Sumatriptan Succinate

Product NDC
64679-728
11-digit product format
646790728
Labeler code
64679
Product ID
64679-728_8fed49a8-01d7-422d-bbb6-212ef36952e4
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Sumatriptan Succinate
Dosage form
INJECTION
Route
SUBCUTANEOUS
Labeler
Wockhardt USA LLC.
Application
ANDA078593
Marketing category
ANDA
Marketing start
2009-02-06
Marketing end
0000-00-00
Substance
SUMATRIPTAN SUCCINATE
Active strength
6 mg/.5mL
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
2021-12-31
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 productproduct64679-728DDiscontinued by firm2026-10-05
excluded packagepackage64679-72864679-728-01DDiscontinued by firm2026-10-05

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 · 2 matching rows.

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

Captured / source date, Dataset, Scope table
Captured / source dateDatasetScopeProduct NDCPackage NDCCodeStatusReporting periodArchiveSnapshotSource SHA-256
2025-12-14 17:58 UTC · source 2025-12-05excluded productproduct64679-728DDiscontinued by firmexcluded / ndc_excluded.zipd630ba8d3edf…732f749b63fb…
2025-12-14 17:58 UTC · source 2025-12-05excluded packagepackage64679-72864679-728-01DDiscontinued by firmexcluded / ndc_excluded.zipd630ba8d3edf…732f749b63fb…

Source provenance: Browse the complete Orange Book source catalog · source snapshot 43.

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
A078593-001SUMATRIPTAN SUCCINATESUMATRIPTAN SUCCINATEEQ 6MG BASE/0.5ML (EQ 12MG BASE/ML)INJECTABLE / SUBCUTANEOUSAP2009-02-06

Therapeutic equivalence codes#

Current TE-code rows page 1 of 1 · 1 matching rows.

Application-product, TE code table
Application-productTE code
A078593-001AP

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 · 43 observed states.

