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Hydromorphone Hydrochloride

HYDROMORPHONE HYDROCHLORIDE TABLETS USP, 2 mg, 4 mg, and 8 mg

Approved
Approval ID

7c122909-cedb-469a-99de-a44bcd51238d

Product Type

HUMAN PRESCRIPTION DRUG LABEL

Effective Date

Dec 8, 2011

Manufacturers
FDA

H.J. Harkins Company, Inc.

DUNS: 147681894

Products 3

Detailed information about drug products covered under this FDA approval, including NDC codes, dosage forms, ingredients, and administration routes.

Hydromorphone Hydrochloride

PRODUCT DETAILS

NDC Product Code52959-420
Application NumberANDA078439
Marketing CategoryC73584
Route of AdministrationORAL
Effective DateDecember 8, 2011
Generic NameHydromorphone Hydrochloride

INGREDIENTS (4)

Anhydrous LactoseInactive
Code: 3SY5LH9PMK
Classification: IACT
Hydromorphone HydrochlorideActive
Quantity: 2 mg in 1 1
Code: L960UP2KRW
Classification: ACTIB
Magnesium StearateInactive
Code: 70097M6I30
Classification: IACT
Lactose MonohydrateInactive
Code: EWQ57Q8I5X
Classification: IACT

Hydromorphone Hydrochloride

PRODUCT DETAILS

NDC Product Code52959-413
Application NumberANDA077471
Marketing CategoryC73584
Route of AdministrationORAL
Effective DateDecember 8, 2011
Generic NameHydromorphone Hydrochloride

INGREDIENTS (4)

Hydromorphone HydrochlorideActive
Quantity: 8 mg in 1 1
Code: L960UP2KRW
Classification: ACTIB
Anhydrous LactoseInactive
Code: 3SY5LH9PMK
Classification: IACT
Lactose MonohydrateInactive
Code: EWQ57Q8I5X
Classification: IACT
Magnesium StearateInactive
Code: 70097M6I30
Classification: IACT

Hydromorphone Hydrochloride

PRODUCT DETAILS

NDC Product Code52959-408
Application NumberANDA078439
Marketing CategoryC73584
Route of AdministrationORAL
Effective DateDecember 8, 2011
Generic NameHydromorphone Hydrochloride

INGREDIENTS (4)

Anhydrous LactoseInactive
Code: 3SY5LH9PMK
Classification: IACT
Lactose MonohydrateInactive
Code: EWQ57Q8I5X
Classification: IACT
Hydromorphone HydrochlorideActive
Quantity: 4 mg in 1 1
Code: L960UP2KRW
Classification: ACTIB
Magnesium StearateInactive
Code: 70097M6I30
Classification: IACT

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Hydromorphone Hydrochloride - FDA Drug Approval Details