SUMATRIPTAN

Product NDC
50436-4623
11-digit product format
504364623
Labeler code
50436
Product ID
50436-4623_1e6a54ec-5b23-40e2-879e-db839374bc7a
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
SUMATRIPTAN
Dosage form
TABLET
Route
ORAL
Labeler
Unit Dose Services
Application
ANDA076554
Marketing category
ANDA
Marketing start
2009-08-13
Marketing end
0000-00-00
Substance
SUMATRIPTAN SUCCINATE
Active strength
50 mg/1
Pharmacologic classes
Serotonin 1d Receptor Agonists [MoA],Serotonin-1b and Serotonin-1d Receptor Agonist [EPC],Serotonin 1b Receptor Agonists [MoA]
NDC exclude flag
No
Listing certified through
2020-12-31
Current FDA listing
Historical FDA.report record

NDC auxiliary status#

These records are reproduced from FDA’s unfinished, excluded, and compounder listings. They describe what appeared in the source files; a missing record does not establish a regulatory status. View all current auxiliary records, including entries without an NDC. · View the auxiliary file history.

Current NDC status page 1 of 1 · 2 matching rows.

Dataset, Scope, Product NDC table
DatasetScopeProduct NDCPackage NDCCodeStatusReporting periodSource date
excluded productproduct50436-4623IInactivated by FDA2026-08-17
excluded packagepackage50436-462350436-4623-1IInactivated by FDA2026-08-17

Observed NDC auxiliary status history#

This history shows the information present in each captured FDA auxiliary file. It is not a continuous regulatory timeline, and a missing record does not establish a status.

Historic NDC status page 1 of 1 · 38 matching rows.

View current auxiliary records. · View the auxiliary file history.

