FDA.reportPublic FDA data

SUMATRIPTAN

Product NDC
50090-2497
11-digit product format
500902497
Labeler code
50090
Product ID
50090-2497_32d8434e-550e-4ba9-a709-eb10fe9a596f
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
sumatriptan
Dosage form
INJECTION
Route
SUBCUTANEOUS
Labeler
A-S Medication Solutions
Application
ANDA200183
Marketing category
ANDA
Marketing start
2013-09-16
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
2026-12-31
Current FDA listing
Yes

Additional Listing Data#

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

Active Ingredients#

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

Harmonized Identifiers#

Field, Values table
FieldValues
UniiJ8BDZ68989
Rxcui313165

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
50090-2497-02023-02-07C16284748780-1f386c649-e796-0266-e053-dadaa90a7c1aThese highlights do not include all the information needed to use sumatriptan safely and effectively. See full prescribing information for sumatriptan. SU MATRIPTAN Injection, USP, for subcutaneous use Initial U.S. Approval: 1992
50090-2497-02023-01-30C16284748780-1f386c649-e796-0266-e053-dadaa90a7c1aThese highlights do not include all the information needed to use sumatriptan safely and effectively. See full prescribing information for sumatriptan. SU MATRIPTAN Injection, USP, for subcutaneous use Initial U.S. Approval: 1992

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
50090-2497-0SUMATRIPTAN.5 mL in 1 VIALINJECTION.512
50090-2497-0SUMATRIPTAN5 in 1 CARTONINJECTION512

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
50090-2497-0ML - Milliliter50090-2497ba78f17d-0612-431e-800f-be37717ed28b12019-03-12

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
50090-2497SUMATRIPTAN INJECTION [A-S MEDICATION SOLUTIONS]12Current NDC, Legacy NDC, 2 package rows20240108_f675d0db-f356-4eda-be62-b00af476326c.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
313165SUMAtriptan 6 MG in 0.5 ML InjectionPSNf675d0db-f356-4eda-be62-b00af476326c12
3131650.5 ML sumatriptan 12 MG/ML InjectionSCDf675d0db-f356-4eda-be62-b00af476326c12
313165sumatriptan (as sumatriptan succinate) 12 MG/ML InjectionSYf675d0db-f356-4eda-be62-b00af476326c12
313165sumatriptan 6 MG per 0.5 ML InjectionSYf675d0db-f356-4eda-be62-b00af476326c12

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
50090-2497-0500902497005 VIAL in 1 CARTON (50090-2497-0) / .5 mL in 1 VIAL5 vial2016-10-130000-00-00NoNoCurrent