Captured, Edition, Application-product table
CapturedEditionApplication-productTrade nameStrengthDosage form / routeProduct TE source textRLD / RSApproval dateSource SHA-256
2026-09-14 22:38:342026-08A078593-001SUMATRIPTAN SUCCINATEEQ 6MG BASE/0.5ML (EQ 12MG BASE/ML)INJECTABLE / SUBCUTANEOUSAP2009-02-0684e616aacf4f…
2026-08-18 06:07:402026-07A078593-001SUMATRIPTAN SUCCINATEEQ 6MG BASE/0.5ML (EQ 12MG BASE/ML)INJECTABLE / SUBCUTANEOUSAP2009-02-06caaa826d4ba7…
2026-02-19 14:30 UTC2026-02A078593-001SUMATRIPTAN SUCCINATEEQ 6MG BASE/0.5ML (EQ 12MG BASE/ML)INJECTABLE / SUBCUTANEOUSAP2009-02-06011fe1cb6892…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A078593-001SUMATRIPTAN SUCCINATEEQ 6MG BASE/0.5ML (EQ 12MG BASE/ML)INJECTABLE / SUBCUTANEOUSAP2009-02-0631067a03dcf5…
2025-08-23 18:47 UTC2025-08A078593-001SUMATRIPTAN SUCCINATEEQ 6MG BASE/0.5ML (EQ 12MG BASE/ML)INJECTABLE / SUBCUTANEOUSAP2009-02-066a471c1ec25d…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A078593-001SUMATRIPTAN SUCCINATEEQ 6MG BASE/0.5ML (EQ 12MG BASE/ML)INJECTABLE / SUBCUTANEOUSAP2009-02-06fd3edfee7708…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A078593-001SUMATRIPTAN SUCCINATEEQ 6MG BASE/0.5ML (EQ 12MG BASE/ML)INJECTABLE / SUBCUTANEOUSAP2009-02-06b8a1b40f171c…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A078593-001SUMATRIPTAN SUCCINATEEQ 6MG BASE/0.5ML (EQ 12MG BASE/ML)INJECTABLE / SUBCUTANEOUSAP2009-02-0603ed91905a0d…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A078593-001SUMATRIPTAN SUCCINATEEQ 6MG BASE/0.5ML (EQ 12MG BASE/ML)INJECTABLE / SUBCUTANEOUSAP2009-02-062680178bc6a6…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A078593-001SUMATRIPTAN SUCCINATEEQ 6MG BASE/0.5ML (EQ 12MG BASE/ML)INJECTABLE / SUBCUTANEOUSAP2009-02-065bbf6a4d5a75…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A078593-001SUMATRIPTAN SUCCINATEEQ 6MG BASE/0.5ML (EQ 12MG BASE/ML)INJECTABLE / SUBCUTANEOUSAP2009-02-06d8e5a09893c0…
2024-10-29 15:01 UTC2024-10A078593-001SUMATRIPTAN SUCCINATEEQ 6MG BASE/0.5ML (EQ 12MG BASE/ML)INJECTABLE / SUBCUTANEOUSAP2009-02-06d06236e962d9…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08A078593-001SUMATRIPTAN SUCCINATEEQ 6MG BASE/0.5ML (EQ 12MG BASE/ML)INJECTABLE / SUBCUTANEOUSAP2009-02-0679d66fd596c7…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07A078593-001SUMATRIPTAN SUCCINATEEQ 6MG BASE/0.5ML (EQ 12MG BASE/ML)INJECTABLE / SUBCUTANEOUSAP2009-02-06301d65b070ca…
2024-06-18 03:08 UTC · 5 captures of this ZIP2024-06A078593-001SUMATRIPTAN SUCCINATEEQ 6MG BASE/0.5ML (EQ 12MG BASE/ML)INJECTABLE / SUBCUTANEOUSAP2009-02-061e350fbaab3a…
2024-05-31 18:47 UTC2024-05A078593-001SUMATRIPTAN SUCCINATEEQ 6MG BASE/0.5ML (EQ 12MG BASE/ML)INJECTABLE / SUBCUTANEOUSAP2009-02-068072bd15b7f6…
2022-06-29 02:47 UTC · 2 captures of this ZIP2022-06A078593-001SUMATRIPTAN SUCCINATEEQ 6MG BASE/0.5ML (EQ 12MG BASE/ML)INJECTABLE / SUBCUTANEOUSAP2009-02-065c6f7cd8ea54…
2022-04-08 23:34 UTC2022-04A078593-001SUMATRIPTAN SUCCINATEEQ 6MG BASE/0.5ML (EQ 12MG BASE/ML)INJECTABLE / SUBCUTANEOUSAP2009-02-065d02ea3f76ae…
2022-04-04 05:41 UTC2022-04A078593-001SUMATRIPTAN SUCCINATEEQ 6MG BASE/0.5ML (EQ 12MG BASE/ML)INJECTABLE / SUBCUTANEOUSAP2009-02-064b0b4de00fa7…
