FDA.reportPublic FDA data

rizatriptan benzoate

Product NDC
68462-468
11-digit product format
684620468
Labeler code
68462
Product ID
68462-468_d0d83e24-265b-4802-96e0-e0d18bef299d
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
rizatriptan benzoate
Dosage form
TABLET, ORALLY DISINTEGRATING
Route
ORAL
Labeler
Glenmark Pharmaceuticals Inc., USA
Application
ANDA201914
Marketing category
ANDA
Marketing start
2013-07-01
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
68462-468-06rizatriptan benzoate6 in 1 CARTONTABLET, ORALLY DISINTEGRATING613
68462-468-46rizatriptan benzoate1 in 1 POUCHTABLET, ORALLY DISINTEGRATING113
68462-468-46rizatriptan benzoate3 in 1 BOXTABLET, ORALLY DISINTEGRATING313
68462-468-74rizatriptan benzoate3 in 1 BOXTABLET, ORALLY DISINTEGRATING313
68462-468-74rizatriptan benzoate4 in 1 CARTONTABLET, ORALLY DISINTEGRATING413

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
68462-468-06EA - Each68462-4688ec2e906-69a4-4884-ad4a-dc040669f2a912013-08-02
68462-468-46EA - Each68462-46802cfb728-e4ae-47ee-a2ff-c3b36395887712017-03-06

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIIDailyMed labelSPL versionUploaded
RIZATRIPTAN BENZOATEACTIVE INGREDIENTWR978S7QHHRIZATRIPTAN BENZOATE TABLET, ORALLY DISINTEGRATING [GLENMARK PHARMACEUTICALS INC., USA]5
RIZATRIPTANACTIVE MOIETY51086HBW8GRIZATRIPTAN BENZOATE TABLET, ORALLY DISINTEGRATING [GLENMARK PHARMACEUTICALS INC., USA]5
ASPARTAMEINACTIVE INGREDIENTZ0H242BBR1RIZATRIPTAN BENZOATE TABLET, ORALLY DISINTEGRATING [GLENMARK PHARMACEUTICALS INC., USA]5
CELLULOSE, MICROCRYSTALLINEINACTIVE INGREDIENTOP1R32D61URIZATRIPTAN BENZOATE TABLET, ORALLY DISINTEGRATING [GLENMARK PHARMACEUTICALS INC., USA]5
CROSPOVIDONEINACTIVE INGREDIENT68401960MKRIZATRIPTAN BENZOATE TABLET, ORALLY DISINTEGRATING [GLENMARK PHARMACEUTICALS INC., USA]5
MAGNESIUM STEARATEINACTIVE INGREDIENT70097M6I30RIZATRIPTAN BENZOATE TABLET, ORALLY DISINTEGRATING [GLENMARK PHARMACEUTICALS INC., USA]5
MANNITOLINACTIVE INGREDIENT3OWL53L36ARIZATRIPTAN BENZOATE TABLET, ORALLY DISINTEGRATING [GLENMARK PHARMACEUTICALS INC., USA]5
SILICON DIOXIDEINACTIVE INGREDIENTETJ7Z6XBU4RIZATRIPTAN BENZOATE TABLET, ORALLY DISINTEGRATING [GLENMARK PHARMACEUTICALS INC., USA]5

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
68462-468RIZATRIPTAN BENZOATE TABLET, ORALLY DISINTEGRATING [GLENMARK PHARMACEUTICALS INC., USA]13Current NDC, Legacy NDC, 5 package rows20240104_4de33a24-db69-444a-b04d-c69ccba57ab2.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
312837rizatriptan benzoate 10 MG Disintegrating Oral TabletPSN4de33a24-db69-444a-b04d-c69ccba57ab213
312839rizatriptan benzoate 5 MG Disintegrating Oral TabletPSN4de33a24-db69-444a-b04d-c69ccba57ab213
312837rizatriptan 10 MG Disintegrating Oral TabletSCD4de33a24-db69-444a-b04d-c69ccba57ab213
312839rizatriptan 5 MG Disintegrating Oral TabletSCD4de33a24-db69-444a-b04d-c69ccba57ab213
312837rizatriptan 10 MG (as rizatriptan benzoate 14.53 MG) Disintegrating Oral TabletSY4de33a24-db69-444a-b04d-c69ccba57ab213
312839rizatriptan 5 MG (as rizatriptan benzoate 7.265 MG) Disintegrating Oral TabletSY4de33a24-db69-444a-b04d-c69ccba57ab213

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
68462-468-06684620468066 BOX in 1 CARTON (68462-468-06) / 3 POUCH in 1 BOX (68462-468-46) / 1 BLISTER PACK in 1 POUCH / 1 TABLET, ORALLY DISINTEGRATING in 1 BLISTER PACK6 box2013-07-010000-00-00NoNoCurrent
68462-468-46684620468461 in 1 POUCHHistorical
68462-468-74684620468744 BOX in 1 CARTON (68462-468-74) / 3 POUCH in 1 BOX / 1 BLISTER PACK in 1 POUCH / 1 TABLET, ORALLY DISINTEGRATING in 1 BLISTER PACK4 box2013-07-010000-00-00NoNoCurrent