MedPath
FDA Product

ibuprofen

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

Basic Information

ibuprofen

11788-008

Regulatory Information

11788-008

ANDA202413

C73584

May 13, 2020

USA

Ibuprofen Tablets, USP 400 mg, 600 mg and 800 mg

HUMAN PRESCRIPTION DRUG LABEL

8

Company Information

079674526

Active Ingredients

SILICON DIOXIDE

Code: ETJ7Z6XBU4

Class Code: IACT

CELLULOSE, MICROCRYSTALLINE

Code: OP1R32D61U

Class Code: IACT

SODIUM STARCH GLYCOLATE TYPE A POTATO

Code: 5856J3G2A2

Class Code: IACT

STEARIC ACID

Code: 4ELV7Z65AP

Class Code: IACT

MAGNESIUM STEARATE

Code: 70097M6I30

Class Code: IACT

POLYVINYL ALCOHOL

Code: 532B59J990

Class Code: IACT

POLYETHYLENE GLYCOL 1000

Code: U076Q6Q621

Class Code: IACT

TITANIUM DIOXIDE

Code: 15FIX9V2JP

Class Code: IACT

IBUPROFEN

Quantity: 400 mg in 1 1

Code: WK2XYI10QM

Class Code: ACTIB

STARCH, CORN

Code: O8232NY3SJ

Class Code: IACT

CROSCARMELLOSE SODIUM

Code: M28OL1HH48

Class Code: IACT

LECITHIN, SOYBEAN

Code: 1DI56QDM62

Class Code: IACT

TALC

Code: 7SEV7J4R1U

Class Code: IACT

Active Moieties

IBUPROFEN

Code: WK2XYI10QM

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