sumatriptan

Product NDC
83270-156
11-digit product format
832700156
Labeler code
83270
Product ID
83270-156_4996682c-cd86-6e39-e063-6294a90a90ae
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
sumatriptan
Dosage form
INJECTION, SOLUTION
Route
SUBCUTANEOUS
Labeler
ONESOURCE SPECIALTY PHARMA LIMITED
Application
ANDA090641
Marketing category
ANDA
Marketing start
2023-07-09
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
83270-156-06sumatriptan0.5 mL in 1 VIALINJECTION, SOLUTION0.51
83270-156-06sumatriptan5 in 1 CARTONINJECTION, SOLUTION51

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
313165SUMAtriptan 6 MG in 0.5 ML InjectionPSN4996682c-cd85-6e39-e063-6294a90a90ae1
3131650.5 ML sumatriptan 12 MG/ML InjectionSCD4996682c-cd85-6e39-e063-6294a90a90ae1
313165sumatriptan (as sumatriptan succinate) 12 MG/ML InjectionSY4996682c-cd85-6e39-e063-6294a90a90ae1
313165sumatriptan 6 MG per 0.5 ML InjectionSY4996682c-cd85-6e39-e063-6294a90a90ae1

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startSampleExclude flagStatus
83270-156-06832700156065 VIAL in 1 CARTON (83270-156-06) / .5 mL in 1 VIAL5 vial2023-07-09NoNoCurrent