MedPath
FDA Product

Ibuprofen

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

Basic Information

Ibuprofen

62207-356

Regulatory Information

62207-356

ANDA091625

C73584

April 24, 2023

USA

Ibuprofen Rx Tablets

HUMAN PRESCRIPTION DRUG LABEL

22

Company Information

915000087

Active Ingredients

HYDROXYPROPYL CELLULOSE (1600000 WAMW)

Code: RFW2ET671P

Class Code: IACT

HYPROMELLOSE 2910 (5 MPA.S)

Code: R75537T0T4

Class Code: IACT

SILICON DIOXIDE

Code: ETJ7Z6XBU4

Class Code: IACT

CROSCARMELLOSE SODIUM

Code: M28OL1HH48

Class Code: IACT

HYPROMELLOSE 2910 (3 MPA.S)

Code: 0VUT3PMY82

Class Code: IACT

SODIUM LAURYL SULFATE

Code: 368GB5141J

Class Code: IACT

CELLULOSE, MICROCRYSTALLINE

Code: OP1R32D61U

Class Code: IACT

POVIDONE K90

Code: RDH86HJV5Z

Class Code: IACT

WATER

Code: 059QF0KO0R

Class Code: IACT

TITANIUM DIOXIDE

Code: 15FIX9V2JP

Class Code: IACT

HYPROMELLOSE 2910 (6 MPA.S)

Code: 0WZ8WG20P6

Class Code: IACT

POLYETHYLENE GLYCOL 400

Code: B697894SGQ

Class Code: IACT

STARCH, CORN

Code: O8232NY3SJ

Class Code: IACT

IBUPROFEN

Quantity: 800 mg in 1 1

Code: WK2XYI10QM

Class Code: ACTIB

MAGNESIUM STEARATE

Code: 70097M6I30

Class Code: IACT

Active Moieties

IBUPROFEN

Code: WK2XYI10QM

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