FDA.reportPublic FDA data

Rizatriptan Benzoate

Product NDC
67877-262
11-digit product format
678770262
Labeler code
67877
Product ID
67877-262_9fd3ccaa-ae93-475b-9591-5c4af70f51c5
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Rizatriptan Benzoate
Dosage form
TABLET
Route
ORAL
Labeler
Ascend Laboratories, LLC
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
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
67877-262-01Rizatriptan Benzoate100 in 1 BOTTLETABLET10014
67877-262-05Rizatriptan Benzoate500 in 1 BOTTLETABLET50014
67877-262-18Rizatriptan Benzoate3 in 1 CARTONTABLET314
67877-262-18Rizatriptan Benzoate6 in 1 BLISTER PACKTABLET614
67877-262-25Rizatriptan Benzoate6 in 1 BLISTER PACKTABLET614
67877-262-25Rizatriptan Benzoate2 in 1 CARTONTABLET214
67877-262-30Rizatriptan Benzoate30 in 1 BOTTLETABLET3014

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
67877-262-18EA - Each67877-26234e9d268-0213-45d0-a783-a8b3a9e77cab12016-07-19
67877-262-25EA - Each67877-262e47a3d28-6cfc-4aed-96e1-9d06e6ff049812016-07-19

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
67877-262RIZATRIPTAN BENZOATE TABLET [ASCEND LABORATORIES, LLC]14Current NDC, Legacy NDC, 7 package rows20221004_07e66554-bc85-4853-9f40-1249617630a9.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
314209rizatriptan benzoate 10 MG Oral TabletPSN07e66554-bc85-4853-9f40-1249617630a914
312840rizatriptan benzoate 5 MG Oral TabletPSN07e66554-bc85-4853-9f40-1249617630a914
314209rizatriptan 10 MG Oral TabletSCD07e66554-bc85-4853-9f40-1249617630a914
312840rizatriptan 5 MG Oral TabletSCD07e66554-bc85-4853-9f40-1249617630a914
314209rizatriptan 10 MG (as rizatriptan benzoate 14.53 MG) Oral TabletSY07e66554-bc85-4853-9f40-1249617630a914
312840rizatriptan 5 MG (as rizatriptan benzoate 7.265 MG) Oral TabletSY07e66554-bc85-4853-9f40-1249617630a914
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
314209rizatriptan benzoate 10 MG Oral TabletPSN700d2061-dfe8-4352-9b83-befef21e3f351
314209rizatriptan 10 MG Oral TabletSCD700d2061-dfe8-4352-9b83-befef21e3f351
314209rizatriptan 10 MG (as rizatriptan benzoate 14.53 MG) Oral TabletSY700d2061-dfe8-4352-9b83-befef21e3f351

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
67877-262-0167877026201100 TABLET in 1 BOTTLE (67877-262-01) 100 tablet2012-06-250000-00-00NoNoCurrent
67877-262-0567877026205500 TABLET in 1 BOTTLE (67877-262-05) 500 tablet2012-06-250000-00-00NoNoCurrent
67877-262-18678770262183 BLISTER PACK in 1 CARTON (67877-262-18) / 6 TABLET in 1 BLISTER PACK3 blister pack2012-06-250000-00-00NoNoCurrent
67877-262-25678770262252 BLISTER PACK in 1 CARTON (67877-262-25) / 6 TABLET in 1 BLISTER PACK2 blister pack2012-06-250000-00-00NoNoCurrent
67877-262-306787702623030 TABLET in 1 BOTTLE (67877-262-30) 30 tablet2012-06-250000-00-00NoNoCurrent