FDA.reportPublic FDA data

Sumatriptan

Product NDC
50436-0147
11-digit product format
504360147
Labeler code
50436
Product ID
50436-0147_5c7f3427-8ed8-4155-8264-b05d746fff7a
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Sumatriptan Succinate
Dosage form
TABLET
Route
ORAL
Labeler
Unit Dose Services
Application
ANDA078327
Marketing category
ANDA
Marketing start
2009-08-17
Marketing end
0000-00-00
Substance
SUMATRIPTAN SUCCINATE
Active strength
50 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
fb7ab793-2c12-4079-b100-a64f73bef25aProduct name420240712
b0cbf770-6cc3-4aa4-9158-755110c2b9f7Product name220230717
dc7c5daa-021f-40dd-b00d-63982cb2067aProduct name120230426
1e973b2d-e028-69cd-9258-4613ba80fdc5Product name320210512
08ffbcbf-26df-b99c-1dab-64fc4cfae89fProduct name520200925
3eb481d3-8b69-436f-82dd-4a66345568abProduct name120190611
816b97af-edc5-4060-aff1-b814bdbcad50Product name120190415
e76dbbc1-775d-722c-08ff-ed45e8a80defProduct name320181002
7cda52fc-125f-421c-8fea-bc1974370c49Product name220180703
419aab54-5d5a-4146-9453-026d4a9991beProduct name220170525
08ffbcbf-26df-b99c-1dab-64fc4cfae89fProduct name220160823
c100f0c7-e9dd-42f4-b0a8-0d81bd2a877cProduct name120160303
49615343-b619-4365-8118-8f2ed6046e78Product name120160224
a6319377-430a-43db-82f9-30d1d9d89cf8Product name120151216
89dac932-b90a-4410-9ab1-84c53e57de25Product name120150316
f6199b09-e585-7ceb-4b09-803cf5ce1ed1Product name120140508

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDCEffectiveActionDocumentIndexing SPLRelated label
50436-0147-12021-01-29C16284748780-1ba0f9c33-37d4-a910-e053-dadaa90a0b85These highlights do not include all the information needed to use SUMATRIPTAN TABLETS safely and effectively. See full prescribing information for SUMATRIPTAN TABLETS. SUMATRIPTAN tablets, for oral use Initial U.S. Approval: 1992

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
50436-0147-1Sumatriptan9 in 1 BOTTLETABLET94

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
50436-0147-1EA - Each50436-0147fa47895e-b93f-468d-9f19-eb4f6950e2d912018-09-05

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
50436-0147SUMATRIPTAN (SUMATRIPTAN SUCCINATE) TABLET [UNIT DOSE SERVICES]4Legacy NDC, 1 package rows20180831_80282282-057f-4c99-9017-5280829313f7.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
313161SUMAtriptan succinate 50 MG Oral TabletPSN80282282-057f-4c99-9017-5280829313f74
313161sumatriptan 50 MG Oral TabletSCD80282282-057f-4c99-9017-5280829313f74
313161sumatriptan 50 MG (as sumatriptan succinate 70 MG) Oral TabletSY80282282-057f-4c99-9017-5280829313f74

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionStatus
50436-0147-1504360147019 in 1 BOTTLEHistorical