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