FDA.reportPublic FDA data

Sumatriptan Succinate

Product NDC
42254-220
11-digit product format
422540220
Labeler code
42254
Product ID
42254-220_b56f236d-fbf8-48e3-ad42-8abe4aafcbfc
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
sumatriptan succinate
Dosage form
TABLET, COATED
Route
ORAL
Labeler
Rebel Distributors Corp
Application
ANDA076933
Marketing category
ANDA
Marketing start
2009-08-10
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
E
Listing certified through
2017-12-31
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
42254-220-092019-09-24C16284748780-19350213a-3c2c-c013-e053-90daa90a1393SUMATRIPTAN TABLETS, USP

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
42254-220-09Sumatriptan Succinate9 in 1 BLISTER PACKTABLET, COATED91

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
42254-220-09EA - Each42254-220dd62e732-ea37-427d-ac79-edf264fd119a12012-07-24

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIIDailyMed labelSPL versionUploaded
SUMATRIPTAN SUCCINATEACTIVE INGREDIENTJ8BDZ68989SUMATRIPTAN SUCCINATE TABLET, COATED [REBEL DISTRIBUTORS CORP]1
sumatriptanACTIVE MOIETY8R78F6L9VOSUMATRIPTAN SUCCINATE TABLET, COATED [REBEL DISTRIBUTORS CORP]1
ANHYDROUS LACTOSEINACTIVE INGREDIENT3SY5LH9PMKSUMATRIPTAN SUCCINATE TABLET, COATED [REBEL DISTRIBUTORS CORP]1
CELLULOSE, MICROCRYSTALLINEINACTIVE INGREDIENTOP1R32D61USUMATRIPTAN SUCCINATE TABLET, COATED [REBEL DISTRIBUTORS CORP]1
CROSCARMELLOSE SODIUMINACTIVE INGREDIENTM28OL1HH48SUMATRIPTAN SUCCINATE TABLET, COATED [REBEL DISTRIBUTORS CORP]1
MAGNESIUM STEARATEINACTIVE INGREDIENT70097M6I30SUMATRIPTAN SUCCINATE TABLET, COATED [REBEL DISTRIBUTORS CORP]1

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
42254-220SUMATRIPTAN SUCCINATE TABLET, COATED [REBEL DISTRIBUTORS CORP]1Legacy NDC, 1 package rows20120621_b56f236d-fbf8-48e3-ad42-8abe4aafcbfc.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
315223SUMAtriptan succinate 25 MG Oral TabletPSNb56f236d-fbf8-48e3-ad42-8abe4aafcbfc1
315223sumatriptan 25 MG Oral TabletSCDb56f236d-fbf8-48e3-ad42-8abe4aafcbfc1
315223sumatriptan 25 MG (as sumatriptan succinate 35 MG) Oral TabletSYb56f236d-fbf8-48e3-ad42-8abe4aafcbfc1

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionStatus
42254-220-09422540220099 in 1 BLISTER PACKHistorical