Sumatriptan

Product NDC
53002-3562
11-digit product format
530023562
Labeler code
53002
Product ID
53002-3562_ac34049a-f89d-4c7c-a47e-b00154e95dcf
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Sumatriptan
Dosage form
TABLET, FILM COATED
Route
ORAL
Labeler
RPK Pharmaceuticals, Inc.
Application
ANDA078284
Marketing category
ANDA
Marketing start
2020-03-04
Marketing end
0000-00-00
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
2023-12-31
Current FDA listing
Historical FDA.report record

Related Records

Related UNII Ingredients

UNIIPreferred termRegistry numberMatched term
J8BDZ68989SUMATRIPTAN SUCCINATE103628-48-4SUMATRIPTAN SUCCINATE
8R78F6L9VOSUMATRIPTAN103628-46-2Sumatriptan

Packages

Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
53002-3562-9530023562091 BLISTER PACK in 1 CARTON (53002-3562-9) > 9 TABLET, FILM COATED in 1 BLISTER PACK1 blister pack2022-05-010000-00-00NoNoCurrent

Related DailyMed Labels

TitleManufacturerEffective dateTypeVersion
SumatriptanRPK Pharmaceuticals, Inc.2022-03-30HUMAN PRESCRIPTION DRUG LABEL1