SUMATRIPTAN

Product NDC
63187-323
11-digit product format
631870323
Labeler code
63187
Product ID
63187-323_0cdfb1de-15e5-4697-b443-ec4c7db9d432
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
SUMATRIPTAN
Dosage form
TABLET
Route
ORAL
Labeler
Proficient Rx LP
Application
ANDA076572
Marketing category
ANDA
Marketing start
2009-02-10
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
2026-12-31
Current FDA listing
Yes

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

Orange Book products#

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

Application-product, Trade name, Ingredient table
Application-productTrade nameIngredientStrengthDosage form / routeTE codesRLD / RSApproval date
A076572-001SUMATRIPTAN SUCCINATESUMATRIPTAN SUCCINATEEQ 100MG BASETABLET / ORAL2009-02-09

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 2 · 42 observed states.

Captured, Edition, Application-product table
CapturedEditionApplication-productTrade nameStrengthDosage form / routeProduct TE source textRLD / RSApproval dateSource SHA-256
2026-08-18 06:07:402026-07A076572-001SUMATRIPTAN SUCCINATEEQ 100MG BASETABLET / ORAL2009-02-09caaa826d4ba7…
2026-02-19 14:30 UTC2026-02A076572-001SUMATRIPTAN SUCCINATEEQ 100MG BASETABLET / ORAL2009-02-09011fe1cb6892…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A076572-001SUMATRIPTAN SUCCINATEEQ 100MG BASETABLET / ORAL2009-02-0931067a03dcf5…
2025-08-23 18:47 UTC2025-08A076572-001SUMATRIPTAN SUCCINATEEQ 100MG BASETABLET / ORAL2009-02-096a471c1ec25d…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A076572-001SUMATRIPTAN SUCCINATEEQ 100MG BASETABLET / ORAL2009-02-09fd3edfee7708…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A076572-001SUMATRIPTAN SUCCINATEEQ 100MG BASETABLET / ORAL2009-02-09b8a1b40f171c…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A076572-001SUMATRIPTAN SUCCINATEEQ 100MG BASETABLET / ORAL2009-02-0903ed91905a0d…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A076572-001SUMATRIPTAN SUCCINATEEQ 100MG BASETABLET / ORAL2009-02-092680178bc6a6…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A076572-001SUMATRIPTAN SUCCINATEEQ 100MG BASETABLET / ORAL2009-02-095bbf6a4d5a75…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A076572-001SUMATRIPTAN SUCCINATEEQ 100MG BASETABLET / ORAL2009-02-09d8e5a09893c0…
2024-10-29 15:01 UTC2024-10A076572-001SUMATRIPTAN SUCCINATEEQ 100MG BASETABLET / ORAL2009-02-09d06236e962d9…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08A076572-001SUMATRIPTAN SUCCINATEEQ 100MG BASETABLET / ORAL2009-02-0979d66fd596c7…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07A076572-001SUMATRIPTAN SUCCINATEEQ 100MG BASETABLET / ORAL2009-02-09301d65b070ca…
2024-06-18 03:08 UTC · 5 captures of this ZIP2024-06A076572-001SUMATRIPTAN SUCCINATEEQ 100MG BASETABLET / ORAL2009-02-091e350fbaab3a…
2024-05-31 18:47 UTC2024-05A076572-001SUMATRIPTAN SUCCINATEEQ 100MG BASETABLET / ORAL2009-02-098072bd15b7f6…
2022-06-29 02:47 UTC · 2 captures of this ZIP2022-06A076572-001SUMATRIPTAN SUCCINATEEQ 100MG BASETABLET / ORALAB2009-02-095c6f7cd8ea54…
2022-04-08 23:34 UTC2022-04A076572-001SUMATRIPTAN SUCCINATEEQ 100MG BASETABLET / ORALAB2009-02-095d02ea3f76ae…
2022-04-04 05:41 UTC2022-04A076572-001SUMATRIPTAN SUCCINATEEQ 100MG BASETABLET / ORALAB2009-02-094b0b4de00fa7…
2019-12-13 00:20 UTC2019-12A076572-001SUMATRIPTAN SUCCINATEEQ 100MG BASETABLET / ORALAB2009-02-0974a2ff9319b5…
2022-03-09 01:35 UTC2022-03A076572-001SUMATRIPTAN SUCCINATEEQ 100MG BASETABLET / ORALAB2009-02-09bb7c543d1eb4…
2021-12-28 21:50 UTC2021-12A076572-001SUMATRIPTAN SUCCINATEEQ 100MG BASETABLET / ORALAB2009-02-09782e0a99824c…
2021-05-05 16:15 UTC · 3 captures of this ZIP2021-05A076572-001SUMATRIPTAN SUCCINATEEQ 100MG BASETABLET / ORALAB2009-02-0987673890dc5c…
2021-03-12 10:30 UTC2021-03A076572-001SUMATRIPTAN SUCCINATEEQ 100MG BASETABLET / ORALAB2009-02-095aa47cf7b7d7…
2020-12-22 03:56 UTC2020-12A076572-001SUMATRIPTAN SUCCINATEEQ 100MG BASETABLET / ORALAB2009-02-098869cabd3fbd…
2020-11-12 02:37 UTC2020-11A076572-001SUMATRIPTAN SUCCINATEEQ 100MG BASETABLET / ORALAB2009-02-09c0c555d07b60…
2019-12-14 00:12 UTC2019-12A076572-001SUMATRIPTAN SUCCINATEEQ 100MG BASETABLET / ORALAB2009-02-093f01610625f2…
2019-09-15 20:21 UTC2019-09A076572-001SUMATRIPTAN SUCCINATEEQ 100MG BASETABLET / ORALAB2009-02-09b00525d2431f…
2019-07-19 19:46 UTC2019-07A076572-001SUMATRIPTAN SUCCINATEEQ 100MG BASETABLET / ORALAB2009-02-09ea99ee380514…
2024-03-16 18:09 UTC · 4 captures of this ZIP2024-03A076572-001SUMATRIPTAN SUCCINATEEQ 100MG BASETABLET / ORAL2009-02-096a51e52b5d6a…
2024-02-18 07:12 UTC2024-02A076572-001SUMATRIPTAN SUCCINATEEQ 100MG BASETABLET / ORAL2009-02-091c564ffb4f44…
2023-12-20 04:57 UTC2023-12A076572-001SUMATRIPTAN SUCCINATEEQ 100MG BASETABLET / ORAL2009-02-09ea1830bbd6c7…
2023-11-28 05:40 UTC · 2 captures of this ZIP2023-11A076572-001SUMATRIPTAN SUCCINATEEQ 100MG BASETABLET / ORAL2009-02-09a72a2bbeb626…
2023-10-25 00:34 UTC · 2 captures of this ZIP2023-10A076572-001SUMATRIPTAN SUCCINATEEQ 100MG BASETABLET / ORAL2009-02-099b2671bbb829…
2023-07-15 15:27 UTC · 2 captures of this ZIP2023-07A076572-001SUMATRIPTAN SUCCINATEEQ 100MG BASETABLET / ORALAB2009-02-09a67488948f0b…
2023-06-13 01:57 UTC · 3 captures of this ZIP2023-06A076572-001SUMATRIPTAN SUCCINATEEQ 100MG BASETABLET / ORALAB2009-02-093f0d92c62455…
2023-05-13 08:27 UTC2023-05A076572-001SUMATRIPTAN SUCCINATEEQ 100MG BASETABLET / ORALAB2009-02-09053a50430f4f…
2023-01-26 05:58 UTC2023-01A076572-001SUMATRIPTAN SUCCINATEEQ 100MG BASETABLET / ORALAB2009-02-093bdfa0b2c4d7…
2022-11-12 20:34 UTC · 5 captures of this ZIP2022-11A076572-001SUMATRIPTAN SUCCINATEEQ 100MG BASETABLET / ORALAB2009-02-093a93d1ddd44b…
2022-10-28 04:53 UTC2022-10A076572-001SUMATRIPTAN SUCCINATEEQ 100MG BASETABLET / ORALAB2009-02-09f41ea6bd6efb…
2022-09-29 23:25 UTC2022-09A076572-001SUMATRIPTAN SUCCINATEEQ 100MG BASETABLET / ORALAB2009-02-09e64feba35796…

