FDA.reportPublic FDA data

Sumatriptan Succinate

Product NDC
55111-292
11-digit product format
551110292
Labeler code
55111
Product ID
55111-292_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
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
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 SUCCINATE50 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
d9bd4853-037c-6968-f4d4-9bb9a0efd1eaProduct name220250722
2839c963-7eb3-970a-287f-ff1b6d381268Product name220250103
594e2c86-3079-4e6e-96c9-48f7a8afc78dProduct name120230718
6bd95106-a412-1dad-b9cc-4cb74bfb27ceProduct name220230315
a62a50ac-1535-4461-9768-8ae703e2e9fbProduct name120210525
1e973b2d-e028-69cd-9258-4613ba80fdc5Product name320210512
32e23bc9-ce14-4555-bb6d-bcb654d7d296Product name120201015
e459f50a-1553-4aab-b6bd-1e5f0c211c49Product name120201015
3eb481d3-8b69-436f-82dd-4a66345568abProduct name120190611
e76dbbc1-775d-722c-08ff-ed45e8a80defProduct name320181002
7cda52fc-125f-421c-8fea-bc1974370c49Product name220180703
909480fe-0d18-c1c1-a658-0bd9a7131822Product name520170829
c100f0c7-e9dd-42f4-b0a8-0d81bd2a877cProduct name120160303
49615343-b619-4365-8118-8f2ed6046e78Product name120160224
a6319377-430a-43db-82f9-30d1d9d89cf8Product name120151216
d5e51f11-ad28-caa4-4b49-4143974782adProduct name120150831
290f523a-f9db-9774-b5a9-e1f908ac1782Product name120150828
9514609b-a2a9-f8ec-6ba6-3f8e5ee89877Product name120140508
bc07ef78-e82d-0c19-31f4-31f263780582Product name120140508
c6b65c52-69c7-df49-550a-a50c137f6218Product name120140508
f6199b09-e585-7ceb-4b09-803cf5ce1ed1Product name120140508

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
55111-292-01Sumatriptan Succinate100 in 1 BOTTLETABLET10019
55111-292-05Sumatriptan Succinate500 in 1 BOTTLETABLET50019
55111-292-09Sumatriptan Succinate9 in 1 CARTONTABLET919
55111-292-09Sumatriptan Succinate9 in 1 BLISTER PACKTABLET919
55111-292-30Sumatriptan Succinate30 in 1 BOTTLETABLET3019
55111-292-36Sumatriptan Succinate36 in 1 BOTTLETABLET3619
55111-292-90Sumatriptan Succinate90 in 1 BOTTLETABLET9019
55111-292-98Sumatriptan Succinate3 in 1 CARTONTABLET319
55111-292-98Sumatriptan Succinate9 in 1 BLISTER PACKTABLET919

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
55111-292-09EA - Each55111-292f3f9b998-14b9-4b69-8dd1-b24bf8e02b7012012-07-24
55111-292-36EA - Each55111-292b73be838-4a73-41dd-8a9c-822935f77f8112012-07-24
55111-292-90EA - Each55111-2928e3dc639-32c0-4c60-939a-9ba295d2aa7d12012-07-24
55111-292-98EA - Each55111-292d1943578-b7a8-4999-ae76-3bfa388212ab12021-01-08

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIIDailyMed labelSPL versionUploaded
sumatriptan succinateACTIVE INGREDIENTJ8BDZ68989SUMATRIPTAN SUCCINATE TABLET [DR. REDDY'S LABORATORIES LIMITED]7
SUMATRIPTANACTIVE MOIETY8R78F6L9VOSUMATRIPTAN SUCCINATE TABLET [DR. REDDY'S LABORATORIES LIMITED]7
ANHYDROUS LACTOSEINACTIVE INGREDIENT3SY5LH9PMKSUMATRIPTAN SUCCINATE TABLET [DR. REDDY'S LABORATORIES LIMITED]7
