Sumatriptan

Product NDC
82804-169
11-digit product format
828040169
Labeler code
82804
Product ID
82804-169_85bf8e58-0984-427b-9ed4-7e0df4e444d2
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Sumatriptan
Dosage form
TABLET, FILM COATED
Route
ORAL
Labeler
Proficient Rx LP
Application
ANDA078284
Marketing category
ANDA
Marketing start
2022-02-18
Substance
SUMATRIPTAN SUCCINATE
Active strength
50 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
82804-169-09828040169091 BLISTER PACK in 1 CARTON (82804-169-09) / 9 TABLET, FILM COATED in 1 BLISTER PACK1 blister pack2024-12-23NoNoHistorical

Related DailyMed Labels

TitleManufacturerEffective dateTypeVersion
SumatriptanProficient Rx LP2025-01-01HUMAN PRESCRIPTION DRUG LABEL1