FDA.reportPublic FDA data

Rizatriptan Benzoate

Product NDC
71335-0810
11-digit product format
713350810
Labeler code
71335
Product ID
71335-0810_3ad0286c-3909-4f0c-8d74-0250a08a22f3
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Rizatriptan Benzoate
Dosage form
TABLET
Route
ORAL
Labeler
Bryant Ranch Prepack
Application
ANDA204339
Marketing category
ANDA
Marketing start
2016-07-22
Marketing end
0000-00-00
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
2023-12-31
Current FDA listing
Historical FDA.report record

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

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDCEffectiveActionDocumentIndexing SPLRelated label
71335-0810-12024-01-30C16284748780-11030e365-65da-111a-e063-dadaa90a10e2These highlights do not include all the information needed to use rizatriptan benzoate tablets safely and effectively. See full prescribing information for rizatriptan benzoate tablets. Rizatriptan Benzoate Tablets, for oral use Initial U.S. Approval: 1998
71335-0810-22024-01-30C16284748780-11030e365-65da-111a-e063-dadaa90a10e2These highlights do not include all the information needed to use rizatriptan benzoate tablets safely and effectively. See full prescribing information for rizatriptan benzoate tablets. Rizatriptan Benzoate Tablets, for oral use Initial U.S. Approval: 1998

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
71335-0810-1Rizatriptan Benzoate30 in 1 BOTTLETABLET304
71335-0810-2Rizatriptan Benzoate18 in 1 BOTTLETABLET184

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
71335-0810RIZATRIPTAN BENZOATE TABLET [BRYANT RANCH PREPACK]4Legacy NDC, 2 package rows20220202_3ad0286c-3909-4f0c-8d74-0250a08a22f3.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
312840rizatriptan benzoate 5 MG Oral TabletPSN3ad0286c-3909-4f0c-8d74-0250a08a22f34
312840rizatriptan 5 MG Oral TabletSCD3ad0286c-3909-4f0c-8d74-0250a08a22f34
312840rizatriptan 5 MG (as rizatriptan benzoate 7.265 MG) Oral TabletSY3ad0286c-3909-4f0c-8d74-0250a08a22f34

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
71335-0810-17133508100130 TABLET in 1 BOTTLE (71335-0810-1) 30 tablet2018-05-070000-00-00NoNoCurrent
71335-0810-27133508100218 TABLET in 1 BOTTLE (71335-0810-2) 18 tablet2018-05-070000-00-00NoNoCurrent