FDA.reportPublic FDA data

Rizatriptan Benzoate

Product NDC
65862-600
11-digit product format
658620600
Labeler code
65862
Product ID
65862-600_6993ceca-3f2c-4a98-8749-fd9f65dbfc9b
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Rizatriptan Benzoate
Dosage form
TABLET
Route
ORAL
Labeler
Aurobindo Pharma Limited
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
65862-600-03Rizatriptan Benzoate3 in 1 BLISTER PACKTABLET314
65862-600-06Rizatriptan Benzoate6 in 1 BLISTER PACKTABLET614
65862-600-12Rizatriptan Benzoate4 in 1 CARTONTABLET414
65862-600-18Rizatriptan Benzoate3 in 1 CARTONTABLET314
65862-600-90Rizatriptan Benzoate3 in 1 CARTONTABLET314

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
65862-600-03EA - Each65862-6007ea2a346-4cdc-463c-a0bb-a392009716ad12013-02-13
65862-600-12EA - Each65862-60056ce3e0e-3e92-4136-8ee7-a9899a6ac6f112013-02-13

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIIDailyMed labelSPL versionUploaded
RIZATRIPTAN BENZOATEACTIVE INGREDIENTWR978S7QHHRIZATRIPTAN BENZOATE TABLET [AUROBINDO PHARMA LIMITED]3
RIZATRIPTANACTIVE MOIETY51086HBW8GRIZATRIPTAN BENZOATE TABLET [AUROBINDO PHARMA LIMITED]3
CELLULOSE, MICROCRYSTALLINEINACTIVE INGREDIENTOP1R32D61URIZATRIPTAN BENZOATE TABLET [AUROBINDO PHARMA LIMITED]3
FERRIC OXIDE REDINACTIVE INGREDIENT1K09F3G675RIZATRIPTAN BENZOATE TABLET [AUROBINDO PHARMA LIMITED]3
LACTOSE MONOHYDRATEINACTIVE INGREDIENTEWQ57Q8I5XRIZATRIPTAN BENZOATE TABLET [AUROBINDO PHARMA LIMITED]3
MAGNESIUM STEARATEINACTIVE INGREDIENT70097M6I30RIZATRIPTAN BENZOATE TABLET [AUROBINDO PHARMA LIMITED]3
STARCH, CORNINACTIVE INGREDIENTO8232NY3SJRIZATRIPTAN BENZOATE TABLET [AUROBINDO PHARMA LIMITED]3

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
65862-600RIZATRIPTAN BENZOATE TABLET [AUROBINDO PHARMA LIMITED]14Current NDC, Legacy NDC, 5 package rows20240218_fa0f65b8-96b0-49e4-ac47-9a86fb4aa5f1.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
314209rizatriptan benzoate 10 MG Oral TabletPSNfa0f65b8-96b0-49e4-ac47-9a86fb4aa5f114
312840rizatriptan benzoate 5 MG Oral TabletPSNfa0f65b8-96b0-49e4-ac47-9a86fb4aa5f114
314209rizatriptan 10 MG Oral TabletSCDfa0f65b8-96b0-49e4-ac47-9a86fb4aa5f114
312840rizatriptan 5 MG Oral TabletSCDfa0f65b8-96b0-49e4-ac47-9a86fb4aa5f114
314209rizatriptan 10 MG (as rizatriptan benzoate 14.53 MG) Oral TabletSYfa0f65b8-96b0-49e4-ac47-9a86fb4aa5f114
312840rizatriptan 5 MG (as rizatriptan benzoate 7.265 MG) Oral TabletSYfa0f65b8-96b0-49e4-ac47-9a86fb4aa5f114
314209rizatriptan benzoate 10 MG Oral TabletPSN673d584c-0691-d2fb-e053-2991aa0a77973
312840rizatriptan benzoate 5 MG Oral TabletPSN673d584c-0691-d2fb-e053-2991aa0a77973
314209rizatriptan 10 MG Oral TabletSCD673d584c-0691-d2fb-e053-2991aa0a77973
312840rizatriptan 5 MG Oral TabletSCD673d584c-0691-d2fb-e053-2991aa0a77973
314209rizatriptan 10 MG (as rizatriptan benzoate 14.53 MG) Oral TabletSY673d584c-0691-d2fb-e053-2991aa0a77973
312840rizatriptan 5 MG (as rizatriptan benzoate 7.265 MG) Oral TabletSY673d584c-0691-d2fb-e053-2991aa0a77973
314209rizatriptan benzoate 10 MG Oral TabletPSN4a5b43f6-a5ea-4d6f-941f-3c19f242c8962
314209rizatriptan 10 MG Oral TabletSCD4a5b43f6-a5ea-4d6f-941f-3c19f242c8962
314209rizatriptan 10 MG (as rizatriptan benzoate 14.53 MG) Oral TabletSY4a5b43f6-a5ea-4d6f-941f-3c19f242c8962

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
65862-600-03658620600033 in 1 BLISTER PACKHistorical
65862-600-06658620600066 in 1 BLISTER PACKHistorical
65862-600-12658620600124 BLISTER PACK in 1 CARTON (65862-600-12) / 3 TABLET in 1 BLISTER PACK (65862-600-03) 4 blister pack2012-12-310000-00-00NoNoCurrent
65862-600-18658620600183 BLISTER PACK in 1 CARTON (65862-600-18) / 6 TABLET in 1 BLISTER PACK (65862-600-06) 3 blister pack2012-12-310000-00-00NoNoCurrent
65862-600-90658620600903 BLISTER PACK in 1 CARTON (65862-600-90) / 3 TABLET in 1 BLISTER PACK (65862-600-03) 3 blister pack2012-12-310000-00-00NoNoCurrent