Sumatriptan Succinate

Product NDC
47335-276
11-digit product format
473350276
Labeler code
47335
Product ID
47335-276_2642fcb9-4170-4b4c-818b-74c071cb567e
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Sumatriptan Succinate
Dosage form
INJECTION
Route
SUBCUTANEOUS
Labeler
Sun Pharmaceutical Industries, Inc.
Application
ANDA090358
Marketing category
ANDA
Marketing start
2025-08-20
Substance
SUMATRIPTAN SUCCINATE
Active strength
6 mg/.5mL
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

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
A090358-001SUMATRIPTAN SUCCINATESUMATRIPTAN SUCCINATEEQ 6MG BASE/0.5ML (EQ 12MG BASE/ML)INJECTABLE / SUBCUTANEOUSAB2011-06-21

Therapeutic equivalence codes#

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

Application-product, TE code table
Application-productTE code
A090358-001AB

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 06:07:402026-07A090358-001SUMATRIPTAN SUCCINATEEQ 6MG BASE/0.5ML (EQ 12MG BASE/ML)INJECTABLE / SUBCUTANEOUSAB2011-06-21caaa826d4ba7…
2026-02-19 14:30 UTC2026-02A090358-001SUMATRIPTAN SUCCINATEEQ 6MG BASE/0.5ML (EQ 12MG BASE/ML)INJECTABLE / SUBCUTANEOUSAB2011-06-21011fe1cb6892…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A090358-001SUMATRIPTAN SUCCINATEEQ 6MG BASE/0.5ML (EQ 12MG BASE/ML)INJECTABLE / SUBCUTANEOUSAB2011-06-2131067a03dcf5…
2025-08-23 18:47 UTC2025-08A090358-001SUMATRIPTAN SUCCINATEEQ 6MG BASE/0.5ML (EQ 12MG BASE/ML)INJECTABLE / SUBCUTANEOUSAB2011-06-216a471c1ec25d…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A090358-001SUMATRIPTAN SUCCINATEEQ 6MG BASE/0.5ML (EQ 12MG BASE/ML)INJECTABLE / SUBCUTANEOUS2011-06-21fd3edfee7708…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A090358-001SUMATRIPTAN SUCCINATEEQ 6MG BASE/0.5ML (EQ 12MG BASE/ML)INJECTABLE / SUBCUTANEOUS2011-06-21b8a1b40f171c…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A090358-001SUMATRIPTAN SUCCINATEEQ 6MG BASE/0.5ML (EQ 12MG BASE/ML)INJECTABLE / SUBCUTANEOUS2011-06-2103ed91905a0d…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A090358-001SUMATRIPTAN SUCCINATEEQ 6MG BASE/0.5ML (EQ 12MG BASE/ML)INJECTABLE / SUBCUTANEOUS2011-06-212680178bc6a6…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A090358-001SUMATRIPTAN SUCCINATEEQ 6MG BASE/0.5ML (EQ 12MG BASE/ML)INJECTABLE / SUBCUTANEOUSAB2011-06-215bbf6a4d5a75…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A090358-001SUMATRIPTAN SUCCINATEEQ 6MG BASE/0.5ML (EQ 12MG BASE/ML)INJECTABLE / SUBCUTANEOUSAB2011-06-21d8e5a09893c0…
2024-10-29 15:01 UTC2024-10A090358-001SUMATRIPTAN SUCCINATEEQ 6MG BASE/0.5ML (EQ 12MG BASE/ML)INJECTABLE / SUBCUTANEOUSAB2011-06-21d06236e962d9…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08A090358-001SUMATRIPTAN SUCCINATEEQ 6MG BASE/0.5ML (EQ 12MG BASE/ML)INJECTABLE / SUBCUTANEOUSAB2011-06-2179d66fd596c7…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07A090358-001SUMATRIPTAN SUCCINATEEQ 6MG BASE/0.5ML (EQ 12MG BASE/ML)INJECTABLE / SUBCUTANEOUSAB2011-06-21301d65b070ca…
2024-06-18 03:08 UTC · 5 captures of this ZIP2024-06A090358-001SUMATRIPTAN SUCCINATEEQ 6MG BASE/0.5ML (EQ 12MG BASE/ML)INJECTABLE / SUBCUTANEOUSAB2011-06-211e350fbaab3a…
2024-05-31 18:47 UTC2024-05A090358-001SUMATRIPTAN SUCCINATEEQ 6MG BASE/0.5ML (EQ 12MG BASE/ML)INJECTABLE / SUBCUTANEOUSAB2011-06-218072bd15b7f6…
2022-06-29 02:47 UTC · 2 captures of this ZIP2022-06A090358-001SUMATRIPTAN SUCCINATEEQ 6MG BASE/0.5ML (EQ 12MG BASE/ML)INJECTABLE / SUBCUTANEOUSAB2011-06-215c6f7cd8ea54…
2022-04-08 23:34 UTC2022-04A090358-001SUMATRIPTAN SUCCINATEEQ 6MG BASE/0.5ML (EQ 12MG BASE/ML)INJECTABLE / SUBCUTANEOUSAB2011-06-215d02ea3f76ae…
