Sumatriptan Succinate

Product NDC
43598-768
11-digit product format
435980768
Labeler code
43598
Product ID
43598-768_d0cf8002-71d2-7e4b-f04e-0120cc95dc1a
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Sumatriptan Succinate
Dosage form
INJECTION
Route
SUBCUTANEOUS
Labeler
Dr. Reddy�s Laboratories Inc.,
Application
ANDA090495
Marketing category
ANDA
Marketing start
2023-04-20
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
A090495-001SUMATRIPTAN SUCCINATESUMATRIPTAN SUCCINATEEQ 6MG BASE/0.5ML (EQ 12MG BASE/ML)INJECTABLE / SUBCUTANEOUSAB2014-01-29

Therapeutic equivalence codes#

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

Application-product, TE code table
Application-productTE code
A090495-001AB

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 06:07:402026-07A090495-001SUMATRIPTAN SUCCINATEEQ 6MG BASE/0.5ML (EQ 12MG BASE/ML)INJECTABLE / SUBCUTANEOUSAB2014-01-29caaa826d4ba7…
2026-02-19 14:30 UTC2026-02A090495-001SUMATRIPTAN SUCCINATEEQ 6MG BASE/0.5ML (EQ 12MG BASE/ML)INJECTABLE / SUBCUTANEOUSAB2014-01-29011fe1cb6892…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A090495-001SUMATRIPTAN SUCCINATEEQ 6MG BASE/0.5ML (EQ 12MG BASE/ML)INJECTABLE / SUBCUTANEOUSAB2014-01-2931067a03dcf5…
2025-08-23 18:47 UTC2025-08A090495-001SUMATRIPTAN SUCCINATEEQ 6MG BASE/0.5ML (EQ 12MG BASE/ML)INJECTABLE / SUBCUTANEOUSAB2014-01-296a471c1ec25d…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A090495-001SUMATRIPTAN SUCCINATEEQ 6MG BASE/0.5ML (EQ 12MG BASE/ML)INJECTABLE / SUBCUTANEOUSAB2014-01-29fd3edfee7708…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A090495-001SUMATRIPTAN SUCCINATEEQ 6MG BASE/0.5ML (EQ 12MG BASE/ML)INJECTABLE / SUBCUTANEOUSAB2014-01-29b8a1b40f171c…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A090495-001SUMATRIPTAN SUCCINATEEQ 6MG BASE/0.5ML (EQ 12MG BASE/ML)INJECTABLE / SUBCUTANEOUSAB2014-01-2903ed91905a0d…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A090495-001SUMATRIPTAN SUCCINATEEQ 6MG BASE/0.5ML (EQ 12MG BASE/ML)INJECTABLE / SUBCUTANEOUSAB2014-01-292680178bc6a6…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A090495-001SUMATRIPTAN SUCCINATEEQ 6MG BASE/0.5ML (EQ 12MG BASE/ML)INJECTABLE / SUBCUTANEOUSAB2014-01-295bbf6a4d5a75…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A090495-001SUMATRIPTAN SUCCINATEEQ 6MG BASE/0.5ML (EQ 12MG BASE/ML)INJECTABLE / SUBCUTANEOUSAB2014-01-29d8e5a09893c0…
2024-10-29 15:01 UTC2024-10A090495-001SUMATRIPTAN SUCCINATEEQ 6MG BASE/0.5ML (EQ 12MG BASE/ML)INJECTABLE / SUBCUTANEOUSAB2014-01-29d06236e962d9…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08A090495-001SUMATRIPTAN SUCCINATEEQ 6MG BASE/0.5ML (EQ 12MG BASE/ML)INJECTABLE / SUBCUTANEOUSAB2014-01-2979d66fd596c7…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07A090495-001SUMATRIPTAN SUCCINATEEQ 6MG BASE/0.5ML (EQ 12MG BASE/ML)INJECTABLE / SUBCUTANEOUSAB2014-01-29301d65b070ca…
2024-06-18 03:08 UTC · 5 captures of this ZIP2024-06A090495-001SUMATRIPTAN SUCCINATEEQ 6MG BASE/0.5ML (EQ 12MG BASE/ML)INJECTABLE / SUBCUTANEOUSAB2014-01-291e350fbaab3a…
2024-05-31 18:47 UTC2024-05A090495-001SUMATRIPTAN SUCCINATEEQ 6MG BASE/0.5ML (EQ 12MG BASE/ML)INJECTABLE / SUBCUTANEOUSAB2014-01-298072bd15b7f6…
2022-06-29 02:47 UTC · 2 captures of this ZIP2022-06A090495-001SUMATRIPTAN SUCCINATEEQ 6MG BASE/0.5ML (EQ 12MG BASE/ML)INJECTABLE / SUBCUTANEOUSAB2014-01-295c6f7cd8ea54…
2022-04-08 23:34 UTC2022-04A090495-001SUMATRIPTAN SUCCINATEEQ 6MG BASE/0.5ML (EQ 12MG BASE/ML)INJECTABLE / SUBCUTANEOUSAB2014-01-295d02ea3f76ae…
