FDA.reportPublic FDA data

Sumatriptan

Product NDC
63304-097
11-digit product format
633040097
Labeler code
63304
Product ID
63304-097_9bc4f2da-41f0-42e2-98b2-b689c02d0a3e
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Sumatriptan
Dosage form
TABLET
Route
ORAL
Labeler
SUN PHARMACEUTICAL INDUSTRIES, INC.
Application
ANDA076554
Marketing category
ANDA
Marketing start
2009-08-13
Substance
SUMATRIPTAN SUCCINATE
Active strength
25 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
Sumatriptan
Listing expiration
2026-12-31

Active Ingredients#

Ingredient, Strength table
IngredientStrength
SUMATRIPTAN SUCCINATE25 mg/1

Harmonized Identifiers#

Field, Values table
FieldValues
UniiJ8BDZ68989
Rxcui313160, 313161, 315223

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

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDCEffectiveActionDocumentIndexing SPLRelated label
63304-097-132022-01-19C16284748780-19d75b9d0-262c-f424-e053-dadaa90a57ceThese highlights do not include all the information needed to use SUMATRIPTAN TABLETS, USP safely and effectively. See full prescribing information for SUMATRIPTAN TABLETS, USP. SUMATRIPTAN tablets, USP, for oral use Initial U.S. Approval: 1992
63304-097-192022-01-19C16284748780-19d75b9d0-262c-f424-e053-dadaa90a57ceThese highlights do not include all the information needed to use SUMATRIPTAN TABLETS, USP safely and effectively. See full prescribing information for SUMATRIPTAN TABLETS, USP. SUMATRIPTAN tablets, USP, for oral use Initial U.S. Approval: 1992
63304-097-452022-01-19C16284748780-19d75b9d0-262c-f424-e053-dadaa90a57ceThese highlights do not include all the information needed to use SUMATRIPTAN TABLETS, USP safely and effectively. See full prescribing information for SUMATRIPTAN TABLETS, USP. SUMATRIPTAN tablets, USP, for oral use Initial U.S. Approval: 1992
63304-097-132020-01-31C16284748780-19d75b9d0-262c-f424-e053-dadaa90a57ceThese highlights do not include all the information needed to use SUMATRIPTAN TABLETS, USP safely and effectively. See full prescribing information for SUMATRIPTAN TABLETS, USP. SUMATRIPTAN tablets, USP, for oral use Initial U.S. Approval: 1992
63304-097-192020-01-31C16284748780-19d75b9d0-262c-f424-e053-dadaa90a57ceThese highlights do not include all the information needed to use SUMATRIPTAN TABLETS, USP safely and effectively. See full prescribing information for SUMATRIPTAN TABLETS, USP. SUMATRIPTAN tablets, USP, for oral use Initial U.S. Approval: 1992
63304-097-452020-01-31C16284748780-19d75b9d0-262c-f424-e053-dadaa90a57ceThese highlights do not include all the information needed to use SUMATRIPTAN TABLETS, USP safely and effectively. See full prescribing information for SUMATRIPTAN TABLETS, USP. SUMATRIPTAN tablets, USP, for oral use Initial U.S. Approval: 1992

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
63304-097-13Sumatriptan120 in 1 BOTTLETABLET1207
63304-097-19Sumatriptan9 in 1 BLISTER PACKTABLET97
63304-097-19Sumatriptan1 in 1 CARTONTABLET17
63304-097-45Sumatriptan5 in 1 BOTTLETABLET57

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
63304-097-19EA - Each63304-09789dce314-ed07-4547-ba36-ddb8d6cadc3a12012-07-24

