Rizatriptan Benzoate

Product NDC
80425-0535
11-digit product format
804250535
Labeler code
80425
Product ID
80425-0535_41ad1e53-e436-552a-e063-6394a90ac92a
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Rizatriptan Benzoate
Dosage form
TABLET, ORALLY DISINTEGRATING
Route
ORAL
Labeler
Advanced Rx of Tennessee, LLC
Application
ANDA203062
Marketing category
ANDA
Marketing start
2025-10-15
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

Related Records

Related UNII Ingredients

UNIIPreferred termRegistry numberMatched term
WR978S7QHHRIZATRIPTAN BENZOATE145202-66-0RIZATRIPTAN BENZOATE

Packages

Package NDC11-digit formatDescriptionUnitsMarketing startSampleExclude flagStatus
80425-0535-1804250535013 BLISTER PACK in 1 CARTON (80425-0535-1) / 6 TABLET, ORALLY DISINTEGRATING in 1 BLISTER PACK3 blister pack2025-10-15NoNoHistorical

Related DailyMed Labels

TitleManufacturerEffective dateTypeVersion
Rizatriptan BenzoateAdvanced Rx of Tennessee, LLC2025-10-21HUMAN PRESCRIPTION DRUG LABEL2