FDA.reportPublic FDA data

Rizatriptan Benzoate

Product NDC
63629-7433
11-digit product format
636297433
Labeler code
63629
Product ID
63629-7433_440c4581-1f01-4ae7-b627-cb236ef59516
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
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
63629-7433-12024-01-30C16284748780-19d75b9d0-7537-f424-e053-dadaa90a57ceThese 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
63629-7433-22024-01-30C16284748780-19d75b9d0-7537-f424-e053-dadaa90a57ceThese 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
63629-7433-32024-01-30C16284748780-19d75b9d0-7537-f424-e053-dadaa90a57ceThese 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
63629-7433-42024-01-30C16284748780-19d75b9d0-7537-f424-e053-dadaa90a57ceThese 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
63629-7433-52024-01-30C16284748780-19d75b9d0-7537-f424-e053-dadaa90a57ceThese 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
63629-7433-62024-01-30C16284748780-19d75b9d0-7537-f424-e053-dadaa90a57ceThese 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
63629-7433-72024-01-30C16284748780-19d75b9d0-7537-f424-e053-dadaa90a57ceThese 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
63629-7433-12020-10-28C16284748780-19d75b9d0-7537-f424-e053-dadaa90a57ceThese 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
63629-7433-22020-10-28C16284748780-19d75b9d0-7537-f424-e053-dadaa90a57ceThese 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
63629-7433-32020-10-28C16284748780-19d75b9d0-7537-f424-e053-dadaa90a57ceThese 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
63629-7433-42020-10-28C16284748780-19d75b9d0-7537-f424-e053-dadaa90a57ceThese 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
63629-7433-52020-10-28C16284748780-19d75b9d0-7537-f424-e053-dadaa90a57ceThese 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
63629-7433-12020-01-31C16284748780-19d75b9d0-7537-f424-e053-dadaa90a57ceThese 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
63629-7433-22020-01-31C16284748780-19d75b9d0-7537-f424-e053-dadaa90a57ceThese 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
63629-7433-32020-01-31C16284748780-19d75b9d0-7537-f424-e053-dadaa90a57ceThese 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
63629-7433-42020-01-31C16284748780-19d75b9d0-7537-f424-e053-dadaa90a57ceThese 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
63629-7433-52020-01-31C16284748780-19d75b9d0-7537-f424-e053-dadaa90a57ceThese 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
63629-7433-1Rizatriptan Benzoate10 in 1 BOTTLETABLET107
63629-7433-2Rizatriptan Benzoate6 in 1 BOTTLETABLET67
63629-7433-3Rizatriptan Benzoate90 in 1 BOTTLETABLET907
63629-7433-4Rizatriptan Benzoate9 in 1 BOTTLETABLET97
63629-7433-5Rizatriptan Benzoate30 in 1 BOTTLETABLET307
63629-7433-6Rizatriptan Benzoate18 in 1 BOTTLETABLET187
63629-7433-7Rizatriptan Benzoate12 in 1 BOTTLETABLET127

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
63629-7433RIZATRIPTAN BENZOATE TABLET [BRYANT RANCH PREPACK]7Legacy NDC, 7 package rows20220115_32094145-be64-4f14-ace7-b29c9b051daf.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
314209rizatriptan benzoate 10 MG Oral TabletPSN32094145-be64-4f14-ace7-b29c9b051daf7
314209rizatriptan 10 MG Oral TabletSCD32094145-be64-4f14-ace7-b29c9b051daf7
314209rizatriptan 10 MG (as rizatriptan benzoate 14.53 MG) Oral TabletSY32094145-be64-4f14-ace7-b29c9b051daf7

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
63629-7433-16362974330110 TABLET in 1 BOTTLE (63629-7433-1) 10 tablet2017-11-030000-00-00NoNoCurrent
63629-7433-2636297433026 TABLET in 1 BOTTLE (63629-7433-2) 6 tablet2020-10-280000-00-00NoNoCurrent
63629-7433-36362974330390 TABLET in 1 BOTTLE (63629-7433-3) 90 tablet2020-10-280000-00-00NoNoCurrent
63629-7433-4636297433049 TABLET in 1 BOTTLE (63629-7433-4) 9 tablet2018-01-250000-00-00NoNoCurrent
63629-7433-56362974330530 TABLET in 1 BOTTLE (63629-7433-5) 30 tablet2019-03-190000-00-00NoNoCurrent
63629-7433-66362974330618 TABLET in 1 BOTTLE (63629-7433-6) 18 tablet2020-03-020000-00-00NoNoCurrent
63629-7433-76362974330712 TABLET in 1 BOTTLE (63629-7433-7) 12 tablet2020-10-280000-00-00NoNoCurrent