Label: IBUPROFEN tablet, film coated
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NDC Code(s):
50090-5160-0,
50090-5160-1,
50090-5160-3,
50090-5160-4, view more50090-5160-8
- Packager: A-S Medication Solutions
- 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 February 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:50090-5160(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) 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 ROUND Size 13mm Flavor Imprint Code 121 Contains Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:50090-5160-4 20 in 1 BOTTLE; Type 0: Not a Combination Product 09/21/2020 01/31/2023 2 NDC:50090-5160-0 16 in 1 BOTTLE; Type 0: Not a Combination Product 09/21/2020 3 NDC:50090-5160-3 100 in 1 BOTTLE; Type 0: Not a Combination Product 09/21/2020 09/30/2022 4 NDC:50090-5160-1 30 in 1 BOTTLE; Type 0: Not a Combination Product 09/21/2020 09/30/2022 5 NDC:50090-5160-8 60 in 1 BOTTLE; Type 0: Not a Combination Product 09/21/2020 04/30/2022 Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date ANDA ANDA090796 12/30/2015 Labeler - A-S Medication Solutions (830016429) Establishment Name Address ID/FEI Business Operations A-S Medication Solutions 830016429 RELABEL(50090-5160) , REPACK(50090-5160)