2022-04-04 05:41 UTC2022-04A090358-001SUMATRIPTAN SUCCINATEEQ 6MG BASE/0.5ML (EQ 12MG BASE/ML)INJECTABLE / SUBCUTANEOUSAB2011-06-214b0b4de00fa7…
2019-12-13 00:20 UTC2019-12A090358-001SUMATRIPTAN SUCCINATEEQ 6MG BASE/0.5ML (EQ 12MG BASE/ML)INJECTABLE / SUBCUTANEOUSAB2011-06-2174a2ff9319b5…
2022-03-09 01:35 UTC2022-03A090358-001SUMATRIPTAN SUCCINATEEQ 6MG BASE/0.5ML (EQ 12MG BASE/ML)INJECTABLE / SUBCUTANEOUSAB2011-06-21bb7c543d1eb4…
2021-12-28 21:50 UTC2021-12A090358-001SUMATRIPTAN SUCCINATEEQ 6MG BASE/0.5ML (EQ 12MG BASE/ML)INJECTABLE / SUBCUTANEOUSAB2011-06-21782e0a99824c…
2021-05-05 16:15 UTC · 3 captures of this ZIP2021-05A090358-001SUMATRIPTAN SUCCINATEEQ 6MG BASE/0.5ML (EQ 12MG BASE/ML)INJECTABLE / SUBCUTANEOUSAB2011-06-2187673890dc5c…
2021-03-12 10:30 UTC2021-03A090358-001SUMATRIPTAN SUCCINATEEQ 6MG BASE/0.5ML (EQ 12MG BASE/ML)INJECTABLE / SUBCUTANEOUSAB2011-06-215aa47cf7b7d7…
2020-12-22 03:56 UTC2020-12A090358-001SUMATRIPTAN SUCCINATEEQ 6MG BASE/0.5ML (EQ 12MG BASE/ML)INJECTABLE / SUBCUTANEOUSAB2011-06-218869cabd3fbd…
2020-11-12 02:37 UTC2020-11A090358-001SUMATRIPTAN SUCCINATEEQ 6MG BASE/0.5ML (EQ 12MG BASE/ML)INJECTABLE / SUBCUTANEOUSAB2011-06-21c0c555d07b60…
2019-12-14 00:12 UTC2019-12A090358-001SUMATRIPTAN SUCCINATEEQ 6MG BASE/0.5ML (EQ 12MG BASE/ML)INJECTABLE / SUBCUTANEOUSAB2011-06-213f01610625f2…
2019-09-15 20:21 UTC2019-09A090358-001SUMATRIPTAN SUCCINATEEQ 6MG BASE/0.5ML (EQ 12MG BASE/ML)INJECTABLE / SUBCUTANEOUSAB2011-06-21b00525d2431f…
2019-07-19 19:46 UTC2019-07A090358-001SUMATRIPTAN SUCCINATEEQ 6MG BASE/0.5ML (EQ 12MG BASE/ML)INJECTABLE / SUBCUTANEOUSAB2011-06-21ea99ee380514…
2024-03-16 18:09 UTC · 4 captures of this ZIP2024-03A090358-001SUMATRIPTAN SUCCINATEEQ 6MG BASE/0.5ML (EQ 12MG BASE/ML)INJECTABLE / SUBCUTANEOUSAB2011-06-216a51e52b5d6a…
2024-02-18 07:12 UTC2024-02A090358-001SUMATRIPTAN SUCCINATEEQ 6MG BASE/0.5ML (EQ 12MG BASE/ML)INJECTABLE / SUBCUTANEOUSAB2011-06-211c564ffb4f44…
2023-12-20 04:57 UTC2023-12A090358-001SUMATRIPTAN SUCCINATEEQ 6MG BASE/0.5ML (EQ 12MG BASE/ML)INJECTABLE / SUBCUTANEOUSAB2011-06-21ea1830bbd6c7…
2023-11-28 05:40 UTC · 2 captures of this ZIP2023-11A090358-001SUMATRIPTAN SUCCINATEEQ 6MG BASE/0.5ML (EQ 12MG BASE/ML)INJECTABLE / SUBCUTANEOUSAB2011-06-21a72a2bbeb626…
2023-10-25 00:34 UTC · 2 captures of this ZIP2023-10A090358-001SUMATRIPTAN SUCCINATEEQ 6MG BASE/0.5ML (EQ 12MG BASE/ML)INJECTABLE / SUBCUTANEOUSAB2011-06-219b2671bbb829…
2023-07-15 15:27 UTC · 2 captures of this ZIP2023-07A090358-001SUMATRIPTAN SUCCINATEEQ 6MG BASE/0.5ML (EQ 12MG BASE/ML)INJECTABLE / SUBCUTANEOUSAB2011-06-21a67488948f0b…
2023-06-13 01:57 UTC · 3 captures of this ZIP2023-06A090358-001SUMATRIPTAN SUCCINATEEQ 6MG BASE/0.5ML (EQ 12MG BASE/ML)INJECTABLE / SUBCUTANEOUSAB2011-06-213f0d92c62455…
2023-05-13 08:27 UTC2023-05A090358-001SUMATRIPTAN SUCCINATEEQ 6MG BASE/0.5ML (EQ 12MG BASE/ML)INJECTABLE / SUBCUTANEOUSAB2011-06-21053a50430f4f…
2023-01-26 05:58 UTC2023-01A090358-001SUMATRIPTAN SUCCINATEEQ 6MG BASE/0.5ML (EQ 12MG BASE/ML)INJECTABLE / SUBCUTANEOUSAB2011-06-213bdfa0b2c4d7…
2022-11-12 20:34 UTC · 5 captures of this ZIP2022-11A090358-001SUMATRIPTAN SUCCINATEEQ 6MG BASE/0.5ML (EQ 12MG BASE/ML)INJECTABLE / SUBCUTANEOUSAB2011-06-213a93d1ddd44b…
2022-10-28 04:53 UTC2022-10A090358-001SUMATRIPTAN SUCCINATEEQ 6MG BASE/0.5ML (EQ 12MG BASE/ML)INJECTABLE / SUBCUTANEOUSAB2011-06-21f41ea6bd6efb…
2022-09-29 23:25 UTC2022-09A090358-001SUMATRIPTAN SUCCINATEEQ 6MG BASE/0.5ML (EQ 12MG BASE/ML)INJECTABLE / SUBCUTANEOUSAB2011-06-21e64feba35796…