Observed Orange Book normalized TE history#

Captured, Edition, Application-product table
CapturedEditionApplication-productTE codeOrderSource SHA-256
2022-06-29 02:47 UTC · 2 captures of this ZIP2022-06A076572-001AB15c6f7cd8ea54…
2022-04-08 23:34 UTC2022-04A076572-001AB15d02ea3f76ae…
2022-04-04 05:41 UTC2022-04A076572-001AB14b0b4de00fa7…
2019-12-13 00:20 UTC2019-12A076572-001AB174a2ff9319b5…
2022-03-09 01:35 UTC2022-03A076572-001AB1bb7c543d1eb4…
2021-12-28 21:50 UTC2021-12A076572-001AB1782e0a99824c…
2021-05-05 16:15 UTC · 3 captures of this ZIP2021-05A076572-001AB187673890dc5c…
2021-03-12 10:30 UTC2021-03A076572-001AB15aa47cf7b7d7…
2020-12-22 03:56 UTC2020-12A076572-001AB18869cabd3fbd…
2020-11-12 02:37 UTC2020-11A076572-001AB1c0c555d07b60…
2019-12-14 00:12 UTC2019-12A076572-001AB13f01610625f2…
2019-09-15 20:21 UTC2019-09A076572-001AB1b00525d2431f…
2019-07-19 19:46 UTC2019-07A076572-001AB1ea99ee380514…
2023-07-15 15:27 UTC · 2 captures of this ZIP2023-07A076572-001AB1a67488948f0b…
2023-06-13 01:57 UTC · 3 captures of this ZIP2023-06A076572-001AB13f0d92c62455…
2023-05-13 08:27 UTC2023-05A076572-001AB1053a50430f4f…
2023-01-26 05:58 UTC2023-01A076572-001AB13bdfa0b2c4d7…
2022-11-12 20:34 UTC · 5 captures of this ZIP2022-11A076572-001AB13a93d1ddd44b…
2022-10-28 04:53 UTC2022-10A076572-001AB1f41ea6bd6efb…
2022-09-29 23:25 UTC2022-09A076572-001AB1e64feba35796…
2022-07-09 03:26 UTC · 3 captures of this ZIP2022-07A076572-001AB1cb3db0bc1861…

