FDA.reportPublic FDA data

Rizatriptan

Product NDC
33342-087
11-digit product format
333420087
Labeler code
33342
Product ID
33342-087_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
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
Listing expiration
2026-12-31

Active Ingredients#

Ingredient, Strength table
IngredientStrength
RIZATRIPTAN BENZOATE5 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
33342-087-02Rizatriptan6 in 1 BLISTER PACKTABLET, FILM COATED67
33342-087-07Rizatriptan30 in 1 CONTAINERTABLET, FILM COATED307
33342-087-12Rizatriptan10 in 1 CARTONTABLET, FILM COATED107
33342-087-12Rizatriptan10 in 1 BLISTER PACKTABLET, FILM COATED107
33342-087-41Rizatriptan3 in 1 CARTONTABLET, FILM COATED37
33342-087-45Rizatriptan2 in 1 CARTONTABLET, FILM COATED27
33342-087-46Rizatriptan200 in 1 CONTAINERTABLET, FILM COATED2007
33342-087-50Rizatriptan4 in 1 CARTONTABLET, FILM COATED47
33342-087-52Rizatriptan3 in 1 BLISTER PACKTABLET, FILM COATED37
33342-087-72Rizatriptan6 in 1 CARTONTABLET, FILM COATED67

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
33342-087-02EA - Each33342-08731681628-355e-470e-ae71-322622e4e5a112019-01-24
33342-087-41EA - Each33342-08780547782-d6fc-49fc-91c8-fe78fe1ab6ab12019-01-24
33342-087-45EA - Each33342-087d5783a19-55df-4d1f-ba86-e001fc6c22a312019-01-24
33342-087-50EA - Each33342-08759084f09-5ae6-43cb-a683-12773e71b91a12015-02-02
33342-087-52EA - Each33342-087c8d774c2-5553-48ec-9366-3d8ed57f0f4012018-12-13
33342-087-72EA - Each33342-087c1755e9d-1add-4b22-9480-435853e9f72912015-02-02

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
33342-087RIZATRIPTAN 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 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

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
33342-087-02333420087026 in 1 BLISTER PACKHistorical
33342-087-073334200870730 TABLET, FILM COATED in 1 CONTAINER (33342-087-07) 2014-03-110000-00-00NoNoCurrent
33342-087-123334200871210 BLISTER PACK in 1 CARTON (33342-087-12) / 10 TABLET, FILM COATED in 1 BLISTER PACK10 blister pack2014-03-110000-00-00NoNoCurrent
33342-087-41333420087413 BLISTER PACK in 1 CARTON (33342-087-41) / 6 TABLET, FILM COATED in 1 BLISTER PACK (33342-087-02) 3 blister pack2018-09-030000-00-00NoNoCurrent
33342-087-45333420087452 BLISTER PACK in 1 CARTON (33342-087-45) / 6 TABLET, FILM COATED in 1 BLISTER PACK (33342-087-02) 2 blister pack2018-09-030000-00-00NoNoCurrent
33342-087-4633342008746200 TABLET, FILM COATED in 1 CONTAINER (33342-087-46) 2014-03-110000-00-00NoNoCurrent
33342-087-50333420087504 BLISTER PACK in 1 CARTON (33342-087-50) / 3 TABLET, FILM COATED in 1 BLISTER PACK (33342-087-52) 4 blister pack2014-03-110000-00-00NoNoCurrent
33342-087-52333420087523 in 1 BLISTER PACKHistorical
33342-087-72333420087726 BLISTER PACK in 1 CARTON (33342-087-72) / 3 TABLET, FILM COATED in 1 BLISTER PACK (33342-087-52) 6 blister pack2014-03-110000-00-00NoNoCurrent