FDA.reportPublic FDA data

Sumatriptan Succinate

Product NDC
72603-141
11-digit product format
726030141
Labeler code
72603
Product ID
72603-141_4bbdfb46-6291-2fa4-948a-b505c0eea287
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Sumatriptan Succinate
Dosage form
INJECTION
Route
SUBCUTANEOUS
Labeler
NorthStar Rx LLC
Application
ANDA090495
Marketing category
ANDA
Marketing start
2023-06-13
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
72603-141-01Sumatriptan Succinate0.5 mL in 1 SYRINGEINJECTION0.52
72603-141-02Sumatriptan Succinate2 in 1 CARTONINJECTION22

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
72603-141-01ML - Milliliter72603-14188630de5-8f35-440f-bec2-5e4974a6257e12023-07-06
72603-141-02ML - Milliliter72603-1419d08c856-2b7b-4e9e-a3ce-511ed88d795a12023-07-06

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
72603-141SUMATRIPTAN SUCCINATE INJECTION [NORTHSTAR RX LLC]1Current NDC, 2 package rows20230615_38fd19bf-b7aa-812c-8a74-2414dfec45f4.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
1657151SUMAtriptan 6 MG in 0.5 ML Auto-InjectorPSN38fd19bf-b7aa-812c-8a74-2414dfec45f42
16571510.5 ML sumatriptan 12 MG/ML Auto-InjectorSCD38fd19bf-b7aa-812c-8a74-2414dfec45f42
1657151sumatriptan (as sumatriptan succinate) 6 MG per 0.5 ML Auto-InjectorSY38fd19bf-b7aa-812c-8a74-2414dfec45f42

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startSampleExclude flagStatus
72603-141-01726030141010.5 mL in 1 SYRINGE0.5 mlHistorical
72603-141-02726030141022 SYRINGE in 1 CARTON (72603-141-02) / .5 mL in 1 SYRINGE (72603-141-01) 2 syringe2023-06-13NoNoCurrent