Label: IBUPROFEN tablet, film coated
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NDC Code(s):
60760-603-20,
60760-603-28,
60760-603-30,
60760-603-40, view more60760-603-60, 60760-603-90
- Packager: St. Mary's Medical Park Pharmacy
- 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 February 17, 2023
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- ibuprofen tablets 400 mg - 600 mg- 800 mg medguide
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- PRINCIPAL DISPLAY PANEL
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INGREDIENTS AND APPEARANCE
IBUPROFEN
ibuprofen tablet, film coatedProduct Information Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:60760-603(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 POLYVINYL ALCOHOL (UNII: 532B59J990) STARCH, PREGELATINIZED CORN (UNII: O8232NY3SJ) TALC (UNII: 7SEV7J4R1U) TITANIUM DIOXIDE (UNII: 15FIX9V2JP) SILICON DIOXIDE (UNII: ETJ7Z6XBU4) CROSCARMELLOSE SODIUM (UNII: M28OL1HH48) MAGNESIUM STEARATE (UNII: 70097M6I30) CELLULOSE, MICROCRYSTALLINE (UNII: OP1R32D61U) POLYETHYLENE GLYCOL, UNSPECIFIED (UNII: 3WJQ0SDW1A) 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:60760-603-20 20 in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product 10/21/2019 2 NDC:60760-603-60 60 in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product 10/21/2019 3 NDC:60760-603-28 28 in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product 12/10/2019 4 NDC:60760-603-40 40 in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product 12/26/2019 5 NDC:60760-603-30 30 in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product 10/20/2021 6 NDC:60760-603-90 90 in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product 02/06/2023 Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date ANDA ANDA090796 10/21/2019 Labeler - St. Mary's Medical Park Pharmacy (063050751) Establishment Name Address ID/FEI Business Operations St. Mary's Medical Park Pharmacy 063050751 relabel(60760-603) , repack(60760-603)
