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FDA Drug information

IBUPROFEN

Read time: 1 mins
Marketing start date: 12 Apr 2025
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Summary of product characteristics


Effective Time

20250102

Version

16

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

70518-0005

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: 70518-0005-0 NDC: 70518-0005-1 NDC: 70518-0005-2 NDC: 70518-0005-3 NDC: 70518-0005-4 NDC: 70518-0005-5 NDC: 70518-0005-6 COLOR: white SHAPE: CAPSULE SCORE: No score SIZE: 19 mm IMPRINT: 123 PACKAGING: 21 in 1 BLISTER PACK PACKAGING: 14 in 1 BLISTER PACK PACKAGING: 30 in 1 BLISTER PACK PACKAGING: 10 in 1 BLISTER PACK PACKAGING: 90 in 1 BOTTLE PLASTIC PACKAGING: 30 in 1 BOTTLE PLASTIC PACKAGING: 30 in 1 BLISTER PACK ACTIVE INGREDIENT(S): IBUPROFEN 800mg in 1 INACTIVE INGREDIENT(S): SILICON DIOXIDE CROSCARMELLOSE SODIUM MAGNESIUM STEARATE CELLULOSE, MICROCRYSTALLINE POLYETHYLENE GLYCOL, UNSPECIFIED POLYVINYL ALCOHOL STARCH, PREGELATINIZED CORN TALC TITANIUM DIOXIDE Remedy_Label

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

HOW SUPPLIED Ibuprofen tablets are available in the following strength: 800 mg (white to off white, capsule shaped, biconvex, film coated tablets debossed with ‘123’ on one side and plain on other side) NDC: 70518-0005-00 NDC: 70518-0005-01 NDC: 70518-0005-02 NDC: 70518-0005-03 NDC: 70518-0005-04 NDC: 70518-0005-05 NDC: 70518-0005-06 PACKAGING: 21 in 1 BLISTER PACK PACKAGING: 14 in 1 BLISTER PACK PACKAGING: 30 in 1 BLISTER PACK PACKAGING: 10 in 1 BLISTER PACK PACKAGING: 90 in 1 BOTTLE PLASTIC PACKAGING: 30 in 1 BOTTLE PLASTIC PACKAGING: 30 in 1 BLISTER PACK “Preserve in well-closed containers” Store at 20 ° to 25°C (68°to 77°F) [See USP Controlled Room Temperature]. Rx only Repackaged and Distributed By: Remedy Repack, Inc. 625 Kolter Dr. Suite #4 Indiana, PA 1-724-465-8762

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