OXYMORPHONE HYDROCHLORIDE
These highlights do not include all the information needed to use OXYMORPHONE HYDROCHLORIDE TABLETS safely and effectively. See full prescribing information for OXYMORPHONE HYDROCHLORIDE TABLETS. OXYMORPHONE HYDROCHLORIDE tablets, for Oral use CII Initial U.S. Approval: 1959
Approved
Approval ID
0ecfcef9-a30f-402c-a650-19186dc5bae3
Product Type
HUMAN PRESCRIPTION DRUG LABEL
Effective Date
Jan 9, 2024
Manufacturers
FDA
Bryant Ranch Prepack
DUNS: 171714327
Products 1
Detailed information about drug products covered under this FDA approval, including NDC codes, dosage forms, ingredients, and administration routes.
OXYMORPHONE HYDROCHLORIDE
PRODUCT DETAILS
NDC Product Code63629-1925
Application NumberANDA210175
Marketing CategoryC73584
Route of AdministrationORAL
Effective DateAugust 27, 2020
Generic NameOXYMORPHONE HYDROCHLORIDE
INGREDIENTS (6)
OXYMORPHONE HYDROCHLORIDEActive
Quantity: 10 mg in 1 1
Code: 5Y2EI94NBC
Classification: ACTIB
ANHYDROUS LACTOSEInactive
Code: 3SY5LH9PMK
Classification: IACT
MAGNESIUM STEARATEInactive
Code: 70097M6I30
Classification: IACT
MICROCRYSTALLINE CELLULOSEInactive
Code: OP1R32D61U
Classification: IACT
STARCH, CORNInactive
Code: O8232NY3SJ
Classification: IACT
D&C RED NO. 30Inactive
Code: 2S42T2808B
Classification: IACT