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIIDailyMed labelSPL versionUploaded
SUMATRIPTAN SUCCINATEACTIVE INGREDIENTJ8BDZ68989SUMATRIPTAN TABLET [RANBAXY PHARMACEUTICALS INC. ]5
SUMATRIPTANACTIVE MOIETY8R78F6L9VOSUMATRIPTAN TABLET [RANBAXY PHARMACEUTICALS INC. ]5
ANHYDROUS LACTOSEINACTIVE INGREDIENT3SY5LH9PMKSUMATRIPTAN TABLET [RANBAXY PHARMACEUTICALS INC. ]5
CELLULOSE, MICROCRYSTALLINEINACTIVE INGREDIENTOP1R32D61USUMATRIPTAN TABLET [RANBAXY PHARMACEUTICALS INC. ]5
CROSCARMELLOSE SODIUMINACTIVE INGREDIENTM28OL1HH48SUMATRIPTAN TABLET [RANBAXY PHARMACEUTICALS INC. ]5
LACTOSE MONOHYDRATEINACTIVE INGREDIENTEWQ57Q8I5XSUMATRIPTAN TABLET [RANBAXY PHARMACEUTICALS INC. ]5
MAGNESIUM STEARATEINACTIVE INGREDIENT70097M6I30SUMATRIPTAN TABLET [RANBAXY PHARMACEUTICALS INC. ]5
SILICON DIOXIDEINACTIVE INGREDIENTETJ7Z6XBU4SUMATRIPTAN TABLET [RANBAXY PHARMACEUTICALS INC. ]5
TALCINACTIVE INGREDIENT7SEV7J4R1USUMATRIPTAN TABLET [RANBAXY PHARMACEUTICALS INC. ]5
SUMATRIPTAN SUCCINATEACTIVE INGREDIENTJ8BDZ68989SUMATRIPTAN TABLET [PHYSICIANS TOTAL CARE, INC.]3
SUMATRIPTANACTIVE MOIETY8R78F6L9VOSUMATRIPTAN TABLET [PHYSICIANS TOTAL CARE, INC.]3
ANHYDROUS LACTOSEINACTIVE INGREDIENT3SY5LH9PMKSUMATRIPTAN TABLET [PHYSICIANS TOTAL CARE, INC.]3
CELLULOSE, MICROCRYSTALLINEINACTIVE INGREDIENTOP1R32D61USUMATRIPTAN TABLET [PHYSICIANS TOTAL CARE, INC.]3
CROSCARMELLOSE SODIUMINACTIVE INGREDIENTM28OL1HH48SUMATRIPTAN TABLET [PHYSICIANS TOTAL CARE, INC.]3
LACTOSE MONOHYDRATEINACTIVE INGREDIENTEWQ57Q8I5XSUMATRIPTAN TABLET [PHYSICIANS TOTAL CARE, INC.]3
MAGNESIUM STEARATEINACTIVE INGREDIENT70097M6I30SUMATRIPTAN TABLET [PHYSICIANS TOTAL CARE, INC.]3
SILICON DIOXIDEINACTIVE INGREDIENTETJ7Z6XBU4SUMATRIPTAN TABLET [PHYSICIANS TOTAL CARE, INC.]3
TALCINACTIVE INGREDIENT7SEV7J4R1USUMATRIPTAN TABLET [PHYSICIANS TOTAL CARE, INC.]3
SUMATRIPTAN SUCCINATEACTIVE INGREDIENTJ8BDZ68989SUMATRIPTAN TABLET [UNIT DOSE SERVICES]2
SUMATRIPTANACTIVE MOIETY8R78F6L9VOSUMATRIPTAN TABLET [UNIT DOSE SERVICES]2
ANHYDROUS LACTOSEINACTIVE INGREDIENT3SY5LH9PMKSUMATRIPTAN TABLET [UNIT DOSE SERVICES]2
CELLULOSE, MICROCRYSTALLINEINACTIVE INGREDIENTOP1R32D61USUMATRIPTAN TABLET [UNIT DOSE SERVICES]2
COLLOIDAL SILICON DIOXIDEINACTIVE INGREDIENTETJ7Z6XBU4SUMATRIPTAN TABLET [UNIT DOSE SERVICES]2
CROSCARMELLOSE SODIUMINACTIVE INGREDIENTM28OL1HH48SUMATRIPTAN TABLET [UNIT DOSE SERVICES]2
LACTOSE MONOHYDRATEINACTIVE INGREDIENTEWQ57Q8I5XSUMATRIPTAN TABLET [UNIT DOSE SERVICES]2
MAGNESIUM STEARATEINACTIVE INGREDIENT70097M6I30SUMATRIPTAN TABLET [UNIT DOSE SERVICES]2
TALCINACTIVE INGREDIENT7SEV7J4R1USUMATRIPTAN TABLET [UNIT DOSE SERVICES]2
SUMATRIPTAN SUCCINATEACTIVE INGREDIENTJ8BDZ68989SUMATRIPTAN TABLET [PROFICIENT RX LP]1
SUMATRIPTANACTIVE MOIETY8R78F6L9VOSUMATRIPTAN TABLET [PROFICIENT RX LP]1
ANHYDROUS LACTOSEINACTIVE INGREDIENT3SY5LH9PMKSUMATRIPTAN TABLET [PROFICIENT RX LP]1
CELLULOSE, MICROCRYSTALLINEINACTIVE INGREDIENTOP1R32D61USUMATRIPTAN TABLET [PROFICIENT RX LP]1
CROSCARMELLOSE SODIUMINACTIVE INGREDIENTM28OL1HH48SUMATRIPTAN TABLET [PROFICIENT RX LP]1
LACTOSE MONOHYDRATEINACTIVE INGREDIENTEWQ57Q8I5XSUMATRIPTAN TABLET [PROFICIENT RX LP]1
MAGNESIUM STEARATEINACTIVE INGREDIENT70097M6I30SUMATRIPTAN TABLET [PROFICIENT RX LP]1
SILICON DIOXIDEINACTIVE INGREDIENTETJ7Z6XBU4SUMATRIPTAN TABLET [PROFICIENT RX LP]1
TALCINACTIVE INGREDIENT7SEV7J4R1USUMATRIPTAN TABLET [PROFICIENT RX LP]1

