FDA.reportPublic FDA data

Rizatriptan

Product NDC
33342-088
11-digit product format
333420088
Labeler code
33342
Product ID
33342-088_fe80232a-c329-47ed-8edd-7786e06f3c08
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Rizatriptan
Dosage form
TABLET, FILM COATED
Route
ORAL
Labeler
Macleods Pharmaceuticals Limited
Application
ANDA203147
Marketing category
ANDA
Marketing start
2014-03-11
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
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
33342-088-02Rizatriptan6 in 1 BLISTER PACKTABLET, FILM COATED67
33342-088-07Rizatriptan30 in 1 CONTAINERTABLET, FILM COATED307
33342-088-12Rizatriptan10 in 1 CARTONTABLET, FILM COATED107
33342-088-12Rizatriptan10 in 1 BLISTER PACKTABLET, FILM COATED107
33342-088-41Rizatriptan3 in 1 CARTONTABLET, FILM COATED37
33342-088-45Rizatriptan2 in 1 CARTONTABLET, FILM COATED27
33342-088-46Rizatriptan200 in 1 CONTAINERTABLET, FILM COATED2007
33342-088-50Rizatriptan4 in 1 CARTONTABLET, FILM COATED47
33342-088-52Rizatriptan3 in 1 BLISTER PACKTABLET, FILM COATED37
33342-088-72Rizatriptan6 in 1 CARTONTABLET, FILM COATED67

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
33342-088-02EA - Each33342-088212191be-1002-4709-b6bb-23ae098d9fb312019-01-24
33342-088-41EA - Each33342-08810a099cb-01b4-4c59-869f-9fb7773ce3d012019-01-24
33342-088-45EA - Each33342-088ce555d7b-f7b7-4047-9715-18c6fe821d8012019-01-24
33342-088-50EA - Each33342-0880c7fe28a-632f-4aa8-8583-4f922f6ab2ee12015-02-02
33342-088-72EA - Each33342-0883871d48f-f725-401a-9040-35dff7e8d98412015-02-02

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIIDailyMed labelSPL versionUploaded
RIZATRIPTAN BENZOATEACTIVE INGREDIENTWR978S7QHHRIZATRIPTAN TABLET, FILM COATED [MACLEODS PHARMACEUTICALS LIMITED]2
RIZATRIPTANACTIVE MOIETY51086HBW8GRIZATRIPTAN TABLET, FILM COATED [MACLEODS PHARMACEUTICALS LIMITED]2
CELLULOSE, MICROCRYSTALLINEINACTIVE INGREDIENTOP1R32D61URIZATRIPTAN TABLET, FILM COATED [MACLEODS PHARMACEUTICALS LIMITED]2
FERRIC OXIDE REDINACTIVE INGREDIENT1K09F3G675RIZATRIPTAN TABLET, FILM COATED [MACLEODS PHARMACEUTICALS LIMITED]2
LACTOSE MONOHYDRATEINACTIVE INGREDIENTEWQ57Q8I5XRIZATRIPTAN TABLET, FILM COATED [MACLEODS PHARMACEUTICALS LIMITED]2
MAGNESIUM STEARATEINACTIVE INGREDIENT70097M6I30RIZATRIPTAN TABLET, FILM COATED [MACLEODS PHARMACEUTICALS LIMITED]2
STARCH, CORNINACTIVE INGREDIENTO8232NY3SJRIZATRIPTAN TABLET, FILM COATED [MACLEODS PHARMACEUTICALS LIMITED]2