Captured / source date, Dataset, Scope table
Captured / source dateDatasetScopePackage NDCSnapshotSource SHA-256
2025-12-14 17:58 UTC · source 2025-12-05excluded productproductd630ba8d3edf…732f749b63fb…
2025-12-14 17:58 UTC · source 2025-12-05excluded packagepackage50436-4623-1d630ba8d3edf…732f749b63fb…
2025-08-27 00:01 UTC · source 2025-08-26excluded productproductf5e01cc5f278…a2eaf40c39c3…
2025-08-27 00:01 UTC · source 2025-08-26excluded packagepackage50436-4623-1f5e01cc5f278…a2eaf40c39c3…
2025-04-01 02:39 UTC · source 2025-03-31excluded productproduct2ef7874e63bc…57b86245f4fa…
2025-04-01 02:39 UTC · source 2025-03-31excluded packagepackage50436-4623-12ef7874e63bc…57b86245f4fa…
2025-03-28 20:22 UTC · source 2025-03-28excluded productproducta1b67e2a42f9…c4cf2c586c0d…
2025-03-28 20:22 UTC · source 2025-03-28excluded packagepackage50436-4623-1a1b67e2a42f9…c4cf2c586c0d…
2025-03-22 03:12 UTC · source 2025-03-21excluded productproductcfe11265f3b6…090c488252e2…
2025-03-22 03:12 UTC · source 2025-03-21excluded packagepackage50436-4623-1cfe11265f3b6…090c488252e2…
2025-03-10 12:48 UTC · source 2025-03-10excluded productproductcdf11ea48f46…ba0047e9e063…
2025-03-10 12:48 UTC · source 2025-03-10excluded packagepackage50436-4623-1cdf11ea48f46…ba0047e9e063…
2025-02-02 03:52 UTC · source 2025-01-31excluded productproduct302b2466d912…e7b80fea0513…
2025-02-02 03:52 UTC · source 2025-01-31excluded packagepackage50436-4623-1302b2466d912…e7b80fea0513…
2025-01-20 13:05 UTC · source 2025-01-20excluded productproducted331223b511…672a5bd82f5f…
2025-01-20 13:05 UTC · source 2025-01-20excluded packagepackage50436-4623-1ed331223b511…672a5bd82f5f…
2025-01-11 03:41 UTC · source 2025-01-10excluded productproduct0efc9e666f02…f202fb6c5f17…
2025-01-11 03:41 UTC · source 2025-01-10excluded packagepackage50436-4623-10efc9e666f02…f202fb6c5f17…
2024-11-09 02:27 UTC · source 2024-11-08excluded productproductad56d346431e…cc804d4bbf1e…
2024-11-09 02:27 UTC · source 2024-11-08excluded packagepackage50436-4623-1ad56d346431e…cc804d4bbf1e…
2024-10-04 04:10 UTC · source 2024-10-03excluded productproduct367a005e9d99…383a685ebd0f…
2024-10-04 04:10 UTC · source 2024-10-03excluded packagepackage50436-4623-1367a005e9d99…383a685ebd0f…
2024-07-10 04:00 UTC · source 2024-07-09excluded productproduct557ba5c1ecfa…9c80585c8c6e…
2024-07-10 04:00 UTC · source 2024-07-09excluded packagepackage50436-4623-1557ba5c1ecfa…9c80585c8c6e…
2024-05-28 21:12 UTC · source 2024-05-28excluded productproduct8af77b9d5b6f…d9bbb34c5368…
2024-05-28 21:12 UTC · source 2024-05-28excluded packagepackage50436-4623-18af77b9d5b6f…d9bbb34c5368…
2024-05-15 03:39 UTC · source 2024-05-14excluded productproduct834df4deac94…adcc014656a3…
2024-05-15 03:39 UTC · source 2024-05-14excluded packagepackage50436-4623-1834df4deac94…adcc014656a3…
2024-03-11 06:39 UTC · source 2024-03-08excluded productproduct1332a3947898…d4bfe170f9cd…
2024-03-11 06:39 UTC · source 2024-03-08excluded packagepackage50436-4623-11332a3947898…d4bfe170f9cd…
2022-08-30 03:57 UTC · source 2022-08-29excluded productproductfb8cb913e6d1…eb8c232b6be0…
2022-08-30 03:57 UTC · source 2022-08-29excluded packagepackage50436-4623-1fb8cb913e6d1…eb8c232b6be0…
2022-04-09 23:13 UTC · source 2022-04-08excluded productproduct86f5da6cb304…a595104c45d7…
2022-04-09 23:13 UTC · source 2022-04-08excluded packagepackage50436-4623-186f5da6cb304…a595104c45d7…
2022-04-04 05:40 UTC · source 2022-04-01excluded productproductbd6a592717d7…303034d00443…
2022-04-04 05:40 UTC · source 2022-04-01excluded packagepackage50436-4623-1bd6a592717d7…303034d00443…
2021-12-27 23:28 UTC · source 2021-12-27excluded productproduct8dfbde2a14a4…c9ff85d89658…
2021-12-27 23:28 UTC · source 2021-12-27excluded packagepackage50436-4623-18dfbde2a14a4…c9ff85d89658…

Source provenance: Browse the complete Orange Book source catalog · source snapshot 42.

Orange Book products#

Current product rows page 1 of 1 · 2 matching rows.

Application-product, Trade name, Ingredient table
Application-productTrade nameIngredientStrengthDosage form / routeTE codesRLD / RSApproval date
A076554-001SUMATRIPTAN SUCCINATESUMATRIPTAN SUCCINATEEQ 25MG BASETABLET / ORAL2009-08-10
A076554-002SUMATRIPTAN SUCCINATESUMATRIPTAN SUCCINATEEQ 50MG BASETABLET / ORAL2009-08-10

Observed Orange Book product history#

Observed FDA ZIP history: Each table is queried independently by exact application/product key from successfully parsed Orange Book snapshots. Capture times identify archived source observations; absence or a change between snapshots is not inferred. FDA publication files that were not recoverable as structured ZIP data are not represented as states.

Product history page 1 of 3 · 84 observed states.