CELLULOSE, MICROCRYSTALLINEINACTIVE INGREDIENTOP1R32D61USUMATRIPTAN SUCCINATE TABLET [DR. REDDY'S LABORATORIES LIMITED]7
croscarmellose sodiumINACTIVE INGREDIENTM28OL1HH48SUMATRIPTAN SUCCINATE TABLET [DR. REDDY'S LABORATORIES LIMITED]7
LACTOSE MONOHYDRATEINACTIVE INGREDIENTEWQ57Q8I5XSUMATRIPTAN SUCCINATE TABLET [DR. REDDY'S LABORATORIES LIMITED]7
magnesium stearateINACTIVE INGREDIENT70097M6I30SUMATRIPTAN SUCCINATE TABLET [DR. REDDY'S LABORATORIES LIMITED]7
mannitolINACTIVE INGREDIENT3OWL53L36ASUMATRIPTAN SUCCINATE TABLET [DR. REDDY'S LABORATORIES LIMITED]7
talcINACTIVE INGREDIENT7SEV7J4R1USUMATRIPTAN SUCCINATE TABLET [DR. REDDY'S LABORATORIES LIMITED]7
titanium dioxideINACTIVE INGREDIENT15FIX9V2JPSUMATRIPTAN SUCCINATE TABLET [DR. REDDY'S LABORATORIES LIMITED]7
triacetinINACTIVE INGREDIENTXHX3C3X673SUMATRIPTAN SUCCINATE TABLET [DR. REDDY'S LABORATORIES LIMITED]7
sumatriptan succinateACTIVE INGREDIENTJ8BDZ68989SUMATRIPTAN SUCCINATE TABLET [LAKE ERIE MEDICAL DBA QUALITY CARE PRODUCTS LLC]2
SUMATRIPTAN SUCCINATEACTIVE INGREDIENTJ8BDZ68989SUMATRIPTAN SUCCINATE TABLET [STAT RX USA LLC]2
SUMATRIPTANACTIVE MOIETY8R78F6L9VOSUMATRIPTAN SUCCINATE TABLET [LAKE ERIE MEDICAL DBA QUALITY CARE PRODUCTS LLC]2
SUMATRIPTANACTIVE MOIETY8R78F6L9VOSUMATRIPTAN SUCCINATE TABLET [STAT RX USA LLC]2
ANHYDROUS LACTOSEINACTIVE INGREDIENT3SY5LH9PMKSUMATRIPTAN SUCCINATE TABLET [LAKE ERIE MEDICAL DBA QUALITY CARE PRODUCTS LLC]2
ANHYDROUS LACTOSEINACTIVE INGREDIENT3SY5LH9PMKSUMATRIPTAN SUCCINATE TABLET [STAT RX USA LLC]2
CELLULOSE, MICROCRYSTALLINEINACTIVE INGREDIENTOP1R32D61USUMATRIPTAN SUCCINATE TABLET [LAKE ERIE MEDICAL DBA QUALITY CARE PRODUCTS LLC]2
CELLULOSE, MICROCRYSTALLINEINACTIVE INGREDIENTOP1R32D61USUMATRIPTAN SUCCINATE TABLET [STAT RX USA LLC]2
croscarmellose sodiumINACTIVE INGREDIENTM28OL1HH48SUMATRIPTAN SUCCINATE TABLET [LAKE ERIE MEDICAL DBA QUALITY CARE PRODUCTS LLC]2
CROSCARMELLOSE SODIUMINACTIVE INGREDIENTM28OL1HH48SUMATRIPTAN SUCCINATE TABLET [STAT RX USA LLC]2
LACTOSE MONOHYDRATEINACTIVE INGREDIENTEWQ57Q8I5XSUMATRIPTAN SUCCINATE TABLET [STAT RX USA LLC]2
LACTOSE MONOHYDRATEINACTIVE INGREDIENTEWQ57Q8I5XSUMATRIPTAN SUCCINATE TABLET [LAKE ERIE MEDICAL DBA QUALITY CARE PRODUCTS LLC]2
MAGNESIUM STEARATEINACTIVE INGREDIENT70097M6I30SUMATRIPTAN SUCCINATE TABLET [STAT RX USA LLC]2
magnesium stearateINACTIVE INGREDIENT70097M6I30SUMATRIPTAN SUCCINATE TABLET [LAKE ERIE MEDICAL DBA QUALITY CARE PRODUCTS LLC]2
mannitolINACTIVE INGREDIENT3OWL53L36ASUMATRIPTAN SUCCINATE TABLET [LAKE ERIE MEDICAL DBA QUALITY CARE PRODUCTS LLC]2
MANNITOLINACTIVE INGREDIENT3OWL53L36ASUMATRIPTAN SUCCINATE TABLET [STAT RX USA LLC]2
talcINACTIVE INGREDIENT7SEV7J4R1USUMATRIPTAN SUCCINATE TABLET [LAKE ERIE MEDICAL DBA QUALITY CARE PRODUCTS LLC]2
TALCINACTIVE INGREDIENT7SEV7J4R1USUMATRIPTAN SUCCINATE TABLET [STAT RX USA LLC]2
TITANIUM DIOXIDEINACTIVE INGREDIENT15FIX9V2JPSUMATRIPTAN SUCCINATE TABLET [STAT RX USA LLC]2
titanium dioxideINACTIVE INGREDIENT15FIX9V2JPSUMATRIPTAN SUCCINATE TABLET [LAKE ERIE MEDICAL DBA QUALITY CARE PRODUCTS LLC]2
