FDA.reportPublic FDA data

Rizatriptan Benzoate

Product NDC
68071-3568
11-digit product format
680713568
Labeler code
68071
Product ID
68071-3568_106dcf34-d1e8-5360-e063-6394a90a7e8c
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Rizatriptan Benzoate
Dosage form
TABLET, ORALLY DISINTEGRATING
Route
ORAL
Labeler
NuCare Pharmaceuticals,Inc.
Application
ANDA203062
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

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
68071-3568-8Rizatriptan Benzoate6 in 1 BLISTER PACKTABLET, ORALLY DISINTEGRATING61
68071-3568-8Rizatriptan Benzoate18 in 1 CARTONTABLET, ORALLY DISINTEGRATING181

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
68071-3568RIZATRIPTAN BENZOATE TABLET, ORALLY DISINTEGRATING [NUCARE PHARMACEUTICALS,INC.]1Current NDC, 2 package rows20240203_106dd370-c09c-556a-e063-6394a90acfed.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
312837rizatriptan benzoate 10 MG Disintegrating Oral TabletPSN106dd370-c09c-556a-e063-6394a90acfed1
312837rizatriptan 10 MG Disintegrating Oral TabletSCD106dd370-c09c-556a-e063-6394a90acfed1
312837rizatriptan 10 MG (as rizatriptan benzoate 14.53 MG) Disintegrating Oral TabletSY106dd370-c09c-556a-e063-6394a90acfed1

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startSampleExclude flagStatus
68071-3568-86807135680818 BLISTER PACK in 1 CARTON (68071-3568-8) / 6 TABLET, ORALLY DISINTEGRATING in 1 BLISTER PACK18 blister pack2024-02-02NoNoHistorical