Label: SUMATRIPTAN- sumatriptan succinate tablet
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Contains inactivated NDC Code(s)
NDC Code(s): 68071-5072-9 - Packager: NuCare Pharmaceuticals,Inc.
- This is a repackaged label.
- Source NDC Code(s): 65862-148
- Category: HUMAN PRESCRIPTION DRUG LABEL
- DEA Schedule: None
- Marketing Status: Abbreviated New Drug Application
Drug Label Information
Updated February 19, 2021
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INGREDIENTS AND APPEARANCE
SUMATRIPTAN
sumatriptan succinate tabletProduct Information Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:68071-5072(NDC:65862-148) Route of Administration ORAL Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength SUMATRIPTAN SUCCINATE (UNII: J8BDZ68989) (SUMATRIPTAN - UNII:8R78F6L9VO) SUMATRIPTAN 100 mg Inactive Ingredients Ingredient Name Strength CROSCARMELLOSE SODIUM (UNII: M28OL1HH48) CALCIUM PHOSPHATE, DIBASIC, ANHYDROUS (UNII: L11K75P92J) MAGNESIUM STEARATE (UNII: 70097M6I30) MICROCRYSTALLINE CELLULOSE (UNII: OP1R32D61U) POLYSORBATE 80 (UNII: 6OZP39ZG8H) SODIUM BICARBONATE (UNII: 8MDF5V39QO) Product Characteristics Color white (White to off-white) Score no score Shape CAPSULE (biconvex) Size 12mm Flavor Imprint Code C;34 Contains Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:68071-5072-9 9 in 1 BOX; Type 0: Not a Combination Product 09/23/2019 Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date ANDA ANDA078327 08/17/2009 Labeler - NuCare Pharmaceuticals,Inc. (010632300) Establishment Name Address ID/FEI Business Operations NuCare Pharmaceuticals,Inc. 010632300 relabel(68071-5072)
