Sumatriptan Succinate

Product NDC
35356-439
11-digit product format
353560439
Labeler code
35356
Product ID
35356-439_fdf5e827-a5c9-49f6-b673-79ae2d15c54c
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Sumatriptan Succinate
Dosage form
TABLET
Route
ORAL
Labeler
Quality Care Products, LLC
Application
ANDA076847
Marketing category
ANDA
Marketing start
2009-11-17
Marketing end
0000-00-00
Substance
SUMATRIPTAN SUCCINATE
Active strength
50 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
2023-12-31
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 · 3 matching rows.

Dataset, Scope, Product NDC table
DatasetScopeProduct NDCPackage NDCCodeStatusReporting periodSource date
excluded productproduct35356-439DDiscontinued by firm2026-08-07
excluded packagepackage35356-43935356-439-09DDiscontinued by firm2026-08-07
excluded packagepackage35356-43935356-439-36DDiscontinued by firm2026-08-07

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 · 14 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 packagepackage35356-439-36d630ba8d3edf…732f749b63fb…
2025-12-14 17:58 UTC · source 2025-12-05excluded packagepackage35356-439-09d630ba8d3edf…732f749b63fb…
2025-08-27 00:01 UTC · source 2025-08-26excluded packagepackage35356-439-09f5e01cc5f278…a2eaf40c39c3…
2025-04-01 02:39 UTC · source 2025-03-31excluded packagepackage35356-439-092ef7874e63bc…57b86245f4fa…
2025-03-28 20:22 UTC · source 2025-03-28excluded packagepackage35356-439-09a1b67e2a42f9…c4cf2c586c0d…
2025-03-22 03:12 UTC · source 2025-03-21excluded packagepackage35356-439-09cfe11265f3b6…090c488252e2…
2025-03-10 12:48 UTC · source 2025-03-10excluded packagepackage35356-439-09cdf11ea48f46…ba0047e9e063…
2025-02-02 03:52 UTC · source 2025-01-31excluded packagepackage35356-439-09302b2466d912…e7b80fea0513…
2025-01-20 13:05 UTC · source 2025-01-20excluded packagepackage35356-439-09ed331223b511…672a5bd82f5f…
2025-01-11 03:41 UTC · source 2025-01-10excluded packagepackage35356-439-090efc9e666f02…f202fb6c5f17…
2024-11-09 02:27 UTC · source 2024-11-08excluded packagepackage35356-439-09ad56d346431e…cc804d4bbf1e…
2024-10-04 04:10 UTC · source 2024-10-03excluded packagepackage35356-439-09367a005e9d99…383a685ebd0f…
2024-07-10 04:00 UTC · source 2024-07-09excluded packagepackage35356-439-09557ba5c1ecfa…9c80585c8c6e…

Source provenance: Browse the complete Orange Book source catalog · source snapshot 1.

Orange Book products#

Current product rows page 1 of 1 · 3 matching rows.

Application-product, Trade name, Ingredient table
Application-productTrade nameIngredientStrengthDosage form / routeTE codesRLD / RSApproval date
A076847-001SUMATRIPTAN SUCCINATESUMATRIPTAN SUCCINATEEQ 25MG BASETABLET / ORALAB2009-08-10
A076847-002SUMATRIPTAN SUCCINATESUMATRIPTAN SUCCINATEEQ 50MG BASETABLET / ORALAB2009-08-10
A076847-003SUMATRIPTAN SUCCINATESUMATRIPTAN SUCCINATEEQ 100MG BASETABLET / ORALAB2009-08-10

Therapeutic equivalence codes#

Current TE-code rows page 1 of 1 · 3 matching rows.

Application-product, TE code table
Application-productTE code
A076847-001AB
A076847-002AB
A076847-003AB

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 4 · 123 observed states.

