Label: IBUPROFEN tablet, film coated
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NDC Code(s):
51655-474-20,
51655-474-25,
51655-474-26,
51655-474-51, view more51655-474-52
- Packager: Northwind Pharmaceuticals
- This is a repackaged label.
- Source NDC Code(s): 49483-603
- 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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- Medication Guide: HTML
- Official Label (Printer Friendly)
- ibuprofen tablets 400 mg - 600 mg- 800 mg medguide
- HOW SUPPLIED
- 600 mg 30 count label
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INGREDIENTS AND APPEARANCE
IBUPROFEN
ibuprofen tablet, film coatedProduct Information Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:51655-474(NDC:49483-603) Route of Administration ORAL Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength IBUPROFEN (UNII: WK2XYI10QM) (IBUPROFEN - UNII:WK2XYI10QM) IBUPROFEN 600 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 CAPSULE Size 18mm Flavor Imprint Code 122 Contains Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:51655-474-20 20 in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product 11/19/2020 2 NDC:51655-474-25 60 in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product 11/13/2020 3 NDC:51655-474-51 40 in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product 02/08/2021 4 NDC:51655-474-52 30 in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product 01/14/2021 5 NDC:51655-474-26 90 in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product 06/21/2022 Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date ANDA ANDA090796 11/13/2020 Labeler - Northwind Pharmaceuticals (036986393) Registrant - Northwind Pharmaceuticals (036986393) Establishment Name Address ID/FEI Business Operations Northwind Pharmaceuticals 036986393 repack(51655-474)
