FDA.reportPublic FDA data

Sumatriptan

Product NDC
65862-146
11-digit product format
658620146
Labeler code
65862
Product ID
65862-146_e95a503d-623f-4736-ab25-a23fb9dd1994
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Sumatriptan Succinate
Dosage form
TABLET
Route
ORAL
Labeler
Aurobindo Pharma Limited
Application
ANDA078327
Marketing category
ANDA
Marketing start
2009-08-17
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
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
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
65862-146-36Sumatriptan1 in 1 CARTONTABLET118
65862-146-36Sumatriptan9 in 1 BLISTER PACKTABLET918
65862-146-59Sumatriptan36 in 1 BOTTLETABLET3618

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
65862-146-36EA - Each65862-146a15227fe-608c-4046-be12-a3cdae30892312012-07-24

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIIDailyMed labelSPL versionUploaded
SUMATRIPTAN SUCCINATEACTIVE INGREDIENTJ8BDZ68989SUMATRIPTAN (SUMATRIPTAN SUCCINATE) TABLET [AUROBINDO PHARMA LIMITED]10
SUMATRIPTANACTIVE MOIETY8R78F6L9VOSUMATRIPTAN (SUMATRIPTAN SUCCINATE) TABLET [AUROBINDO PHARMA LIMITED]10
CALCIUM PHOSPHATE, DIBASIC, ANHYDROUSINACTIVE INGREDIENTL11K75P92JSUMATRIPTAN (SUMATRIPTAN SUCCINATE) TABLET [AUROBINDO PHARMA LIMITED]10
CELLULOSE, MICROCRYSTALLINEINACTIVE INGREDIENTOP1R32D61USUMATRIPTAN (SUMATRIPTAN SUCCINATE) TABLET [AUROBINDO PHARMA LIMITED]10
CROSCARMELLOSE SODIUMINACTIVE INGREDIENTM28OL1HH48SUMATRIPTAN (SUMATRIPTAN SUCCINATE) TABLET [AUROBINDO PHARMA LIMITED]10
MAGNESIUM STEARATEINACTIVE INGREDIENT70097M6I30SUMATRIPTAN (SUMATRIPTAN SUCCINATE) TABLET [AUROBINDO PHARMA LIMITED]10
POLYSORBATE 80INACTIVE INGREDIENT6OZP39ZG8HSUMATRIPTAN (SUMATRIPTAN SUCCINATE) TABLET [AUROBINDO PHARMA LIMITED]10
SODIUM BICARBONATEINACTIVE INGREDIENT8MDF5V39QOSUMATRIPTAN (SUMATRIPTAN SUCCINATE) TABLET [AUROBINDO PHARMA LIMITED]10

