Label: IBUPROFEN tablet, film coated
- NDC Code(s): 53002-3981-1, 53002-3981-2, 53002-3981-3, 53002-3981-5
- Packager: RPK Pharmaceuticals, Inc.
- This is a repackaged label.
- Source NDC Code(s): 49483-604
- Category: HUMAN PRESCRIPTION DRUG LABEL
- DEA Schedule: None
- Marketing Status: Abbreviated New Drug Application
Drug Label Information
Updated July 6, 2023
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- ibuprofen tablets 400 mg - 600 mg- 800 mg medguide
- HOW SUPPLIED
- IBUPROFEN TABLET, FILM COATED
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INGREDIENTS AND APPEARANCE
IBUPROFEN
ibuprofen tablet, film coatedProduct Information Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:53002-3981(NDC:49483-604) Route of Administration ORAL Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength IBUPROFEN (UNII: WK2XYI10QM) (IBUPROFEN - UNII:WK2XYI10QM) IBUPROFEN 800 mg Inactive Ingredients Ingredient Name Strength SILICON DIOXIDE (UNII: ETJ7Z6XBU4) CROSCARMELLOSE SODIUM (UNII: M28OL1HH48) MAGNESIUM STEARATE (UNII: 70097M6I30) MICROCRYSTALLINE CELLULOSE (UNII: OP1R32D61U) POLYETHYLENE GLYCOL, UNSPECIFIED (UNII: 3WJQ0SDW1A) POLYVINYL ALCOHOL, UNSPECIFIED (UNII: 532B59J990) STARCH, CORN (UNII: O8232NY3SJ) TALC (UNII: 7SEV7J4R1U) TITANIUM DIOXIDE (UNII: 15FIX9V2JP) Product Characteristics Color white Score no score Shape CAPSULE Size 19mm Flavor Imprint Code 123 Contains Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:53002-3981-2 15 in 1 BOTTLE; Type 0: Not a Combination Product 01/01/2021 2 NDC:53002-3981-3 30 in 1 BOTTLE; Type 0: Not a Combination Product 01/01/2021 3 NDC:53002-3981-5 50 in 1 BOTTLE; Type 0: Not a Combination Product 01/01/2021 4 NDC:53002-3981-1 10 in 1 BOTTLE; Type 0: Not a Combination Product 01/01/2021 Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date ANDA ANDA090796 12/30/2015 Labeler - RPK Pharmaceuticals, Inc. (147096275) Establishment Name Address ID/FEI Business Operations RPK Pharmaceuticals, Inc. 147096275 RELABEL(53002-3981) , REPACK(53002-3981)
