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FDA Drug information

IBUPROFEN

Read time: 1 mins
Marketing start date: 29 Apr 2024

Summary of product characteristics


Effective Time

20230713

Version

4

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

68788-7745

Product Type

HUMAN PRESCRIPTION DRUG

Route

ORAL

Package Label Principal Display Panel

400mg Ibuprofen Ibuprofen Tablets USP 400mg

Spl Medguide

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

How Supplied

HOW SUPPLIED 400mg (white to of white, round, biconvex, film coated tablets debossed with '121' on one side and plain on the other side) Bottles of 20 NDC 68788-7745-02 Bottles of 28 NDC 68788-7745-08 Bottles of 30 NDC 68788-7745-03 Bottles of 50 NDC 68788-7745-05 Bottles of 60 NDC 68788-7745-06 Bottles of 90 NDC 68788-7745-09 Bottles of 100 NDC 68788-7745-01 Repackaged by Preferred Pharmaceuticals, Inc.

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Disclaimer

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