Sumatriptan

Product NDC
36000-289
11-digit product format
360000289
Labeler code
36000
Product ID
36000-289_62c6c207-3e07-498e-ac5c-2f6e1a632a7e
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Sumatriptan
Dosage form
INJECTION
Route
SUBCUTANEOUS
Labeler
Baxter Healthcare Corporation
Application
ANDA207101
Marketing category
ANDA
Marketing start
2023-01-19
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
Listing expiration
2027-12-31

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
36000-289-05Sumatriptan0.5 mL in 1 VIALINJECTION0.55
36000-289-05Sumatriptan5 in 1 CARTONINJECTION55
36000-289-10Sumatriptan10 in 1 CARTONINJECTION105
36000-289-10Sumatriptan0.5 mL in 1 VIALINJECTION0.55
36000-289-25Sumatriptan0.5 mL in 1 VIALINJECTION0.55
36000-289-25Sumatriptan25 in 1 CARTONINJECTION255

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
36000-289SUMATRIPTAN INJECTION [BAXTER HEALTHCARE CORPORATION]3Current NDC, 6 package rows20241101_d13df081-648c-44c0-9854-5a1bfe23ae89.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
313165SUMAtriptan 6 MG in 0.5 ML InjectionPSNd13df081-648c-44c0-9854-5a1bfe23ae895
3131650.5 ML sumatriptan 12 MG/ML InjectionSCDd13df081-648c-44c0-9854-5a1bfe23ae895
313165sumatriptan (as sumatriptan succinate) 12 MG/ML InjectionSYd13df081-648c-44c0-9854-5a1bfe23ae895
313165sumatriptan 6 MG per 0.5 ML InjectionSYd13df081-648c-44c0-9854-5a1bfe23ae895

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startSampleExclude flagStatus
36000-289-05360000289055 VIAL in 1 CARTON (36000-289-05) / .5 mL in 1 VIAL5 vial2023-01-19NoNoCurrent
36000-289-103600002891010 VIAL in 1 CARTON (36000-289-10) / .5 mL in 1 VIAL10 vial2023-01-19NoNoCurrent
36000-289-253600002892525 VIAL in 1 CARTON (36000-289-25) / .5 mL in 1 VIAL25 vial2023-01-19NoNoCurrent