FDA.reportPublic FDA data

Rizatriptan Benzoate

Product NDC
71335-1819
11-digit product format
713351819
Labeler code
71335
Product ID
71335-1819_abfcf849-93ed-4779-8f8d-08583f794cf4
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Rizatriptan Benzoate
Dosage form
TABLET, ORALLY DISINTEGRATING
Route
ORAL
Labeler
Bryant Ranch Prepack
Application
ANDA203062
Marketing category
ANDA
Marketing start
2013-07-01
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
Rxcui312837

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
71335-1819-1Rizatriptan Benzoate10 in 1 BLISTER PACKTABLET, ORALLY DISINTEGRATING10103
71335-1819-2Rizatriptan Benzoate18 in 1 BLISTER PACKTABLET, ORALLY DISINTEGRATING18103
71335-1819-3Rizatriptan Benzoate9 in 1 BLISTER PACKTABLET, ORALLY DISINTEGRATING9103

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
71335-1819-2EA - Each71335-1819c5cd8531-3b26-425b-bbb5-7a0f8917c78912022-03-09

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
71335-1819RIZATRIPTAN BENZOATE TABLET, ORALLY DISINTEGRATING [BRYANT RANCH PREPACK]103Current NDC, Legacy NDC, 3 package rows20241004_74971372-75c6-4682-adbf-1c8e7b748fc1.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
312837rizatriptan benzoate 10 MG Disintegrating Oral TabletPSN74971372-75c6-4682-adbf-1c8e7b748fc1103
312837rizatriptan 10 MG Disintegrating Oral TabletSCD74971372-75c6-4682-adbf-1c8e7b748fc1103
312837rizatriptan 10 MG (as rizatriptan benzoate 14.53 MG) Disintegrating Oral TabletSY74971372-75c6-4682-adbf-1c8e7b748fc1103

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionMarketing startMarketing endSampleExclude flagStatus
71335-1819-17133518190110 TABLET, ORALLY DISINTEGRATING in 1 BLISTER PACK (71335-1819-1) 2020-02-100000-00-00NoNoCurrent
71335-1819-27133518190218 TABLET, ORALLY DISINTEGRATING in 1 BLISTER PACK (71335-1819-2) 2020-02-100000-00-00NoNoCurrent
71335-1819-3713351819039 TABLET, ORALLY DISINTEGRATING in 1 BLISTER PACK (71335-1819-3) 2020-02-10NoNoHistorical