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Hydromorphone Hydrochloride

Synopsis, Chemistry

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DRUG PRODUCT COMPOSITION

INJECTABLE;INJECTION - 0.2MG/ML, INJECTABLE;INJECTION - 0.5MG/0.5ML, INJECTABLE;INJECTION - 10MG/ML, INJECTABLE;INJECTION - 1MG/ML, INJECTABLE;INJECTION - 2MG/ML, INJECTABLE;INJECTION - 4MG/ML, SOLUTION;ORAL - 5MG/5ML, TABLET;ORAL - 2MG, TABLET;ORAL - 4MG, TABLET;ORAL - 8MG, TABLET, EXTENDED RELEASE;ORAL - 12MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**, TABLET, EXTENDED RELEASE;ORAL - 16MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**, TABLET, EXTENDED RELEASE;ORAL - 32MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**, TABLET, EXTENDED RELEASE;ORAL - 8MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**

INJECTABLE;INJECTION - 0.2MG/ML
INJECTABLE;INJECTION - 0.5MG/0.5ML
INJECTABLE;INJECTION - 10MG/ML
INJECTABLE;INJECTION - 1MG/ML
INJECTABLE;INJECTION - 2MG/ML
INJECTABLE;INJECTION - 4MG/ML
SOLUTION;ORAL - 5MG/5ML
TABLET;ORAL - 2MG
TABLET;ORAL - 4MG
TABLET;ORAL - 8MG
TABLET, EXTENDED RELEASE;ORAL - 12MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**
TABLET, EXTENDED RELEASE;ORAL - 16MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**
TABLET, EXTENDED RELEASE;ORAL - 32MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**
TABLET, EXTENDED RELEASE;ORAL - 8MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**

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GLOBAL SALES INFORMATION

44 US Medicaid Prescriptions, 50 Finished Drug Prices

MARKET PLACE

1 APIs, 2 DOSSIERS // FDF

PATENTS

14 US Patents, 12 Health Canada Patents

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2 EDQM Standards, 3 USP Standards, 5 Other Ref. Standards

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USA (Orange Book)

Europe

Canada

Australia

South Africa

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U.S. Medicaid

392.00

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EXCIPIENTS

278

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REF STANDARD

EDQM

USP

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SERVICES

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

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 Formula	C₁₇H₂₀ClNO₃
Molecular Weight	321.8 g/mol
Hydrogen Bond Donor Count	2
Hydrogen Bond Acceptor Count	4
Rotatable Bond Count	0
Exact Mass	321.1131712 g/mol
Monoisotopic Mass	321.1131712 g/mol
Topological Polar Surface Area	49.8 Å²
Heavy Atom Count	22
Formal Charge	0
Complexity	494
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 4
Drug Name	Exalgo
Drug Label	EXALGO 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 Ingredient	Hydromorphone hydrochloride
Dosage Form	Tablet, extended release
Route	Oral
Strength	32mg; 12mg; 16mg; 8mg
Market Status	Prescription
Company	Mallinckrodt

2 of 4
Drug Name	Hydromorphone hydrochloride
PubMed Health	Hydromorphone
Drug Classes	Analgesic, Anesthetic Adjunct, Central Nervous System Agent
Drug Label	Hydromorphone 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 Ingredient	Hydromorphone hydrochloride
Dosage Form	Tablet, extended release; Tablet; Injectable; Solution
Route	Injection; Oral
Strength	2mg/ml; 1mg/ml; 8mg; 10mg/ml; 4mg; 4mg/ml; 12mg; 2mg; 16mg; 5mg/5ml
Market Status	Prescription
Company	Hospira; Actavis Labs Fl; Mallinckrodt; Roxane; Lannett; Elite Labs; Akorn; Barr

3 of 4
Drug Name	Exalgo
Drug Label	EXALGO 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 Ingredient	Hydromorphone hydrochloride
Dosage Form	Tablet, extended release
Route	Oral
Strength	32mg; 12mg; 16mg; 8mg
Market Status	Prescription
Company	Mallinckrodt

4 of 4
Drug Name	Hydromorphone hydrochloride
PubMed Health	Hydromorphone
Drug Classes	Analgesic, Anesthetic Adjunct, Central Nervous System Agent
Drug Label	Hydromorphone 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 Ingredient	Hydromorphone hydrochloride
Dosage Form	Tablet, extended release; Tablet; Injectable; Solution
Route	Injection; Oral
Strength	2mg/ml; 1mg/ml; 8mg; 10mg/ml; 4mg; 4mg/ml; 12mg; 2mg; 16mg; 5mg/5ml
Market Status	Prescription
Company	Hospira; 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]