FDA.reportPublic FDA data

Rizatriptan Benzoate

Product NDC
50090-3343
11-digit product format
500903343
Labeler code
50090
Product ID
50090-3343_90fa90cf-19f1-412f-b950-c360dae8c3e9
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Rizatriptan Benzoate
Dosage form
TABLET
Route
ORAL
Labeler
A-S Medication Solutions
Application
ANDA203269
Marketing category
ANDA
Marketing start
2012-06-25
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
50090-3343-02023-02-07C16284748780-1f386c64a-1c4c-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
50090-3343-02023-01-30C16284748780-1f386c64a-1c4c-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
50090-3343-0Rizatriptan Benzoate3 in 1 CARTONTABLET37
50090-3343-0Rizatriptan Benzoate6 in 1 BLISTER PACKTABLET67

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
50090-3343-0EA - Each50090-33439b13d11e-c427-41d1-8e44-bba22d138a9212019-05-02

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
50090-3343RIZATRIPTAN BENZOATE TABLET [A-S MEDICATION SOLUTIONS]7Current NDC, Legacy NDC, 2 package rows20230208_5001b8cc-8e52-4a00-a830-3b2f79766a03.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
314209rizatriptan benzoate 10 MG Oral TabletPSN5001b8cc-8e52-4a00-a830-3b2f79766a037
314209rizatriptan 10 MG Oral TabletSCD5001b8cc-8e52-4a00-a830-3b2f79766a037
314209rizatriptan 10 MG (as rizatriptan benzoate 14.53 MG) Oral TabletSY5001b8cc-8e52-4a00-a830-3b2f79766a037

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
50090-3343-0500903343003 BLISTER PACK in 1 CARTON (50090-3343-0) / 6 TABLET in 1 BLISTER PACK3 blister pack2018-01-220000-00-00NoNoCurrent