FDA.reportPublic FDA data

Sumatriptan

Product NDC
85766-093
11-digit product format
857660093
Labeler code
85766
Product ID
85766-093_5031bc93-6ea4-e9d4-e063-6394a90a5afd
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Sumatriptan Succinate
Dosage form
TABLET
Route
ORAL
Labeler
Sportpharm LLC
Application
ANDA078327
Marketing category
ANDA
Marketing start
2009-08-17
Substance
SUMATRIPTAN SUCCINATE
Active strength
25 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
2027-12-31
Current FDA listing
Yes

Additional Listing Data#

Finished product
Yes
Brand name base
Sumatriptan
Listing expiration
2027-12-31

Active Ingredients#

Ingredient, Strength table
IngredientStrength
SUMATRIPTAN SUCCINATE25 mg/1

Harmonized Identifiers#

Field, Values table
FieldValues
UniiJ8BDZ68989
Rxcui313160, 313161, 315223

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
59adc2ba-d5f0-4a52-b35a-cc77921a79d2Product name420250724
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 Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
85766-093-09Sumatriptan1 in 1 CARTONTABLET12
85766-093-09Sumatriptan9 in 1 BLISTER PACKTABLET92
85766-093-10Sumatriptan10 in 1 BOTTLETABLET102
85766-093-20Sumatriptan20 in 1 BOTTLETABLET202
85766-093-30Sumatriptan30 in 1 BOTTLETABLET302
85766-093-36Sumatriptan36 in 1 BOTTLETABLET362
85766-093-60Sumatriptan60 in 1 BOTTLETABLET602
85766-093-90Sumatriptan90 in 1 BOTTLETABLET902

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
313160SUMAtriptan succinate 100 MG Oral TabletPSNd071aef6-a5bd-4f68-ba6d-03004466897c2
315223SUMAtriptan succinate 25 MG Oral TabletPSNd071aef6-a5bd-4f68-ba6d-03004466897c2
313161SUMAtriptan succinate 50 MG Oral TabletPSNd071aef6-a5bd-4f68-ba6d-03004466897c2
313160sumatriptan 100 MG Oral TabletSCDd071aef6-a5bd-4f68-ba6d-03004466897c2
315223sumatriptan 25 MG Oral TabletSCDd071aef6-a5bd-4f68-ba6d-03004466897c2
313161sumatriptan 50 MG Oral TabletSCDd071aef6-a5bd-4f68-ba6d-03004466897c2
313160sumatriptan 100 MG (as sumatriptan succinate 140 MG) Oral TabletSYd071aef6-a5bd-4f68-ba6d-03004466897c2
315223sumatriptan 25 MG (as sumatriptan succinate 35 MG) Oral TabletSYd071aef6-a5bd-4f68-ba6d-03004466897c2
313161sumatriptan 50 MG (as sumatriptan succinate 70 MG) Oral TabletSYd071aef6-a5bd-4f68-ba6d-03004466897c2

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startSampleExclude flagStatus
85766-093-09857660093091 BLISTER PACK in 1 CARTON (85766-093-09) / 9 TABLET in 1 BLISTER PACK1 blister pack2025-10-10NoNoHistorical
85766-093-108576600931010 TABLET in 1 BOTTLE (85766-093-10) 10 tablet2025-10-10NoNoHistorical
85766-093-208576600932020 TABLET in 1 BOTTLE (85766-093-20) 20 tablet2025-10-10NoNoHistorical
85766-093-308576600933030 TABLET in 1 BOTTLE (85766-093-30) 30 tablet2025-10-10NoNoHistorical
85766-093-368576600933636 TABLET in 1 BOTTLE (85766-093-36) 36 tablet2025-10-10NoNoHistorical
85766-093-608576600936060 TABLET in 1 BOTTLE (85766-093-60) 60 tablet2025-10-10NoNoHistorical
85766-093-908576600939090 TABLET in 1 BOTTLE (85766-093-90) 90 tablet2025-10-10NoNoHistorical