2019-12-13 00:20 UTC2019-12A078593-001SUMATRIPTAN SUCCINATEEQ 6MG BASE/0.5ML (EQ 12MG BASE/ML)INJECTABLE / SUBCUTANEOUSAP2009-02-0674a2ff9319b5…
2022-03-09 01:35 UTC2022-03A078593-001SUMATRIPTAN SUCCINATEEQ 6MG BASE/0.5ML (EQ 12MG BASE/ML)INJECTABLE / SUBCUTANEOUSAP2009-02-06bb7c543d1eb4…
2021-12-28 21:50 UTC2021-12A078593-001SUMATRIPTAN SUCCINATEEQ 6MG BASE/0.5ML (EQ 12MG BASE/ML)INJECTABLE / SUBCUTANEOUSAP2009-02-06782e0a99824c…
2021-05-05 16:15 UTC · 3 captures of this ZIP2021-05A078593-001SUMATRIPTAN SUCCINATEEQ 6MG BASE/0.5ML (EQ 12MG BASE/ML)INJECTABLE / SUBCUTANEOUSAP2009-02-0687673890dc5c…
2021-03-12 10:30 UTC2021-03A078593-001SUMATRIPTAN SUCCINATEEQ 6MG BASE/0.5ML (EQ 12MG BASE/ML)INJECTABLE / SUBCUTANEOUSAP2009-02-065aa47cf7b7d7…
2020-12-22 03:56 UTC2020-12A078593-001SUMATRIPTAN SUCCINATEEQ 6MG BASE/0.5ML (EQ 12MG BASE/ML)INJECTABLE / SUBCUTANEOUSAP2009-02-068869cabd3fbd…
2020-11-12 02:37 UTC2020-11A078593-001SUMATRIPTAN SUCCINATEEQ 6MG BASE/0.5ML (EQ 12MG BASE/ML)INJECTABLE / SUBCUTANEOUSAP2009-02-06c0c555d07b60…
2019-12-14 00:12 UTC2019-12A078593-001SUMATRIPTAN SUCCINATEEQ 6MG BASE/0.5ML (EQ 12MG BASE/ML)INJECTABLE / SUBCUTANEOUSAP2009-02-063f01610625f2…
2019-09-15 20:21 UTC2019-09A078593-001SUMATRIPTAN SUCCINATEEQ 6MG BASE/0.5ML (EQ 12MG BASE/ML)INJECTABLE / SUBCUTANEOUSAP2009-02-06b00525d2431f…
2019-07-19 19:46 UTC2019-07A078593-001SUMATRIPTAN SUCCINATEEQ 6MG BASE/0.5ML (EQ 12MG BASE/ML)INJECTABLE / SUBCUTANEOUSAP2009-02-06ea99ee380514…
2024-03-16 18:09 UTC · 4 captures of this ZIP2024-03A078593-001SUMATRIPTAN SUCCINATEEQ 6MG BASE/0.5ML (EQ 12MG BASE/ML)INJECTABLE / SUBCUTANEOUSAP2009-02-066a51e52b5d6a…
2024-02-18 07:12 UTC2024-02A078593-001SUMATRIPTAN SUCCINATEEQ 6MG BASE/0.5ML (EQ 12MG BASE/ML)INJECTABLE / SUBCUTANEOUSAP2009-02-061c564ffb4f44…
2023-12-20 04:57 UTC2023-12A078593-001SUMATRIPTAN SUCCINATEEQ 6MG BASE/0.5ML (EQ 12MG BASE/ML)INJECTABLE / SUBCUTANEOUSAP2009-02-06ea1830bbd6c7…
2023-11-28 05:40 UTC · 2 captures of this ZIP2023-11A078593-001SUMATRIPTAN SUCCINATEEQ 6MG BASE/0.5ML (EQ 12MG BASE/ML)INJECTABLE / SUBCUTANEOUSAP2009-02-06a72a2bbeb626…
2023-10-25 00:34 UTC · 2 captures of this ZIP2023-10A078593-001SUMATRIPTAN SUCCINATEEQ 6MG BASE/0.5ML (EQ 12MG BASE/ML)INJECTABLE / SUBCUTANEOUSAP2009-02-069b2671bbb829…
2023-07-15 15:27 UTC · 2 captures of this ZIP2023-07A078593-001SUMATRIPTAN SUCCINATEEQ 6MG BASE/0.5ML (EQ 12MG BASE/ML)INJECTABLE / SUBCUTANEOUSAP2009-02-06a67488948f0b…
2023-06-13 01:57 UTC · 3 captures of this ZIP2023-06A078593-001SUMATRIPTAN SUCCINATEEQ 6MG BASE/0.5ML (EQ 12MG BASE/ML)INJECTABLE / SUBCUTANEOUSAP2009-02-063f0d92c62455…
2023-05-13 08:27 UTC2023-05A078593-001SUMATRIPTAN SUCCINATEEQ 6MG BASE/0.5ML (EQ 12MG BASE/ML)INJECTABLE / SUBCUTANEOUSAP2009-02-06053a50430f4f…
2023-01-26 05:58 UTC2023-01A078593-001SUMATRIPTAN SUCCINATEEQ 6MG BASE/0.5ML (EQ 12MG BASE/ML)INJECTABLE / SUBCUTANEOUSAP2009-02-063bdfa0b2c4d7…
2022-11-12 20:34 UTC · 5 captures of this ZIP2022-11A078593-001SUMATRIPTAN SUCCINATEEQ 6MG BASE/0.5ML (EQ 12MG BASE/ML)INJECTABLE / SUBCUTANEOUSAP2009-02-063a93d1ddd44b…
2022-10-28 04:53 UTC2022-10A078593-001SUMATRIPTAN SUCCINATEEQ 6MG BASE/0.5ML (EQ 12MG BASE/ML)INJECTABLE / SUBCUTANEOUSAP2009-02-06f41ea6bd6efb…

