FDA.reportPublic FDA data

Rizatriptan Benzoate

Product NDC
76420-908
11-digit product format
764200908
Labeler code
76420
Product ID
76420-908_2cb4448b-6604-9be4-e063-6394a90a1b6d
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Rizatriptan Benzoate
Dosage form
TABLET, ORALLY DISINTEGRATING
Route
ORAL
Labeler
Asclemed USA, Inc.
Application
ANDA203062
Marketing category
ANDA
Marketing start
2013-07-01
Substance
RIZATRIPTAN BENZOATE
Active strength
5 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 Benzoate
Listing expiration
2026-12-31

Active Ingredients#

Ingredient, Strength table
IngredientStrength
RIZATRIPTAN BENZOATE5 mg/1

Harmonized Identifiers#

Field, Values table
FieldValues
UniiWR978S7QHH
Rxcui312837, 312839

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
76420-908-18Rizatriptan Benzoate6 in 1 BLISTER PACKTABLET, ORALLY DISINTEGRATING61
76420-908-18Rizatriptan Benzoate3 in 1 CARTONTABLET, ORALLY DISINTEGRATING31

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
76420-908RIZATRIPTAN BENZOATE TABLET, ORALLY DISINTEGRATING [ASCLEMED USA, INC.]1Current NDC, 2 package rows20250129_8fa794f4-4253-485d-b4ee-986178031339.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
312837rizatriptan benzoate 10 MG Disintegrating Oral TabletPSN8fa794f4-4253-485d-b4ee-9861780313391
312839rizatriptan benzoate 5 MG Disintegrating Oral TabletPSN8fa794f4-4253-485d-b4ee-9861780313391
312837rizatriptan 10 MG Disintegrating Oral TabletSCD8fa794f4-4253-485d-b4ee-9861780313391
312839rizatriptan 5 MG Disintegrating Oral TabletSCD8fa794f4-4253-485d-b4ee-9861780313391
312837rizatriptan 10 MG (as rizatriptan benzoate 14.53 MG) Disintegrating Oral TabletSY8fa794f4-4253-485d-b4ee-9861780313391
312839rizatriptan 5 MG (as rizatriptan benzoate 7.265 MG) Disintegrating Oral TabletSY8fa794f4-4253-485d-b4ee-9861780313391

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startSampleExclude flagStatus
76420-908-18764200908183 BLISTER PACK in 1 CARTON (76420-908-18) / 6 TABLET, ORALLY DISINTEGRATING in 1 BLISTER PACK3 blister pack2025-01-27NoNoCurrent