SUMATRIPTAN

Product NDC
0781-6523
11-digit product format
007816523
Labeler code
0781
Product ID
0781-6523_f9989be0-513c-4c19-a4cf-4069531895ed
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
sumatriptan
Dosage form
SPRAY
Route
NASAL
Labeler
Sandoz Inc
Application
NDA020626
Marketing category
NDA AUTHORIZED GENERIC
Marketing start
2008-09-11
Marketing end
2022-01-31
Substance
SUMATRIPTAN
Active strength
20 mg/100uL
Pharmacologic classes
Serotonin 1d Receptor Agonists [MoA],Serotonin-1b and Serotonin-1d Receptor Agonist [EPC],Serotonin 1b Receptor Agonists [MoA]
NDC exclude flag
No
Listing certified through
0000-00-00
Current FDA listing
Historical FDA.report record

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
59adc2ba-d5f0-4a52-b35a-cc77921a79d2Product name420250724
4b7700e3-6e0e-45e5-9d22-6f754d61386eProduct name220250304
2839c963-7eb3-970a-287f-ff1b6d381268Product name220250103
1e973b2d-e028-69cd-9258-4613ba80fdc5Product name320210512
3eb481d3-8b69-436f-82dd-4a66345568abProduct name120190611
e76dbbc1-775d-722c-08ff-ed45e8a80defProduct name320181002
c100f0c7-e9dd-42f4-b0a8-0d81bd2a877cProduct name120160303
49615343-b619-4365-8118-8f2ed6046e78Product name120160224
a6319377-430a-43db-82f9-30d1d9d89cf8Product name120151216
f6199b09-e585-7ceb-4b09-803cf5ce1ed1Product name120140508

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
0781-6523-06EA - Each0781-65232c0719b0-e66f-4d14-be94-7bb21318dc5112012-07-24
0781-6523-86EA - Each0781-6523f12339a3-ef15-41e3-be2a-109db04d708a12012-07-24

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIIDailyMed labelSPL versionUploaded
SUMATRIPTANACTIVE INGREDIENT8R78F6L9VOSUMATRIPTAN SPRAY [PHYSICIANS TOTAL CARE, INC.]2
SUMATRIPTANACTIVE MOIETY8R78F6L9VOSUMATRIPTAN SPRAY [PHYSICIANS TOTAL CARE, INC.]2
POTASSIUM PHOSPHATE, MONOBASICINACTIVE INGREDIENT4J9FJ0HL51SUMATRIPTAN SPRAY [PHYSICIANS TOTAL CARE, INC.]2
SODIUM HYDROXIDEINACTIVE INGREDIENT55X04QC32ISUMATRIPTAN SPRAY [PHYSICIANS TOTAL CARE, INC.]2
SODIUM PHOSPHATE, DIBASIC ANHYDROUSINACTIVE INGREDIENT22ADO53M6FSUMATRIPTAN SPRAY [PHYSICIANS TOTAL CARE, INC.]2
SULFURIC ACIDINACTIVE INGREDIENTO40UQP6WCFSUMATRIPTAN SPRAY [PHYSICIANS TOTAL CARE, INC.]2
WATERINACTIVE INGREDIENT059QF0KO0RSUMATRIPTAN SPRAY [PHYSICIANS TOTAL CARE, INC.]2

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
314227SUMAtriptan 20 MG/ACTUAT Nasal SprayPSN24bc527e-c682-4c66-964e-c21d31eca5dd2
314227sumatriptan 20 MG/ACTUAT Nasal SpraySCD24bc527e-c682-4c66-964e-c21d31eca5dd2
314227sumatriptan 20 MG/0.1 ML Nasal SpraySY24bc527e-c682-4c66-964e-c21d31eca5dd2

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
0781-6523-86007816523866 CONTAINER in 1 BOX (0781-6523-86) > 100 uL in 1 CONTAINER (0781-6523-06) 6 container2008-09-110000-00-00NoNoCurrent