Observed Orange Book normalized TE history#

Captured, Edition, Application-product table
CapturedEditionApplication-productTE codeOrderSource SHA-256
2026-08-18 06:07:402026-07A090358-001AB1caaa826d4ba7…
2026-02-19 14:30 UTC2026-02A090358-001AB1011fe1cb6892…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A090358-001AB131067a03dcf5…
2025-08-23 18:47 UTC2025-08A090358-001AB16a471c1ec25d…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A090358-001AB15bbf6a4d5a75…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A090358-001AB1d8e5a09893c0…
2024-10-29 15:01 UTC2024-10A090358-001AB1d06236e962d9…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08A090358-001AB179d66fd596c7…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07A090358-001AB1301d65b070ca…
2024-06-18 03:08 UTC · 5 captures of this ZIP2024-06A090358-001AB11e350fbaab3a…
2024-05-31 18:47 UTC2024-05A090358-001AB18072bd15b7f6…
2022-06-29 02:47 UTC · 2 captures of this ZIP2022-06A090358-001AB15c6f7cd8ea54…
2022-04-08 23:34 UTC2022-04A090358-001AB15d02ea3f76ae…
2022-04-04 05:41 UTC2022-04A090358-001AB14b0b4de00fa7…
2019-12-13 00:20 UTC2019-12A090358-001AB174a2ff9319b5…
2022-03-09 01:35 UTC2022-03A090358-001AB1bb7c543d1eb4…
2021-12-28 21:50 UTC2021-12A090358-001AB1782e0a99824c…
2021-05-05 16:15 UTC · 3 captures of this ZIP2021-05A090358-001AB187673890dc5c…
2021-03-12 10:30 UTC2021-03A090358-001AB15aa47cf7b7d7…
2020-12-22 03:56 UTC2020-12A090358-001AB18869cabd3fbd…
2020-11-12 02:37 UTC2020-11A090358-001AB1c0c555d07b60…
2019-12-14 00:12 UTC2019-12A090358-001AB13f01610625f2…
2019-09-15 20:21 UTC2019-09A090358-001AB1b00525d2431f…
2019-07-19 19:46 UTC2019-07A090358-001AB1ea99ee380514…
2024-03-16 18:09 UTC · 4 captures of this ZIP2024-03A090358-001AB16a51e52b5d6a…
2024-02-18 07:12 UTC2024-02A090358-001AB11c564ffb4f44…
2023-12-20 04:57 UTC2023-12A090358-001AB1ea1830bbd6c7…
2023-11-28 05:40 UTC · 2 captures of this ZIP2023-11A090358-001AB1a72a2bbeb626…
2023-10-25 00:34 UTC · 2 captures of this ZIP2023-10A090358-001AB19b2671bbb829…
2023-07-15 15:27 UTC · 2 captures of this ZIP2023-07A090358-001AB1a67488948f0b…
2023-06-13 01:57 UTC · 3 captures of this ZIP2023-06A090358-001AB13f0d92c62455…
2023-05-13 08:27 UTC2023-05A090358-001AB1053a50430f4f…
2023-01-26 05:58 UTC2023-01A090358-001AB13bdfa0b2c4d7…
2022-11-12 20:34 UTC · 5 captures of this ZIP2022-11A090358-001AB13a93d1ddd44b…
2022-10-28 04:53 UTC2022-10A090358-001AB1f41ea6bd6efb…
2022-09-29 23:25 UTC2022-09A090358-001AB1e64feba35796…
2022-07-09 03:26 UTC · 3 captures of this ZIP2022-07A090358-001AB1cb3db0bc1861…
2026-07-26 02:55 UTC · 3 captures of this ZIP2026-06A090358-001AB1a50c72e98297…

