Oxycodone Hydrochloride
These highlights do not include all the information needed to use OXYCODONE HCl TABLETS safely and effectively. See full prescribing information for OXYCODONE HCl TABLETS. OXYCODONE HCl tablets, for oral use, CIIInitial U.S. Approval: 1950
Approved
Approval ID
6b6db42b-9821-4aa6-8566-297037d84079
Product Type
HUMAN PRESCRIPTION DRUG LABEL
Effective Date
Feb 8, 2022
Manufacturers
FDA
Major Pharmaceuticals
DUNS: 191427277
Products 2
Detailed information about drug products covered under this FDA approval, including NDC codes, dosage forms, ingredients, and administration routes.
Oxycodone
Product Details
FDA regulatory identification and product classification information
FDA Identifiers
NDC Product Code0904-7180
Application NumberANDA203638
Product Classification
M
Marketing Category
C73584
G
Generic Name
Oxycodone
Product Specifications
Route of AdministrationORAL
Effective DateFebruary 8, 2022
FDA Product Classification
INGREDIENTS (8)
STARCH, CORNInactive
Code: O8232NY3SJ
Classification: IACT
OXYCODONE HYDROCHLORIDEActive
Quantity: 15 mg in 1 1
Code: C1ENJ2TE6C
Classification: ACTIB
MICROCRYSTALLINE CELLULOSEInactive
Code: OP1R32D61U
Classification: IACT
LACTOSE MONOHYDRATEInactive
Code: EWQ57Q8I5X
Classification: IACT
STEARIC ACIDInactive
Code: 4ELV7Z65AP
Classification: IACT
D&C YELLOW NO. 10Inactive
Code: 35SW5USQ3G
Classification: IACT
FD&C BLUE NO. 2Inactive
Code: L06K8R7DQK
Classification: IACT
SODIUM STARCH GLYCOLATE TYPE A POTATOInactive
Code: 5856J3G2A2
Classification: IACT
Oxycodone
Product Details
FDA regulatory identification and product classification information
FDA Identifiers
NDC Product Code0904-6966
Application NumberANDA203638
Product Classification
M
Marketing Category
C73584
G
Generic Name
Oxycodone
Product Specifications
Route of AdministrationORAL
Effective DateFebruary 8, 2022
FDA Product Classification
INGREDIENTS (6)
OXYCODONE HYDROCHLORIDEActive
Quantity: 5 mg in 1 1
Code: C1ENJ2TE6C
Classification: ACTIB
STARCH, CORNInactive
Code: O8232NY3SJ
Classification: IACT
LACTOSE MONOHYDRATEInactive
Code: EWQ57Q8I5X
Classification: IACT
SODIUM STARCH GLYCOLATE TYPE A POTATOInactive
Code: 5856J3G2A2
Classification: IACT
MICROCRYSTALLINE CELLULOSEInactive
Code: OP1R32D61U
Classification: IACT
STEARIC ACIDInactive
Code: 4ELV7Z65AP
Classification: IACT