FDA.reportPublic FDA data

IMITREX

Product NDC
0173-0736
11-digit product format
001730736
Labeler code
0173
Product ID
0173-0736_21c610c9-8ab7-4bc6-bb14-7d5faa26a0fc
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
sumatriptan
Dosage form
TABLET, FILM COATED
Route
ORAL
Labeler
GlaxoSmithKline LLC
Application
NDA020132
Marketing category
NDA
Marketing start
2003-12-17
Substance
SUMATRIPTAN SUCCINATE
Active strength
50 mg/1
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 SUCCINATE50 mg/1

Harmonized Identifiers#

Field, Values table
FieldValues
UniiJ8BDZ68989
Rxcui208450, 209169, 284460, 313160, 313161, 315223

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
59adc2ba-d5f0-4a52-b35a-cc77921a79d2Product name420250724
2839c963-7eb3-970a-287f-ff1b6d381268Product name220250103
fb7ab793-2c12-4079-b100-a64f73bef25aProduct name420240712
b0cbf770-6cc3-4aa4-9158-755110c2b9f7Product name220230717
dc7c5daa-021f-40dd-b00d-63982cb2067aProduct name120230426
1e973b2d-e028-69cd-9258-4613ba80fdc5Product name320210512
08ffbcbf-26df-b99c-1dab-64fc4cfae89fProduct name520200925
3eb481d3-8b69-436f-82dd-4a66345568abProduct name120190611
816b97af-edc5-4060-aff1-b814bdbcad50Product name120190415
e76dbbc1-775d-722c-08ff-ed45e8a80defProduct name320181002
7cda52fc-125f-421c-8fea-bc1974370c49Product name220180703
419aab54-5d5a-4146-9453-026d4a9991beProduct name220170525
08ffbcbf-26df-b99c-1dab-64fc4cfae89fProduct name220160823
c100f0c7-e9dd-42f4-b0a8-0d81bd2a877cProduct name120160303
49615343-b619-4365-8118-8f2ed6046e78Product name120160224
a6319377-430a-43db-82f9-30d1d9d89cf8Product name120151216
89dac932-b90a-4410-9ab1-84c53e57de25Product name120150316
f6199b09-e585-7ceb-4b09-803cf5ce1ed1Product name120140508

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
0173-0736-01IMITREX1 in 1 CARTONTABLET, FILM COATED123

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
0173-0736-01EA - Each0173-07363e4c9e32-2dbf-49f1-b5ab-0a466003357112012-07-24