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
65862-146SUMATRIPTAN (SUMATRIPTAN SUCCINATE) TABLET [AUROBINDO PHARMA LIMITED]16Current NDC, Legacy NDC, 3 package rows20240131_b2503fff-c978-4efa-b1b4-d7740b6b26f2.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
313160SUMAtriptan succinate 100 MG Oral TabletPSN62ba6fef-467a-4500-993c-51907f12a67c31
315223SUMAtriptan succinate 25 MG Oral TabletPSN62ba6fef-467a-4500-993c-51907f12a67c31
313161SUMAtriptan succinate 50 MG Oral TabletPSN62ba6fef-467a-4500-993c-51907f12a67c31
313160sumatriptan 100 MG Oral TabletSCD62ba6fef-467a-4500-993c-51907f12a67c31
315223sumatriptan 25 MG Oral TabletSCD62ba6fef-467a-4500-993c-51907f12a67c31
313161sumatriptan 50 MG Oral TabletSCD62ba6fef-467a-4500-993c-51907f12a67c31
313160sumatriptan 100 MG (as sumatriptan succinate 140 MG) Oral TabletSY62ba6fef-467a-4500-993c-51907f12a67c31
315223sumatriptan 25 MG (as sumatriptan succinate 35 MG) Oral TabletSY62ba6fef-467a-4500-993c-51907f12a67c31
313161sumatriptan 50 MG (as sumatriptan succinate 70 MG) Oral TabletSY62ba6fef-467a-4500-993c-51907f12a67c31
313160SUMAtriptan succinate 100 MG Oral TabletPSNb2503fff-c978-4efa-b1b4-d7740b6b26f218
315223SUMAtriptan succinate 25 MG Oral TabletPSNb2503fff-c978-4efa-b1b4-d7740b6b26f218
313161SUMAtriptan succinate 50 MG Oral TabletPSNb2503fff-c978-4efa-b1b4-d7740b6b26f218
313160sumatriptan 100 MG Oral TabletSCDb2503fff-c978-4efa-b1b4-d7740b6b26f218
315223sumatriptan 25 MG Oral TabletSCDb2503fff-c978-4efa-b1b4-d7740b6b26f218
313161sumatriptan 50 MG Oral TabletSCDb2503fff-c978-4efa-b1b4-d7740b6b26f218
313160sumatriptan 100 MG (as sumatriptan succinate 140 MG) Oral TabletSYb2503fff-c978-4efa-b1b4-d7740b6b26f218
315223sumatriptan 25 MG (as sumatriptan succinate 35 MG) Oral TabletSYb2503fff-c978-4efa-b1b4-d7740b6b26f218
313161sumatriptan 50 MG (as sumatriptan succinate 70 MG) Oral TabletSYb2503fff-c978-4efa-b1b4-d7740b6b26f218
313160SUMAtriptan succinate 100 MG Oral TabletPSN9fffdcd3-e3c7-4fe6-ba6d-374335bc76559
315223SUMAtriptan succinate 25 MG Oral TabletPSN9fffdcd3-e3c7-4fe6-ba6d-374335bc76559
315223SUMAtriptan succinate 25 MG Oral TabletPSNbaf37e8c-d414-4ca7-a366-97dc202372ff9
313161SUMAtriptan succinate 50 MG Oral TabletPSN9fffdcd3-e3c7-4fe6-ba6d-374335bc76559
313160sumatriptan 100 MG Oral TabletSCD9fffdcd3-e3c7-4fe6-ba6d-374335bc76559
315223sumatriptan 25 MG Oral TabletSCDbaf37e8c-d414-4ca7-a366-97dc202372ff9
315223sumatriptan 25 MG Oral TabletSCD9fffdcd3-e3c7-4fe6-ba6d-374335bc76559
313161sumatriptan 50 MG Oral TabletSCD9fffdcd3-e3c7-4fe6-ba6d-374335bc76559
313160sumatriptan 100 MG (as sumatriptan succinate 140 MG) Oral TabletSY9fffdcd3-e3c7-4fe6-ba6d-374335bc76559
315223sumatriptan 25 MG (as sumatriptan succinate 35 MG) Oral TabletSYbaf37e8c-d414-4ca7-a366-97dc202372ff9
315223sumatriptan 25 MG (as sumatriptan succinate 35 MG) Oral TabletSY9fffdcd3-e3c7-4fe6-ba6d-374335bc76559
313161sumatriptan 50 MG (as sumatriptan succinate 70 MG) Oral TabletSY9fffdcd3-e3c7-4fe6-ba6d-374335bc76559
315223SUMAtriptan succinate 25 MG Oral TabletPSNabbd2168-1523-4eb6-a75c-dc4d7d1b1c9b5
