WHO GMP. Different countries can also set their own guidelines for GMP like China (Chinese GMP) or the EU (EU GMP).

PharmaCompass offers a list of Naloxone Hydrochloride Dihydrate GMP manufacturers, exporters & distributors, which can be sorted by USDMF, JDMF, KDMF, CEP (COS), WC, API price, and more, enabling you to easily find the right Naloxone Hydrochloride Dihydrate GMP manufacturer or Naloxone Hydrochloride Dihydrate GMP API supplier for your needs.

Naloxone Hydrochloride Dihydrate CoA

A Naloxone Hydrochloride Dihydrate CoA (Certificate of Analysis) is a formal document that attests to Naloxone Hydrochloride Dihydrate's compliance with Naloxone Hydrochloride Dihydrate specifications and serves as a tool for batch-level quality control.

Naloxone Hydrochloride Dihydrate CoA mostly includes findings from lab analyses of a specific batch. For each Naloxone Hydrochloride Dihydrate CoA document that a company creates, the USFDA specifies specific requirements, such as supplier information, material identification, transportation data, evidence of conformity and signature data.

Naloxone Hydrochloride Dihydrate may be tested according to a variety of international standards, such as European Pharmacopoeia (Naloxone Hydrochloride Dihydrate EP), Naloxone Hydrochloride Dihydrate JP (Japanese Pharmacopeia) and the US Pharmacopoeia (Naloxone Hydrochloride Dihydrate USP).

Inform the supplier about your product requirements, specifying if you need a product with particular monograph like EP (Ph. Eur.), USP, JP, BP, or any other quality. In addition, clarify whether you need hydrochloride (HCl), anhydricum, base, micronisatum or a specific level of purity. To find reputable suppliers, utilize the filters and select those certified by GMP, FDA, or any other certification as per your requirement.
For your convenience, we have listed synonyms and CAS numbers to help you find the best supplier. The use of synonyms and CAS numbers can be helpful in identifying potential suppliers, but it is crucial to note that they might not always indicate the exact same product. It is important to confirm the product details with the supplier before making a purchase to ensure that it meets your requirements.
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