Label: SUMATRIPTAN- sumatriptan succinate tablet
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- NDC Code(s): 63629-8134-1, 63629-8188-1
- Packager: Bryant Ranch Prepack
- This is a repackaged label.
- Source NDC Code(s): 65862-147, 65862-148
- Category: HUMAN PRESCRIPTION DRUG LABEL
- DEA Schedule: None
- Marketing Status: Abbreviated New Drug Application
Drug Label Information
Updated August 7, 2019
If you are a consumer or patient please visit this version.
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- HOW SUPPLIED
- SUMATRIPTAN 50MG TABLET
- SUMATRIPTAN SUCCINATE 100MG TAB
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INGREDIENTS AND APPEARANCE
SUMATRIPTAN
sumatriptan succinate tabletProduct Information Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:63629-8134(NDC:65862-147) Route of Administration ORAL Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength SUMATRIPTAN SUCCINATE (UNII: J8BDZ68989) (SUMATRIPTAN - UNII:8R78F6L9VO) SUMATRIPTAN 50 mg Inactive Ingredients Ingredient Name Strength CROSCARMELLOSE SODIUM (UNII: M28OL1HH48) ANHYDROUS DIBASIC CALCIUM PHOSPHATE (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 11mm Flavor Imprint Code C;33 Contains Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:63629-8134-1 9 in 1 BOTTLE; Type 0: Not a Combination Product 07/29/2019 Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date ANDA ANDA078327 08/17/2009 SUMATRIPTAN
sumatriptan succinate tabletProduct Information Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:63629-8188(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) ANHYDROUS DIBASIC CALCIUM PHOSPHATE (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:63629-8188-1 9 in 1 BOTTLE; Type 0: Not a Combination Product 08/02/2019 Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date ANDA ANDA078327 08/17/2009 Labeler - Bryant Ranch Prepack (171714327) Establishment Name Address ID/FEI Business Operations Bryant Ranch Prepack 171714327 REPACK(63629-8188, 63629-8134) , RELABEL(63629-8134, 63629-8188)
