FDA.reportPublic FDA data

rizatriptan benzoate

Product NDC
33342-094
11-digit product format
333420094
Labeler code
33342
Product ID
33342-094_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
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
33342-094-04rizatriptan benzoate12 in 1 CONTAINERTABLET, ORALLY DISINTEGRATING127
33342-094-07rizatriptan benzoate30 in 1 CONTAINERTABLET, ORALLY DISINTEGRATING307
33342-094-12rizatriptan benzoate10 in 1 CARTONTABLET, ORALLY DISINTEGRATING107
33342-094-12rizatriptan benzoate10 in 1 BLISTER PACKTABLET, ORALLY DISINTEGRATING107
33342-094-23rizatriptan benzoate18 in 1 CONTAINERTABLET, ORALLY DISINTEGRATING187
33342-094-41rizatriptan benzoate6 in 1 BLISTER PACKTABLET, ORALLY DISINTEGRATING67
33342-094-41rizatriptan benzoate3 in 1 CARTONTABLET, ORALLY DISINTEGRATING37
33342-094-45rizatriptan benzoate2 in 1 CARTONTABLET, ORALLY DISINTEGRATING27
33342-094-45rizatriptan benzoate6 in 1 BLISTER PACKTABLET, ORALLY DISINTEGRATING67
33342-094-46rizatriptan benzoate200 in 1 CONTAINERTABLET, ORALLY DISINTEGRATING2007
33342-094-47rizatriptan benzoate4 in 1 CARTONTABLET, ORALLY DISINTEGRATING47
33342-094-47rizatriptan benzoate1 in 1 POUCHTABLET, ORALLY DISINTEGRATING17
33342-094-52rizatriptan benzoate3 in 1 BLISTER PACKTABLET, ORALLY DISINTEGRATING37
33342-094-52rizatriptan benzoate1 in 1 CARTONTABLET, ORALLY DISINTEGRATING17
33342-094-72rizatriptan benzoate6 in 1 CARTONTABLET, ORALLY DISINTEGRATING67
33342-094-72rizatriptan benzoate3 in 1 BLISTER PACKTABLET, ORALLY DISINTEGRATING37
33342-094-73rizatriptan benzoate3 in 1 CARTONTABLET, ORALLY DISINTEGRATING37
33342-094-73rizatriptan benzoate3 in 1 BLISTER PACKTABLET, ORALLY DISINTEGRATING37

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
33342-094-41EA - Each33342-094e9a31423-68dd-4a9d-98fb-e36a83105b6612018-08-13
33342-094-45EA - Each33342-0942ca3d8e3-da2f-4355-80a5-b6077ccbb99412019-11-12
33342-094-52EA - Each33342-0944ec8b0f5-dfcf-408a-bc81-96b8627830a012018-01-12
33342-094-72EA - Each33342-094735b0779-2a95-4f54-aeb3-baf5d735c45112015-09-10
33342-094-73EA - Each33342-0942c9cd0da-e1f8-4bc4-a0a3-86262d9bfa4912016-07-19

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
33342-094RIZATRIPTAN 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
312837rizatriptan benzoate 10 MG Disintegrating Oral TabletPSN2c29e066-c018-22e7-e063-6294a90a035c2
312837rizatriptan 10 MG Disintegrating Oral TabletSCD2c29e066-c018-22e7-e063-6294a90a035c2
312837rizatriptan 10 MG (as rizatriptan benzoate 14.53 MG) Disintegrating Oral TabletSY2c29e066-c018-22e7-e063-6294a90a035c2

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
33342-094-043334200940412 TABLET, ORALLY DISINTEGRATING in 1 CONTAINER (33342-094-04) 2023-02-27NoNoHistorical
33342-094-073334200940730 TABLET, ORALLY DISINTEGRATING in 1 CONTAINER (33342-094-07) 2014-09-230000-00-00NoNoCurrent
33342-094-123334200941210 BLISTER PACK in 1 CARTON (33342-094-12) / 10 TABLET, ORALLY DISINTEGRATING in 1 BLISTER PACK10 blister pack2014-09-230000-00-00NoNoCurrent
33342-094-233334200942318 TABLET, ORALLY DISINTEGRATING in 1 CONTAINER (33342-094-23) 2023-02-27NoNoHistorical
33342-094-41333420094413 BLISTER PACK in 1 CARTON (33342-094-41) / 6 TABLET, ORALLY DISINTEGRATING in 1 BLISTER PACK3 blister pack2018-06-040000-00-00NoNoCurrent
33342-094-45333420094452 BLISTER PACK in 1 CARTON (33342-094-45) / 6 TABLET, ORALLY DISINTEGRATING in 1 BLISTER PACK2 blister pack2018-12-190000-00-00NoNoCurrent
33342-094-4633342009446200 TABLET, ORALLY DISINTEGRATING in 1 CONTAINER (33342-094-46) 2014-09-230000-00-00NoNoCurrent
33342-094-47333420094474 POUCH in 1 CARTON (33342-094-47) / 1 BLISTER PACK in 1 POUCH / 5 TABLET, ORALLY DISINTEGRATING in 1 BLISTER PACK4 pouch2014-09-230000-00-00NoNoCurrent
33342-094-52333420094521 BLISTER PACK in 1 CARTON (33342-094-52) / 3 TABLET, ORALLY DISINTEGRATING in 1 BLISTER PACK1 blister pack2017-02-130000-00-00NoNoCurrent
33342-094-72333420094726 BLISTER PACK in 1 CARTON (33342-094-72) / 3 TABLET, ORALLY DISINTEGRATING in 1 BLISTER PACK6 blister pack2017-02-130000-00-00NoNoCurrent
33342-094-73333420094733 BLISTER PACK in 1 CARTON (33342-094-73) / 3 TABLET, ORALLY DISINTEGRATING in 1 BLISTER PACK3 blister pack2017-02-130000-00-00NoNoCurrent