Land: USA
Språk: engelsk
Kilde: NLM (National Library of Medicine)
IBUPROFEN (UNII: WK2XYI10QM) (IBUPROFEN - UNII:WK2XYI10QM)
Preferred Pharmaceuticals Inc.
ORAL
PRESCRIPTION DRUG
800 mg (white to off-white, capsule shaped, biconvex, film-coated tablets debossed with ‘123’ on one side and plain on other side) Repackaged By: Preferred Pharmaceuticals Inc.
Abbreviated New Drug Application
Preferred Pharmaceuticals Inc. ---------- IBUPROFEN TABLETS 400 MG - 600 MG- 800 MG MEDGUIDE Revised: 7/2022 Document Id: eaa39be7-ba41-4c20-8330-a44d52602860 34391-3 Set id: f4b778cf-0741-46b3-ace9-7ac8d0695e31 Version: 3 Effective Time: 20220707 Preferred Pharmaceuticals Inc. read_full_document
IBUPROFEN- IBUPROFEN TABLET, FILM COATED PREFERRED PHARMACEUTICALS INC. ---------- IBUPROFEN 400 MG - 600 MG AND 800 MG TABLETS IBUPROFEN TABLETS 400 MG - 600 MG- 800 MG MEDGUIDE HOW SUPPLIED 800 mg (white to off-white, capsule shaped, biconvex, film-coated tablets debossed with ‘123’ on one side and plain on other side) Repackaged By: Preferred Pharmaceuticals Inc. 800MG LABEL IBUPROFEN ibuprofen tablet, film coated Bottles of 14 NDC 68788-7079-4 PRODUCT INFORMATION PRODUCT TYPE HUMAN PRESCRIPTION DRUG ITEM CODE (SOURCE) NDC:68788-7079(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) 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 CAPSULE SIZE 19mm FLAVOR IMPRINT CODE 123 CONTAINS PACKAGING # ITEM CODE PACKAGE DESCRIPTION MARKETING START DATE MARKETING END DATE 1 NDC:68788- 7079-4 14 in 1 BOTTLE; Type 0: Not a Combination Product 06/17/2020 2 NDC:68788- 7079-2 20 in 1 BOTTLE; Type 0: Not a Combination Product 06/17/2020 3 NDC:68788- 7079-7 21 in 1 BOTTLE; Type 0: Not a Combination Product 06/17/2020 4 NDC:68788- 7079-3 30 in 1 BOTTLE; Type 0: Not a Combination Product 06/17/2020 5 NDC:68788- 7079-5 50 in 1 BOTTLE; Type 0: Not a Combination Product 06/17/2020 6 NDC:68788- 7079-6 60 in 1 BOTTLE; Type 0: Not a Combination Product 06/17/2020 7 NDC:68788- 7079-9 90 in 1 BOTTLE; Type 0: Not a Combination Product 06/17/2020 8 NDC:68788- 7079-1 100 in 1 BOTTLE; Type 0: Not a Combination Product 06/17/2020 9 NDC:68788- 120 in 1 BOTTLE; Type 0: Not a Combination 06/17/2 read_full_document