Additional Listing Data#

Finished product
Yes
Brand name base
Sumatriptan Succinate
Listing expiration
2027-12-31

Active Ingredients#

Ingredient, Strength table
IngredientStrength
SUMATRIPTAN SUCCINATE6 mg/.5mL

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
1657151Internal RxNorm lookup

Harmonized SPL set identifiers#

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

Identifier, FDA.report destination table
IdentifierFDA.report destination
f235152e-dd8d-4679-9d9f-404fe5ff4fbaAvailable 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
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
47335-276-40Sumatriptan Succinate0.5 mL in 1 SYRINGEINJECTION0.517
47335-276-40Sumatriptan Succinate1 in 1 PACKAGEINJECTION117
47335-276-41Sumatriptan Succinate2 in 1 PACKAGEINJECTION217
47335-276-41Sumatriptan Succinate0.5 mL in 1 SYRINGEINJECTION0.517

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
47335-276-40ML - Milliliter47335-276a770d22f-eefd-4419-897c-795c667a356612025-10-14
47335-276-41ML - Milliliter47335-276e6229381-61c9-45b8-a3a5-3b6df0ee728312012-07-24

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIIDailyMed labelSPL versionUploaded
SUMATRIPTAN SUCCINATEACTIVE INGREDIENTJ8BDZ68989SUMATRIPTAN SUCCINATE INJECTION [SUN PHARMA GLOBAL FZE]10
SUMATRIPTANACTIVE MOIETY8R78F6L9VOSUMATRIPTAN SUCCINATE INJECTION [SUN PHARMA GLOBAL FZE]10
SODIUM CHLORIDEINACTIVE INGREDIENT451W47IQ8XSUMATRIPTAN SUCCINATE INJECTION [SUN PHARMA GLOBAL FZE]10
WATERINACTIVE INGREDIENT059QF0KO0RSUMATRIPTAN SUCCINATE INJECTION [SUN PHARMA GLOBAL FZE]10

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
47335-276SUMATRIPTAN SUCCINATE INJECTION [SUN PHARMACEUTICAL INDUSTRIES, INC.]15Current NDC, Legacy NDC, 4 package rows20220402_f235152e-dd8d-4679-9d9f-404fe5ff4fba.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 SUCCINATESun Pharmaceutical Industries, Inc.f235152e-dd8d-4679-9d9f-404fe5ff4fba2026-01-08Warnings, Adverse reactionsExact identifier
application applno (ANDA): 090358
application number: ANDA090358
ndc (product): 47335-276

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
1657151SUMAtriptan 6 MG in 0.5 ML Auto-InjectorPSNf235152e-dd8d-4679-9d9f-404fe5ff4fba17
16571510.5 ML sumatriptan 12 MG/ML Auto-InjectorSCDf235152e-dd8d-4679-9d9f-404fe5ff4fba17
1657151sumatriptan (as sumatriptan succinate) 6 MG per 0.5 ML Auto-InjectorSYf235152e-dd8d-4679-9d9f-404fe5ff4fba17

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
47335-276-40473350276401 SYRINGE in 1 PACKAGE (47335-276-40) / .5 mL in 1 SYRINGE1 syringe2025-08-200000-00-00NoNoCurrent
47335-276-41473350276412 SYRINGE in 1 PACKAGE (47335-276-41) / .5 mL in 1 SYRINGE2 syringe2025-08-200000-00-00NoNoCurrent