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIIDailyMed labelSPL versionUploaded
SUMATRIPTAN SUCCINATEACTIVE INGREDIENTJ8BDZ68989IMITREX (SUMATRIPTAN SUCCINATE) TABLET, FILM COATED [GLAXOSMITHKLINE LLC]10
SUMATRIPTANACTIVE MOIETY8R78F6L9VOIMITREX (SUMATRIPTAN SUCCINATE) TABLET, FILM COATED [GLAXOSMITHKLINE LLC]10
CALCIUM PHOSPHATE, DIBASIC, ANHYDROUSINACTIVE INGREDIENTL11K75P92JIMITREX (SUMATRIPTAN SUCCINATE) TABLET, FILM COATED [GLAXOSMITHKLINE LLC]10
CELLULOSE, MICROCRYSTALLINEINACTIVE INGREDIENTOP1R32D61UIMITREX (SUMATRIPTAN SUCCINATE) TABLET, FILM COATED [GLAXOSMITHKLINE LLC]10
CROSCARMELLOSE SODIUMINACTIVE INGREDIENTM28OL1HH48IMITREX (SUMATRIPTAN SUCCINATE) TABLET, FILM COATED [GLAXOSMITHKLINE LLC]10
HYPROMELLOSESINACTIVE INGREDIENT3NXW29V3WOIMITREX (SUMATRIPTAN SUCCINATE) TABLET, FILM COATED [GLAXOSMITHKLINE LLC]10
MAGNESIUM STEARATEINACTIVE INGREDIENT70097M6I30IMITREX (SUMATRIPTAN SUCCINATE) TABLET, FILM COATED [GLAXOSMITHKLINE LLC]10
SODIUM BICARBONATEINACTIVE INGREDIENT8MDF5V39QOIMITREX (SUMATRIPTAN SUCCINATE) TABLET, FILM COATED [GLAXOSMITHKLINE LLC]10
TITANIUM DIOXIDEINACTIVE INGREDIENT15FIX9V2JPIMITREX (SUMATRIPTAN SUCCINATE) TABLET, FILM COATED [GLAXOSMITHKLINE LLC]10
TRIACETININACTIVE INGREDIENTXHX3C3X673IMITREX (SUMATRIPTAN SUCCINATE) TABLET, FILM COATED [GLAXOSMITHKLINE LLC]10
SUMATRIPTAN SUCCINATEACTIVE INGREDIENTJ8BDZ68989IMITREX (SUMATRIPTAN SUCCINATE) TABLET, FILM COATED [PHYSICIANS TOTAL CARE, INC.]4
SUMATRIPTANACTIVE MOIETY8R78F6L9VOIMITREX (SUMATRIPTAN SUCCINATE) TABLET, FILM COATED [PHYSICIANS TOTAL CARE, INC.]4
CALCIUM PHOSPHATE, DIBASIC, ANHYDROUSINACTIVE INGREDIENTL11K75P92JIMITREX (SUMATRIPTAN SUCCINATE) TABLET, FILM COATED [PHYSICIANS TOTAL CARE, INC.]4
CELLULOSE, MICROCRYSTALLINEINACTIVE INGREDIENTOP1R32D61UIMITREX (SUMATRIPTAN SUCCINATE) TABLET, FILM COATED [PHYSICIANS TOTAL CARE, INC.]4
CROSCARMELLOSE SODIUMINACTIVE INGREDIENTM28OL1HH48IMITREX (SUMATRIPTAN SUCCINATE) TABLET, FILM COATED [PHYSICIANS TOTAL CARE, INC.]4
HYPROMELLOSESINACTIVE INGREDIENT3NXW29V3WOIMITREX (SUMATRIPTAN SUCCINATE) TABLET, FILM COATED [PHYSICIANS TOTAL CARE, INC.]4
MAGNESIUM STEARATEINACTIVE INGREDIENT70097M6I30IMITREX (SUMATRIPTAN SUCCINATE) TABLET, FILM COATED [PHYSICIANS TOTAL CARE, INC.]4
SODIUM BICARBONATEINACTIVE INGREDIENT8MDF5V39QOIMITREX (SUMATRIPTAN SUCCINATE) TABLET, FILM COATED [PHYSICIANS TOTAL CARE, INC.]4
TITANIUM DIOXIDEINACTIVE INGREDIENT15FIX9V2JPIMITREX (SUMATRIPTAN SUCCINATE) TABLET, FILM COATED [PHYSICIANS TOTAL CARE, INC.]4
TRIACETININACTIVE INGREDIENTXHX3C3X673IMITREX (SUMATRIPTAN SUCCINATE) TABLET, FILM COATED [PHYSICIANS TOTAL CARE, INC.]4
SUMATRIPTAN SUCCINATEACTIVE INGREDIENTJ8BDZ68989IMITREX (SUMATRIPTAN SUCCINATE) TABLET, FILM COATED [REBEL DISTRIBUTORS CORP]1
SUMATRIPTANACTIVE MOIETY8R78F6L9VOIMITREX (SUMATRIPTAN SUCCINATE) TABLET, FILM COATED [REBEL DISTRIBUTORS CORP]1
ANHYDROUS DIBASIC CALCIUM PHOSPHATEINACTIVE INGREDIENTL11K75P92JIMITREX (SUMATRIPTAN SUCCINATE) TABLET, FILM COATED [REBEL DISTRIBUTORS CORP]1
CELLULOSE, MICROCRYSTALLINEINACTIVE INGREDIENTOP1R32D61UIMITREX (SUMATRIPTAN SUCCINATE) TABLET, FILM COATED [REBEL DISTRIBUTORS CORP]1
CROSCARMELLOSE SODIUMINACTIVE INGREDIENTM28OL1HH48IMITREX (SUMATRIPTAN SUCCINATE) TABLET, FILM COATED [REBEL DISTRIBUTORS CORP]1
MAGNESIUM STEARATEINACTIVE INGREDIENT70097M6I30IMITREX (SUMATRIPTAN SUCCINATE) TABLET, FILM COATED [REBEL DISTRIBUTORS CORP]1
SODIUM BICARBONATEINACTIVE INGREDIENT8MDF5V39QOIMITREX (SUMATRIPTAN SUCCINATE) TABLET, FILM COATED [REBEL DISTRIBUTORS CORP]1

