Hydromorphone Hydrochloride
These highlights do not include all the information needed to use HYDROMORPHONE HYDROCHLORIDE TABLETS USP safely and effectively. See full prescribing information for HYDROMORPHONE HYDROCHLORIDE TABLETS USP. HYDROMORPHONE HYDROCHLORIDE tablets USP, for oral use, CII Initial U.S. Approval: January 1984
Approved
Approval ID
e4758743-9b2c-4612-8399-ad2db372e2b7
Product Type
HUMAN PRESCRIPTION DRUG LABEL
Effective Date
Dec 11, 2023
Manufacturers
FDA
American Health Packaging
DUNS: 929561009
Products 2
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 Code60687-579
Application NumberANDA076855
Product Classification
M
Marketing Category
C73584
G
Generic Name
Hydromorphone Hydrochloride
Product Specifications
Route of AdministrationORAL
Effective DateDecember 11, 2023
FDA Product Classification
INGREDIENTS (5)
LACTOSE MONOHYDRATEInactive
Code: EWQ57Q8I5X
Classification: IACT
MAGNESIUM STEARATEInactive
Code: 70097M6I30
Classification: IACT
MICROCRYSTALLINE CELLULOSEInactive
Code: OP1R32D61U
Classification: IACT
STEARIC ACIDInactive
Code: 4ELV7Z65AP
Classification: IACT
HYDROMORPHONE HYDROCHLORIDEActive
Quantity: 2 mg in 1 1
Code: L960UP2KRW
Classification: ACTIB
hydromorphone hydrochloride
Product Details
FDA regulatory identification and product classification information
FDA Identifiers
NDC Product Code60687-590
Application NumberANDA076855
Product Classification
M
Marketing Category
C73584
G
Generic Name
hydromorphone hydrochloride
Product Specifications
Route of AdministrationORAL
Effective DateDecember 11, 2023
FDA Product Classification
INGREDIENTS (5)
LACTOSE MONOHYDRATEInactive
Code: EWQ57Q8I5X
Classification: IACT
MAGNESIUM STEARATEInactive
Code: 70097M6I30
Classification: IACT
MICROCRYSTALLINE CELLULOSEInactive
Code: OP1R32D61U
Classification: IACT
STEARIC ACIDInactive
Code: 4ELV7Z65AP
Classification: IACT
HYDROMORPHONE HYDROCHLORIDEActive
Quantity: 4 mg in 1 1
Code: L960UP2KRW
Classification: ACTIB