FDA.reportPublic FDA data

Sumatriptan Succinate

Product NDC
0378-5632
11-digit product format
003785632
Labeler code
0378
Product ID
0378-5632_cd918be8-d6c0-4dcc-aa7d-32bd7017fa1d
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
sumatriptan succinate
Dosage form
TABLET, FILM COATED
Route
ORAL
Labeler
Mylan Pharmaceuticals Inc.
Application
ANDA077744
Marketing category
ANDA
Marketing start
2009-08-10
Substance
SUMATRIPTAN SUCCINATE
Active strength
100 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
2027-12-31
Current FDA listing
Yes

Additional Listing Data#

Finished product
Yes
Brand name base
Sumatriptan Succinate
Listing expiration
2027-12-31

Active Ingredients#

Ingredient, Strength table
IngredientStrength
SUMATRIPTAN SUCCINATE100 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

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
0378-5632-59Sumatriptan Succinate9 in 1 BOTTLE, PLASTICTABLET, FILM COATED915

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
0378-5632-59EA - Each0378-563226bb22f7-87a7-4396-85e1-573e11d405e912012-07-24

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIIDailyMed labelSPL versionUploaded
SUMATRIPTAN SUCCINATEACTIVE INGREDIENTJ8BDZ68989SUMATRIPTAN SUCCINATE TABLET, FILM COATED [MYLAN PHARMACEUTICALS INC.]6
SUMATRIPTANACTIVE MOIETY8R78F6L9VOSUMATRIPTAN SUCCINATE TABLET, FILM COATED [MYLAN PHARMACEUTICALS INC.]6
CELLULOSE, MICROCRYSTALLINEINACTIVE INGREDIENTOP1R32D61USUMATRIPTAN SUCCINATE TABLET, FILM COATED [MYLAN PHARMACEUTICALS INC.]6
CROSCARMELLOSE SODIUMINACTIVE INGREDIENTM28OL1HH48SUMATRIPTAN SUCCINATE TABLET, FILM COATED [MYLAN PHARMACEUTICALS INC.]6
HYPROMELLOSESINACTIVE INGREDIENT3NXW29V3WOSUMATRIPTAN SUCCINATE TABLET, FILM COATED [MYLAN PHARMACEUTICALS INC.]6
LACTOSE MONOHYDRATEINACTIVE INGREDIENTEWQ57Q8I5XSUMATRIPTAN SUCCINATE TABLET, FILM COATED [MYLAN PHARMACEUTICALS INC.]6
MAGNESIUM STEARATEINACTIVE INGREDIENT70097M6I30SUMATRIPTAN SUCCINATE TABLET, FILM COATED [MYLAN PHARMACEUTICALS INC.]6
POLYDEXTROSEINACTIVE INGREDIENTVH2XOU12IESUMATRIPTAN SUCCINATE TABLET, FILM COATED [MYLAN PHARMACEUTICALS INC.]6
POLYETHYLENE GLYCOLSINACTIVE INGREDIENT3WJQ0SDW1ASUMATRIPTAN SUCCINATE TABLET, FILM COATED [MYLAN PHARMACEUTICALS INC.]6
POVIDONESINACTIVE INGREDIENTFZ989GH94ESUMATRIPTAN SUCCINATE TABLET, FILM COATED [MYLAN PHARMACEUTICALS INC.]6
SILICON DIOXIDEINACTIVE INGREDIENTETJ7Z6XBU4SUMATRIPTAN SUCCINATE TABLET, FILM COATED [MYLAN PHARMACEUTICALS INC.]6
SODIUM LAURYL SULFATEINACTIVE INGREDIENT368GB5141JSUMATRIPTAN SUCCINATE TABLET, FILM COATED [MYLAN PHARMACEUTICALS INC.]6
TITANIUM DIOXIDEINACTIVE INGREDIENT15FIX9V2JPSUMATRIPTAN SUCCINATE TABLET, FILM COATED [MYLAN PHARMACEUTICALS INC.]6
TRIACETININACTIVE INGREDIENTXHX3C3X673SUMATRIPTAN SUCCINATE TABLET, FILM COATED [MYLAN PHARMACEUTICALS INC.]6

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
0378-5632SUMATRIPTAN SUCCINATE TABLET, FILM COATED [MYLAN PHARMACEUTICALS INC.]14Current NDC, Legacy NDC, 1 package rows20230801_1d2cd01c-05e7-44cf-a71d-0f474e826b7e.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
313160SUMAtriptan succinate 100 MG Oral TabletPSN1d2cd01c-05e7-44cf-a71d-0f474e826b7e15
315223SUMAtriptan succinate 25 MG Oral TabletPSN1d2cd01c-05e7-44cf-a71d-0f474e826b7e15
313161SUMAtriptan succinate 50 MG Oral TabletPSN1d2cd01c-05e7-44cf-a71d-0f474e826b7e15
313160sumatriptan 100 MG Oral TabletSCD1d2cd01c-05e7-44cf-a71d-0f474e826b7e15
315223sumatriptan 25 MG Oral TabletSCD1d2cd01c-05e7-44cf-a71d-0f474e826b7e15
313161sumatriptan 50 MG Oral TabletSCD1d2cd01c-05e7-44cf-a71d-0f474e826b7e15
313160sumatriptan 100 MG (as sumatriptan succinate 140 MG) Oral TabletSY1d2cd01c-05e7-44cf-a71d-0f474e826b7e15
315223sumatriptan 25 MG (as sumatriptan succinate 35 MG) Oral TabletSY1d2cd01c-05e7-44cf-a71d-0f474e826b7e15
313161sumatriptan 50 MG (as sumatriptan succinate 70 MG) Oral TabletSY1d2cd01c-05e7-44cf-a71d-0f474e826b7e15
313160SUMAtriptan succinate 100 MG Oral TabletPSN1bf70380-8272-4c0d-8841-d39ef277235111
315223SUMAtriptan succinate 25 MG Oral TabletPSN1bf70380-8272-4c0d-8841-d39ef277235111
313161SUMAtriptan succinate 50 MG Oral TabletPSN1bf70380-8272-4c0d-8841-d39ef277235111
313160sumatriptan 100 MG Oral TabletSCD1bf70380-8272-4c0d-8841-d39ef277235111
315223sumatriptan 25 MG Oral TabletSCD1bf70380-8272-4c0d-8841-d39ef277235111
313161sumatriptan 50 MG Oral TabletSCD1bf70380-8272-4c0d-8841-d39ef277235111
313160sumatriptan 100 MG (as sumatriptan succinate 140 MG) Oral TabletSY1bf70380-8272-4c0d-8841-d39ef277235111
315223sumatriptan 25 MG (as sumatriptan succinate 35 MG) Oral TabletSY1bf70380-8272-4c0d-8841-d39ef277235111
313161sumatriptan 50 MG (as sumatriptan succinate 70 MG) Oral TabletSY1bf70380-8272-4c0d-8841-d39ef277235111

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionMarketing startMarketing endSampleExclude flagStatus
0378-5632-59003785632599 TABLET, FILM COATED in 1 BOTTLE, PLASTIC (0378-5632-59) 2009-08-100000-00-00NoNoCurrent