Label: IBUPROFEN tablet, film coated
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NDC Code(s):
43063-858-01,
43063-858-04,
43063-858-06,
43063-858-09, view more43063-858-10, 43063-858-12, 43063-858-15, 43063-858-18, 43063-858-20, 43063-858-21, 43063-858-24, 43063-858-28, 43063-858-30, 43063-858-40, 43063-858-60, 43063-858-82, 43063-858-90, 43063-858-93, 43063-858-94
- Packager: PD-Rx 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 March 9, 2020
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- ibuprofen tablets 400 mg - 600 mg- 800 mg medguide
- HOW SUPPLIED
- 800 mg label
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INGREDIENTS AND APPEARANCE
IBUPROFEN
ibuprofen tablet, film coatedProduct Information Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:43063-858(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) 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 19mm Flavor Imprint Code 123 Contains Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:43063-858-04 4 in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product 10/22/2018 2 NDC:43063-858-06 6 in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product 01/04/2019 3 NDC:43063-858-09 9 in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product 06/20/2019 4 NDC:43063-858-10 10 in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product 08/06/2018 5 NDC:43063-858-12 12 in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product 06/08/2018 6 NDC:43063-858-15 15 in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product 06/08/2018 7 NDC:43063-858-18 18 in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product 06/08/2018 8 NDC:43063-858-20 20 in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product 08/21/2018 9 NDC:43063-858-21 21 in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product 07/20/2018 10 NDC:43063-858-24 24 in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product 08/08/2019 11 NDC:43063-858-28 28 in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product 09/24/2019 12 NDC:43063-858-30 30 in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product 06/08/2018 13 NDC:43063-858-40 40 in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product 10/03/2018 14 NDC:43063-858-60 60 in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product 06/08/2018 15 NDC:43063-858-82 500 in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product 02/24/2020 16 NDC:43063-858-90 90 in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product 06/08/2018 17 NDC:43063-858-01 100 in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product 05/03/2019 18 NDC:43063-858-93 180 in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product 06/08/2018 19 NDC:43063-858-94 270 in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product 06/08/2018 Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date ANDA ANDA090796 12/30/2015 Labeler - PD-Rx Pharmaceuticals, Inc. (156893695) Registrant - PD-Rx Pharmaceuticals, Inc. (156893695) Establishment Name Address ID/FEI Business Operations PD-Rx Pharmaceuticals, Inc. 156893695 repack(43063-858)