Captured, Edition, Application-product table
CapturedEditionApplication-productTrade nameStrengthDosage form / routeProduct TE source textRLD / RSApproval dateSource SHA-256
2026-08-18 06:07:402026-07A076554-001SUMATRIPTAN SUCCINATEEQ 25MG BASETABLET / ORAL2009-08-10caaa826d4ba7…
2026-08-18 06:07:402026-07A076554-002SUMATRIPTAN SUCCINATEEQ 50MG BASETABLET / ORAL2009-08-10caaa826d4ba7…
2026-02-19 14:30 UTC2026-02A076554-001SUMATRIPTAN SUCCINATEEQ 25MG BASETABLET / ORAL2009-08-10011fe1cb6892…
2026-02-19 14:30 UTC2026-02A076554-002SUMATRIPTAN SUCCINATEEQ 50MG BASETABLET / ORAL2009-08-10011fe1cb6892…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A076554-001SUMATRIPTAN SUCCINATEEQ 25MG BASETABLET / ORAL2009-08-1031067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A076554-002SUMATRIPTAN SUCCINATEEQ 50MG BASETABLET / ORAL2009-08-1031067a03dcf5…
2025-08-23 18:47 UTC2025-08A076554-001SUMATRIPTAN SUCCINATEEQ 25MG BASETABLET / ORAL2009-08-106a471c1ec25d…
2025-08-23 18:47 UTC2025-08A076554-002SUMATRIPTAN SUCCINATEEQ 50MG BASETABLET / ORAL2009-08-106a471c1ec25d…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A076554-001SUMATRIPTAN SUCCINATEEQ 25MG BASETABLET / ORAL2009-08-10fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A076554-002SUMATRIPTAN SUCCINATEEQ 50MG BASETABLET / ORAL2009-08-10fd3edfee7708…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A076554-001SUMATRIPTAN SUCCINATEEQ 25MG BASETABLET / ORAL2009-08-10b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A076554-002SUMATRIPTAN SUCCINATEEQ 50MG BASETABLET / ORAL2009-08-10b8a1b40f171c…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A076554-001SUMATRIPTAN SUCCINATEEQ 25MG BASETABLET / ORAL2009-08-1003ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A076554-002SUMATRIPTAN SUCCINATEEQ 50MG BASETABLET / ORAL2009-08-1003ed91905a0d…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A076554-001SUMATRIPTAN SUCCINATEEQ 25MG BASETABLET / ORAL2009-08-102680178bc6a6…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A076554-002SUMATRIPTAN SUCCINATEEQ 50MG BASETABLET / ORAL2009-08-102680178bc6a6…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A076554-001SUMATRIPTAN SUCCINATEEQ 25MG BASETABLET / ORAL2009-08-105bbf6a4d5a75…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A076554-002SUMATRIPTAN SUCCINATEEQ 50MG BASETABLET / ORAL2009-08-105bbf6a4d5a75…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A076554-001SUMATRIPTAN SUCCINATEEQ 25MG BASETABLET / ORAL2009-08-10d8e5a09893c0…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A076554-002SUMATRIPTAN SUCCINATEEQ 50MG BASETABLET / ORAL2009-08-10d8e5a09893c0…