TRIACETININACTIVE INGREDIENTXHX3C3X673SUMATRIPTAN SUCCINATE TABLET [STAT RX USA LLC]2
triacetinINACTIVE INGREDIENTXHX3C3X673SUMATRIPTAN SUCCINATE TABLET [LAKE ERIE MEDICAL DBA QUALITY CARE PRODUCTS LLC]2
sumatriptan succinateACTIVE INGREDIENTJ8BDZ68989SUMATRIPTAN SUCCINATE TABLET [PROFICIENT RX LP]1
sumatriptan succinateACTIVE INGREDIENTJ8BDZ68989SUMATRIPTAN SUCCINATE TABLET [REBEL DISTRIBUTORS CORP]1
SUMATRIPTANACTIVE MOIETY8R78F6L9VOSUMATRIPTAN SUCCINATE TABLET [PROFICIENT RX LP]1
SUMATRIPTANACTIVE MOIETY8R78F6L9VOSUMATRIPTAN SUCCINATE TABLET [REBEL DISTRIBUTORS CORP]1
ANHYDROUS LACTOSEINACTIVE INGREDIENT3SY5LH9PMKSUMATRIPTAN SUCCINATE TABLET [PROFICIENT RX LP]1
ANHYDROUS LACTOSEINACTIVE INGREDIENT3SY5LH9PMKSUMATRIPTAN SUCCINATE TABLET [REBEL DISTRIBUTORS CORP]1
CELLULOSE, MICROCRYSTALLINEINACTIVE INGREDIENTOP1R32D61USUMATRIPTAN SUCCINATE TABLET [PROFICIENT RX LP]1
CELLULOSE, MICROCRYSTALLINEINACTIVE INGREDIENTOP1R32D61USUMATRIPTAN SUCCINATE TABLET [REBEL DISTRIBUTORS CORP]1
croscarmellose sodiumINACTIVE INGREDIENTM28OL1HH48SUMATRIPTAN SUCCINATE TABLET [REBEL DISTRIBUTORS CORP]1
croscarmellose sodiumINACTIVE INGREDIENTM28OL1HH48SUMATRIPTAN SUCCINATE TABLET [PROFICIENT RX LP]1
LACTOSE MONOHYDRATEINACTIVE INGREDIENTEWQ57Q8I5XSUMATRIPTAN SUCCINATE TABLET [PROFICIENT RX LP]1
LACTOSE MONOHYDRATEINACTIVE INGREDIENTEWQ57Q8I5XSUMATRIPTAN SUCCINATE TABLET [REBEL DISTRIBUTORS CORP]1
magnesium stearateINACTIVE INGREDIENT70097M6I30SUMATRIPTAN SUCCINATE TABLET [REBEL DISTRIBUTORS CORP]1
magnesium stearateINACTIVE INGREDIENT70097M6I30SUMATRIPTAN SUCCINATE TABLET [PROFICIENT RX LP]1
mannitolINACTIVE INGREDIENT3OWL53L36ASUMATRIPTAN SUCCINATE TABLET [REBEL DISTRIBUTORS CORP]1
mannitolINACTIVE INGREDIENT3OWL53L36ASUMATRIPTAN SUCCINATE TABLET [PROFICIENT RX LP]1
talcINACTIVE INGREDIENT7SEV7J4R1USUMATRIPTAN SUCCINATE TABLET [REBEL DISTRIBUTORS CORP]1
talcINACTIVE INGREDIENT7SEV7J4R1USUMATRIPTAN SUCCINATE TABLET [PROFICIENT RX LP]1
titanium dioxideINACTIVE INGREDIENT15FIX9V2JPSUMATRIPTAN SUCCINATE TABLET [PROFICIENT RX LP]1
titanium dioxideINACTIVE INGREDIENT15FIX9V2JPSUMATRIPTAN SUCCINATE TABLET [REBEL DISTRIBUTORS CORP]1
triacetinINACTIVE INGREDIENTXHX3C3X673SUMATRIPTAN SUCCINATE TABLET [REBEL DISTRIBUTORS CORP]1
triacetinINACTIVE INGREDIENTXHX3C3X673SUMATRIPTAN SUCCINATE TABLET [PROFICIENT RX LP]1

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
55111-292SUMATRIPTAN SUCCINATE (SUMATRIPTAN SUCCINATE ) TABLET [DR. REDDY'S LABORATORIES LIMITED]18Current NDC, Legacy NDC, 9 package rows20201211_ac80d018-6abf-2e41-ddea-90b4ff9e9013.zip
55111-292MIGRANOW (SUMATRIPTAN SUCCINATE, CAMPHOR, MENTHOL) KIT [PURETEK CORPORATION]6Current NDC, Legacy NDC20241215_b82d7d65-9ef4-4f05-9a7d-10440683332e.zip
55111-292SUMANSETRON (SUMATRIPTAN SUCCINATE, ONDANSETRON) KIT [PURETEK CORPORATION]2Current NDC, Legacy NDC20230112_b69f0762-a2f7-28c7-e053-2995a90a0484.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
1039731camphor 4 % / menthol 10 % Topical GelPSNb82d7d65-9ef4-4f05-9a7d-10440683332e6