Observed Orange Book normalized TE history#

Normalized TE history page 1 of 2 · 43 observed states.

Captured, Edition, Application-product table
CapturedEditionApplication-productTE codeOrderSource SHA-256
2026-09-14 22:38:342026-08A078593-001AP184e616aacf4f…
2026-08-18 06:07:402026-07A078593-001AP1caaa826d4ba7…
2026-02-19 14:30 UTC2026-02A078593-001AP1011fe1cb6892…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A078593-001AP131067a03dcf5…
2025-08-23 18:47 UTC2025-08A078593-001AP16a471c1ec25d…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A078593-001AP1fd3edfee7708…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A078593-001AP1b8a1b40f171c…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A078593-001AP103ed91905a0d…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A078593-001AP12680178bc6a6…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A078593-001AP15bbf6a4d5a75…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A078593-001AP1d8e5a09893c0…
2024-10-29 15:01 UTC2024-10A078593-001AP1d06236e962d9…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08A078593-001AP179d66fd596c7…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07A078593-001AP1301d65b070ca…
2024-06-18 03:08 UTC · 5 captures of this ZIP2024-06A078593-001AP11e350fbaab3a…
2024-05-31 18:47 UTC2024-05A078593-001AP18072bd15b7f6…
2022-06-29 02:47 UTC · 2 captures of this ZIP2022-06A078593-001AP15c6f7cd8ea54…
2022-04-08 23:34 UTC2022-04A078593-001AP15d02ea3f76ae…
2022-04-04 05:41 UTC2022-04A078593-001AP14b0b4de00fa7…
2019-12-13 00:20 UTC2019-12A078593-001AP174a2ff9319b5…
2022-03-09 01:35 UTC2022-03A078593-001AP1bb7c543d1eb4…
2021-12-28 21:50 UTC2021-12A078593-001AP1782e0a99824c…
2021-05-05 16:15 UTC · 3 captures of this ZIP2021-05A078593-001AP187673890dc5c…
2021-03-12 10:30 UTC2021-03A078593-001AP15aa47cf7b7d7…
2020-12-22 03:56 UTC2020-12A078593-001AP18869cabd3fbd…
2020-11-12 02:37 UTC2020-11A078593-001AP1c0c555d07b60…
2019-12-14 00:12 UTC2019-12A078593-001AP13f01610625f2…
2019-09-15 20:21 UTC2019-09A078593-001AP1b00525d2431f…
2019-07-19 19:46 UTC2019-07A078593-001AP1ea99ee380514…
2024-03-16 18:09 UTC · 4 captures of this ZIP2024-03A078593-001AP16a51e52b5d6a…
2024-02-18 07:12 UTC2024-02A078593-001AP11c564ffb4f44…
2023-12-20 04:57 UTC2023-12A078593-001AP1ea1830bbd6c7…
2023-11-28 05:40 UTC · 2 captures of this ZIP2023-11A078593-001AP1a72a2bbeb626…
2023-10-25 00:34 UTC · 2 captures of this ZIP2023-10A078593-001AP19b2671bbb829…
2023-07-15 15:27 UTC · 2 captures of this ZIP2023-07A078593-001AP1a67488948f0b…
2023-06-13 01:57 UTC · 3 captures of this ZIP2023-06A078593-001AP13f0d92c62455…
2023-05-13 08:27 UTC2023-05A078593-001AP1053a50430f4f…
2023-01-26 05:58 UTC2023-01A078593-001AP13bdfa0b2c4d7…
2022-11-12 20:34 UTC · 5 captures of this ZIP2022-11A078593-001AP13a93d1ddd44b…
2022-10-28 04:53 UTC2022-10A078593-001AP1f41ea6bd6efb…

Reported adverse events (FAERS/openFDA)#

Adverse event summaries are temporarily unavailable. Other product information remains available.

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
59adc2ba-d5f0-4a52-b35a-cc77921a79d2Product name420250724
2839c963-7eb3-970a-287f-ff1b6d381268Product name220250103
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 Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
64679-728-01ML - Milliliter64679-728ec5f5682-c453-4ded-a27e-b2915745c79712012-07-24
64679-728-08ML - Milliliter64679-728c5ea05ba-913b-40a6-85ba-2b6b178b099312018-02-20

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIIDailyMed labelSPL versionUploaded
SUMATRIPTAN SUCCINATEACTIVE INGREDIENTJ8BDZ68989SUMATRIPTAN SUCCINATE INJECTION [WOCKHARDT USA LLC.]1
SUMATRIPTANACTIVE MOIETY8R78F6L9VOSUMATRIPTAN SUCCINATE INJECTION [WOCKHARDT USA LLC.]1
SODIUM CHLORIDEINACTIVE INGREDIENT451W47IQ8XSUMATRIPTAN SUCCINATE INJECTION [WOCKHARDT USA LLC.]1
WATERINACTIVE INGREDIENT059QF0KO0RSUMATRIPTAN SUCCINATE INJECTION [WOCKHARDT USA LLC.]1

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
64679-728SUMATRIPTAN SUCCINATE INJECTION [WOCKHARDT USA LLC.]5Legacy NDC20231227_e0917960-87bf-4650-b60b-64bef2ccc4d6.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 · 1 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
Sumatriptan SuccinateSUMATRIPTAN SUCCINATEProficient Rx LP44d6d757-489c-4262-a518-af8c470734d62019-10-01Warnings, Adverse reactionsExact identifier
application applno (ANDA): 078593
application number: ANDA078593

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
313165SUMAtriptan 6 MG in 0.5 ML InjectionPSN44d6d757-489c-4262-a518-af8c470734d63
3131650.5 ML sumatriptan 12 MG/ML InjectionSCD44d6d757-489c-4262-a518-af8c470734d63
313165sumatriptan (as sumatriptan succinate) 12 MG/ML InjectionSY44d6d757-489c-4262-a518-af8c470734d63
313165sumatriptan 6 MG per 0.5 ML InjectionSY44d6d757-489c-4262-a518-af8c470734d63

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
64679-728-01646790728015 VIAL in 1 CARTON (64679-728-01) > .5 mL in 1 VIAL (64679-728-08) 5 vial2009-02-060000-00-00NoNoCurrent