Sumatriptan Succinate (Page 6 of 6)

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SUMATRIPTAN SUCCINATE sumatriptan succinate tablet, film coated
Product Information
Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:55700-093(NDC:62756-521)
Route of Administration ORAL DEA Schedule
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
SUMATRIPTAN SUCCINATE (SUMATRIPTAN) SUMATRIPTAN 50 mg
Inactive Ingredients
Ingredient Name Strength
ANHYDROUS DIBASIC CALCIUM PHOSPHATE
HYPROMELLOSES
CELLULOSE, MICROCRYSTALLINE
CROSCARMELLOSE SODIUM
SILICON DIOXIDE
TALC
MAGNESIUM STEARATE
TITANIUM DIOXIDE
POLYETHYLENE GLYCOL 400
POLYSORBATE 80
Product Characteristics
Color WHITE Score no score
Shape TRIANGLE Size 8mm
Flavor Imprint Code S;50
Contains
Packaging
# Item Code Package Description Multilevel Packaging
1 NDC:55700-093-09 9 TABLET, FILM COATED in 1 BLISTER PACK None
2 NDC:55700-093-30 30 TABLET, FILM COATED in 1 BOTTLE None
3 NDC:55700-093-60 60 TABLET, FILM COATED in 1 BOTTLE None
4 NDC:55700-093-90 90 TABLET, FILM COATED in 1 BOTTLE None
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
ANDA ANDA078295 08/10/2009
Labeler — Lake Erie Medical DBA Quality Care Products LLC (831276758)
Establishment
Name Address ID/FEI Operations
Lake Erie Medical DBA Quality Care Products LLC 831276758 repack (55700-093)

Revised: 04/2021 Lake Erie Medical DBA Quality Care Products LLC

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