2022-04-04 05:41 UTC2022-04A090495-001SUMATRIPTAN SUCCINATEEQ 6MG BASE/0.5ML (EQ 12MG BASE/ML)INJECTABLE / SUBCUTANEOUSAB2014-01-294b0b4de00fa7…
2019-12-13 00:20 UTC2019-12A090495-001SUMATRIPTAN SUCCINATEEQ 6MG BASE/0.5ML (EQ 12MG BASE/ML)INJECTABLE / SUBCUTANEOUSAB2014-01-2974a2ff9319b5…
2022-03-09 01:35 UTC2022-03A090495-001SUMATRIPTAN SUCCINATEEQ 6MG BASE/0.5ML (EQ 12MG BASE/ML)INJECTABLE / SUBCUTANEOUSAB2014-01-29bb7c543d1eb4…
2021-12-28 21:50 UTC2021-12A090495-001SUMATRIPTAN SUCCINATEEQ 6MG BASE/0.5ML (EQ 12MG BASE/ML)INJECTABLE / SUBCUTANEOUSAB2014-01-29782e0a99824c…
2021-05-05 16:15 UTC · 3 captures of this ZIP2021-05A090495-001SUMATRIPTAN SUCCINATEEQ 6MG BASE/0.5ML (EQ 12MG BASE/ML)INJECTABLE / SUBCUTANEOUSAB2014-01-2987673890dc5c…
2021-03-12 10:30 UTC2021-03A090495-001SUMATRIPTAN SUCCINATEEQ 6MG BASE/0.5ML (EQ 12MG BASE/ML)INJECTABLE / SUBCUTANEOUSAB2014-01-295aa47cf7b7d7…
2020-12-22 03:56 UTC2020-12A090495-001SUMATRIPTAN SUCCINATEEQ 6MG BASE/0.5ML (EQ 12MG BASE/ML)INJECTABLE / SUBCUTANEOUSAB2014-01-298869cabd3fbd…
2020-11-12 02:37 UTC2020-11A090495-001SUMATRIPTAN SUCCINATEEQ 6MG BASE/0.5ML (EQ 12MG BASE/ML)INJECTABLE / SUBCUTANEOUSAB2014-01-29c0c555d07b60…
2019-12-14 00:12 UTC2019-12A090495-001SUMATRIPTAN SUCCINATEEQ 6MG BASE/0.5ML (EQ 12MG BASE/ML)INJECTABLE / SUBCUTANEOUSAB2014-01-293f01610625f2…
2019-09-15 20:21 UTC2019-09A090495-001SUMATRIPTAN SUCCINATEEQ 6MG BASE/0.5ML (EQ 12MG BASE/ML)INJECTABLE / SUBCUTANEOUSAB2014-01-29b00525d2431f…
2019-07-19 19:46 UTC2019-07A090495-001SUMATRIPTAN SUCCINATEEQ 6MG BASE/0.5ML (EQ 12MG BASE/ML)INJECTABLE / SUBCUTANEOUSAB2014-01-29ea99ee380514…
2024-03-16 18:09 UTC · 4 captures of this ZIP2024-03A090495-001SUMATRIPTAN SUCCINATEEQ 6MG BASE/0.5ML (EQ 12MG BASE/ML)INJECTABLE / SUBCUTANEOUSAB2014-01-296a51e52b5d6a…
2024-02-18 07:12 UTC2024-02A090495-001SUMATRIPTAN SUCCINATEEQ 6MG BASE/0.5ML (EQ 12MG BASE/ML)INJECTABLE / SUBCUTANEOUSAB2014-01-291c564ffb4f44…
2023-12-20 04:57 UTC2023-12A090495-001SUMATRIPTAN SUCCINATEEQ 6MG BASE/0.5ML (EQ 12MG BASE/ML)INJECTABLE / SUBCUTANEOUSAB2014-01-29ea1830bbd6c7…
2023-11-28 05:40 UTC · 2 captures of this ZIP2023-11A090495-001SUMATRIPTAN SUCCINATEEQ 6MG BASE/0.5ML (EQ 12MG BASE/ML)INJECTABLE / SUBCUTANEOUSAB2014-01-29a72a2bbeb626…
2023-10-25 00:34 UTC · 2 captures of this ZIP2023-10A090495-001SUMATRIPTAN SUCCINATEEQ 6MG BASE/0.5ML (EQ 12MG BASE/ML)INJECTABLE / SUBCUTANEOUSAB2014-01-299b2671bbb829…
2023-07-15 15:27 UTC · 2 captures of this ZIP2023-07A090495-001SUMATRIPTAN SUCCINATEEQ 6MG BASE/0.5ML (EQ 12MG BASE/ML)INJECTABLE / SUBCUTANEOUSAB2014-01-29a67488948f0b…
2023-06-13 01:57 UTC · 3 captures of this ZIP2023-06A090495-001SUMATRIPTAN SUCCINATEEQ 6MG BASE/0.5ML (EQ 12MG BASE/ML)INJECTABLE / SUBCUTANEOUSAB2014-01-293f0d92c62455…
2023-05-13 08:27 UTC2023-05A090495-001SUMATRIPTAN SUCCINATEEQ 6MG BASE/0.5ML (EQ 12MG BASE/ML)INJECTABLE / SUBCUTANEOUSAB2014-01-29053a50430f4f…
2023-01-26 05:58 UTC2023-01A090495-001SUMATRIPTAN SUCCINATEEQ 6MG BASE/0.5ML (EQ 12MG BASE/ML)INJECTABLE / SUBCUTANEOUSAB2014-01-293bdfa0b2c4d7…
2022-11-12 20:34 UTC · 5 captures of this ZIP2022-11A090495-001SUMATRIPTAN SUCCINATEEQ 6MG BASE/0.5ML (EQ 12MG BASE/ML)INJECTABLE / SUBCUTANEOUSAB2014-01-293a93d1ddd44b…
2022-10-28 04:53 UTC2022-10A090495-001SUMATRIPTAN SUCCINATEEQ 6MG BASE/0.5ML (EQ 12MG BASE/ML)INJECTABLE / SUBCUTANEOUSAB2014-01-29f41ea6bd6efb…
2022-09-29 23:25 UTC2022-09A090495-001SUMATRIPTAN SUCCINATEEQ 6MG BASE/0.5ML (EQ 12MG BASE/ML)INJECTABLE / SUBCUTANEOUSAB2014-01-29e64feba35796…

