Sumatriptan

Product NDC
68071-3525
11-digit product format
680713525
Labeler code
68071
Product ID
68071-3525_2d3f79b8-4f8c-495e-e063-6394a90a723a
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Sumatriptan
Dosage form
TABLET, FILM COATED
Route
ORAL
Labeler
NuCare Pharmaceuticals,Inc.
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
68071-3525-9680713525091 BLISTER PACK in 1 CARTON (68071-3525-9) / 9 TABLET, FILM COATED in 1 BLISTER PACK1 blister pack2023-10-20NoNoHistorical

Related DailyMed Labels

TitleManufacturerEffective dateTypeVersion
SumatriptanNuCare Pharmaceuticals,Inc.2025-02-03HUMAN PRESCRIPTION DRUG LABEL2