Label: IBUPROFEN tablet, film coated
- NDC Code(s): 51655-759-52
- Packager: Northwind Pharmaceuticals
- This is a repackaged label.
- Source NDC Code(s): 49483-602
- Category: HUMAN PRESCRIPTION DRUG LABEL
- DEA Schedule: None
- Marketing Status: Abbreviated New Drug Application
Drug Label Information
Updated January 1, 2023
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- ibuprofen tablets 400 mg - 600 mg- 800 mg medguide
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INGREDIENTS AND APPEARANCE
IBUPROFEN
ibuprofen tablet, film coatedProduct Information Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:51655-759(NDC:49483-602) Route of Administration ORAL Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength IBUPROFEN (UNII: WK2XYI10QM) (IBUPROFEN - UNII:WK2XYI10QM) IBUPROFEN 400 mg Inactive Ingredients Ingredient Name Strength SILICON DIOXIDE (UNII: ETJ7Z6XBU4) CROSCARMELLOSE SODIUM (UNII: M28OL1HH48) MAGNESIUM STEARATE (UNII: 70097M6I30) CELLULOSE, MICROCRYSTALLINE (UNII: OP1R32D61U) POLYETHYLENE GLYCOL, UNSPECIFIED (UNII: 3WJQ0SDW1A) POLYVINYL ALCOHOL (UNII: 532B59J990) STARCH, PREGELATINIZED CORN (UNII: O8232NY3SJ) TALC (UNII: 7SEV7J4R1U) TITANIUM DIOXIDE (UNII: 15FIX9V2JP) Product Characteristics Color white Score no score Shape ROUND Size 13mm Flavor Imprint Code 121 Contains Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:51655-759-52 30 in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product 08/05/2021 Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date ANDA ANDA090796 08/05/2021 Labeler - Northwind Pharmaceuticals (036986393) Registrant - Northwind Pharmaceuticals (036986393) Establishment Name Address ID/FEI Business Operations Northwind Pharmaceuticals 036986393 repack(51655-759)
