Sumatriptan

Basic Information

Product Name

Sumatriptan

FDA Product Code

63187-969

Regulatory Information

NDC Product Code

63187-969

Application Number

ANDA078327

Marketing Category

C73584

Effective Date

June 1, 2022

Territorial Authority

USA

FDA Title

These highlights do not include all the information needed to use SUMATRIPTAN TABLETS safely and effectively. See full prescribing information for SUMATRIPTAN TABLETS. SUMATRIPTAN tablets, for oral useInitial U.S. Approval: 1992

Labeling Type

HUMAN PRESCRIPTION DRUG LABEL

Version Number

Active Ingredients

ANHYDROUS DIBASIC CALCIUM PHOSPHATE

Code: L11K75P92J

Class Code: IACT

POLYSORBATE 80

Code: 6OZP39ZG8H

Class Code: IACT

SUMATRIPTAN SUCCINATE

Quantity: 25 mg in 1 1

Code: J8BDZ68989

Class Code: ACTIM

CROSCARMELLOSE SODIUM

Code: M28OL1HH48

Class Code: IACT

MAGNESIUM STEARATE

Code: 70097M6I30

Class Code: IACT

MICROCRYSTALLINE CELLULOSE

Code: OP1R32D61U

Class Code: IACT

SODIUM BICARBONATE

Code: 8MDF5V39QO

Class Code: IACT

Active Moieties

Code: 8R78F6L9VO

Sumatriptan

Basic Information

Regulatory Information

Company Information

Active Ingredients

ANHYDROUS DIBASIC CALCIUM PHOSPHATE

POLYSORBATE 80

CROSCARMELLOSE SODIUM

MAGNESIUM STEARATE

MICROCRYSTALLINE CELLULOSE

SODIUM BICARBONATE

Active Moieties

SUMATRIPTAN