FDA.reportPublic FDA data

Rizatriptan Benzoate

Product NDC
65862-625
11-digit product format
658620625
Labeler code
65862
Product ID
65862-625_b813e372-4315-4a35-a6dd-592b69aee7b8
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Rizatriptan Benzoate
Dosage form
TABLET, ORALLY DISINTEGRATING
Route
ORAL
Labeler
Aurobindo Pharma Limited
Application
ANDA203062
Marketing category
ANDA
Marketing start
2013-07-01
Substance
RIZATRIPTAN BENZOATE
Active strength
5 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 BENZOATE5 mg/1

Harmonized Identifiers#

Field, Values table
FieldValues
UniiWR978S7QHH
Rxcui312837, 312839

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
65862-625-03Rizatriptan Benzoate3 in 1 BLISTER PACKTABLET, ORALLY DISINTEGRATING314
65862-625-06Rizatriptan Benzoate6 in 1 BLISTER PACKTABLET, ORALLY DISINTEGRATING614
65862-625-12Rizatriptan Benzoate4 in 1 CARTONTABLET, ORALLY DISINTEGRATING414
65862-625-18Rizatriptan Benzoate3 in 1 CARTONTABLET, ORALLY DISINTEGRATING314
65862-625-36Rizatriptan Benzoate9 in 1 BOTTLETABLET, ORALLY DISINTEGRATING914
65862-625-48Rizatriptan Benzoate18 in 1 BOTTLETABLET, ORALLY DISINTEGRATING1814
65862-625-64Rizatriptan Benzoate1 in 1 CARTONTABLET, ORALLY DISINTEGRATING114
65862-625-90Rizatriptan Benzoate3 in 1 CARTONTABLET, ORALLY DISINTEGRATING314

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
65862-625RIZATRIPTAN BENZOATE TABLET, ORALLY DISINTEGRATING [AUROBINDO PHARMA LIMITED]13Current NDC, Legacy NDC, 8 package rows20240221_a8e37688-426c-4290-933d-54a34ae86000.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
312837rizatriptan benzoate 10 MG Disintegrating Oral TabletPSNa8e37688-426c-4290-933d-54a34ae8600014
312839rizatriptan benzoate 5 MG Disintegrating Oral TabletPSNa8e37688-426c-4290-933d-54a34ae8600014
312837rizatriptan 10 MG Disintegrating Oral TabletSCDa8e37688-426c-4290-933d-54a34ae8600014
312839rizatriptan 5 MG Disintegrating Oral TabletSCDa8e37688-426c-4290-933d-54a34ae8600014
312837rizatriptan 10 MG (as rizatriptan benzoate 14.53 MG) Disintegrating Oral TabletSYa8e37688-426c-4290-933d-54a34ae8600014
312839rizatriptan 5 MG (as rizatriptan benzoate 7.265 MG) Disintegrating Oral TabletSYa8e37688-426c-4290-933d-54a34ae8600014

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
65862-625-03658620625033 in 1 BLISTER PACKHistorical
65862-625-06658620625066 in 1 BLISTER PACKHistorical
65862-625-12658620625124 BLISTER PACK in 1 CARTON (65862-625-12) / 3 TABLET, ORALLY DISINTEGRATING in 1 BLISTER PACK (65862-625-03) 4 blister pack2013-07-010000-00-00NoNoCurrent
65862-625-18658620625183 BLISTER PACK in 1 CARTON (65862-625-18) / 6 TABLET, ORALLY DISINTEGRATING in 1 BLISTER PACK (65862-625-06) 3 blister pack2013-07-010000-00-00NoNoCurrent
65862-625-36658620625369 TABLET, ORALLY DISINTEGRATING in 1 BOTTLE (65862-625-36) 2018-03-050000-00-00NoNoCurrent
65862-625-486586206254818 TABLET, ORALLY DISINTEGRATING in 1 BOTTLE (65862-625-48) 2018-03-050000-00-00NoNoCurrent
65862-625-49658620625494000 TABLET, ORALLY DISINTEGRATING in 1 BAG (65862-625-49)01-JUL-13Current
65862-625-64658620625641 BLISTER PACK in 1 CARTON (65862-625-64) / 3 TABLET, ORALLY DISINTEGRATING in 1 BLISTER PACK (65862-625-03) 1 blister pack2023-08-28NoNoCurrent
65862-625-90658620625903 BLISTER PACK in 1 CARTON (65862-625-90) / 3 TABLET, ORALLY DISINTEGRATING in 1 BLISTER PACK (65862-625-03) 3 blister pack2013-07-010000-00-00NoNoCurrent