Sumatriptan Succinate

Product NDC
63187-049
11-digit product format
631870049
Labeler code
63187
Product ID
63187-049_bcf1b59f-5656-4913-882c-95ffe205273b
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Sumatriptan Succinate
Dosage form
TABLET
Route
ORAL
Labeler
Proficient Rx LP
Application
ANDA076847
Marketing category
ANDA
Marketing start
2009-11-17
Substance
SUMATRIPTAN SUCCINATE
Active strength
50 mg/1
Pharmacologic classes
Serotonin 1b Receptor Agonists [MoA], Serotonin 1d Receptor Agonists [MoA], Serotonin-1b and Serotonin-1d Receptor Agonist [EPC]
NDC exclude flag
No
Listing certified through
2026-12-31
Current FDA listing
Yes

Additional Listing Data#

Finished product
Yes
Brand name base
Sumatriptan Succinate
Listing expiration
2026-12-31

Active Ingredients#

Ingredient, Strength table
IngredientStrength
SUMATRIPTAN SUCCINATE50 mg/1

Harmonized Identifiers#

Field, Values table
FieldValues
UniiJ8BDZ68989
Rxcui313161

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
63187-049-092019-11-27C16284748780-19855e2a2-34ef-60a7-e053-dbdaa90a05bdSumatriptan succinate

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
63187-049-09Sumatriptan Succinate9 in 1 BOTTLETABLET93

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIIDailyMed labelSPL versionUploaded
sumatriptan succinateACTIVE INGREDIENTJ8BDZ68989SUMATRIPTAN SUCCINATE TABLET [PROFICIENT RX LP]1
SUMATRIPTANACTIVE MOIETY8R78F6L9VOSUMATRIPTAN SUCCINATE TABLET [PROFICIENT RX LP]1
ANHYDROUS LACTOSEINACTIVE INGREDIENT3SY5LH9PMKSUMATRIPTAN SUCCINATE TABLET [PROFICIENT RX LP]1
CELLULOSE, MICROCRYSTALLINEINACTIVE INGREDIENTOP1R32D61USUMATRIPTAN SUCCINATE TABLET [PROFICIENT RX LP]1
croscarmellose sodiumINACTIVE INGREDIENTM28OL1HH48SUMATRIPTAN SUCCINATE TABLET [PROFICIENT RX LP]1
LACTOSE MONOHYDRATEINACTIVE INGREDIENTEWQ57Q8I5XSUMATRIPTAN SUCCINATE TABLET [PROFICIENT RX LP]1
magnesium stearateINACTIVE INGREDIENT70097M6I30SUMATRIPTAN SUCCINATE TABLET [PROFICIENT RX LP]1
mannitolINACTIVE INGREDIENT3OWL53L36ASUMATRIPTAN SUCCINATE TABLET [PROFICIENT RX LP]1
talcINACTIVE INGREDIENT7SEV7J4R1USUMATRIPTAN SUCCINATE TABLET [PROFICIENT RX LP]1
titanium dioxideINACTIVE INGREDIENT15FIX9V2JPSUMATRIPTAN SUCCINATE TABLET [PROFICIENT RX LP]1
triacetinINACTIVE INGREDIENTXHX3C3X673SUMATRIPTAN SUCCINATE TABLET [PROFICIENT RX LP]1

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
63187-049SUMATRIPTAN SUCCINATE TABLET [PROFICIENT RX LP]3Current NDC, Legacy NDC, 1 package rows20200219_68daf82a-334e-43ca-b4bb-5c66a82f52c8.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
313161SUMAtriptan succinate 50 MG Oral TabletPSN68daf82a-334e-43ca-b4bb-5c66a82f52c83
313161sumatriptan 50 MG Oral TabletSCD68daf82a-334e-43ca-b4bb-5c66a82f52c83
313161sumatriptan 50 MG (as sumatriptan succinate 70 MG) Oral TabletSY68daf82a-334e-43ca-b4bb-5c66a82f52c83

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
63187-049-09631870049099 TABLET in 1 BOTTLE (63187-049-09) 9 tablet2014-05-010000-00-00NoNoCurrent