FDA.reportPublic FDA data

Rizatriptan Benzoate

Product NDC
76282-463
11-digit product format
762820463
Labeler code
76282
Product ID
76282-463_5c316585-d6da-4044-a99d-8aba3bdf6afa
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Rizatriptan Benzoate
Dosage form
TABLET
Route
ORAL
Labeler
Exelan Pharmaceuticals Inc.
Application
ANDA204339
Marketing category
ANDA
Marketing start
2017-06-06
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
76282-463-062022-01-28C16284748780-1d6a99b39-99c4-a426-e053-dadaa90af4c2These 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
76282-463-182022-01-28C16284748780-1d6a99b39-99c4-a426-e053-dadaa90af4c2These 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
76282-463-06Rizatriptan Benzoate6 in 1 BLISTER PACKTABLET65
76282-463-18Rizatriptan Benzoate3 in 1 CARTONTABLET35

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
76282-463-06EA - Each76282-463b08598fe-9db8-483e-bbeb-7e7b9d75d1d512017-07-07
76282-463-18EA - Each76282-4630d891c24-20d7-414b-aee7-70e04a5c6c0812017-07-07

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
76282-463RIZATRIPTAN BENZOATE (RIZATRIPTAN BENZOATE ) TABLET [EXELAN PHARMACEUTICALS INC.]5Legacy NDC, 2 package rows20201126_9e82135a-3371-4012-92af-0cc7d7d4d0e3.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
314209rizatriptan benzoate 10 MG Oral TabletPSN9e82135a-3371-4012-92af-0cc7d7d4d0e35
312840rizatriptan benzoate 5 MG Oral TabletPSN9e82135a-3371-4012-92af-0cc7d7d4d0e35
314209rizatriptan 10 MG Oral TabletSCD9e82135a-3371-4012-92af-0cc7d7d4d0e35
312840rizatriptan 5 MG Oral TabletSCD9e82135a-3371-4012-92af-0cc7d7d4d0e35
314209rizatriptan 10 MG (as rizatriptan benzoate 14.53 MG) Oral TabletSY9e82135a-3371-4012-92af-0cc7d7d4d0e35
312840rizatriptan 5 MG (as rizatriptan benzoate 7.265 MG) Oral TabletSY9e82135a-3371-4012-92af-0cc7d7d4d0e35

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
76282-463-06762820463066 TABLET in 1 BLISTER PACK (76282-463-06) 6 tablet2017-06-060000-00-00NoNoCurrent
76282-463-18762820463183 TABLET in 1 CARTON (76282-463-18) 3 tablet2017-06-060000-00-00NoNoCurrent