Sumatriptan Succinate

Product NDC
55648-728
11-digit product format
556480728
Labeler code
55648
Product ID
55648-728_677214c1-8f46-4345-8dae-8f0bb97154fc
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Sumatriptan Succinate
Dosage form
INJECTION
Route
SUBCUTANEOUS
Labeler
Wockhardt Limited
Application
ANDA078593
Marketing category
ANDA
Marketing start
2009-02-06
Marketing end
0000-00-00
Substance
SUMATRIPTAN SUCCINATE
Active strength
6 mg/.5mL
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
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
55648-728-012020-01-31C16284748780-19d75b9d0-0139-f424-e053-dadaa90a57cePRESCRIBING INFORMATION Sumatriptan Succinate Injection

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
55648-728-01Sumatriptan Succinate5 in 1 CARTONINJECTION51
55648-728-01Sumatriptan Succinate0.5 mL in 1 VIALINJECTION0.51

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIIDailyMed labelSPL versionUploaded
SUMATRIPTAN SUCCINATEACTIVE INGREDIENTJ8BDZ68989SUMATRIPTAN SUCCINATE INJECTION [WOCKHARDT LIMITED]1
SUMATRIPTANACTIVE MOIETY8R78F6L9VOSUMATRIPTAN SUCCINATE INJECTION [WOCKHARDT LIMITED]1
SODIUM CHLORIDEINACTIVE INGREDIENT451W47IQ8XSUMATRIPTAN SUCCINATE INJECTION [WOCKHARDT LIMITED]1
WATERINACTIVE INGREDIENT059QF0KO0RSUMATRIPTAN SUCCINATE INJECTION [WOCKHARDT LIMITED]1

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
55648-728SUMATRIPTAN SUCCINATE INJECTION [WOCKHARDT LIMITED]1Legacy NDC, 2 package rows20120305_cc5fed6e-37b5-415c-af2c-31e2bfb83c7c.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
313165SUMAtriptan 6 MG in 0.5 ML InjectionPSNcc5fed6e-37b5-415c-af2c-31e2bfb83c7c1
3131650.5 ML sumatriptan 12 MG/ML InjectionSCDcc5fed6e-37b5-415c-af2c-31e2bfb83c7c1
313165sumatriptan (as sumatriptan succinate) 12 MG/ML InjectionSYcc5fed6e-37b5-415c-af2c-31e2bfb83c7c1
313165sumatriptan 6 MG per 0.5 ML InjectionSYcc5fed6e-37b5-415c-af2c-31e2bfb83c7c1

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionStatus
55648-728-01556480728015 in 1 CARTONHistorical