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FDA Drug information

IBUPROFEN

Read time: 1 mins
Marketing start date: 23 Dec 2024
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Summary of product characteristics


Effective Time

20220330

Version

1

Spl Product Data Elements

IBUPROFEN IBUPROFEN SILICON DIOXIDE CROSCARMELLOSE SODIUM MAGNESIUM STEARATE MICROCRYSTALLINE CELLULOSE POLYETHYLENE GLYCOL, UNSPECIFIED POLYVINYL ALCOHOL, UNSPECIFIED STARCH, CORN TALC TITANIUM DIOXIDE IBUPROFEN IBUPROFEN 121

Application Number

ANDA090796

Brand Name

IBUPROFEN

Generic Name

IBUPROFEN

Product Ndc

53002-3372

Product Type

HUMAN PRESCRIPTION DRUG

Route

ORAL

Package Label Principal Display Panel

Ibuprofen 400mg Tablets Label Image

Spl Medguide

ibuprofen tablets 400 mg - 600 mg- 800 mg medguide MEDGUIDE IBUPROFEN TABLETS

How Supplied

HOW SUPPLIED Product: 53002-3372 NDC: 53002-3372-1 15 TABLET, FILM COATED in a BOTTLE NDC: 53002-3372-3 30 TABLET, FILM COATED in a BOTTLE NDC: 53002-3372-5 50 TABLET, FILM COATED in a BOTTLE

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