Additional Listing Data#

Finished product
Yes
Brand name base
SUMATRIPTAN
Listing expiration
2026-12-31

Active Ingredients#

Ingredient, Strength table
IngredientStrength
SUMATRIPTAN SUCCINATE100 mg/1

Harmonized UNII identifiers#

UNII identifiers page 1 of 1 · 1 matching rows.

Identifier, FDA.report destination table
IdentifierFDA.report destination
J8BDZ68989Internal UNII lookup

Harmonized RxCUI identifiers#

RxCUI identifiers page 1 of 1 · 1 matching rows.

Identifier, FDA.report destination table
IdentifierFDA.report destination
313160Internal RxNorm lookup

Harmonized SPL set identifiers#

SPL set identifiers page 1 of 1 · 1 matching rows.

Identifier, FDA.report destination table
IdentifierFDA.report destination
121e36fb-471b-4318-bc47-b087ad68c6f7Available on FDA.report

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

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
63187-323-09SUMATRIPTAN9 in 1 BLISTER PACKTABLET94
63187-323-09SUMATRIPTAN1 in 1 CARTONTABLET14

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIIDailyMed labelSPL versionUploaded
SUMATRIPTAN SUCCINATEACTIVE INGREDIENTJ8BDZ68989SUMATRIPTAN TABLET [PROFICIENT RX LP]1
SUMATRIPTANACTIVE MOIETY8R78F6L9VOSUMATRIPTAN TABLET [PROFICIENT RX LP]1
ANHYDROUS LACTOSEINACTIVE INGREDIENT3SY5LH9PMKSUMATRIPTAN TABLET [PROFICIENT RX LP]1
CELLULOSE, MICROCRYSTALLINEINACTIVE INGREDIENTOP1R32D61USUMATRIPTAN TABLET [PROFICIENT RX LP]1
CROSCARMELLOSE SODIUMINACTIVE INGREDIENTM28OL1HH48SUMATRIPTAN TABLET [PROFICIENT RX LP]1
LACTOSE MONOHYDRATEINACTIVE INGREDIENTEWQ57Q8I5XSUMATRIPTAN TABLET [PROFICIENT RX LP]1
MAGNESIUM STEARATEINACTIVE INGREDIENT70097M6I30SUMATRIPTAN TABLET [PROFICIENT RX LP]1
SILICON DIOXIDEINACTIVE INGREDIENTETJ7Z6XBU4SUMATRIPTAN TABLET [PROFICIENT RX LP]1
TALCINACTIVE INGREDIENT7SEV7J4R1USUMATRIPTAN TABLET [PROFICIENT RX LP]1

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
63187-323SUMATRIPTAN TABLET [PROFICIENT RX LP]4Current NDC, Legacy NDC, 2 package rows20210116_121e36fb-471b-4318-bc47-b087ad68c6f7.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): 076572
application number: ANDA076572
SUMATRIPTANSUMATRIPTANProficient Rx LP121e36fb-471b-4318-bc47-b087ad68c6f72021-01-01Warnings, Adverse reactionsExact identifier
application applno (ANDA): 076572
application number: ANDA076572
ndc (product): 63187-323

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
313160SUMAtriptan succinate 100 MG Oral TabletPSN121e36fb-471b-4318-bc47-b087ad68c6f74
313160sumatriptan 100 MG Oral TabletSCD121e36fb-471b-4318-bc47-b087ad68c6f74
313160sumatriptan 100 MG (as sumatriptan succinate 140 MG) Oral TabletSY121e36fb-471b-4318-bc47-b087ad68c6f74

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
63187-323-09631870323091 BLISTER PACK in 1 CARTON (63187-323-09) / 9 TABLET in 1 BLISTER PACK1 blister pack2015-02-020000-00-00NoNoCurrent