FDA.reportPublic FDA data

rizatriptan benzoate

Product NDC
68462-466
11-digit product format
684620466
Labeler code
68462
Product ID
68462-466_c7909d7b-34a6-42b0-ad12-eb25f3ce886e
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
rizatriptan benzoate
Dosage form
TABLET
Route
ORAL
Labeler
Glenmark Pharmaceuticals Inc., USA
Application
ANDA201967
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
68462-466-72rizatriptan benzoate12 in 1 CARTONTABLET1211
68462-466-72rizatriptan benzoate1 in 1 POUCHTABLET111
68462-466-99rizatriptan benzoate1 in 1 POUCHTABLET111
68462-466-99rizatriptan benzoate18 in 1 CARTONTABLET1811

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
68462-466-99EA - Each68462-46688405214-639d-4313-afda-eab30583ec0312013-02-13

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIIDailyMed labelSPL versionUploaded
RIZATRIPTAN BENZOATEACTIVE INGREDIENTWR978S7QHHRIZATRIPTAN BENZOATE TABLET [GLENMARK PHARMACEUTICALS INC., USA]6
RIZATRIPTANACTIVE MOIETY51086HBW8GRIZATRIPTAN BENZOATE TABLET [GLENMARK PHARMACEUTICALS INC., USA]6
CELLULOSE, MICROCRYSTALLINEINACTIVE INGREDIENTOP1R32D61URIZATRIPTAN BENZOATE TABLET [GLENMARK PHARMACEUTICALS INC., USA]6
FERRIC OXIDE REDINACTIVE INGREDIENT1K09F3G675RIZATRIPTAN BENZOATE TABLET [GLENMARK PHARMACEUTICALS INC., USA]6
LACTOSE MONOHYDRATEINACTIVE INGREDIENTEWQ57Q8I5XRIZATRIPTAN BENZOATE TABLET [GLENMARK PHARMACEUTICALS INC., USA]6
MAGNESIUM STEARATEINACTIVE INGREDIENT70097M6I30RIZATRIPTAN BENZOATE TABLET [GLENMARK PHARMACEUTICALS INC., USA]6
SILICON DIOXIDEINACTIVE INGREDIENTETJ7Z6XBU4RIZATRIPTAN BENZOATE TABLET [GLENMARK PHARMACEUTICALS INC., USA]6
STARCH, CORNINACTIVE INGREDIENTO8232NY3SJRIZATRIPTAN BENZOATE TABLET [GLENMARK PHARMACEUTICALS INC., USA]6
RIZATRIPTAN BENZOATEACTIVE INGREDIENTWR978S7QHHRIZATRIPTAN BENZOATE TABLET [PHYSICIANS TOTAL CARE, INC.]1
RIZATRIPTANACTIVE MOIETY51086HBW8GRIZATRIPTAN BENZOATE TABLET [PHYSICIANS TOTAL CARE, INC.]1
CELLULOSE, MICROCRYSTALLINEINACTIVE INGREDIENTOP1R32D61URIZATRIPTAN BENZOATE TABLET [PHYSICIANS TOTAL CARE, INC.]1
FERRIC OXIDE REDINACTIVE INGREDIENT1K09F3G675RIZATRIPTAN BENZOATE TABLET [PHYSICIANS TOTAL CARE, INC.]1
LACTOSE MONOHYDRATEINACTIVE INGREDIENTEWQ57Q8I5XRIZATRIPTAN BENZOATE TABLET [PHYSICIANS TOTAL CARE, INC.]1
MAGNESIUM STEARATEINACTIVE INGREDIENT70097M6I30RIZATRIPTAN BENZOATE TABLET [PHYSICIANS TOTAL CARE, INC.]1
SILICON DIOXIDEINACTIVE INGREDIENTETJ7Z6XBU4RIZATRIPTAN BENZOATE TABLET [PHYSICIANS TOTAL CARE, INC.]1
STARCH, CORNINACTIVE INGREDIENTO8232NY3SJRIZATRIPTAN BENZOATE TABLET [PHYSICIANS TOTAL CARE, INC.]1

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
68462-466RIZATRIPTAN BENZOATE TABLET [GLENMARK PHARMACEUTICALS INC., USA]11Current NDC, Legacy NDC, 4 package rows20240104_99c66300-bd75-4b31-9fab-88c6e4b12688.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
314209rizatriptan benzoate 10 MG Oral TabletPSN99c66300-bd75-4b31-9fab-88c6e4b1268811
312840rizatriptan benzoate 5 MG Oral TabletPSN99c66300-bd75-4b31-9fab-88c6e4b1268811
314209rizatriptan 10 MG Oral TabletSCD99c66300-bd75-4b31-9fab-88c6e4b1268811
312840rizatriptan 5 MG Oral TabletSCD99c66300-bd75-4b31-9fab-88c6e4b1268811
314209rizatriptan 10 MG (as rizatriptan benzoate 14.53 MG) Oral TabletSY99c66300-bd75-4b31-9fab-88c6e4b1268811
312840rizatriptan 5 MG (as rizatriptan benzoate 7.265 MG) Oral TabletSY99c66300-bd75-4b31-9fab-88c6e4b1268811
314209rizatriptan benzoate 10 MG Oral TabletPSN09b35efc-b716-47c7-8f8e-00f7a52484601
314209rizatriptan 10 MG Oral TabletSCD09b35efc-b716-47c7-8f8e-00f7a52484601
314209rizatriptan 10 MG (as rizatriptan benzoate 14.53 MG) Oral TabletSY09b35efc-b716-47c7-8f8e-00f7a52484601

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
68462-466-726846204667212 POUCH in 1 CARTON (68462-466-72) / 1 BLISTER PACK in 1 POUCH / 1 TABLET in 1 BLISTER PACK12 pouch2012-12-310000-00-00NoNoCurrent
68462-466-996846204669918 POUCH in 1 CARTON (68462-466-99) / 1 BLISTER PACK in 1 POUCH / 1 TABLET in 1 BLISTER PACK18 pouch2012-12-310000-00-00NoNoCurrent