FDA.reportPublic FDA data

IMITREX

Product NDC
0173-0478
11-digit product format
001730478
Labeler code
0173
Product ID
0173-0478_f5834e77-047f-43ab-8b9c-37d3b34afc27
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
sumatriptan
Dosage form
INJECTION
Route
SUBCUTANEOUS
Labeler
GlaxoSmithKline LLC
Application
NDA020080
Marketing category
NDA
Marketing start
1997-01-27
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
IMITREX
Listing expiration
2026-12-31

Active Ingredients#

Ingredient, Strength table
IngredientStrength
SUMATRIPTAN SUCCINATE6 mg/.5mL

Harmonized Identifiers#

Field, Values table
FieldValues
UniiJ8BDZ68989
Rxcui758523, 860088, 1657160, 1657173

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
0173-0478-00IMITREX0.5 mL in 1 SYRINGEINJECTION0.529
0173-0478-00IMITREX2 in 1 CARTONINJECTION229

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
0173-0478-00ML - Milliliter0173-04784cd327b4-2fba-46c0-83e5-182b421c5db712012-07-24

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIIDailyMed labelSPL versionUploaded
SUMATRIPTAN SUCCINATEACTIVE INGREDIENTJ8BDZ68989IMITREX (SUMATRIPTAN SUCCINATE) INJECTION [GLAXOSMITHKLINE LLC]14
SUMATRIPTANACTIVE MOIETY8R78F6L9VOIMITREX (SUMATRIPTAN SUCCINATE) INJECTION [GLAXOSMITHKLINE LLC]14
SODIUM CHLORIDEINACTIVE INGREDIENT451W47IQ8XIMITREX (SUMATRIPTAN SUCCINATE) INJECTION [GLAXOSMITHKLINE LLC]14
WATERINACTIVE INGREDIENT059QF0KO0RIMITREX (SUMATRIPTAN SUCCINATE) INJECTION [GLAXOSMITHKLINE LLC]14

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
0173-0478IMITREX (SUMATRIPTAN) INJECTION [GLAXOSMITHKLINE LLC]27Current NDC, Legacy NDC, 2 package rows20240828_fee7d073-0b99-48f2-7985-0d8cf970894b.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
758523IMITREX 4 MG in 0.5 ML CartridgePSNfee7d073-0b99-48f2-7985-0d8cf970894b29
860088IMITREX 6 MG in 0.5 ML CartridgePSNfee7d073-0b99-48f2-7985-0d8cf970894b29
1657173SUMAtriptan 4 MG in 0.5 ML CartridgePSNfee7d073-0b99-48f2-7985-0d8cf970894b29
1657160SUMAtriptan 6 MG in 0.5 ML CartridgePSNfee7d073-0b99-48f2-7985-0d8cf970894b29
8600880.5 ML sumatriptan 12 MG/ML Cartridge [Imitrex]SBDfee7d073-0b99-48f2-7985-0d8cf970894b29
7585230.5 ML sumatriptan 8 MG/ML Cartridge [Imitrex]SBDfee7d073-0b99-48f2-7985-0d8cf970894b29
16571600.5 ML sumatriptan 12 MG/ML CartridgeSCDfee7d073-0b99-48f2-7985-0d8cf970894b29
16571730.5 ML sumatriptan 8 MG/ML CartridgeSCDfee7d073-0b99-48f2-7985-0d8cf970894b29
8600880.5 ML Imitrex 12 MG/ML CartridgeSYfee7d073-0b99-48f2-7985-0d8cf970894b29
7585230.5 ML Imitrex 8 MG/ML CartridgeSYfee7d073-0b99-48f2-7985-0d8cf970894b29
758523Imitrex 4 MG (as sumatriptan succinate) per 0.5 ML CartridgeSYfee7d073-0b99-48f2-7985-0d8cf970894b29
758523Imitrex 4 MG per 0.5 ML CartridgeSYfee7d073-0b99-48f2-7985-0d8cf970894b29
860088Imitrex 6 MG (as sumatriptan succinate) per 0.5 ML CartridgeSYfee7d073-0b99-48f2-7985-0d8cf970894b29
860088Imitrex 6 MG per 0.5 ML CartridgeSYfee7d073-0b99-48f2-7985-0d8cf970894b29
1657173sumatriptan 4 MG (as sumatriptan succinate) per 0.5 ML CartridgeSYfee7d073-0b99-48f2-7985-0d8cf970894b29
1657173sumatriptan 4 MG per 0.5 ML CartridgeSYfee7d073-0b99-48f2-7985-0d8cf970894b29
1657160sumatriptan 6 MG (as sumatriptan succinate) per 0.5 ML CartridgeSYfee7d073-0b99-48f2-7985-0d8cf970894b29
1657160sumatriptan 6 MG per 0.5 ML CartridgeSYfee7d073-0b99-48f2-7985-0d8cf970894b29

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
0173-0478-00001730478002 SYRINGE in 1 CARTON (0173-0478-00) / .5 mL in 1 SYRINGE2 syringe1997-01-270000-00-00NoNoCurrent