FDA.reportPublic FDA data

Sumatriptan Succinate

Product NDC
63323-273
11-digit product format
633230273
Labeler code
63323
Product ID
63323-273_ae034e54-f171-44df-b13b-6eb588979001
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Sumatriptan Succinate
Dosage form
INJECTION
Route
SUBCUTANEOUS
Labeler
Fresenius Kabi USA, LLC
Application
ANDA079242
Marketing category
ANDA
Marketing start
2011-04-12
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 Succinate
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

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
63323-273-01Sumatriptan Succinate0.5 mL in 1 VIAL, SINGLE-DOSEINJECTION0.57
63323-273-01Sumatriptan Succinate1 in 1 CARTONINJECTION17

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
63323-273SUMATRIPTAN SUCCINATE (SUMATRIPTAN SUCCINATE) INJECTION [FRESENIUS KABI USA, LLC ]7Current NDC, Legacy NDC, 2 package rows20240504_b183c7ba-2cc6-4854-a9a6-71ccd3592586.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
313165SUMAtriptan 6 MG in 0.5 ML InjectionPSNb183c7ba-2cc6-4854-a9a6-71ccd35925867
3131650.5 ML sumatriptan 12 MG/ML InjectionSCDb183c7ba-2cc6-4854-a9a6-71ccd35925867
313165sumatriptan (as sumatriptan succinate) 12 MG/ML InjectionSYb183c7ba-2cc6-4854-a9a6-71ccd35925867
313165sumatriptan 6 MG per 0.5 ML InjectionSYb183c7ba-2cc6-4854-a9a6-71ccd35925867

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionMarketing startMarketing endSampleExclude flagStatus
63323-273-01633230273011 VIAL, SINGLE-DOSE in 1 CARTON (63323-273-01) / .5 mL in 1 VIAL, SINGLE-DOSE2011-04-120000-00-00NoNoCurrent