SUMATRIPTAN

Product NDC
63629-8701
11-digit product format
636298701
Labeler code
63629
Product ID
63629-8701_08918eab-05d3-4d11-b013-4c6ee1835fe7
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
sumatriptan
Dosage form
SPRAY
Route
NASAL
Labeler
Bryant Ranch Prepack
Application
ANDA213650
Marketing category
ANDA
Marketing start
2020-10-04
Substance
SUMATRIPTAN
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

Related Records

Related UNII Ingredients

UNIIPreferred termRegistry numberMatched term
8R78F6L9VOSUMATRIPTAN103628-46-2SUMATRIPTAN

Packages

Package NDC11-digit formatDescriptionUnitsMarketing startSampleExclude flagStatus
63629-8701-1636298701016 CONTAINER in 1 CARTON (63629-8701-1) / 1 SPRAY in 1 CONTAINER6 container2021-07-21NoNoHistorical

Related DailyMed Labels

TitleManufacturerEffective dateTypeVersion
SUMATRIPTANBryant Ranch Prepack2023-07-17HUMAN PRESCRIPTION DRUG LABEL102