FDA.reportPublic FDA data

Rizatriptan Benzoate

Product NDC
71205-398
11-digit product format
712050398
Labeler code
71205
Product ID
71205-398_f5520526-1cc5-489f-b142-92f92fec77d3
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Rizatriptan Benzoate
Dosage form
TABLET, ORALLY DISINTEGRATING
Route
ORAL
Labeler
Proficient Rx LP
Application
ANDA207835
Marketing category
ANDA
Marketing start
2017-03-07
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
8b537454-32b8-7e64-1395-258682782d07Product name520170424

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
71205-398-06Rizatriptan Benzoate6 in 1 BLISTER PACKTABLET, ORALLY DISINTEGRATING61
71205-398-06Rizatriptan Benzoate1 in 1 CARTONTABLET, ORALLY DISINTEGRATING11

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
71205-398-06EA - Each71205-39834ae18e8-e3f0-4815-b0cc-bf33fa35ec8c12020-04-20

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
71205-398RIZATRIPTAN BENZOATE TABLET, ORALLY DISINTEGRATING [PROFICIENT RX LP]1Current NDC, Legacy NDC, 2 package rows20200222_f5520526-1cc5-489f-b142-92f92fec77d3.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
312837rizatriptan benzoate 10 MG Disintegrating Oral TabletPSNf5520526-1cc5-489f-b142-92f92fec77d31
312837rizatriptan 10 MG Disintegrating Oral TabletSCDf5520526-1cc5-489f-b142-92f92fec77d31
312837rizatriptan 10 MG (as rizatriptan benzoate 14.53 MG) Disintegrating Oral TabletSYf5520526-1cc5-489f-b142-92f92fec77d31

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
71205-398-06712050398061 BLISTER PACK in 1 CARTON (71205-398-06) / 6 TABLET, ORALLY DISINTEGRATING in 1 BLISTER PACK1 blister pack2020-02-130000-00-00NoNoCurrent