FDA.reportPublic FDA data

SUMATRIPTAN

Product NDC
50436-4622
11-digit product format
504364622
Labeler code
50436
Product ID
50436-4622_c44a39ca-0040-4ad9-8a59-d023379facf7
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
SUMATRIPTAN
Dosage form
TABLET
Route
ORAL
Labeler
Unit Dose Services
Application
ANDA076554
Marketing category
ANDA
Marketing start
2009-08-13
Marketing end
0000-00-00
Substance
SUMATRIPTAN SUCCINATE
Active strength
25 mg/1
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
2020-12-31
Current FDA listing
Historical FDA.report record

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

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDCEffectiveActionDocumentIndexing SPLRelated label
50436-4622-12021-01-29C16284748780-1ba0f9c33-1239-a910-e053-dadaa90a0b85These highlights do not include all the information needed to use SUMATRIPTAN Tablets, USP safely and effectively. See full prescribing information for SUMATRIPTAN Tablets, USP. SUMATRIPTAN Tablets, USP, for oral use Initial U.S. Approval: 1992

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
50436-4622-1SUMATRIPTAN9 in 1 BOTTLETABLET96

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
50436-4622-1EA - Each50436-4622e1256366-f68e-4ddd-86da-949b56adc75d12013-03-03

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIIDailyMed labelSPL versionUploaded
SUMATRIPTAN SUCCINATEACTIVE INGREDIENTJ8BDZ68989SUMATRIPTAN TABLET [UNIT DOSE SERVICES]2
SUMATRIPTANACTIVE MOIETY8R78F6L9VOSUMATRIPTAN TABLET [UNIT DOSE SERVICES]2
ANHYDROUS LACTOSEINACTIVE INGREDIENT3SY5LH9PMKSUMATRIPTAN TABLET [UNIT DOSE SERVICES]2
CELLULOSE, MICROCRYSTALLINEINACTIVE INGREDIENTOP1R32D61USUMATRIPTAN TABLET [UNIT DOSE SERVICES]2
COLLOIDAL SILICON DIOXIDEINACTIVE INGREDIENTETJ7Z6XBU4SUMATRIPTAN TABLET [UNIT DOSE SERVICES]2
CROSCARMELLOSE SODIUMINACTIVE INGREDIENTM28OL1HH48SUMATRIPTAN TABLET [UNIT DOSE SERVICES]2
LACTOSE MONOHYDRATEINACTIVE INGREDIENTEWQ57Q8I5XSUMATRIPTAN TABLET [UNIT DOSE SERVICES]2
MAGNESIUM STEARATEINACTIVE INGREDIENT70097M6I30SUMATRIPTAN TABLET [UNIT DOSE SERVICES]2
TALCINACTIVE INGREDIENT7SEV7J4R1USUMATRIPTAN TABLET [UNIT DOSE SERVICES]2

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
50436-4622SUMATRIPTAN TABLET [UNIT DOSE SERVICES]6Legacy NDC, 1 package rows20190531_7ea9b761-4b07-40a1-9b55-d25343e8b024.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
315223SUMAtriptan succinate 25 MG Oral TabletPSN7ea9b761-4b07-40a1-9b55-d25343e8b0246
315223sumatriptan 25 MG Oral TabletSCD7ea9b761-4b07-40a1-9b55-d25343e8b0246
315223sumatriptan 25 MG (as sumatriptan succinate 35 MG) Oral TabletSY7ea9b761-4b07-40a1-9b55-d25343e8b0246

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionStatus
50436-4622-1504364622019 in 1 BOTTLEHistorical