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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

20230217

Version

5

Spl Product Data Elements

IBUPROFEN IBUPROFEN POLYVINYL ALCOHOL STARCH, PREGELATINIZED CORN TALC TITANIUM DIOXIDE IBUPROFEN IBUPROFEN SILICON DIOXIDE CROSCARMELLOSE SODIUM MAGNESIUM STEARATE CELLULOSE, MICROCRYSTALLINE POLYETHYLENE GLYCOL, UNSPECIFIED 122

Application Number

ANDA090796

Brand Name

IBUPROFEN

Generic Name

IBUPROFEN

Product Ndc

60760-603

Product Type

HUMAN PRESCRIPTION DRUG

Route

ORAL

Package Label Principal Display Panel

ibu

Spl Medguide

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

How Supplied

HOW SUPPLIED 600mg (white to off white, capsule shaped, biconvex, film coated tablets debossed with '122' on one side and plain on the other side) NDC 60760-603-20 BOTTLES OF 20 60760-603-28 BOTTLES OF 28 60760-603-30 BOTTLES OF 30 60760-603-40 BOTTLES OF 40 60760-603-60 BOTTLES OF 60 60760-603-90 BOTTLES OF 90

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