Sumatriptan Succinate

Product NDC
53002-1592
11-digit product format
530021592
Labeler code
53002
Product ID
53002-1592_e9546a84-769a-424b-9f13-a4c29cc7ed9d
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Sumatriptan Succinate
Dosage form
TABLET
Route
ORAL
Labeler
RPK Pharmaceuticals, Inc.
Application
ANDA076847
Marketing category
ANDA
Marketing start
2009-11-17
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
2021-12-31
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
53002-1592-92025-01-30C16284748780-19d75b9d1-135c-f424-e053-dadaa90a57ceThese 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
53002-1592-92023-06-07C16284748780-19d75b9d1-135c-f424-e053-dadaa90a57ceThese 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
53002-1592-92023-01-30C16284748780-19d75b9d1-135c-f424-e053-dadaa90a57ceThese 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
53002-1592-92020-02-19C16284748780-19d75b9d1-135c-f424-e053-dadaa90a57ceThese 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
53002-1592-92020-01-31C16284748780-19d75b9d1-135c-f424-e053-dadaa90a57ceThese 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
53002-1592-9Sumatriptan Succinate9 in 1 CARTONTABLET99
53002-1592-9Sumatriptan Succinate9 in 1 BLISTER PACKTABLET99

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
53002-1592SUMATRIPTAN SUCCINATE (SUMATRIPTAN SUCCINATE ) TABLET [RPK PHARMACEUTICALS, INC.]9Legacy NDC, 2 package rows20230609_d3b61201-fb84-446b-83a6-b72e8e1d6d04.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
313160SUMAtriptan succinate 100 MG Oral TabletPSNd3b61201-fb84-446b-83a6-b72e8e1d6d049
315223SUMAtriptan succinate 25 MG Oral TabletPSNd3b61201-fb84-446b-83a6-b72e8e1d6d049
313161SUMAtriptan succinate 50 MG Oral TabletPSNd3b61201-fb84-446b-83a6-b72e8e1d6d049
313160sumatriptan 100 MG Oral TabletSCDd3b61201-fb84-446b-83a6-b72e8e1d6d049
315223sumatriptan 25 MG Oral TabletSCDd3b61201-fb84-446b-83a6-b72e8e1d6d049
313161sumatriptan 50 MG Oral TabletSCDd3b61201-fb84-446b-83a6-b72e8e1d6d049
313160sumatriptan 100 MG (as sumatriptan succinate 140 MG) Oral TabletSYd3b61201-fb84-446b-83a6-b72e8e1d6d049
315223sumatriptan 25 MG (as sumatriptan succinate 35 MG) Oral TabletSYd3b61201-fb84-446b-83a6-b72e8e1d6d049
313161sumatriptan 50 MG (as sumatriptan succinate 70 MG) Oral TabletSYd3b61201-fb84-446b-83a6-b72e8e1d6d049

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
53002-1592-9530021592099 BLISTER PACK in 1 CARTON (53002-1592-9) > 9 TABLET in 1 BLISTER PACK9 blister pack2017-09-010000-00-00NoNoCurrent