Sumatriptan Succinate

Product NDC
47335-276
11-digit product format
473350276
Labeler code
47335
Product ID
47335-276_2642fcb9-4170-4b4c-818b-74c071cb567e
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Sumatriptan Succinate
Dosage form
INJECTION
Route
SUBCUTANEOUS
Labeler
Sun Pharmaceutical Industries, Inc.
Application
ANDA090358
Marketing category
ANDA
Marketing start
2025-08-20
Substance
SUMATRIPTAN SUCCINATE
Active strength
6 mg/.5mL
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
2027-12-31
Current FDA listing
Yes

Additional Listing Data#

Finished product
Yes
Brand name base
Sumatriptan Succinate
Listing expiration
2027-12-31

Active Ingredients#

Ingredient, Strength table
IngredientStrength
SUMATRIPTAN SUCCINATE6 mg/.5mL

Harmonized Identifiers#

Field, Values table
FieldValues
UniiJ8BDZ68989
Rxcui1657151

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

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
47335-276-40Sumatriptan Succinate0.5 mL in 1 SYRINGEINJECTION0.517
47335-276-40Sumatriptan Succinate1 in 1 PACKAGEINJECTION117
47335-276-41Sumatriptan Succinate2 in 1 PACKAGEINJECTION217
47335-276-41Sumatriptan Succinate0.5 mL in 1 SYRINGEINJECTION0.517

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
47335-276SUMATRIPTAN SUCCINATE INJECTION [SUN PHARMACEUTICAL INDUSTRIES, INC.]15Current NDC, Legacy NDC, 4 package rows20220402_f235152e-dd8d-4679-9d9f-404fe5ff4fba.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
1657151SUMAtriptan 6 MG in 0.5 ML Auto-InjectorPSNf235152e-dd8d-4679-9d9f-404fe5ff4fba17
16571510.5 ML sumatriptan 12 MG/ML Auto-InjectorSCDf235152e-dd8d-4679-9d9f-404fe5ff4fba17
1657151sumatriptan (as sumatriptan succinate) 6 MG per 0.5 ML Auto-InjectorSYf235152e-dd8d-4679-9d9f-404fe5ff4fba17

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
47335-276-40473350276401 SYRINGE in 1 PACKAGE (47335-276-40) / .5 mL in 1 SYRINGE1 syringe2025-08-200000-00-00NoNoCurrent
47335-276-41473350276412 SYRINGE in 1 PACKAGE (47335-276-41) / .5 mL in 1 SYRINGE2 syringe2025-08-200000-00-00NoNoCurrent