Sumatriptan

Product NDC
80425-0224
11-digit product format
804250224
Labeler code
80425
Product ID
80425-0224_2a9b792b-f416-e859-e063-6394a90a30e2
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Sumatriptan
Dosage form
TABLET
Route
ORAL
Labeler
Advanced Rx of Tennessee, LLC
Application
ANDA078327
Marketing category
ANDA
Marketing start
2023-01-12
Substance
SUMATRIPTAN SUCCINATE
Active strength
100 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
J8BDZ68989SUMATRIPTAN SUCCINATE103628-48-4SUMATRIPTAN SUCCINATE
8R78F6L9VOSUMATRIPTAN103628-46-2Sumatriptan

Packages

Package NDC11-digit formatDescriptionUnitsMarketing startSampleExclude flagStatus
80425-0224-1804250224011 BLISTER PACK in 1 CARTON (80425-0224-1) / 9 TABLET in 1 BLISTER PACK1 blister pack2023-01-12NoNoHistorical

Related DailyMed Labels

TitleManufacturerEffective dateTypeVersion
Sumatriptan TabletAdvanced Rx of Tennessee, LLC2024-12-31HUMAN PRESCRIPTION DRUG LABEL3