FDA.reportPublic FDA data

Sumatriptan

Product NDC
70594-068
11-digit product format
705940068
Labeler code
70594
Product ID
70594-068_44ed271d-bc7e-48f7-bb63-0ecdb70fdad4
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
SUMATRIPTAN SUCCINATE
Dosage form
INJECTION
Route
SUBCUTANEOUS
Labeler
Xellia Pharmaceuticals USA LLC
Application
ANDA213998
Marketing category
ANDA
Marketing start
2022-01-01
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

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
70594-068-01Sumatriptan0.5 mL in 1 VIALINJECTION0.51
70594-068-02Sumatriptan5 in 1 CARTONINJECTION51

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
70594-068-01ML - Milliliter70594-0683d566ad5-bf9b-4c2b-94f2-98db1483ace812022-03-09
70594-068-02ML - Milliliter70594-06871bd81e2-ba9f-4a2a-8e24-46f2013a4ed112022-03-09

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
70594-068SUMATRIPTAN (SUMATRIPTAN SUCCINATE) INJECTION [XELLIA PHARMACEUTICALS USA LLC]1Current NDC, Legacy NDC, 2 package rows20220101_f42c6e00-e693-48f3-8e84-c3f139e1adf5.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
313165SUMAtriptan 6 MG in 0.5 ML InjectionPSNf42c6e00-e693-48f3-8e84-c3f139e1adf51
3131650.5 ML sumatriptan 12 MG/ML InjectionSCDf42c6e00-e693-48f3-8e84-c3f139e1adf51
313165sumatriptan (as sumatriptan succinate) 12 MG/ML InjectionSYf42c6e00-e693-48f3-8e84-c3f139e1adf51
313165sumatriptan 6 MG per 0.5 ML InjectionSYf42c6e00-e693-48f3-8e84-c3f139e1adf51

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
70594-068-01705940068010.5 mL in 1 VIAL0.5 mlHistorical
70594-068-02705940068025 VIAL in 1 CARTON (70594-068-02) / .5 mL in 1 VIAL (70594-068-01) 5 vial2022-01-010000-00-00NoNoCurrent