Oxycodone Hydrochloride
These highlights do not include all the information needed to use OXYCODONE HYDROCHLORIDE Tablets, USP safely and effectively. See full prescribing information for Oxycodone Hydrochloride Tablets, USP. OXYCODONE HYDROCHLORIDE Tablets, USP, for oral use, CII Initial U.S. Approval: 1950
Approved
Approval ID
0e4dd113-87ab-4a5d-846a-446db3cfd469
Product Type
HUMAN PRESCRIPTION DRUG LABEL
Effective Date
Mar 30, 2023
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.
Oxycodone Hydrochloride
Product Details
FDA regulatory identification and product classification information
FDA Identifiers
NDC Product Code72162-1336
Application NumberANDA091490
Product Classification
M
Marketing Category
C73584
G
Generic Name
Oxycodone Hydrochloride
Product Specifications
Route of AdministrationORAL
Effective DateMarch 16, 2021
FDA Product Classification
INGREDIENTS (5)
OXYCODONE HYDROCHLORIDEActive
Quantity: 15 mg in 1 1
Code: C1ENJ2TE6C
Classification: ACTIB
MICROCRYSTALLINE CELLULOSEInactive
Code: OP1R32D61U
Classification: IACT
LACTOSE MONOHYDRATEInactive
Code: EWQ57Q8I5X
Classification: IACT
CROSPOVIDONE (120 .MU.M)Inactive
Code: 68401960MK
Classification: IACT
MAGNESIUM STEARATEInactive
Code: 70097M6I30
Classification: IACT