MedPath
FDA Product

Ibuprofen

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

Basic Information

Ibuprofen

69677-225

Regulatory Information

69677-225

ANDA091625

C73584

March 27, 2018

USA

IBUPROFEN Tablets, USP

HUMAN PRESCRIPTION DRUG LABEL

2

Company Information

079363782

Active Ingredients

HYPROMELLOSE 2910 (5 MPA.S)

Code: R75537T0T4

Class Code: IACT

IBUPROFEN

Quantity: 600 mg in 1 1

Code: WK2XYI10QM

Class Code: ACTIB

SILICON DIOXIDE

Code: ETJ7Z6XBU4

Class Code: IACT

STARCH, CORN

Code: O8232NY3SJ

Class Code: IACT

HYDROXYPROPYL CELLULOSE, UNSPECIFIED

Code: 9XZ8H6N6OH

Class Code: IACT

SODIUM LAURYL SULFATE

Code: 368GB5141J

Class Code: IACT

TITANIUM DIOXIDE

Code: 15FIX9V2JP

Class Code: IACT

MAGNESIUM STEARATE

Code: 70097M6I30

Class Code: IACT

POVIDONE K90

Code: RDH86HJV5Z

Class Code: IACT

POLYETHYLENE GLYCOL 400

Code: B697894SGQ

Class Code: IACT

CROSCARMELLOSE SODIUM

Code: M28OL1HH48

Class Code: IACT

CELLULOSE, MICROCRYSTALLINE

Code: OP1R32D61U

Class Code: IACT

Active Moieties

IBUPROFEN

Code: WK2XYI10QM

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