FDA.reportPublic FDA data

Sumatriptan

Product NDC
80425-0318
11-digit product format
804250318
Labeler code
80425
Product ID
80425-0318_20ae108a-00c6-a984-e063-6394a90aaaae
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Sumatriptan
Dosage form
TABLET
Route
ORAL
Labeler
Advanced Rx Pharmacy of Tennessee, LLC
Application
ANDA078327
Marketing category
ANDA
Marketing start
2023-04-07
Substance
SUMATRIPTAN SUCCINATE
Active strength
50 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 SUCCINATE50 mg/1

Harmonized Identifiers#

Field, Values table
FieldValues
UniiJ8BDZ68989
Rxcui313161

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
80425-0318-1Sumatriptan1 in 1 CARTONTABLET12
80425-0318-1Sumatriptan9 in 1 BLISTER PACKTABLET92
80425-0318-2Sumatriptan9 in 1 BLISTER PACKTABLET92
80425-0318-2Sumatriptan4 in 1 CARTONTABLET42

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
80425-0318-1EA - Each80425-031838ae2ec2-de34-4dd4-b0b6-d22066b9f76f12023-06-06
80425-0318-2EA - Each80425-03180df75388-d519-4a31-8d32-f1fd155487b412023-06-06

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
80425-0318SUMATRIPTAN TABLET [ADVANCED RX PHARMACY OF TENNESSEE, LLC]2Current NDC, 4 package rows20240829_f8c4bbfb-1586-4610-e053-6394a90a8f09.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
313161SUMAtriptan succinate 50 MG Oral TabletPSNf8c4bbfb-1586-4610-e053-6394a90a8f092
313161sumatriptan 50 MG Oral TabletSCDf8c4bbfb-1586-4610-e053-6394a90a8f092
313161sumatriptan 50 MG (as sumatriptan succinate 70 MG) Oral TabletSYf8c4bbfb-1586-4610-e053-6394a90a8f092

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startSampleExclude flagStatus
80425-0318-1804250318011 BLISTER PACK in 1 CARTON (80425-0318-1) / 9 TABLET in 1 BLISTER PACK1 blister pack2023-04-07NoNoHistorical
80425-0318-2804250318024 BLISTER PACK in 1 CARTON (80425-0318-2) / 9 TABLET in 1 BLISTER PACK4 blister pack2023-04-07NoNoHistorical