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
FDA regulatory identification and product classification information
FDA Identifiers
NDC Product Code52959-420
Application NumberANDA078439
Product Classification
M
Marketing Category
C73584
G
Generic Name
Hydromorphone Hydrochloride
Product Specifications
Route of AdministrationORAL
Effective DateDecember 8, 2011
FDA Product Classification
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
FDA regulatory identification and product classification information
FDA Identifiers
NDC Product Code52959-413
Application NumberANDA077471
Product Classification
M
Marketing Category
C73584
G
Generic Name
Hydromorphone Hydrochloride
Product Specifications
Route of AdministrationORAL
Effective DateDecember 8, 2011
FDA Product Classification
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
FDA regulatory identification and product classification information
FDA Identifiers
NDC Product Code52959-408
Application NumberANDA078439
Product Classification
M
Marketing Category
C73584
G
Generic Name
Hydromorphone Hydrochloride
Product Specifications
Route of AdministrationORAL
Effective DateDecember 8, 2011
FDA Product Classification
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