FDA.reportPublic FDA data

Rizatriptan Benzoate

Product NDC
51407-682
11-digit product format
514070682
Labeler code
51407
Product ID
51407-682_14817bf1-f9e8-c98c-e063-6294a90afc13
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Rizatriptan Benzoate
Dosage form
TABLET
Route
ORAL
Labeler
Golden State Medical Supply, Inc.
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
Rxcui312840, 314209

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

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
51407-682-03Rizatriptan Benzoate3 in 1 BLISTER PACKTABLET32
51407-682-06Rizatriptan Benzoate6 in 1 BLISTER PACKTABLET62
51407-682-12Rizatriptan Benzoate4 in 1 CARTONTABLET42
51407-682-18Rizatriptan Benzoate3 in 1 CARTONTABLET32

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
51407-682-03EA - Each51407-682baa01197-b40c-4062-b309-306e7b68131b12026-01-08
51407-682-06EA - Each51407-68293685fbe-fef7-423c-9a80-61497b1e442712026-01-08

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
51407-682RIZATRIPTAN BENZOATE TABLET [GOLDEN STATE MEDICAL SUPPLY, INC.]2Current NDC, 4 package rows20240404_075f47ee-88d1-102b-e063-6394a90acbf8.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
314209rizatriptan benzoate 10 MG Oral TabletPSN075f47ee-88d1-102b-e063-6394a90acbf82
312840rizatriptan benzoate 5 MG Oral TabletPSN075f47ee-88d1-102b-e063-6394a90acbf82
314209rizatriptan 10 MG Oral TabletSCD075f47ee-88d1-102b-e063-6394a90acbf82
312840rizatriptan 5 MG Oral TabletSCD075f47ee-88d1-102b-e063-6394a90acbf82
314209rizatriptan 10 MG (as rizatriptan benzoate 14.53 MG) Oral TabletSY075f47ee-88d1-102b-e063-6394a90acbf82
312840rizatriptan 5 MG (as rizatriptan benzoate 7.265 MG) Oral TabletSY075f47ee-88d1-102b-e063-6394a90acbf82

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startSampleExclude flagStatus
51407-682-03514070682033 in 1 BLISTER PACKHistorical
51407-682-06514070682066 in 1 BLISTER PACKHistorical
51407-682-12514070682124 BLISTER PACK in 1 CARTON (51407-682-12) / 3 TABLET in 1 BLISTER PACK (51407-682-03) 4 blister pack2023-09-28NoNoCurrent
51407-682-18514070682183 BLISTER PACK in 1 CARTON (51407-682-18) / 6 TABLET in 1 BLISTER PACK (51407-682-06) 3 blister pack2023-09-28NoNoCurrent