Rizatriptan Benzoate

Basic Information

Product Name

FDA Product Code

69097-865

Regulatory Information

NDC Product Code

69097-865

Application Number

ANDA204339

Marketing Category

C73584

Effective Date

May 1, 2020

Territorial Authority

USA

FDA Title

These highlights do not include all the information needed to use rizatriptan benzoate tablets safely and effectively. See full prescribing information for rizatriptan benzoate tablets.Rizatriptan Benzoate Tablets, for oral useInitial U.S. Approval: 1998

Labeling Type

HUMAN PRESCRIPTION DRUG LABEL

Version Number

Active Ingredients

RIZATRIPTAN BENZOATE

Quantity: 5 mg in 1 1

Code: WR978S7QHH

Class Code: ACTIM

LACTOSE MONOHYDRATE

Code: EWQ57Q8I5X

Class Code: IACT

STARCH, CORN

Code: O8232NY3SJ

Class Code: IACT

FERRIC OXIDE RED

Code: 1K09F3G675

Class Code: IACT

MICROCRYSTALLINE CELLULOSE

Code: OP1R32D61U

Class Code: IACT

SILICON DIOXIDE

Code: ETJ7Z6XBU4

Class Code: IACT

MAGNESIUM STEARATE

Code: 70097M6I30

Class Code: IACT

Active Moieties

RIZATRIPTAN

Code: 51086HBW8G

Basic Information

Regulatory Information

Company Information

Active Ingredients

LACTOSE MONOHYDRATE

STARCH, CORN

FERRIC OXIDE RED

MICROCRYSTALLINE CELLULOSE

SILICON DIOXIDE

MAGNESIUM STEARATE

Active Moieties

RIZATRIPTAN