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
0173-0736IMITREX (SUMATRIPTAN) TABLET, FILM COATED [GLAXOSMITHKLINE LLC]21Current NDC, Legacy NDC, 1 package rows20240222_584abe73-8290-4484-ff8e-5890831c095e.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
284460IMITREX 100 MG Oral TabletPSN584abe73-8290-4484-ff8e-5890831c095e23
208450IMITREX 25 MG Oral TabletPSN584abe73-8290-4484-ff8e-5890831c095e23
209169IMITREX 50 MG Oral TabletPSN584abe73-8290-4484-ff8e-5890831c095e23
313160SUMAtriptan succinate 100 MG Oral TabletPSN584abe73-8290-4484-ff8e-5890831c095e23
315223SUMAtriptan succinate 25 MG Oral TabletPSN584abe73-8290-4484-ff8e-5890831c095e23
313161SUMAtriptan succinate 50 MG Oral TabletPSN584abe73-8290-4484-ff8e-5890831c095e23
284460sumatriptan 100 MG Oral Tablet [Imitrex]SBD584abe73-8290-4484-ff8e-5890831c095e23
208450sumatriptan 25 MG Oral Tablet [Imitrex]SBD584abe73-8290-4484-ff8e-5890831c095e23
209169sumatriptan 50 MG Oral Tablet [Imitrex]SBD584abe73-8290-4484-ff8e-5890831c095e23
313160sumatriptan 100 MG Oral TabletSCD584abe73-8290-4484-ff8e-5890831c095e23
315223sumatriptan 25 MG Oral TabletSCD584abe73-8290-4484-ff8e-5890831c095e23
313161sumatriptan 50 MG Oral TabletSCD584abe73-8290-4484-ff8e-5890831c095e23
284460Imitrex 100 MG (sumatriptan succinate 140 MG) Oral TabletSY584abe73-8290-4484-ff8e-5890831c095e23
284460Imitrex 100 MG Oral TabletSY584abe73-8290-4484-ff8e-5890831c095e23
208450Imitrex 25 MG (sumatriptan succinate 35 MG) Oral TabletSY584abe73-8290-4484-ff8e-5890831c095e23
208450Imitrex 25 MG Oral TabletSY584abe73-8290-4484-ff8e-5890831c095e23
209169Imitrex 50 MG (sumatriptan succinate 70 MG) Oral TabletSY584abe73-8290-4484-ff8e-5890831c095e23
209169Imitrex 50 MG Oral TabletSY584abe73-8290-4484-ff8e-5890831c095e23
313160sumatriptan 100 MG (as sumatriptan succinate 140 MG) Oral TabletSY584abe73-8290-4484-ff8e-5890831c095e23
315223sumatriptan 25 MG (as sumatriptan succinate 35 MG) Oral TabletSY584abe73-8290-4484-ff8e-5890831c095e23
313161sumatriptan 50 MG (as sumatriptan succinate 70 MG) Oral TabletSY584abe73-8290-4484-ff8e-5890831c095e23
284460IMITREX 100 MG Oral TabletPSN040abcc1-cc1c-4f00-b302-36070611f7b24
208450IMITREX 25 MG Oral TabletPSN040abcc1-cc1c-4f00-b302-36070611f7b24
209169IMITREX 50 MG Oral TabletPSN040abcc1-cc1c-4f00-b302-36070611f7b24
313160SUMAtriptan succinate 100 MG Oral TabletPSN040abcc1-cc1c-4f00-b302-36070611f7b24
