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FDA Drug information

IBUPROFEN

Read time: 1 mins
Marketing start date: 27 Apr 2024

Summary of product characteristics


Effective Time

20220114

Version

4

Spl Product Data Elements

IBUPROFEN IBUPROFEN SILICON DIOXIDE CROSCARMELLOSE SODIUM MAGNESIUM STEARATE CELLULOSE, MICROCRYSTALLINE POLYETHYLENE GLYCOL, UNSPECIFIED POLYVINYL ALCOHOL STARCH, PREGELATINIZED CORN TALC TITANIUM DIOXIDE IBUPROFEN IBUPROFEN 123

Application Number

ANDA090796

Brand Name

IBUPROFEN

Generic Name

IBUPROFEN

Product Ndc

68071-5140

Product Type

HUMAN PRESCRIPTION DRUG

Route

ORAL

Package Label Principal Display Panel

PDP

Spl Medguide

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

How Supplied

800 mg (white to off-white, capsule shaped, biconvex, film-coated​ tablets debossed with 123 on one side and plain on other side) NDC 68071-5140-3 BOTTLES OF 3

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