FDA.reportPublic FDA data

Sumatriptan

Product NDC
63187-931
11-digit product format
631870931
Labeler code
63187
Product ID
63187-931_798485b6-b33b-4192-b87e-b411643f75b6
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Sumatriptan Succinate
Dosage form
TABLET
Route
ORAL
Labeler
Proficient Rx LP
Application
ANDA078327
Marketing category
ANDA
Marketing start
2009-08-17
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
2026-12-31
Current FDA listing
Yes

Additional Listing Data#

Finished product
Yes
Brand name base
Sumatriptan
Listing expiration
2026-12-31

Active Ingredients#

Ingredient, Strength table
IngredientStrength
SUMATRIPTAN SUCCINATE100 mg/1

Harmonized Identifiers#

Field, Values table
FieldValues
UniiJ8BDZ68989
Rxcui313160

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
63187-931-09Sumatriptan1 in 1 CARTONTABLET14
63187-931-09Sumatriptan9 in 1 BLISTER PACKTABLET94

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
63187-931-09EA - Each63187-9318606af62-6bb3-4ce2-8206-68d8ce34865a12018-01-12

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
63187-931SUMATRIPTAN (SUMATRIPTAN SUCCINATE) TABLET [PROFICIENT RX LP]4Current NDC, Legacy NDC, 2 package rows20230124_fe09fab6-b9e3-469c-9a38-bcc343dcc899.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
313160SUMAtriptan succinate 100 MG Oral TabletPSNfe09fab6-b9e3-469c-9a38-bcc343dcc8994
313160sumatriptan 100 MG Oral TabletSCDfe09fab6-b9e3-469c-9a38-bcc343dcc8994
313160sumatriptan 100 MG (as sumatriptan succinate 140 MG) Oral TabletSYfe09fab6-b9e3-469c-9a38-bcc343dcc8994

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
63187-931-09631870931091 BLISTER PACK in 1 CARTON (63187-931-09) / 9 TABLET in 1 BLISTER PACK1 blister pack2017-11-010000-00-00NoNoCurrent