Oxycodone Hydrochloride
These highlights do not include all the information needed to use OXYCODONE HYDROCHLORIDE CAPSULES safely and effectively. See full prescribing information for OXYCODONE HYDROCHLORIDE CAPSULES. Oxycodone Hydrochloride capsules for oral use, CII Initial U.S. Approval: 1950
Approved
Approval ID
061cf52b-4432-422d-a97b-c3e1f8c4bab6
Product Type
HUMAN PRESCRIPTION DRUG LABEL
Effective Date
Jan 12, 2024
Manufacturers
FDA
Genus Lifesciences Inc.
DUNS: 113290444
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 Code64950-901
Application NumberNDA200534
Product Classification
M
Marketing Category
C73594
G
Generic Name
Oxycodone Hydrochloride
Product Specifications
Route of AdministrationORAL
Effective DateJanuary 12, 2024
FDA Product Classification
INGREDIENTS (12)
STARCH, CORNInactive
Code: O8232NY3SJ
Classification: IACT
MAGNESIUM STEARATEInactive
Code: 70097M6I30
Classification: IACT
SODIUM LAURYL SULFATEInactive
Code: 368GB5141J
Classification: IACT
FD&C YELLOW NO. 6Inactive
Code: H77VEI93A8
Classification: IACT
TITANIUM DIOXIDEInactive
Code: 15FIX9V2JP
Classification: IACT
Oxycodone HydrochlorideActive
Quantity: 5 mg in 1 1
Code: C1ENJ2TE6C
Classification: ACTIB
MICROCRYSTALLINE CELLULOSEInactive
Code: OP1R32D61U
Classification: IACT
ANHYDROUS LACTOSEInactive
Code: 3SY5LH9PMK
Classification: IACT
SODIUM STARCH GLYCOLATE TYPE A POTATOInactive
Code: 5856J3G2A2
Classification: IACT
SILICON DIOXIDEInactive
Code: ETJ7Z6XBU4
Classification: IACT
GELATIN, UNSPECIFIEDInactive
Code: 2G86QN327L
Classification: IACT
FERRIC OXIDE YELLOWInactive
Code: EX438O2MRT
Classification: IACT