FDA.reportPublic FDA data

Rizatriptan

Product NDC
71335-2980
11-digit product format
713352980
Labeler code
71335
Product ID
71335-2980_32eb56b6-9cb6-4ad2-bffb-1cf9af4bfd2d
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Rizatriptan
Dosage form
TABLET, FILM COATED
Route
ORAL
Labeler
Bryant Ranch Prepack
Application
ANDA203147
Marketing category
ANDA
Marketing start
2014-03-11
Substance
RIZATRIPTAN BENZOATE
Active strength
10 mg/1
Pharmacologic classes
Serotonin 1b Receptor Agonists [MoA], Serotonin 1d Receptor Agonists [MoA], Serotonin-1b and Serotonin-1d Receptor Agonist [EPC]
NDC exclude flag
No
Listing certified through
2026-12-31
Current FDA listing
Yes

Additional Listing Data#

Finished product
Yes
Brand name base
Rizatriptan
Listing expiration
2026-12-31

Active Ingredients#

Ingredient, Strength table
IngredientStrength
RIZATRIPTAN BENZOATE10 mg/1

Harmonized Identifiers#

Field, Values table
FieldValues
UniiWR978S7QHH
Rxcui314209

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
f2791553-0b76-42f4-8d49-af3eda072bfbProduct name120251117
707ffe6e-db52-42b0-9a65-a0c00213f04fProduct name120231006
8b537454-32b8-7e64-1395-258682782d07Product name520170424

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
71335-2980-1Rizatriptan12 in 1 BOTTLETABLET, FILM COATED121

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
314209rizatriptan benzoate 10 MG Oral TabletPSNf000d96c-42a0-4aac-96ca-8cef289979ce1
314209rizatriptan 10 MG Oral TabletSCDf000d96c-42a0-4aac-96ca-8cef289979ce1
314209rizatriptan 10 MG (as rizatriptan benzoate 14.53 MG) Oral TabletSYf000d96c-42a0-4aac-96ca-8cef289979ce1

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionMarketing startSampleExclude flagStatus
71335-2980-17133529800112 TABLET, FILM COATED in 1 BOTTLE (71335-2980-1) 2025-11-26NoNoHistorical