FDA.reportPublic FDA data

Sumatriptan

Product NDC
80425-0258
11-digit product format
804250258
Labeler code
80425
Product ID
80425-0258_2a9ba8f4-6ce4-e827-e063-6394a90a0300
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Sumatriptan
Dosage form
TABLET, FILM COATED
Route
ORAL
Labeler
Advanced Rx Pharmacy of Tennessee, LLC
Application
ANDA078284
Marketing category
ANDA
Marketing start
2023-01-17
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
80425-0258-1Sumatriptan9 in 1 BLISTER PACKTABLET, FILM COATED92
80425-0258-1Sumatriptan1 in 1 CARTONTABLET, FILM COATED12

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
80425-0258-1EA - Each80425-02581d093b12-1514-4166-86d7-8f750f34623f12023-06-06

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
80425-0258SUMATRIPTAN TABLET, FILM COATED [ADVANCED RX PHARMACY OF TENNESSEE, LLC]2Current NDC, 2 package rows20250102_f27ca3c0-9de0-ff9c-e053-2a95a90ab894.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
313160SUMAtriptan succinate 100 MG Oral TabletPSNf27ca3c0-9de0-ff9c-e053-2a95a90ab8942
313160sumatriptan 100 MG Oral TabletSCDf27ca3c0-9de0-ff9c-e053-2a95a90ab8942
313160sumatriptan 100 MG (as sumatriptan succinate 140 MG) Oral TabletSYf27ca3c0-9de0-ff9c-e053-2a95a90ab8942

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startSampleExclude flagStatus
80425-0258-1804250258011 BLISTER PACK in 1 CARTON (80425-0258-1) / 9 TABLET, FILM COATED in 1 BLISTER PACK1 blister pack2023-01-17NoNoHistorical