Sumatriptan Succinate (Page 7 of 7)

PRINCIPAL DISPLAY PANEL — 50 mg Label

NDC 68788-7157-9
Sumatriptan Succinate Tablets
50 mg
Rx only SUN PHARMA

Relabeled By: Preferred Pharmaceuticals Inc.

Sumatriptan Succinate Tablets, USP 50mg
(click image for full-size original)
SUMATRIPTAN SUCCINATE sumatriptan succinate tablet, film coated
Product Information
Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:68788-7158(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
SILICON DIOXIDE
CROSCARMELLOSE SODIUM
ANHYDROUS DIBASIC CALCIUM PHOSPHATE
HYPROMELLOSE, UNSPECIFIED
MAGNESIUM STEARATE
MICROCRYSTALLINE CELLULOSE
POLYETHYLENE GLYCOL, UNSPECIFIED
POLYSORBATE 80
TALC
TITANIUM DIOXIDE
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:68788-7158-9 9 BLISTER PACK in 1 CARTON contains a BLISTER PACK
1 1 TABLET, FILM COATED in 1 BLISTER PACK This package is contained within the CARTON (68788-7158-9)
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
ANDA ANDA078295 06/05/2018
Labeler — Preferred Pharmaceuticals Inc. (791119022)
Registrant — Preferred Pharmaceuticals Inc. (791119022)
Establishment
Name Address ID/FEI Operations
Preferred Pharmaceuticals Inc. 791119022 RELABEL (68788-7158)

Revised: 09/2020 Preferred Pharmaceuticals Inc.

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