FDA.reportPublic FDA data

rizatriptan benzoate

Product NDC
33342-093
11-digit product format
333420093
Labeler code
33342
Product ID
33342-093_137f6265-8c70-4748-a0d5-3976274e4ea0
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
rizatriptan benzoate
Dosage form
TABLET, ORALLY DISINTEGRATING
Route
ORAL
Labeler
Macleods Pharmaceuticals Limited
Application
ANDA203146
Marketing category
ANDA
Marketing start
2014-09-23
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
33342-093-04rizatriptan benzoate12 in 1 CONTAINERTABLET, ORALLY DISINTEGRATING127
33342-093-07rizatriptan benzoate30 in 1 CONTAINERTABLET, ORALLY DISINTEGRATING307
33342-093-12rizatriptan benzoate10 in 1 CARTONTABLET, ORALLY DISINTEGRATING107
33342-093-12rizatriptan benzoate10 in 1 BLISTER PACKTABLET, ORALLY DISINTEGRATING107
33342-093-23rizatriptan benzoate18 in 1 CONTAINERTABLET, ORALLY DISINTEGRATING187
33342-093-41rizatriptan benzoate3 in 1 CARTONTABLET, ORALLY DISINTEGRATING37
33342-093-41rizatriptan benzoate6 in 1 BLISTER PACKTABLET, ORALLY DISINTEGRATING67
33342-093-45rizatriptan benzoate2 in 1 CARTONTABLET, ORALLY DISINTEGRATING27
33342-093-45rizatriptan benzoate6 in 1 BLISTER PACKTABLET, ORALLY DISINTEGRATING67
33342-093-46rizatriptan benzoate200 in 1 CONTAINERTABLET, ORALLY DISINTEGRATING2007
33342-093-48rizatriptan benzoate4 in 1 CARTONTABLET, ORALLY DISINTEGRATING47
33342-093-48rizatriptan benzoate1 in 1 POUCHTABLET, ORALLY DISINTEGRATING17
33342-093-52rizatriptan benzoate1 in 1 CARTONTABLET, ORALLY DISINTEGRATING17
33342-093-52rizatriptan benzoate3 in 1 BLISTER PACKTABLET, ORALLY DISINTEGRATING37
33342-093-72rizatriptan benzoate6 in 1 CARTONTABLET, ORALLY DISINTEGRATING67
33342-093-72rizatriptan benzoate3 in 1 BLISTER PACKTABLET, ORALLY DISINTEGRATING37
33342-093-73rizatriptan benzoate3 in 1 BLISTER PACKTABLET, ORALLY DISINTEGRATING37
33342-093-73rizatriptan benzoate3 in 1 CARTONTABLET, ORALLY DISINTEGRATING37

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
33342-093-41EA - Each33342-0933cd5e93e-24ae-4929-9899-ac15a48fd80012018-08-13
33342-093-45EA - Each33342-093312036eb-dbfa-44e7-b732-c31e8969df6e12019-11-12
33342-093-52EA - Each33342-0938f29b7b0-1b60-4efe-a4e5-b02f7f16799612018-01-12
33342-093-72EA - Each33342-093bdbc6970-80b4-49a9-8159-e44384cdc6c012015-09-10
33342-093-73EA - Each33342-0933c5ca6de-d9db-4279-90af-6804dd2b60e012016-07-19

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIIDailyMed labelSPL versionUploaded
RIZATRIPTAN BENZOATEACTIVE INGREDIENTWR978S7QHHRIZATRIPTAN BENZOATE TABLET, ORALLY DISINTEGRATING [MACLEODS PHARMACEUTICALS LIMITED]2
RIZATRIPTANACTIVE MOIETY51086HBW8GRIZATRIPTAN BENZOATE TABLET, ORALLY DISINTEGRATING [MACLEODS PHARMACEUTICALS LIMITED]2
ASPARTAMEINACTIVE INGREDIENTZ0H242BBR1RIZATRIPTAN BENZOATE TABLET, ORALLY DISINTEGRATING [MACLEODS PHARMACEUTICALS LIMITED]2
CARBOXYMETHYLCELLULOSE CALCIUMINACTIVE INGREDIENTUTY7PDF93LRIZATRIPTAN BENZOATE TABLET, ORALLY DISINTEGRATING [MACLEODS PHARMACEUTICALS LIMITED]2
CELLULOSE, MICROCRYSTALLINEINACTIVE INGREDIENTOP1R32D61URIZATRIPTAN BENZOATE TABLET, ORALLY DISINTEGRATING [MACLEODS PHARMACEUTICALS LIMITED]2
COLLOIDAL SILICON DIOXIDEINACTIVE INGREDIENTETJ7Z6XBU4RIZATRIPTAN BENZOATE TABLET, ORALLY DISINTEGRATING [MACLEODS PHARMACEUTICALS LIMITED]2
MAGNESIUM STEARATEINACTIVE INGREDIENT70097M6I30RIZATRIPTAN BENZOATE TABLET, ORALLY DISINTEGRATING [MACLEODS PHARMACEUTICALS LIMITED]2
MANNITOLINACTIVE INGREDIENT3OWL53L36ARIZATRIPTAN BENZOATE TABLET, ORALLY DISINTEGRATING [MACLEODS PHARMACEUTICALS LIMITED]2
PEPPERMINTINACTIVE INGREDIENTV95R5KMY2BRIZATRIPTAN BENZOATE TABLET, ORALLY DISINTEGRATING [MACLEODS PHARMACEUTICALS LIMITED]2

