FDA.reportPublic FDA data

SUMATRIPTAN

Product NDC
0143-9638
11-digit product format
001439638
Labeler code
0143
Product ID
0143-9638_38f8761d-784e-407e-9dda-73fd78a829f4
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
sumatriptan
Dosage form
INJECTION
Route
SUBCUTANEOUS
Labeler
Hikma Pharmaceuticals USA Inc.
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

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
0143-9638-01SUMATRIPTAN0.5 mL in 1 VIALINJECTION0.56
0143-9638-05SUMATRIPTAN5 in 1 CARTONINJECTION56
0143-9638-25SUMATRIPTAN25 in 1 CARTONINJECTION256

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
0143-9638-01ML - Milliliter0143-96387e2e60b5-459e-4602-85d4-9b52ead9cb6312014-02-04
0143-9638-05ML - Milliliter0143-9638a3ca7ff0-8049-473b-bf87-18cd7cd0585b12014-02-04

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIIDailyMed labelSPL versionUploaded
SUMATRIPTAN SUCCINATEACTIVE INGREDIENTJ8BDZ68989SUMATRIPTAN INJECTION [WEST-WARD PHARMACEUTICALS CORP]4
SUMATRIPTANACTIVE MOIETY8R78F6L9VOSUMATRIPTAN INJECTION [WEST-WARD PHARMACEUTICALS CORP]4
SODIUM CHLORIDEINACTIVE INGREDIENT451W47IQ8XSUMATRIPTAN INJECTION [WEST-WARD PHARMACEUTICALS CORP]4
WATERINACTIVE INGREDIENT059QF0KO0RSUMATRIPTAN INJECTION [WEST-WARD PHARMACEUTICALS CORP]4

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
0143-9638SUMATRIPTAN INJECTION [HIKMA PHARMACEUTICALS USA INC.]6Current NDC, Legacy NDC, 3 package rows20231024_2b417f8c-9e5b-45a1-b8af-183818258df9.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
313165SUMAtriptan 6 MG in 0.5 ML InjectionPSN2b417f8c-9e5b-45a1-b8af-183818258df96
3131650.5 ML sumatriptan 12 MG/ML InjectionSCD2b417f8c-9e5b-45a1-b8af-183818258df96
313165sumatriptan (as sumatriptan succinate) 12 MG/ML InjectionSY2b417f8c-9e5b-45a1-b8af-183818258df96
313165sumatriptan 6 MG per 0.5 ML InjectionSY2b417f8c-9e5b-45a1-b8af-183818258df96

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
0143-9638-01001439638010.5 mL in 1 VIAL0.5 mlHistorical
0143-9638-05001439638055 VIAL in 1 CARTON (0143-9638-05) / .5 mL in 1 VIAL (0143-9638-01) 5 vial2013-09-160000-00-00NoNoCurrent
0143-9638-250014396382525 VIAL in 1 CARTON (0143-9638-25) / .5 mL in 1 VIAL (0143-9638-01) 25 vial2013-09-160000-00-00NoNoCurrent