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Oxycodone and Acetaminophen

Oxycodone and Acetaminophen Tablets, USP 10 mg / 325 mg CII

Approved
Approval ID

a6cce10a-23ba-4eb1-9b1b-0f962f42df81

Product Type

HUMAN PRESCRIPTION DRUG LABEL

Effective Date

Aug 31, 2011

Manufacturers
FDA

H.J. Harkins Company, Inc.

DUNS: 147681894

Products 1

Detailed information about drug products covered under this FDA approval, including NDC codes, dosage forms, ingredients, and administration routes.

Oxycodone and Acetaminophen

Product Details

FDA regulatory identification and product classification information

FDA Identifiers
NDC Product Code52959-119
Application NumberANDA040778
Product Classification
M
Marketing Category
C73584
G
Generic Name
Oxycodone and Acetaminophen
Product Specifications
Route of AdministrationORAL
Effective DateAugust 31, 2011
FDA Product Classification

INGREDIENTS (9)

OXYCODONE HYDROCHLORIDEActive
Quantity: 10 mg in 1 1
Code: C1ENJ2TE6C
Classification: ACTIB
ACETAMINOPHENActive
Quantity: 325 mg in 1 1
Code: 362O9ITL9D
Classification: ACTIB
SILICON DIOXIDEInactive
Code: ETJ7Z6XBU4
Classification: IACT
CROSPOVIDONEInactive
Code: 68401960MK
Classification: IACT
MAGNESIUM STEARATEInactive
Code: 70097M6I30
Classification: IACT
CELLULOSE, MICROCRYSTALLINEInactive
Code: OP1R32D61U
Classification: IACT
POVIDONEInactive
Code: FZ989GH94E
Classification: IACT
STARCH, CORNInactive
Code: O8232NY3SJ
Classification: IACT
STEARIC ACIDInactive
Code: 4ELV7Z65AP
Classification: IACT

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Oxycodone and Acetaminophen - FDA Drug Approval Details