Rizatriptan Benzoate ODT

Product NDC
72189-609
11-digit product format
721890609
Labeler code
72189
Product ID
72189-609_4d3aab18-54e6-cb65-e063-6394a90a9b26
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Rizatriptan Benzoate ODT
Dosage form
TABLET, ORALLY DISINTEGRATING
Route
ORAL
Labeler
Direct_rx
Application
ANDA203146
Marketing category
ANDA
Marketing start
2025-01-20
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
2027-12-31
Current FDA listing
Yes

Additional Listing Data#

Finished product
Yes
Brand name base
Rizatriptan Benzoate ODT
Listing expiration
2027-12-31

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
a62a50ac-1535-4461-9768-8ae703e2e9fbProduct name120210525
8b537454-32b8-7e64-1395-258682782d07Product name520170424
9514609b-a2a9-f8ec-6ba6-3f8e5ee89877Product name120140508
bc07ef78-e82d-0c19-31f4-31f263780582Product name120140508

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
72189-609-18Rizatriptan Benzoate ODT18 in 1 CARTONTABLET, ORALLY DISINTEGRATING182

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
72189-609RIZATRIPTAN BENZOATE ODT TABLET, ORALLY DISINTEGRATING [DIRECT_RX]1Current NDC, 1 package rows20250122_2c29e066-c018-22e7-e063-6294a90a035c.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
312837rizatriptan benzoate 10 MG Disintegrating Oral TabletPSN2c29e066-c018-22e7-e063-6294a90a035c2
312837rizatriptan 10 MG Disintegrating Oral TabletSCD2c29e066-c018-22e7-e063-6294a90a035c2
312837rizatriptan 10 MG (as rizatriptan benzoate 14.53 MG) Disintegrating Oral TabletSY2c29e066-c018-22e7-e063-6294a90a035c2

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionMarketing startSampleExclude flagStatus
72189-609-187218906091818 TABLET, ORALLY DISINTEGRATING in 1 CARTON (72189-609-18) 2025-01-20NoNoCurrent