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
63304-097SUMATRIPTAN TABLET [SUN PHARMACEUTICAL INDUSTRIES, INC.]7Current NDC, Legacy NDC, 4 package rows20220120_c87cf537-9f7f-400e-ac4b-86e6f7e78775.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
313160SUMAtriptan succinate 100 MG Oral TabletPSNc87cf537-9f7f-400e-ac4b-86e6f7e787757
315223SUMAtriptan succinate 25 MG Oral TabletPSNc87cf537-9f7f-400e-ac4b-86e6f7e787757
313161SUMAtriptan succinate 50 MG Oral TabletPSNc87cf537-9f7f-400e-ac4b-86e6f7e787757
313160sumatriptan 100 MG Oral TabletSCDc87cf537-9f7f-400e-ac4b-86e6f7e787757
315223sumatriptan 25 MG Oral TabletSCDc87cf537-9f7f-400e-ac4b-86e6f7e787757
313161sumatriptan 50 MG Oral TabletSCDc87cf537-9f7f-400e-ac4b-86e6f7e787757
313160sumatriptan 100 MG (as sumatriptan succinate 140 MG) Oral TabletSYc87cf537-9f7f-400e-ac4b-86e6f7e787757
315223sumatriptan 25 MG (as sumatriptan succinate 35 MG) Oral TabletSYc87cf537-9f7f-400e-ac4b-86e6f7e787757
313161sumatriptan 50 MG (as sumatriptan succinate 70 MG) Oral TabletSYc87cf537-9f7f-400e-ac4b-86e6f7e787757
315223SUMAtriptan succinate 25 MG Oral TabletPSN7ea9b761-4b07-40a1-9b55-d25343e8b0246
315223sumatriptan 25 MG Oral TabletSCD7ea9b761-4b07-40a1-9b55-d25343e8b0246
315223sumatriptan 25 MG (as sumatriptan succinate 35 MG) Oral TabletSY7ea9b761-4b07-40a1-9b55-d25343e8b0246
315223SUMAtriptan succinate 25 MG Oral TabletPSNa02f2474-4752-45cf-85ab-0f33430305e43
315223SUMAtriptan succinate 25 MG Oral TabletPSN5cba3661-9b16-416b-b0c0-bbb12549d48f3
315223sumatriptan 25 MG Oral TabletSCDa02f2474-4752-45cf-85ab-0f33430305e43
315223sumatriptan 25 MG Oral TabletSCD5cba3661-9b16-416b-b0c0-bbb12549d48f3
315223sumatriptan 25 MG (as sumatriptan succinate 35 MG) Oral TabletSYa02f2474-4752-45cf-85ab-0f33430305e43
315223sumatriptan 25 MG (as sumatriptan succinate 35 MG) Oral TabletSY5cba3661-9b16-416b-b0c0-bbb12549d48f3

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
63304-097-1363304009713120 TABLET in 1 BOTTLE (63304-097-13) 120 tablet2009-08-130000-00-00NoNoCurrent
63304-097-19633040097191 BLISTER PACK in 1 CARTON (63304-097-19) / 9 TABLET in 1 BLISTER PACK1 blister pack2009-08-130000-00-00NoNoCurrent
63304-097-45633040097455 TABLET in 1 BOTTLE (63304-097-45) 5 tablet2009-08-130000-00-00NoNoCurrent