315223SUMAtriptan succinate 25 MG Oral TabletPSN040abcc1-cc1c-4f00-b302-36070611f7b24
313161SUMAtriptan succinate 50 MG Oral TabletPSN040abcc1-cc1c-4f00-b302-36070611f7b24
284460sumatriptan 100 MG Oral Tablet [Imitrex]SBD040abcc1-cc1c-4f00-b302-36070611f7b24
208450sumatriptan 25 MG Oral Tablet [Imitrex]SBD040abcc1-cc1c-4f00-b302-36070611f7b24
209169sumatriptan 50 MG Oral Tablet [Imitrex]SBD040abcc1-cc1c-4f00-b302-36070611f7b24
313160sumatriptan 100 MG Oral TabletSCD040abcc1-cc1c-4f00-b302-36070611f7b24
315223sumatriptan 25 MG Oral TabletSCD040abcc1-cc1c-4f00-b302-36070611f7b24
313161sumatriptan 50 MG Oral TabletSCD040abcc1-cc1c-4f00-b302-36070611f7b24
284460Imitrex 100 MG (sumatriptan succinate 140 MG) Oral TabletSY040abcc1-cc1c-4f00-b302-36070611f7b24
284460Imitrex 100 MG Oral TabletSY040abcc1-cc1c-4f00-b302-36070611f7b24
208450Imitrex 25 MG (sumatriptan succinate 35 MG) Oral TabletSY040abcc1-cc1c-4f00-b302-36070611f7b24
208450Imitrex 25 MG Oral TabletSY040abcc1-cc1c-4f00-b302-36070611f7b24
209169Imitrex 50 MG (sumatriptan succinate 70 MG) Oral TabletSY040abcc1-cc1c-4f00-b302-36070611f7b24
209169Imitrex 50 MG Oral TabletSY040abcc1-cc1c-4f00-b302-36070611f7b24
313160sumatriptan 100 MG (as sumatriptan succinate 140 MG) Oral TabletSY040abcc1-cc1c-4f00-b302-36070611f7b24
315223sumatriptan 25 MG (as sumatriptan succinate 35 MG) Oral TabletSY040abcc1-cc1c-4f00-b302-36070611f7b24
313161sumatriptan 50 MG (as sumatriptan succinate 70 MG) Oral TabletSY040abcc1-cc1c-4f00-b302-36070611f7b24
209169IMITREX 50 MG Oral TabletPSNa169b0c0-600f-4072-8ab7-fafc386eab801
313161SUMAtriptan succinate 50 MG Oral TabletPSNa169b0c0-600f-4072-8ab7-fafc386eab801
209169sumatriptan 50 MG Oral Tablet [Imitrex]SBDa169b0c0-600f-4072-8ab7-fafc386eab801
313161sumatriptan 50 MG Oral TabletSCDa169b0c0-600f-4072-8ab7-fafc386eab801
209169Imitrex 50 MG (sumatriptan succinate 70 MG) Oral TabletSYa169b0c0-600f-4072-8ab7-fafc386eab801
209169Imitrex 50 MG Oral TabletSYa169b0c0-600f-4072-8ab7-fafc386eab801
313161sumatriptan 50 MG (as sumatriptan succinate 70 MG) Oral TabletSYa169b0c0-600f-4072-8ab7-fafc386eab801

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
0173-0736-01001730736011 CARTON in 1 CARTON (0173-0736-01) / 1 BLISTER PACK in 1 CARTON / 9 TABLET, FILM COATED in 1 BLISTER PACK1 carton2003-12-170000-00-00NoNoCurrent