FDA.reportPublic FDA data

Sumatriptan Succinate

Product NDC
55111-291
11-digit product format
551110291
Labeler code
55111
Product ID
55111-291_3f0a2fa1-9b69-588d-f3f8-f2af5561edd0
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Sumatriptan Succinate
Dosage form
TABLET
Route
ORAL
Labeler
Dr. Reddy's Laboratories Limited
Application
ANDA076847
Marketing category
ANDA
Marketing start
2009-11-17
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
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 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
a62a50ac-1535-4461-9768-8ae703e2e9fbProduct name120210525
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
9514609b-a2a9-f8ec-6ba6-3f8e5ee89877Product name120140508
bc07ef78-e82d-0c19-31f4-31f263780582Product name120140508
f6199b09-e585-7ceb-4b09-803cf5ce1ed1Product name120140508

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
55111-291-01Sumatriptan Succinate100 in 1 BOTTLETABLET10019
55111-291-05Sumatriptan Succinate500 in 1 BOTTLETABLET50019
55111-291-09Sumatriptan Succinate9 in 1 CARTONTABLET919
55111-291-09Sumatriptan Succinate1 in 1 BLISTER PACKTABLET119
55111-291-30Sumatriptan Succinate30 in 1 BOTTLETABLET3019
55111-291-36Sumatriptan Succinate36 in 1 BOTTLETABLET3619
55111-291-90Sumatriptan Succinate90 in 1 BOTTLETABLET9019
55111-291-98Sumatriptan Succinate3 in 1 CARTONTABLET319
55111-291-98Sumatriptan Succinate9 in 1 BLISTER PACKTABLET919

