FDA.reportPublic FDA data

Rizatriptan Benzoate

Product NDC
71335-2031
11-digit product format
713352031
Labeler code
71335
Product ID
71335-2031_95a24865-793b-4bcd-b074-e4a22e826769
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Rizatriptan Benzoate
Dosage form
TABLET
Route
ORAL
Labeler
Bryant Ranch Prepack
Application
ANDA203269
Marketing category
ANDA
Marketing start
2012-06-25
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
Rxcui312840

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
71335-2031-1Rizatriptan Benzoate30 in 1 BOTTLETABLET30101
71335-2031-2Rizatriptan Benzoate18 in 1 BOTTLETABLET18101

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
71335-2031RIZATRIPTAN BENZOATE TABLET [BRYANT RANCH PREPACK]101Current NDC, Legacy NDC, 2 package rows20230324_65ae33a2-975f-4a4e-a1a5-42fe451a2434.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
312840rizatriptan benzoate 5 MG Oral TabletPSN65ae33a2-975f-4a4e-a1a5-42fe451a2434101
312840rizatriptan 5 MG Oral TabletSCD65ae33a2-975f-4a4e-a1a5-42fe451a2434101
312840rizatriptan 5 MG (as rizatriptan benzoate 7.265 MG) Oral TabletSY65ae33a2-975f-4a4e-a1a5-42fe451a2434101

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
71335-2031-17133520310130 TABLET in 1 BOTTLE (71335-2031-1) 30 tablet2022-02-100000-00-00NoNoCurrent
71335-2031-27133520310218 TABLET in 1 BOTTLE (71335-2031-2) 18 tablet2022-02-100000-00-00NoNoCurrent