FDA.reportPublic FDA data

Sumatriptan Succinate

Product NDC
52959-510
11-digit product format
529590510
Labeler code
52959
Product ID
52959-510_cf6af122-0acc-4dcf-8d52-5f283c6f0666
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Sumatriptan Succinate
Dosage form
TABLET
Route
ORAL
Labeler
H.J. Harkins Company, Inc.
Application
ANDA076847
Marketing category
ANDA
Marketing start
2009-11-17
Marketing end
0000-00-00
Substance
SUMATRIPTAN SUCCINATE
Active strength
100 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
E
Listing certified through
2018-12-31
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
a62a50ac-1535-4461-9768-8ae703e2e9fbProduct name120210525
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
9514609b-a2a9-f8ec-6ba6-3f8e5ee89877Product name120140508
bc07ef78-e82d-0c19-31f4-31f263780582Product name120140508
f6199b09-e585-7ceb-4b09-803cf5ce1ed1Product name120140508

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDCEffectiveActionDocumentIndexing SPLRelated label
52959-510-092020-01-31C16284748780-19d75b9d0-ef53-f424-e053-dadaa90a57ceSumatriptan succinate

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
52959-510-09Sumatriptan Succinate9 in 1 BOTTLETABLET92

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
52959-510-09EA - Each52959-510af55a33b-8a4e-4dd0-b1c9-490339bb370012015-10-02

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIIDailyMed labelSPL versionUploaded
sumatriptan succinateACTIVE INGREDIENTJ8BDZ68989SUMATRIPTAN SUCCINATE TABLET [H.J. HARKINS COMPANY, INC.]2
SUMATRIPTANACTIVE MOIETY8R78F6L9VOSUMATRIPTAN SUCCINATE TABLET [H.J. HARKINS COMPANY, INC.]2

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
52959-510SUMATRIPTAN SUCCINATE TABLET [H.J. HARKINS COMPANY, INC.]2Legacy NDC, 1 package rows20111230_2e5048c1-735f-434d-ae4c-5e822a95a2c4.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
313160SUMAtriptan succinate 100 MG Oral TabletPSN2e5048c1-735f-434d-ae4c-5e822a95a2c42
313160sumatriptan 100 MG Oral TabletSCD2e5048c1-735f-434d-ae4c-5e822a95a2c42
313160sumatriptan 100 MG (as sumatriptan succinate 140 MG) Oral TabletSY2e5048c1-735f-434d-ae4c-5e822a95a2c42

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionStatus
52959-510-09529590510099 in 1 BOTTLEHistorical