Label: IBUPROFEN tablet, film coated
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NDC Code(s):
68788-7745-1,
68788-7745-2,
68788-7745-3,
68788-7745-5, view more68788-7745-6, 68788-7745-8, 68788-7745-9
- Packager: Preferred Pharmaceuticals, Inc.
- 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 May 24, 2024
If you are a consumer or patient please visit this version.
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- Medication Guide: HTML
- Official Label (Printer Friendly)
- ibuprofen tablets 400 mg - 600 mg- 800 mg medguide
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HOW SUPPLIED
400mg (white to of white, round, biconvex, film coated tablets debossed with '121' on one side and plain on the other side)
- Bottles of 20 NDC 68788-7745-02
Bottles of 28 NDC 68788-7745-08
Bottles of 30 NDC 68788-7745-03
Bottles of 50 NDC 68788-7745-05
Bottles of 60 NDC 68788-7745-06
Bottles of 90 NDC 68788-7745-09
Bottles of 100 NDC 68788-7745-01
Repackaged by Preferred Pharmaceuticals, Inc.
- 400mg Ibuprofen
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INGREDIENTS AND APPEARANCE
IBUPROFEN
ibuprofen tablet, film coatedProduct Information Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:68788-7745(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:68788-7745-2 20 in 1 BOTTLE; Type 0: Not a Combination Product 07/01/2020 2 NDC:68788-7745-8 28 in 1 BOTTLE; Type 0: Not a Combination Product 07/01/2020 3 NDC:68788-7745-3 30 in 1 BOTTLE; Type 0: Not a Combination Product 07/01/2020 4 NDC:68788-7745-5 50 in 1 BOTTLE; Type 0: Not a Combination Product 07/01/2020 5 NDC:68788-7745-6 60 in 1 BOTTLE; Type 0: Not a Combination Product 07/01/2020 6 NDC:68788-7745-9 90 in 1 BOTTLE; Type 0: Not a Combination Product 07/01/2020 7 NDC:68788-7745-1 100 in 1 BOTTLE; Type 0: Not a Combination Product 07/01/2020 Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date ANDA ANDA090796 07/01/2020 Labeler - Preferred Pharmaceuticals, Inc. (791119022) Registrant - Preferred Pharmaceuticals, Inc. (791119022) Establishment Name Address ID/FEI Business Operations Preferred Pharmaceuticals, Inc. 791119022 REPACK(68788-7745)
