FDA.reportPublic FDA data

Rizatriptan Benzoate

Product NDC
50090-3921
11-digit product format
500903921
Labeler code
50090
Product ID
50090-3921_7d97f524-4134-43e0-8b0d-ab4e7f672a14
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Rizatriptan Benzoate
Dosage form
TABLET
Route
ORAL
Labeler
A-S Medication Solutions
Application
ANDA200482
Marketing category
ANDA
Marketing start
2012-12-31
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
2022-12-31
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
50090-3921-02023-01-30C16284748780-1f386c64a-1b3f-0266-e053-dadaa90a7c1aThese 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 USP, for oral use Initial U.S. Approval: 1998

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
50090-3921-0Rizatriptan Benzoate18 in 1 CARTONTABLET185
50090-3921-0Rizatriptan Benzoate6 in 1 BLISTER PACKTABLET65

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
50090-3921RIZATRIPTAN BENZOATE (RIZATRIPTAN BENZOATE ) TABLET [A-S MEDICATION SOLUTIONS]5Legacy NDC, 2 package rows20210417_e76ddcf1-32e5-4288-ac8e-36c4bb22910d.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
314209rizatriptan benzoate 10 MG Oral TabletPSNe76ddcf1-32e5-4288-ac8e-36c4bb22910d5
314209rizatriptan 10 MG Oral TabletSCDe76ddcf1-32e5-4288-ac8e-36c4bb22910d5
314209rizatriptan 10 MG (as rizatriptan benzoate 14.53 MG) Oral TabletSYe76ddcf1-32e5-4288-ac8e-36c4bb22910d5

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
50090-3921-05009039210018 BLISTER PACK in 1 CARTON (50090-3921-0) > 6 TABLET in 1 BLISTER PACK18 blister pack2018-12-060000-00-00NoNoCurrent