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
2026-08-18 06:07:402026-07A090495-001AB1caaa826d4ba7…
2026-02-19 14:30 UTC2026-02A090495-001AB1011fe1cb6892…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A090495-001AB131067a03dcf5…
2025-08-23 18:47 UTC2025-08A090495-001AB16a471c1ec25d…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A090495-001AB1fd3edfee7708…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A090495-001AB1b8a1b40f171c…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A090495-001AB103ed91905a0d…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A090495-001AB12680178bc6a6…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A090495-001AB15bbf6a4d5a75…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A090495-001AB1d8e5a09893c0…
2024-10-29 15:01 UTC2024-10A090495-001AB1d06236e962d9…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08A090495-001AB179d66fd596c7…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07A090495-001AB1301d65b070ca…
2024-06-18 03:08 UTC · 5 captures of this ZIP2024-06A090495-001AB11e350fbaab3a…
2024-05-31 18:47 UTC2024-05A090495-001AB18072bd15b7f6…
2022-06-29 02:47 UTC · 2 captures of this ZIP2022-06A090495-001AB15c6f7cd8ea54…
2022-04-08 23:34 UTC2022-04A090495-001AB15d02ea3f76ae…
2022-04-04 05:41 UTC2022-04A090495-001AB14b0b4de00fa7…
2019-12-13 00:20 UTC2019-12A090495-001AB174a2ff9319b5…
2022-03-09 01:35 UTC2022-03A090495-001AB1bb7c543d1eb4…
2021-12-28 21:50 UTC2021-12A090495-001AB1782e0a99824c…
2021-05-05 16:15 UTC · 3 captures of this ZIP2021-05A090495-001AB187673890dc5c…
2021-03-12 10:30 UTC2021-03A090495-001AB15aa47cf7b7d7…
2020-12-22 03:56 UTC2020-12A090495-001AB18869cabd3fbd…
2020-11-12 02:37 UTC2020-11A090495-001AB1c0c555d07b60…
2019-12-14 00:12 UTC2019-12A090495-001AB13f01610625f2…
2019-09-15 20:21 UTC2019-09A090495-001AB1b00525d2431f…
2019-07-19 19:46 UTC2019-07A090495-001AB1ea99ee380514…
2024-03-16 18:09 UTC · 4 captures of this ZIP2024-03A090495-001AB16a51e52b5d6a…
2024-02-18 07:12 UTC2024-02A090495-001AB11c564ffb4f44…
2023-12-20 04:57 UTC2023-12A090495-001AB1ea1830bbd6c7…
2023-11-28 05:40 UTC · 2 captures of this ZIP2023-11A090495-001AB1a72a2bbeb626…
2023-10-25 00:34 UTC · 2 captures of this ZIP2023-10A090495-001AB19b2671bbb829…
2023-07-15 15:27 UTC · 2 captures of this ZIP2023-07A090495-001AB1a67488948f0b…
2023-06-13 01:57 UTC · 3 captures of this ZIP2023-06A090495-001AB13f0d92c62455…
2023-05-13 08:27 UTC2023-05A090495-001AB1053a50430f4f…
2023-01-26 05:58 UTC2023-01A090495-001AB13bdfa0b2c4d7…
2022-11-12 20:34 UTC · 5 captures of this ZIP2022-11A090495-001AB13a93d1ddd44b…
2022-10-28 04:53 UTC2022-10A090495-001AB1f41ea6bd6efb…
2022-09-29 23:25 UTC2022-09A090495-001AB1e64feba35796…