2024-10-29 15:01 UTC2024-10A076554-001SUMATRIPTAN SUCCINATEEQ 25MG BASETABLET / ORAL2009-08-10d06236e962d9…
2024-10-29 15:01 UTC2024-10A076554-002SUMATRIPTAN SUCCINATEEQ 50MG BASETABLET / ORAL2009-08-10d06236e962d9…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08A076554-001SUMATRIPTAN SUCCINATEEQ 25MG BASETABLET / ORAL2009-08-1079d66fd596c7…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08A076554-002SUMATRIPTAN SUCCINATEEQ 50MG BASETABLET / ORAL2009-08-1079d66fd596c7…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07A076554-001SUMATRIPTAN SUCCINATEEQ 25MG BASETABLET / ORAL2009-08-10301d65b070ca…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07A076554-002SUMATRIPTAN SUCCINATEEQ 50MG BASETABLET / ORAL2009-08-10301d65b070ca…
2024-06-18 03:08 UTC · 5 captures of this ZIP2024-06A076554-001SUMATRIPTAN SUCCINATEEQ 25MG BASETABLET / ORAL2009-08-101e350fbaab3a…
2024-06-18 03:08 UTC · 5 captures of this ZIP2024-06A076554-002SUMATRIPTAN SUCCINATEEQ 50MG BASETABLET / ORAL2009-08-101e350fbaab3a…
2024-05-31 18:47 UTC2024-05A076554-001SUMATRIPTAN SUCCINATEEQ 25MG BASETABLET / ORAL2009-08-108072bd15b7f6…
2024-05-31 18:47 UTC2024-05A076554-002SUMATRIPTAN SUCCINATEEQ 50MG BASETABLET / ORAL2009-08-108072bd15b7f6…
2022-06-29 02:47 UTC · 2 captures of this ZIP2022-06A076554-001SUMATRIPTAN SUCCINATEEQ 25MG BASETABLET / ORALAB2009-08-105c6f7cd8ea54…
2022-06-29 02:47 UTC · 2 captures of this ZIP2022-06A076554-002SUMATRIPTAN SUCCINATEEQ 50MG BASETABLET / ORALAB2009-08-105c6f7cd8ea54…
2022-04-08 23:34 UTC2022-04A076554-001SUMATRIPTAN SUCCINATEEQ 25MG BASETABLET / ORALAB2009-08-105d02ea3f76ae…
2022-04-08 23:34 UTC2022-04A076554-002SUMATRIPTAN SUCCINATEEQ 50MG BASETABLET / ORALAB2009-08-105d02ea3f76ae…
2022-04-04 05:41 UTC2022-04A076554-001SUMATRIPTAN SUCCINATEEQ 25MG BASETABLET / ORALAB2009-08-104b0b4de00fa7…
2022-04-04 05:41 UTC2022-04A076554-002SUMATRIPTAN SUCCINATEEQ 50MG BASETABLET / ORALAB2009-08-104b0b4de00fa7…
2019-12-13 00:20 UTC2019-12A076554-001SUMATRIPTAN SUCCINATEEQ 25MG BASETABLET / ORALAB2009-08-1074a2ff9319b5…
2019-12-13 00:20 UTC2019-12A076554-002SUMATRIPTAN SUCCINATEEQ 50MG BASETABLET / ORALAB2009-08-1074a2ff9319b5…
2022-03-09 01:35 UTC2022-03A076554-001SUMATRIPTAN SUCCINATEEQ 25MG BASETABLET / ORALAB2009-08-10bb7c543d1eb4…
2022-03-09 01:35 UTC2022-03A076554-002SUMATRIPTAN SUCCINATEEQ 50MG BASETABLET / ORALAB2009-08-10bb7c543d1eb4…

