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FDA Drug information

IBUPROFEN

Read time: 1 mins
Marketing start date: 01 May 2024

Summary of product characteristics


Effective Time

20230309

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 121

Application Number

ANDA090796

Brand Name

IBUPROFEN

Generic Name

IBUPROFEN

Product Ndc

70518-2432

Product Type

HUMAN PRESCRIPTION DRUG

Route

ORAL

Package Label Principal Display Panel

PRINCIPAL DISPLAY PANEL DRUG: IBUPROFEN GENERIC: IBUPROFEN DOSAGE: TABLET, FILM COATED ADMINSTRATION: ORAL NDC: 70518-2432-0 NDC: 70518-2432-1 COLOR: white SHAPE: ROUND SCORE: No score SIZE: 13 mm IMPRINT: 121 PACKAGING: 21 in 1 BLISTER PACK PACKAGING: 30 in 1 BLISTER PACK ACTIVE INGREDIENT(S): IBUPROFEN 400mg in 1 INACTIVE INGREDIENT(S): SILICON DIOXIDE CROSCARMELLOSE SODIUM MAGNESIUM STEARATE CELLULOSE, MICROCRYSTALLINE POLYETHYLENE GLYCOL, UNSPECIFIED POLYVINYL ALCOHOL STARCH, PREGELATINIZED CORN TALC TITANIUM DIOXIDE MM2

Spl Medguide

ibuprofen tablets 400 mg - 600 mg- 800 mg medguide Repackaged By / Distributed By: RemedyRepack Inc. 625 Kolter Drive, Indiana, PA 15701 (724) 465-8762 MEDGUIDE IBUPROFEN TABLETS

How Supplied

Ibuprofen 400mg, white, round, tablet, imprint: 121 NDC: 70518-2432-00 NDC: 70518-2432-01 PACKAGING: 21 in 1 BLISTER PACK PACKAGING: 30 in 1 BLISTER PACK Repackaged and Distributed By: Remedy Repack, Inc. 625 Kolter Dr. Suite #4 Indiana, PA 1-724-465-8762

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Disclaimer

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