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
33342-088RIZATRIPTAN TABLET, FILM COATED [MACLEODS PHARMACEUTICALS LIMITED]7Current NDC, Legacy NDC, 10 package rows20220703_27bc2cfc-fefb-4b50-a0dc-6268c69b4902.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
314209rizatriptan benzoate 10 MG Oral TabletPSN7db81532-6781-47f7-a5cd-6aeda9b8bf6f10
314209rizatriptan 10 MG Oral TabletSCD7db81532-6781-47f7-a5cd-6aeda9b8bf6f10
314209rizatriptan 10 MG (as rizatriptan benzoate 14.53 MG) Oral TabletSY7db81532-6781-47f7-a5cd-6aeda9b8bf6f10
314209rizatriptan benzoate 10 MG Oral TabletPSN27bc2cfc-fefb-4b50-a0dc-6268c69b49027
312840rizatriptan benzoate 5 MG Oral TabletPSN27bc2cfc-fefb-4b50-a0dc-6268c69b49027
314209rizatriptan 10 MG Oral TabletSCD27bc2cfc-fefb-4b50-a0dc-6268c69b49027
312840rizatriptan 5 MG Oral TabletSCD27bc2cfc-fefb-4b50-a0dc-6268c69b49027
314209rizatriptan 10 MG (as rizatriptan benzoate 14.53 MG) Oral TabletSY27bc2cfc-fefb-4b50-a0dc-6268c69b49027
312840rizatriptan 5 MG (as rizatriptan benzoate 7.265 MG) Oral TabletSY27bc2cfc-fefb-4b50-a0dc-6268c69b49027
314209rizatriptan benzoate 10 MG Oral TabletPSNf754388d-77f1-0d8d-e053-6394a90a7b7e4
314209rizatriptan 10 MG Oral TabletSCDf754388d-77f1-0d8d-e053-6394a90a7b7e4
314209rizatriptan 10 MG (as rizatriptan benzoate 14.53 MG) Oral TabletSYf754388d-77f1-0d8d-e053-6394a90a7b7e4
314209rizatriptan benzoate 10 MG Oral TabletPSN34395ed2-97b7-4220-9089-0e90169d30831
314209rizatriptan benzoate 10 MG Oral TabletPSNf000d96c-42a0-4aac-96ca-8cef289979ce1
314209rizatriptan 10 MG Oral TabletSCD34395ed2-97b7-4220-9089-0e90169d30831
314209rizatriptan 10 MG Oral TabletSCDf000d96c-42a0-4aac-96ca-8cef289979ce1
314209rizatriptan 10 MG (as rizatriptan benzoate 14.53 MG) Oral TabletSY34395ed2-97b7-4220-9089-0e90169d30831
314209rizatriptan 10 MG (as rizatriptan benzoate 14.53 MG) Oral TabletSYf000d96c-42a0-4aac-96ca-8cef289979ce1

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
33342-088-02333420088026 in 1 BLISTER PACKHistorical
33342-088-073334200880730 TABLET, FILM COATED in 1 CONTAINER (33342-088-07) 2014-03-110000-00-00NoNoCurrent
33342-088-123334200881210 BLISTER PACK in 1 CARTON (33342-088-12) / 10 TABLET, FILM COATED in 1 BLISTER PACK10 blister pack2014-03-110000-00-00NoNoCurrent
33342-088-41333420088413 BLISTER PACK in 1 CARTON (33342-088-41) / 6 TABLET, FILM COATED in 1 BLISTER PACK (33342-088-02) 3 blister pack2018-09-030000-00-00NoNoCurrent
33342-088-45333420088452 BLISTER PACK in 1 CARTON (33342-088-45) / 6 TABLET, FILM COATED in 1 BLISTER PACK (33342-088-02) 2 blister pack2018-09-030000-00-00NoNoCurrent
33342-088-4633342008846200 TABLET, FILM COATED in 1 CONTAINER (33342-088-46) 2014-03-110000-00-00NoNoCurrent
33342-088-50333420088504 BLISTER PACK in 1 CARTON (33342-088-50) / 3 TABLET, FILM COATED in 1 BLISTER PACK (33342-088-52) 4 blister pack2014-03-110000-00-00NoNoCurrent
33342-088-52333420088523 in 1 BLISTER PACKHistorical
33342-088-72333420088726 BLISTER PACK in 1 CARTON (33342-088-72) / 3 TABLET, FILM COATED in 1 BLISTER PACK (33342-088-52) 6 blister pack2014-03-110000-00-00NoNoCurrent