Rizatriptan Benzoate

Product NDC
76420-908
11-digit product format
764200908
Labeler code
76420
Product ID
76420-908_2cb4448b-6604-9be4-e063-6394a90a1b6d
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Rizatriptan Benzoate
Dosage form
TABLET, ORALLY DISINTEGRATING
Route
ORAL
Labeler
Asclemed USA, Inc.
Application
ANDA203062
Marketing category
ANDA
Marketing start
2013-07-01
Substance
RIZATRIPTAN BENZOATE
Active strength
5 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

openFDA Listing Details

Product ID
76420-908_2cb4448b-6604-9be4-e063-6394a90a1b6d
SPL ID
2cb4448b-6604-9be4-e063-6394a90a1b6d
Product type
HUMAN PRESCRIPTION DRUG
Finished product
Yes
Brand name base
Rizatriptan Benzoate
Generic name
Rizatriptan Benzoate
Dosage form
TABLET, ORALLY DISINTEGRATING
Route
ORAL
Marketing start
2013-07-01
Marketing category
ANDA
Application number
ANDA203062
Pharmacologic classes
Serotonin 1b Receptor Agonists [MoA]; Serotonin 1d Receptor Agonists [MoA]; Serotonin-1b and Serotonin-1d Receptor Agonist [EPC]
Listing expiration
2026-12-31

openFDA Active Ingredients

IngredientStrength
RIZATRIPTAN BENZOATE5 mg/1

openFDA Harmonized Identifiers

FieldValues
UniiWR978S7QHH
Rxcui312837, 312839
Spl Set Id8fa794f4-4253-485d-b4ee-986178031339
Manufacturer NameAsclemed USA, Inc.

openFDA Package Details

Package NDCDescriptionMarketing startSample
76420-908-183 BLISTER PACK in 1 CARTON (76420-908-18) / 6 TABLET, ORALLY DISINTEGRATING in 1 BLISTER PACK2025-01-27No

Related Records

Related UNII Ingredients

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

Packages

Package NDC11-digit formatDescriptionUnitsMarketing startSampleExclude flagStatus
76420-908-18764200908183 BLISTER PACK in 1 CARTON (76420-908-18) / 6 TABLET, ORALLY DISINTEGRATING in 1 BLISTER PACK3 blister pack2025-01-27NoNoHistorical

Related DailyMed Labels

TitleManufacturerEffective dateTypeVersion
Rizatriptan BenzoateAsclemed USA, Inc. | ASCLEMED USA INC. DBA ENOVACHEM2025-01-27HUMAN PRESCRIPTION DRUG LABEL1