FDA.reportPublic FDA data

Rizatriptan Benzoate

Product NDC
65862-626
11-digit product format
658620626
Labeler code
65862
Product ID
65862-626_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
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, 312839

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
f2791553-0b76-42f4-8d49-af3eda072bfbProduct name120251117
707ffe6e-db52-42b0-9a65-a0c00213f04fProduct name120231006
a62a50ac-1535-4461-9768-8ae703e2e9fbProduct name120210525
8b537454-32b8-7e64-1395-258682782d07Product name520170424
9514609b-a2a9-f8ec-6ba6-3f8e5ee89877Product name120140508
bc07ef78-e82d-0c19-31f4-31f263780582Product name120140508

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
65862-626-03Rizatriptan Benzoate3 in 1 BLISTER PACKTABLET, ORALLY DISINTEGRATING314
65862-626-06Rizatriptan Benzoate6 in 1 BLISTER PACKTABLET, ORALLY DISINTEGRATING614
65862-626-12Rizatriptan Benzoate4 in 1 CARTONTABLET, ORALLY DISINTEGRATING414
65862-626-18Rizatriptan Benzoate3 in 1 CARTONTABLET, ORALLY DISINTEGRATING314
65862-626-36Rizatriptan Benzoate9 in 1 BOTTLETABLET, ORALLY DISINTEGRATING914
65862-626-48Rizatriptan Benzoate18 in 1 BOTTLETABLET, ORALLY DISINTEGRATING1814
65862-626-64Rizatriptan Benzoate1 in 1 CARTONTABLET, ORALLY DISINTEGRATING114
65862-626-90Rizatriptan Benzoate3 in 1 CARTONTABLET, ORALLY DISINTEGRATING314

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
65862-626RIZATRIPTAN 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
312837rizatriptan benzoate 10 MG Disintegrating Oral TabletPSNdb489d19-1509-c979-e053-2a95a90a44102
312837rizatriptan 10 MG Disintegrating Oral TabletSCDdb489d19-1509-c979-e053-2a95a90a44102
312837rizatriptan 10 MG (as rizatriptan benzoate 14.53 MG) Disintegrating Oral TabletSYdb489d19-1509-c979-e053-2a95a90a44102
312837rizatriptan benzoate 10 MG Disintegrating Oral TabletPSN11a7f243-3a8b-41fd-a9fa-1dd2dcafab931
312837rizatriptan benzoate 10 MG Disintegrating Oral TabletPSN1e547fac-a9e5-4c7b-adba-4e6b751411831
312837rizatriptan 10 MG Disintegrating Oral TabletSCD11a7f243-3a8b-41fd-a9fa-1dd2dcafab931
312837rizatriptan 10 MG Disintegrating Oral TabletSCD1e547fac-a9e5-4c7b-adba-4e6b751411831
312837rizatriptan 10 MG (as rizatriptan benzoate 14.53 MG) Disintegrating Oral TabletSY11a7f243-3a8b-41fd-a9fa-1dd2dcafab931
312837rizatriptan 10 MG (as rizatriptan benzoate 14.53 MG) Disintegrating Oral TabletSY1e547fac-a9e5-4c7b-adba-4e6b751411831

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
65862-626-03658620626033 in 1 BLISTER PACKHistorical
65862-626-06658620626066 in 1 BLISTER PACKHistorical
65862-626-12658620626124 BLISTER PACK in 1 CARTON (65862-626-12) / 3 TABLET, ORALLY DISINTEGRATING in 1 BLISTER PACK (65862-626-03) 4 blister pack2013-07-010000-00-00NoNoCurrent
65862-626-18658620626183 BLISTER PACK in 1 CARTON (65862-626-18) / 6 TABLET, ORALLY DISINTEGRATING in 1 BLISTER PACK (65862-626-06) 3 blister pack2013-07-010000-00-00NoNoCurrent
65862-626-36658620626369 TABLET, ORALLY DISINTEGRATING in 1 BOTTLE (65862-626-36) 2018-03-050000-00-00NoNoCurrent
65862-626-39658620626393000 TABLET, ORALLY DISINTEGRATING in 1 BAG (65862-626-39)01-JUL-13Current
65862-626-486586206264818 TABLET, ORALLY DISINTEGRATING in 1 BOTTLE (65862-626-48) 2018-03-050000-00-00NoNoCurrent
65862-626-64658620626641 BLISTER PACK in 1 CARTON (65862-626-64) / 3 TABLET, ORALLY DISINTEGRATING in 1 BLISTER PACK (65862-626-03) 1 blister pack2023-08-28NoNoCurrent
65862-626-90658620626903 BLISTER PACK in 1 CARTON (65862-626-90) / 3 TABLET, ORALLY DISINTEGRATING in 1 BLISTER PACK (65862-626-03) 3 blister pack2013-07-010000-00-00NoNoCurrent