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
33342-093RIZATRIPTAN BENZOATE TABLET, ORALLY DISINTEGRATING [MACLEODS PHARMACEUTICALS LIMITED]7Current NDC, Legacy NDC, 18 package rows20230301_57ed2505-28f1-4292-b3c3-a49bf0f7c683.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
312837rizatriptan benzoate 10 MG Disintegrating Oral TabletPSN57ed2505-28f1-4292-b3c3-a49bf0f7c6837
312839rizatriptan benzoate 5 MG Disintegrating Oral TabletPSN57ed2505-28f1-4292-b3c3-a49bf0f7c6837
312837rizatriptan 10 MG Disintegrating Oral TabletSCD57ed2505-28f1-4292-b3c3-a49bf0f7c6837
312839rizatriptan 5 MG Disintegrating Oral TabletSCD57ed2505-28f1-4292-b3c3-a49bf0f7c6837
312837rizatriptan 10 MG (as rizatriptan benzoate 14.53 MG) Disintegrating Oral TabletSY57ed2505-28f1-4292-b3c3-a49bf0f7c6837
312839rizatriptan 5 MG (as rizatriptan benzoate 7.265 MG) Disintegrating Oral TabletSY57ed2505-28f1-4292-b3c3-a49bf0f7c6837

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
33342-093-043334200930412 TABLET, ORALLY DISINTEGRATING in 1 CONTAINER (33342-093-04) 2023-02-27NoNoHistorical
33342-093-073334200930730 TABLET, ORALLY DISINTEGRATING in 1 CONTAINER (33342-093-07) 2014-09-230000-00-00NoNoCurrent
33342-093-123334200931210 BLISTER PACK in 1 CARTON (33342-093-12) / 10 TABLET, ORALLY DISINTEGRATING in 1 BLISTER PACK10 blister pack2014-09-230000-00-00NoNoCurrent
33342-093-233334200932318 TABLET, ORALLY DISINTEGRATING in 1 CONTAINER (33342-093-23) 2023-02-27NoNoHistorical
33342-093-41333420093413 BLISTER PACK in 1 CARTON (33342-093-41) / 6 TABLET, ORALLY DISINTEGRATING in 1 BLISTER PACK3 blister pack2018-06-040000-00-00NoNoCurrent
33342-093-45333420093452 BLISTER PACK in 1 CARTON (33342-093-45) / 6 TABLET, ORALLY DISINTEGRATING in 1 BLISTER PACK2 blister pack2018-12-190000-00-00NoNoCurrent
33342-093-4633342009346200 TABLET, ORALLY DISINTEGRATING in 1 CONTAINER (33342-093-46) 2014-09-230000-00-00NoNoCurrent
33342-093-48333420093484 POUCH in 1 CARTON (33342-093-48) / 1 BLISTER PACK in 1 POUCH / 10 TABLET, ORALLY DISINTEGRATING in 1 BLISTER PACK4 pouch2014-09-230000-00-00NoNoCurrent
33342-093-52333420093521 BLISTER PACK in 1 CARTON (33342-093-52) / 3 TABLET, ORALLY DISINTEGRATING in 1 BLISTER PACK1 blister pack2017-02-130000-00-00NoNoCurrent
33342-093-72333420093726 BLISTER PACK in 1 CARTON (33342-093-72) / 3 TABLET, ORALLY DISINTEGRATING in 1 BLISTER PACK6 blister pack2017-02-130000-00-00NoNoCurrent
33342-093-73333420093733 BLISTER PACK in 1 CARTON (33342-093-73) / 3 TABLET, ORALLY DISINTEGRATING in 1 BLISTER PACK3 blister pack2017-02-130000-00-00NoNoCurrent