315223sumatriptan 25 MG Oral TabletSCDabbd2168-1523-4eb6-a75c-dc4d7d1b1c9b5
315223sumatriptan 25 MG (as sumatriptan succinate 35 MG) Oral TabletSYabbd2168-1523-4eb6-a75c-dc4d7d1b1c9b5
313160SUMAtriptan succinate 100 MG Oral TabletPSNd071aef6-a5bd-4f68-ba6d-03004466897c2
315223SUMAtriptan succinate 25 MG Oral TabletPSNd071aef6-a5bd-4f68-ba6d-03004466897c2
313161SUMAtriptan succinate 50 MG Oral TabletPSNd071aef6-a5bd-4f68-ba6d-03004466897c2
313160sumatriptan 100 MG Oral TabletSCDd071aef6-a5bd-4f68-ba6d-03004466897c2
315223sumatriptan 25 MG Oral TabletSCDd071aef6-a5bd-4f68-ba6d-03004466897c2
313161sumatriptan 50 MG Oral TabletSCDd071aef6-a5bd-4f68-ba6d-03004466897c2
313160sumatriptan 100 MG (as sumatriptan succinate 140 MG) Oral TabletSYd071aef6-a5bd-4f68-ba6d-03004466897c2
315223sumatriptan 25 MG (as sumatriptan succinate 35 MG) Oral TabletSYd071aef6-a5bd-4f68-ba6d-03004466897c2
313161sumatriptan 50 MG (as sumatriptan succinate 70 MG) Oral TabletSYd071aef6-a5bd-4f68-ba6d-03004466897c2
208450IMITREX 25 MG Oral TabletPSN32f6d89b-4aea-5396-e054-00144ff88e881
313160SUMAtriptan succinate 100 MG Oral TabletPSN77f9f135-e840-48f0-81e8-73e08433e7681
315223SUMAtriptan succinate 25 MG Oral TabletPSN1d5375f3-2528-e027-e063-6394a90af5141
315223SUMAtriptan succinate 25 MG Oral TabletPSN32f6d89b-4aea-5396-e054-00144ff88e881
315223SUMAtriptan succinate 25 MG Oral TabletPSN77f9f135-e840-48f0-81e8-73e08433e7681
313161SUMAtriptan succinate 50 MG Oral TabletPSN77f9f135-e840-48f0-81e8-73e08433e7681
208450sumatriptan 25 MG Oral Tablet [Imitrex]SBD32f6d89b-4aea-5396-e054-00144ff88e881
313160sumatriptan 100 MG Oral TabletSCD77f9f135-e840-48f0-81e8-73e08433e7681
315223sumatriptan 25 MG Oral TabletSCD77f9f135-e840-48f0-81e8-73e08433e7681
315223sumatriptan 25 MG Oral TabletSCD32f6d89b-4aea-5396-e054-00144ff88e881
315223sumatriptan 25 MG Oral TabletSCD1d5375f3-2528-e027-e063-6394a90af5141
313161sumatriptan 50 MG Oral TabletSCD77f9f135-e840-48f0-81e8-73e08433e7681
208450Imitrex 25 MG (sumatriptan succinate 35 MG) Oral TabletSY32f6d89b-4aea-5396-e054-00144ff88e881
208450Imitrex 25 MG Oral TabletSY32f6d89b-4aea-5396-e054-00144ff88e881
313160sumatriptan 100 MG (as sumatriptan succinate 140 MG) Oral TabletSY77f9f135-e840-48f0-81e8-73e08433e7681
315223sumatriptan 25 MG (as sumatriptan succinate 35 MG) Oral TabletSY1d5375f3-2528-e027-e063-6394a90af5141
315223sumatriptan 25 MG (as sumatriptan succinate 35 MG) Oral TabletSY32f6d89b-4aea-5396-e054-00144ff88e881
315223sumatriptan 25 MG (as sumatriptan succinate 35 MG) Oral TabletSY77f9f135-e840-48f0-81e8-73e08433e7681
313161sumatriptan 50 MG (as sumatriptan succinate 70 MG) Oral TabletSY77f9f135-e840-48f0-81e8-73e08433e7681

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
65862-146-196586201461910000 TABLET in 1 BAG (65862-146-19)10000 tablet17-AUG-09Current
65862-146-36658620146361 BLISTER PACK in 1 CARTON (65862-146-36) / 9 TABLET in 1 BLISTER PACK1 blister pack2009-08-170000-00-00NoNoCurrent
65862-146-596586201465936 TABLET in 1 BOTTLE (65862-146-59) 36 tablet2022-06-220000-00-00NoNoCurrent