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
55111-291SUMATRIPTAN SUCCINATE (SUMATRIPTAN SUCCINATE ) TABLET [DR. REDDY'S LABORATORIES LIMITED]18Current NDC, Legacy NDC, 9 package rows20201211_ac80d018-6abf-2e41-ddea-90b4ff9e9013.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
313160SUMAtriptan succinate 100 MG Oral TabletPSNac80d018-6abf-2e41-ddea-90b4ff9e901319
315223SUMAtriptan succinate 25 MG Oral TabletPSNac80d018-6abf-2e41-ddea-90b4ff9e901319
313161SUMAtriptan succinate 50 MG Oral TabletPSNac80d018-6abf-2e41-ddea-90b4ff9e901319
313160sumatriptan 100 MG Oral TabletSCDac80d018-6abf-2e41-ddea-90b4ff9e901319
315223sumatriptan 25 MG Oral TabletSCDac80d018-6abf-2e41-ddea-90b4ff9e901319
313161sumatriptan 50 MG Oral TabletSCDac80d018-6abf-2e41-ddea-90b4ff9e901319
313160sumatriptan 100 MG (as sumatriptan succinate 140 MG) Oral TabletSYac80d018-6abf-2e41-ddea-90b4ff9e901319
315223sumatriptan 25 MG (as sumatriptan succinate 35 MG) Oral TabletSYac80d018-6abf-2e41-ddea-90b4ff9e901319
313161sumatriptan 50 MG (as sumatriptan succinate 70 MG) Oral TabletSYac80d018-6abf-2e41-ddea-90b4ff9e901319
313160SUMAtriptan succinate 100 MG Oral TabletPSNd3b61201-fb84-446b-83a6-b72e8e1d6d049
315223SUMAtriptan succinate 25 MG Oral TabletPSNd3b61201-fb84-446b-83a6-b72e8e1d6d049
313161SUMAtriptan succinate 50 MG Oral TabletPSNd3b61201-fb84-446b-83a6-b72e8e1d6d049
313160sumatriptan 100 MG Oral TabletSCDd3b61201-fb84-446b-83a6-b72e8e1d6d049
315223sumatriptan 25 MG Oral TabletSCDd3b61201-fb84-446b-83a6-b72e8e1d6d049
313161sumatriptan 50 MG Oral TabletSCDd3b61201-fb84-446b-83a6-b72e8e1d6d049
313160sumatriptan 100 MG (as sumatriptan succinate 140 MG) Oral TabletSYd3b61201-fb84-446b-83a6-b72e8e1d6d049
315223sumatriptan 25 MG (as sumatriptan succinate 35 MG) Oral TabletSYd3b61201-fb84-446b-83a6-b72e8e1d6d049
313161sumatriptan 50 MG (as sumatriptan succinate 70 MG) Oral TabletSYd3b61201-fb84-446b-83a6-b72e8e1d6d049
315223SUMAtriptan succinate 25 MG Oral TabletPSN77a41cca-02d2-4b84-975e-d1925f0fca803
315223sumatriptan 25 MG Oral TabletSCD77a41cca-02d2-4b84-975e-d1925f0fca803
315223sumatriptan 25 MG (as sumatriptan succinate 35 MG) Oral TabletSY77a41cca-02d2-4b84-975e-d1925f0fca803
315223SUMAtriptan succinate 25 MG Oral TabletPSN1ecbd827-e22b-113d-e054-00144ff8d46c2
315223SUMAtriptan succinate 25 MG Oral TabletPSN77523882-3a1e-48ea-9bbb-9fffdd7aa4152
313161SUMAtriptan succinate 50 MG Oral TabletPSN77523882-3a1e-48ea-9bbb-9fffdd7aa4152
315223sumatriptan 25 MG Oral TabletSCD1ecbd827-e22b-113d-e054-00144ff8d46c2
315223sumatriptan 25 MG Oral TabletSCD77523882-3a1e-48ea-9bbb-9fffdd7aa4152
313161sumatriptan 50 MG Oral TabletSCD77523882-3a1e-48ea-9bbb-9fffdd7aa4152
315223sumatriptan 25 MG (as sumatriptan succinate 35 MG) Oral TabletSY1ecbd827-e22b-113d-e054-00144ff8d46c2
315223sumatriptan 25 MG (as sumatriptan succinate 35 MG) Oral TabletSY77523882-3a1e-48ea-9bbb-9fffdd7aa4152
313161sumatriptan 50 MG (as sumatriptan succinate 70 MG) Oral TabletSY77523882-3a1e-48ea-9bbb-9fffdd7aa4152
313160SUMAtriptan succinate 100 MG Oral TabletPSN7c960eb1-839d-4d96-ba70-a5068a7b6a671
315223SUMAtriptan succinate 25 MG Oral TabletPSN7c960eb1-839d-4d96-ba70-a5068a7b6a671
313161SUMAtriptan succinate 50 MG Oral TabletPSN7c960eb1-839d-4d96-ba70-a5068a7b6a671
313160sumatriptan 100 MG Oral TabletSCD7c960eb1-839d-4d96-ba70-a5068a7b6a671
315223sumatriptan 25 MG Oral TabletSCD7c960eb1-839d-4d96-ba70-a5068a7b6a671
313161sumatriptan 50 MG Oral TabletSCD7c960eb1-839d-4d96-ba70-a5068a7b6a671
313160sumatriptan 100 MG (as sumatriptan succinate 140 MG) Oral TabletSY7c960eb1-839d-4d96-ba70-a5068a7b6a671
315223sumatriptan 25 MG (as sumatriptan succinate 35 MG) Oral TabletSY7c960eb1-839d-4d96-ba70-a5068a7b6a671
313161sumatriptan 50 MG (as sumatriptan succinate 70 MG) Oral TabletSY7c960eb1-839d-4d96-ba70-a5068a7b6a671

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
55111-291-0155111029101100 TABLET in 1 BOTTLE (55111-291-01) 100 tablet2009-11-170000-00-00NoNoCurrent
55111-291-0555111029105500 TABLET in 1 BOTTLE (55111-291-05) 500 tablet2009-11-170000-00-00NoNoCurrent
55111-291-09551110291099 BLISTER PACK in 1 CARTON (55111-291-09) / 1 TABLET in 1 BLISTER PACK9 blister pack2009-11-170000-00-00NoNoCurrent
55111-291-305511102913030 TABLET in 1 BOTTLE (55111-291-30) 30 tablet2009-11-170000-00-00NoNoCurrent
55111-291-365511102913636 TABLET in 1 BOTTLE (55111-291-36) 36 tablet2009-11-170000-00-00NoNoCurrent
55111-291-905511102919090 TABLET in 1 BOTTLE (55111-291-90) 90 tablet2009-11-170000-00-00NoNoCurrent
55111-291-98551110291983 BLISTER PACK in 1 CARTON (55111-291-98) / 9 TABLET in 1 BLISTER PACK3 blister pack2020-12-100000-00-00NoNoCurrent