Rizatriptan Benzoate ODT

Product NDC
72189-341
11-digit product format
721890341
Labeler code
72189
Product ID
72189-341_2c4c5f32-a754-7f96-e063-6394a90ad938
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Rizatriptan Benzoate ODT
Dosage form
TABLET, ORALLY DISINTEGRATING
Route
ORAL
Labeler
Direct Rx
Application
ANDA203062
Marketing category
ANDA
Marketing start
2022-03-28
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 Benzoate ODT
Listing expiration
2026-12-31

Active Ingredients#

Ingredient, Strength table
IngredientStrength
RIZATRIPTAN BENZOATE10 mg/1

Harmonized Identifiers#

Field, Values table
FieldValues
UniiWR978S7QHH
Rxcui312837

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
72189-341-09Rizatriptan Benzoate ODT9 in 1 BOTTLETABLET, ORALLY DISINTEGRATING92

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
72189-341-09EA - Each72189-3415ebe3040-1ffd-4d33-b759-1ce69607e4e812022-04-06

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
72189-341RIZATRIPTAN BENZOATE ODT TABLET, ORALLY DISINTEGRATING [DIRECT RX]2Current NDC, Legacy NDC, 1 package rows20250123_db489d19-1509-c979-e053-2a95a90a4410.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
312837rizatriptan benzoate 10 MG Disintegrating Oral TabletPSNdb489d19-1509-c979-e053-2a95a90a44102
312837rizatriptan 10 MG Disintegrating Oral TabletSCDdb489d19-1509-c979-e053-2a95a90a44102
312837rizatriptan 10 MG (as rizatriptan benzoate 14.53 MG) Disintegrating Oral TabletSYdb489d19-1509-c979-e053-2a95a90a44102

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionMarketing startMarketing endSampleExclude flagStatus
72189-341-09721890341099 TABLET, ORALLY DISINTEGRATING in 1 BOTTLE (72189-341-09) 2022-03-280000-00-00NoNoCurrent