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
8fef1176-7a38-eca3-22ca-83efe5ca6620Available 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
43598-768-11Sumatriptan Succinate0.5 mL in 1 SYRINGEINJECTION0.53
43598-768-23Sumatriptan Succinate2 in 1 CARTONINJECTION23

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
43598-768-11ML - Milliliter43598-7680fa2a1ac-4243-47be-b001-cb950111a5d012023-07-06
43598-768-23ML - Milliliter43598-7685162f6d8-e571-43fb-b078-c0313a182edc12023-06-06

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
43598-768SUMATRIPTAN SUCCINATE INJECTION [DR. REDDY’S LABORATORIES INC.,]2Current NDC, 2 package rows20240802_8fef1176-7a38-eca3-22ca-83efe5ca6620.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 · 4 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
Sumatriptan SuccinateSUMATRIPTAN SUCCINATESportpharm LLC7d3602a1-1cd5-41c2-a0a3-3d20e90a92fa2026-07-09Warnings, Adverse reactionsExact identifier
application applno (ANDA): 090495
application number: ANDA090495
Sumatriptan SuccinateSUMATRIPTAN SUCCINATEDr. Reddys Laboratories Inc.,8fef1176-7a38-eca3-22ca-83efe5ca66202026-01-21Warnings, Adverse reactionsExact identifier
application applno (ANDA): 090495
application number: ANDA090495
ndc (product): 43598-768
Sumatriptan SuccinateSUMATRIPTAN SUCCINATENorthStar Rx LLC38fd19bf-b7aa-812c-8a74-2414dfec45f42023-03-01Warnings, Adverse reactionsExact identifier
application applno (ANDA): 090495
application number: ANDA090495
Sumatriptan SuccinateSUMATRIPTAN SUCCINATEDr. Reddy's Laboratories Limited4e26764d-ce26-e5ac-e6db-0f1f7a1d5c2b2021-12-21Warnings, Adverse reactionsExact identifier
application applno (ANDA): 090495
application number: ANDA090495

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
1657151SUMAtriptan 6 MG in 0.5 ML Auto-InjectorPSN8fef1176-7a38-eca3-22ca-83efe5ca66203
16571510.5 ML sumatriptan 12 MG/ML Auto-InjectorSCD8fef1176-7a38-eca3-22ca-83efe5ca66203
1657151sumatriptan (as sumatriptan succinate) 6 MG per 0.5 ML Auto-InjectorSY8fef1176-7a38-eca3-22ca-83efe5ca66203

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startSampleExclude flagStatus
43598-768-11435980768110.5 mL in 1 SYRINGE0.5 mlHistorical
43598-768-23435980768232 SYRINGE in 1 CARTON (43598-768-23) / .5 mL in 1 SYRINGE (43598-768-11) 2 syringe2023-04-20NoNoCurrent