Rizatriptan Benzoate

Product NDC
53002-1713
11-digit product format
530021713
Labeler code
53002
Product ID
53002-1713_67f55b41-eb9b-4568-b162-d7e7c1df64ad
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Rizatriptan Benzoate
Dosage form
TABLET
Route
ORAL
Labeler
RPK Pharmaceuticals, Inc.
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
2021-12-31
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
53002-1713-12025-01-30C16284748780-19d75b9d0-1cff-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
53002-1713-12023-06-07C16284748780-19d75b9d0-1cff-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
53002-1713-12023-01-30C16284748780-19d75b9d0-1cff-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
53002-1713-12020-12-15C16284748780-19d75b9d0-1cff-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
53002-1713-12020-01-31C16284748780-19d75b9d0-1cff-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
53002-1713-1Rizatriptan Benzoate3 in 1 CARTONTABLET35

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
53002-1713RIZATRIPTAN BENZOATE TABLET [RPK PHARMACEUTICALS, INC.]5Legacy NDC, 1 package rows20230609_6535f200-ffa3-4564-972c-3bdadcde4a9b.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
314209rizatriptan benzoate 10 MG Oral TabletPSN6535f200-ffa3-4564-972c-3bdadcde4a9b5
314209rizatriptan 10 MG Oral TabletSCD6535f200-ffa3-4564-972c-3bdadcde4a9b5
314209rizatriptan 10 MG (as rizatriptan benzoate 14.53 MG) Oral TabletSY6535f200-ffa3-4564-972c-3bdadcde4a9b5

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
53002-1713-1530021713013 TABLET in 1 CARTON (53002-1713-1) 3 tablet2018-10-010000-00-00NoNoCurrent