Oxycodone Hydrochloride
OXYCODONE HYDROCHLORIDE TABLETS, USP5 mg, 15 mg, and 30 mg CII Rx only
Approved
Approval ID
3efb2cf8-9b0e-4d76-afb1-c4ecd514d534
Product Type
HUMAN PRESCRIPTION DRUG LABEL
Effective Date
Dec 15, 2011
Manufacturers
FDA
H.J. Harkins Company, Inc.
DUNS: 147681894
Products 2
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 Code52959-131
Application NumberANDA077712
Product Classification
M
Marketing Category
C73584
G
Generic Name
Oxycodone Hydrochloride
Product Specifications
Route of AdministrationORAL
Effective DateDecember 15, 2011
FDA Product Classification
INGREDIENTS (7)
LACTOSE MONOHYDRATEInactive
Code: EWQ57Q8I5X
Classification: IACT
OXYCODONE HYDROCHLORIDEActive
Quantity: 5 mg in 1 1
Code: C1ENJ2TE6C
Classification: ACTIB
MAGNESIUM STEARATEInactive
Code: 70097M6I30
Classification: IACT
CELLULOSE, MICROCRYSTALLINEInactive
Code: OP1R32D61U
Classification: IACT
POVIDONEInactive
Code: FZ989GH94E
Classification: IACT
STEARIC ACIDInactive
Code: 4ELV7Z65AP
Classification: IACT
SODIUM STARCH GLYCOLATE TYPE A POTATOInactive
Code: 5856J3G2A2
Classification: IACT
Oxycodone Hydrochloride
Product Details
FDA regulatory identification and product classification information
FDA Identifiers
NDC Product Code52959-129
Application NumberANDA077712
Product Classification
M
Marketing Category
C73584
G
Generic Name
Oxycodone Hydrochloride
Product Specifications
Route of AdministrationORAL
Effective DateDecember 15, 2011
FDA Product Classification
INGREDIENTS (9)
OXYCODONE HYDROCHLORIDEActive
Quantity: 15 mg in 1 1
Code: C1ENJ2TE6C
Classification: ACTIB
CELLULOSE, MICROCRYSTALLINEInactive
Code: OP1R32D61U
Classification: IACT
LACTOSE MONOHYDRATEInactive
Code: EWQ57Q8I5X
Classification: IACT
MAGNESIUM STEARATEInactive
Code: 70097M6I30
Classification: IACT
D&C YELLOW NO. 10Inactive
Code: 35SW5USQ3G
Classification: IACT
FD&C BLUE NO. 1Inactive
Code: H3R47K3TBD
Classification: IACT
SODIUM STARCH GLYCOLATE TYPE A POTATOInactive
Code: 5856J3G2A2
Classification: IACT
POVIDONEInactive
Code: FZ989GH94E
Classification: IACT
STEARIC ACIDInactive
Code: 4ELV7Z65AP
Classification: IACT