FDA.reportPublic FDA data

RIZATRIPTAN BENZOATE

Product NDC
63629-8256
11-digit product format
636298256
Labeler code
63629
Product ID
63629-8256_cbc8714e-823e-4280-9b1d-6f8270c15524
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
rizatriptan benzoate
Dosage form
TABLET, ORALLY DISINTEGRATING
Route
ORAL
Labeler
Bryant Ranch Prepack
Application
ANDA204722
Marketing category
ANDA
Marketing start
2017-01-17
Marketing end
0000-00-00
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
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
63629-8256-12024-01-30C16284748780-11030e365-65fc-111a-e063-dadaa90a10e2These highlights do not include all the information needed to use RIZATRIPTAN BENZOATE ORALLY DISINTEGRATING TABLETS, USP safely and effectively. See full prescribing information for RIZATRIPTAN BENZOATE ORALLY DISINTEGRATING TABLETS, USP. RIZATRIPTAN BENZOATE orally disintegrating tablets, USP Initial U.S. Approval: 1998
63629-8256-22024-01-30C16284748780-11030e365-65fc-111a-e063-dadaa90a10e2These highlights do not include all the information needed to use RIZATRIPTAN BENZOATE ORALLY DISINTEGRATING TABLETS, USP safely and effectively. See full prescribing information for RIZATRIPTAN BENZOATE ORALLY DISINTEGRATING TABLETS, USP. RIZATRIPTAN BENZOATE orally disintegrating tablets, USP Initial U.S. Approval: 1998

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
63629-8256-1RIZATRIPTAN BENZOATE10 in 1 BOTTLETABLET, ORALLY DISINTEGRATING103
63629-8256-2RIZATRIPTAN BENZOATE18 in 1 BOTTLETABLET, ORALLY DISINTEGRATING183

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
63629-8256RIZATRIPTAN BENZOATE TABLET, ORALLY DISINTEGRATING [BRYANT RANCH PREPACK]3Legacy NDC, 2 package rows20220120_8455360f-3b3f-4101-ad1b-0ca3fc7e45e4.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
312837rizatriptan benzoate 10 MG Disintegrating Oral TabletPSN8455360f-3b3f-4101-ad1b-0ca3fc7e45e43
312837rizatriptan 10 MG Disintegrating Oral TabletSCD8455360f-3b3f-4101-ad1b-0ca3fc7e45e43
312837rizatriptan 10 MG (as rizatriptan benzoate 14.53 MG) Disintegrating Oral TabletSY8455360f-3b3f-4101-ad1b-0ca3fc7e45e43

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionMarketing startMarketing endSampleExclude flagStatus
63629-8256-16362982560110 TABLET, ORALLY DISINTEGRATING in 1 BOTTLE (63629-8256-1) 2020-10-150000-00-00NoNoCurrent
63629-8256-26362982560218 TABLET, ORALLY DISINTEGRATING in 1 BOTTLE (63629-8256-2) 2020-09-230000-00-00NoNoCurrent