Sumatriptan Succinate

Product NDC
53002-2562
11-digit product format
530022562
Labeler code
53002
Product ID
53002-2562_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
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
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#

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
53002-2562-9Sumatriptan Succinate9 in 1 BLISTER PACKTABLET99
53002-2562-9Sumatriptan Succinate9 in 1 CARTONTABLET99

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
53002-2562SUMATRIPTAN 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
53002-2562-9530022562099 BLISTER PACK in 1 CARTON (53002-2562-9) > 9 TABLET in 1 BLISTER PACK9 blister pack2018-10-010000-00-00NoNoCurrent