FDA.reportPublic FDA data

RIZATRIPTAN BENZOATE

Product NDC
72189-258
11-digit product format
721890258
Labeler code
72189
Product ID
72189-258_4c4bf9d8-0622-f896-e063-6294a90a3674
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
RIZATRIPTAN BENZOATE
Dosage form
TABLET
Route
ORAL
Labeler
direct rx
Application
ANDA202490
Marketing category
ANDA
Marketing start
2021-08-10
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
Listing expiration
2027-12-31

Active Ingredients#

Ingredient, Strength table
IngredientStrength
RIZATRIPTAN BENZOATE10 mg/1

Harmonized Identifiers#

Field, Values table
FieldValues
UniiWR978S7QHH
Rxcui312840, 314209

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
72189-258-12RIZATRIPTAN BENZOATE12 in 1 BOTTLETABLET127
72189-258-18RIZATRIPTAN BENZOATE18 in 1 BLISTER PACKTABLET187

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
72189-258RIZATRIPTAN BENZOATE TABLET [DIRECT RX]6Current NDC, Legacy NDC, 2 package rows20250121_b3d981bc-3c9e-8a9e-e053-2995a90a8f65.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
314209rizatriptan benzoate 10 MG Oral TabletPSNb3d981bc-3c9e-8a9e-e053-2995a90a8f657
312840rizatriptan benzoate 5 MG Oral TabletPSNb3d981bc-3c9e-8a9e-e053-2995a90a8f657
314209rizatriptan 10 MG Oral TabletSCDb3d981bc-3c9e-8a9e-e053-2995a90a8f657
312840rizatriptan 5 MG Oral TabletSCDb3d981bc-3c9e-8a9e-e053-2995a90a8f657
314209rizatriptan 10 MG (as rizatriptan benzoate 14.53 MG) Oral TabletSYb3d981bc-3c9e-8a9e-e053-2995a90a8f657
312840rizatriptan 5 MG (as rizatriptan benzoate 7.265 MG) Oral TabletSYb3d981bc-3c9e-8a9e-e053-2995a90a8f657

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
72189-258-127218902581212 TABLET in 1 BOTTLE (72189-258-12) 12 tablet2021-08-100000-00-00NoNoCurrent
72189-258-187218902581818 TABLET in 1 BLISTER PACK (72189-258-18) 18 tablet2021-08-10NoNoCurrent