313161SUMAtriptan succinate 50 MG Oral TabletPSNb82d7d65-9ef4-4f05-9a7d-10440683332e6
1039731camphor 0.04 MG/MG / menthol 0.1 MG/MG Topical GelSCDb82d7d65-9ef4-4f05-9a7d-10440683332e6
313161sumatriptan 50 MG Oral TabletSCDb82d7d65-9ef4-4f05-9a7d-10440683332e6
1039731camphor 4 % / menthol 10 % Topical GelSYb82d7d65-9ef4-4f05-9a7d-10440683332e6
313161sumatriptan 50 MG (as sumatriptan succinate 70 MG) Oral TabletSYb82d7d65-9ef4-4f05-9a7d-10440683332e6
313161SUMAtriptan succinate 50 MG Oral TabletPSN7628caf4-5272-4e42-e053-2a91aa0a2f245
313161sumatriptan 50 MG Oral TabletSCD7628caf4-5272-4e42-e053-2a91aa0a2f245
313161sumatriptan 50 MG (as sumatriptan succinate 70 MG) Oral TabletSY7628caf4-5272-4e42-e053-2a91aa0a2f245
313161SUMAtriptan succinate 50 MG Oral TabletPSN68daf82a-334e-43ca-b4bb-5c66a82f52c83
313161sumatriptan 50 MG Oral TabletSCD68daf82a-334e-43ca-b4bb-5c66a82f52c83
313161sumatriptan 50 MG (as sumatriptan succinate 70 MG) Oral TabletSY68daf82a-334e-43ca-b4bb-5c66a82f52c83
198052ondansetron HCl 4 MG Oral TabletPSNb69f0762-a2f7-28c7-e053-2995a90a04842
315223SUMAtriptan succinate 25 MG Oral TabletPSN77523882-3a1e-48ea-9bbb-9fffdd7aa4152
313161SUMAtriptan succinate 50 MG Oral TabletPSNb69f0762-a2f7-28c7-e053-2995a90a04842
313161SUMAtriptan succinate 50 MG Oral TabletPSN77523882-3a1e-48ea-9bbb-9fffdd7aa4152
198052ondansetron 4 MG Oral TabletSCDb69f0762-a2f7-28c7-e053-2995a90a04842
315223sumatriptan 25 MG Oral TabletSCD77523882-3a1e-48ea-9bbb-9fffdd7aa4152
313161sumatriptan 50 MG Oral TabletSCDb69f0762-a2f7-28c7-e053-2995a90a04842
313161sumatriptan 50 MG Oral TabletSCD77523882-3a1e-48ea-9bbb-9fffdd7aa4152
198052ondansetron 4 MG (as ondansetron HCl dihydrate 5 MG) Oral TabletSYb69f0762-a2f7-28c7-e053-2995a90a04842
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
313161sumatriptan 50 MG (as sumatriptan succinate 70 MG) Oral TabletSYb69f0762-a2f7-28c7-e053-2995a90a04842
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 TabletPSNb16886d0-224b-4d83-85c4-bc3eb3606c171
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 TabletSCDb16886d0-224b-4d83-85c4-bc3eb3606c171
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 TabletSYb16886d0-224b-4d83-85c4-bc3eb3606c171
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
55111-292-0155111029201100 TABLET in 1 BOTTLE (55111-292-01) 100 tablet2009-11-170000-00-00NoNoCurrent
55111-292-0555111029205500 TABLET in 1 BOTTLE (55111-292-05) 500 tablet2009-11-170000-00-00NoNoCurrent
55111-292-09551110292099 BLISTER PACK in 1 CARTON (55111-292-09) / 9 TABLET in 1 BLISTER PACK9 blister pack2009-11-170000-00-00NoNoCurrent
55111-292-305511102923030 TABLET in 1 BOTTLE (55111-292-30) 30 tablet2009-11-170000-00-00NoNoCurrent
55111-292-365511102923636 TABLET in 1 BOTTLE (55111-292-36) 36 tablet2009-11-170000-00-00NoNoCurrent
55111-292-905511102929090 TABLET in 1 BOTTLE (55111-292-90) 90 tablet2009-11-170000-00-00NoNoCurrent
55111-292-98551110292983 BLISTER PACK in 1 CARTON (55111-292-98) / 9 TABLET in 1 BLISTER PACK3 blister pack2020-12-100000-00-00NoNoCurrent