IMITREX

Product NDC
0173-0524
11-digit product format
001730524
Labeler code
0173
Product ID
0173-0524_1a2c2653-17a8-430b-b9c9-aa3acfe70bed
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
sumatriptan
Dosage form
SPRAY
Route
NASAL
Labeler
GlaxoSmithKline LLC
Application
NDA020626
Marketing category
NDA
Marketing start
1997-10-10
Marketing end
0000-00-00
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
2023-12-31
Current FDA listing
Historical FDA.report record

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
0173-0524-00EA - Each0173-052460e19848-2f5f-4aae-929b-8d998d7ce11d12012-07-24

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIIDailyMed labelSPL versionUploaded
SUMATRIPTANACTIVE INGREDIENT8R78F6L9VOIMITREX (SUMATRIPTAN) SPRAY [GLAXOSMITHKLINE LLC]12
SUMATRIPTANACTIVE MOIETY8R78F6L9VOIMITREX (SUMATRIPTAN) SPRAY [GLAXOSMITHKLINE LLC]12
POTASSIUM PHOSPHATE, MONOBASICINACTIVE INGREDIENT4J9FJ0HL51IMITREX (SUMATRIPTAN) SPRAY [GLAXOSMITHKLINE LLC]12
SODIUM HYDROXIDEINACTIVE INGREDIENT55X04QC32IIMITREX (SUMATRIPTAN) SPRAY [GLAXOSMITHKLINE LLC]12
SODIUM PHOSPHATE, DIBASIC, ANHYDROUSINACTIVE INGREDIENT22ADO53M6FIMITREX (SUMATRIPTAN) SPRAY [GLAXOSMITHKLINE LLC]12
SULFURIC ACIDINACTIVE INGREDIENTO40UQP6WCFIMITREX (SUMATRIPTAN) SPRAY [GLAXOSMITHKLINE LLC]12
WATERINACTIVE INGREDIENT059QF0KO0RIMITREX (SUMATRIPTAN) SPRAY [GLAXOSMITHKLINE LLC]12

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
0173-0524IMITREX (SUMATRIPTAN) SPRAY [GLAXOSMITHKLINE LLC]22Legacy NDC20240328_cc11b09d-e6cc-4cf8-1495-5ac64d5aae5f.zip

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
0173-0524-00001730524006 CONTAINER in 1 BOX (0173-0524-00) > 1 SPRAY in 1 CONTAINER6 container1997-10-100000-00-00NoNoCurrent