Observed Orange Book normalized TE history#

Normalized TE history page 1 of 2 · 42 observed states.

Captured, Edition, Application-product table
CapturedEditionApplication-productTE codeOrderSource SHA-256
2022-06-29 02:47 UTC · 2 captures of this ZIP2022-06A076554-001AB15c6f7cd8ea54…
2022-06-29 02:47 UTC · 2 captures of this ZIP2022-06A076554-002AB15c6f7cd8ea54…
2022-04-08 23:34 UTC2022-04A076554-001AB15d02ea3f76ae…
2022-04-08 23:34 UTC2022-04A076554-002AB15d02ea3f76ae…
2022-04-04 05:41 UTC2022-04A076554-001AB14b0b4de00fa7…
2022-04-04 05:41 UTC2022-04A076554-002AB14b0b4de00fa7…
2019-12-13 00:20 UTC2019-12A076554-001AB174a2ff9319b5…
2019-12-13 00:20 UTC2019-12A076554-002AB174a2ff9319b5…
2022-03-09 01:35 UTC2022-03A076554-001AB1bb7c543d1eb4…
2022-03-09 01:35 UTC2022-03A076554-002AB1bb7c543d1eb4…
2021-12-28 21:50 UTC2021-12A076554-001AB1782e0a99824c…
2021-12-28 21:50 UTC2021-12A076554-002AB1782e0a99824c…
2021-05-05 16:15 UTC · 3 captures of this ZIP2021-05A076554-001AB187673890dc5c…
2021-05-05 16:15 UTC · 3 captures of this ZIP2021-05A076554-002AB187673890dc5c…
2021-03-12 10:30 UTC2021-03A076554-001AB15aa47cf7b7d7…
2021-03-12 10:30 UTC2021-03A076554-002AB15aa47cf7b7d7…
2020-12-22 03:56 UTC2020-12A076554-001AB18869cabd3fbd…
2020-12-22 03:56 UTC2020-12A076554-002AB18869cabd3fbd…
2020-11-12 02:37 UTC2020-11A076554-001AB1c0c555d07b60…
2020-11-12 02:37 UTC2020-11A076554-002AB1c0c555d07b60…
2019-12-14 00:12 UTC2019-12A076554-001AB13f01610625f2…
2019-12-14 00:12 UTC2019-12A076554-002AB13f01610625f2…
2019-09-15 20:21 UTC2019-09A076554-001AB1b00525d2431f…
2019-09-15 20:21 UTC2019-09A076554-002AB1b00525d2431f…
2019-07-19 19:46 UTC2019-07A076554-001AB1ea99ee380514…
2019-07-19 19:46 UTC2019-07A076554-002AB1ea99ee380514…
2023-07-15 15:27 UTC · 2 captures of this ZIP2023-07A076554-001AB1a67488948f0b…
2023-07-15 15:27 UTC · 2 captures of this ZIP2023-07A076554-002AB1a67488948f0b…
2023-06-13 01:57 UTC · 3 captures of this ZIP2023-06A076554-001AB13f0d92c62455…
2023-06-13 01:57 UTC · 3 captures of this ZIP2023-06A076554-002AB13f0d92c62455…
2023-05-13 08:27 UTC2023-05A076554-001AB1053a50430f4f…
2023-05-13 08:27 UTC2023-05A076554-002AB1053a50430f4f…
2023-01-26 05:58 UTC2023-01A076554-001AB13bdfa0b2c4d7…
2023-01-26 05:58 UTC2023-01A076554-002AB13bdfa0b2c4d7…
2022-11-12 20:34 UTC · 5 captures of this ZIP2022-11A076554-001AB13a93d1ddd44b…
2022-11-12 20:34 UTC · 5 captures of this ZIP2022-11A076554-002AB13a93d1ddd44b…
2022-10-28 04:53 UTC2022-10A076554-001AB1f41ea6bd6efb…
2022-10-28 04:53 UTC2022-10A076554-002AB1f41ea6bd6efb…
2022-09-29 23:25 UTC2022-09A076554-001AB1e64feba35796…
2022-09-29 23:25 UTC2022-09A076554-002AB1e64feba35796…

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
59adc2ba-d5f0-4a52-b35a-cc77921a79d2Product name420250724
2839c963-7eb3-970a-287f-ff1b6d381268Product name220250103
594e2c86-3079-4e6e-96c9-48f7a8afc78dProduct name120230718
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#

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
50436-4623-1SUMATRIPTAN9 in 1 BOTTLETABLET94

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
50436-4623-1EA - Each50436-4623237182ce-8858-4b12-94c9-04dc2e76932312013-03-03

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIIDailyMed labelSPL versionUploaded
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

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
50436-4623SUMATRIPTAN TABLET [UNIT DOSE SERVICES]4Legacy NDC, 1 package rows20170702_0ec6d61f-2900-44f4-b444-8fd48603e1e8.zip

openFDA label cross-check#

OpenFDA label data provides additional search and identifier links. DailyMed’s Structured Product Label is the canonical label on FDA.report. Matching records are deduplicated before they are shown below.

Matched openFDA labels page 1 of 1 · 2 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
SumatriptanSUMATRIPTANSUN PHARMACEUTICAL INDUSTRIES, INC.c87cf537-9f7f-400e-ac4b-86e6f7e787752022-01-19Warnings, Adverse reactionsExact identifier
application applno (ANDA): 076554
application number: ANDA076554
SUMATRIPTANSUMATRIPTANProficient Rx LP5cba3661-9b16-416b-b0c0-bbb12549d48f2021-01-01Warnings, Adverse reactionsExact identifier
application applno (ANDA): 076554
application number: ANDA076554

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
313161SUMAtriptan succinate 50 MG Oral TabletPSN0ec6d61f-2900-44f4-b444-8fd48603e1e84
313161sumatriptan 50 MG Oral TabletSCD0ec6d61f-2900-44f4-b444-8fd48603e1e84
313161sumatriptan 50 MG (as sumatriptan succinate 70 MG) Oral TabletSY0ec6d61f-2900-44f4-b444-8fd48603e1e84

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionStatus
50436-4623-1504364623019 in 1 BOTTLEHistorical