MedPath
FDA Product

Oxycodone and Acetaminophen

Product approved by U.S. Food and Drug Administration (US)

Basic Information

Oxycodone and Acetaminophen

55700-496

Regulatory Information

55700-496

ANDA201972

C73584

October 6, 2022

USA

Oxycodone and Acetaminophen Tablets, USP CII

Human Prescription Drug Label

22

Company Information

831276758

Active Ingredients

POVIDONE

Code: FZ989GH94E

Class Code: IACT

STEARIC ACID

Code: 4ELV7Z65AP

Class Code: IACT

OXYCODONE HYDROCHLORIDE

Quantity: 10 mg in 1 1

Code: C1ENJ2TE6C

Class Code: ACTIB

ACETAMINOPHEN

Quantity: 325 mg in 1 1

Code: 362O9ITL9D

Class Code: ACTIB

CROSCARMELLOSE SODIUM

Code: M28OL1HH48

Class Code: IACT

SILICON DIOXIDE

Code: ETJ7Z6XBU4

Class Code: IACT

CROSPOVIDONE

Code: 2S7830E561

Class Code: IACT

CELLULOSE, MICROCRYSTALLINE

Code: OP1R32D61U

Class Code: IACT

MAGNESIUM STEARATE

Code: 70097M6I30

Class Code: IACT

STARCH, CORN

Code: O8232NY3SJ

Class Code: IACT

Active Moieties

ACETAMINOPHEN

Code: 362O9ITL9D

OXYCODONE

Code: CD35PMG570

© Copyright 2025. All Rights Reserved by MedPath