FDA.reportPublic FDA data

Rizatriptan Benzoate

Product NDC
50090-3367
11-digit product format
500903367
Labeler code
50090
Product ID
50090-3367_c1671ce9-11a8-4cc8-8b0c-2a170f1de507
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Rizatriptan Benzoate
Dosage form
TABLET
Route
ORAL
Labeler
A-S Medication Solutions
Application
ANDA202490
Marketing category
ANDA
Marketing start
2012-12-31
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
2026-12-31
Current FDA listing
Yes

Additional Listing Data#

Finished product
Yes
Brand name base
Rizatriptan Benzoate
Listing expiration
2026-12-31

Active Ingredients#

Ingredient, Strength table
IngredientStrength
RIZATRIPTAN BENZOATE10 mg/1

Harmonized Identifiers#

Field, Values table
FieldValues
UniiWR978S7QHH
Rxcui314209

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
50090-3367-02023-02-06C16284748780-1f386c649-d916-0266-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, for oral use Initial U.S. Approval: 1998
50090-3367-02023-02-06C16284748780-1f386c649-d916-0266-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, for oral use Initial U.S. Approval: 1998
50090-3367-02023-01-30C16284748780-1f386c649-d916-0266-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, for oral use Initial U.S. Approval: 1998
50090-3367-02023-01-30C16284748780-1f386c649-d916-0266-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, for oral use Initial U.S. Approval: 1998

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
50090-3367-0Rizatriptan Benzoate6 in 1 BLISTER PACKTABLET611
50090-3367-0Rizatriptan Benzoate3 in 1 CARTONTABLET311

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
50090-3367-0EA - Each50090-3367ac14d96d-3c78-4a9a-afee-a0fc8b7e171712019-05-02

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
50090-3367RIZATRIPTAN BENZOATE TABLET [A-S MEDICATION SOLUTIONS]9Current NDC, Legacy NDC, 2 package rows20240426_187204ef-5370-476a-84b1-e3c54b60c6c2.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
314209rizatriptan benzoate 10 MG Oral TabletPSN187204ef-5370-476a-84b1-e3c54b60c6c211
314209rizatriptan 10 MG Oral TabletSCD187204ef-5370-476a-84b1-e3c54b60c6c211
314209rizatriptan 10 MG (as rizatriptan benzoate 14.53 MG) Oral TabletSY187204ef-5370-476a-84b1-e3c54b60c6c211

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
50090-3367-0500903367003 BLISTER PACK in 1 CARTON (50090-3367-0) / 6 TABLET in 1 BLISTER PACK3 blister pack2018-02-080000-00-00NoNoCurrent