Captured, Edition, Application-product table
CapturedEditionApplication-productTrade nameStrengthDosage form / routeProduct TE source textRLD / RSApproval dateSource SHA-256
2026-02-19 14:30 UTC2026-02A076847-001SUMATRIPTAN SUCCINATEEQ 25MG BASETABLET / ORALAB2009-08-10011fe1cb6892…
2026-02-19 14:30 UTC2026-02A076847-002SUMATRIPTAN SUCCINATEEQ 50MG BASETABLET / ORALAB2009-08-10011fe1cb6892…
2026-02-19 14:30 UTC2026-02A076847-003SUMATRIPTAN SUCCINATEEQ 100MG BASETABLET / ORALAB2009-08-10011fe1cb6892…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A076847-001SUMATRIPTAN SUCCINATEEQ 25MG BASETABLET / ORALAB2009-08-1031067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A076847-002SUMATRIPTAN SUCCINATEEQ 50MG BASETABLET / ORALAB2009-08-1031067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A076847-003SUMATRIPTAN SUCCINATEEQ 100MG BASETABLET / ORALAB2009-08-1031067a03dcf5…
2025-08-23 18:47 UTC2025-08A076847-001SUMATRIPTAN SUCCINATEEQ 25MG BASETABLET / ORALAB2009-08-106a471c1ec25d…
2025-08-23 18:47 UTC2025-08A076847-002SUMATRIPTAN SUCCINATEEQ 50MG BASETABLET / ORALAB2009-08-106a471c1ec25d…
2025-08-23 18:47 UTC2025-08A076847-003SUMATRIPTAN SUCCINATEEQ 100MG BASETABLET / ORALAB2009-08-106a471c1ec25d…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A076847-001SUMATRIPTAN SUCCINATEEQ 25MG BASETABLET / ORALAB2009-08-10fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A076847-002SUMATRIPTAN SUCCINATEEQ 50MG BASETABLET / ORALAB2009-08-10fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A076847-003SUMATRIPTAN SUCCINATEEQ 100MG BASETABLET / ORALAB2009-08-10fd3edfee7708…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A076847-001SUMATRIPTAN SUCCINATEEQ 25MG BASETABLET / ORALAB2009-08-10b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A076847-002SUMATRIPTAN SUCCINATEEQ 50MG BASETABLET / ORALAB2009-08-10b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A076847-003SUMATRIPTAN SUCCINATEEQ 100MG BASETABLET / ORALAB2009-08-10b8a1b40f171c…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A076847-001SUMATRIPTAN SUCCINATEEQ 25MG BASETABLET / ORALAB2009-08-1003ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A076847-002SUMATRIPTAN SUCCINATEEQ 50MG BASETABLET / ORALAB2009-08-1003ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A076847-003SUMATRIPTAN SUCCINATEEQ 100MG BASETABLET / ORALAB2009-08-1003ed91905a0d…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A076847-001SUMATRIPTAN SUCCINATEEQ 25MG BASETABLET / ORALAB2009-08-102680178bc6a6…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A076847-002SUMATRIPTAN SUCCINATEEQ 50MG BASETABLET / ORALAB2009-08-102680178bc6a6…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A076847-003SUMATRIPTAN SUCCINATEEQ 100MG BASETABLET / ORALAB2009-08-102680178bc6a6…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A076847-001SUMATRIPTAN SUCCINATEEQ 25MG BASETABLET / ORALAB2009-08-105bbf6a4d5a75…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A076847-002SUMATRIPTAN SUCCINATEEQ 50MG BASETABLET / ORALAB2009-08-105bbf6a4d5a75…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A076847-003SUMATRIPTAN SUCCINATEEQ 100MG BASETABLET / ORALAB2009-08-105bbf6a4d5a75…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A076847-001SUMATRIPTAN SUCCINATEEQ 25MG BASETABLET / ORALAB2009-08-10d8e5a09893c0…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A076847-002SUMATRIPTAN SUCCINATEEQ 50MG BASETABLET / ORALAB2009-08-10d8e5a09893c0…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A076847-003SUMATRIPTAN SUCCINATEEQ 100MG BASETABLET / ORALAB2009-08-10d8e5a09893c0…
2024-10-29 15:01 UTC2024-10A076847-001SUMATRIPTAN SUCCINATEEQ 25MG BASETABLET / ORALAB2009-08-10d06236e962d9…
2024-10-29 15:01 UTC2024-10A076847-002SUMATRIPTAN SUCCINATEEQ 50MG BASETABLET / ORALAB2009-08-10d06236e962d9…
2024-10-29 15:01 UTC2024-10A076847-003SUMATRIPTAN SUCCINATEEQ 100MG BASETABLET / ORALAB2009-08-10d06236e962d9…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08A076847-001SUMATRIPTAN SUCCINATEEQ 25MG BASETABLET / ORALAB2009-08-1079d66fd596c7…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08A076847-002SUMATRIPTAN SUCCINATEEQ 50MG BASETABLET / ORALAB2009-08-1079d66fd596c7…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08A076847-003SUMATRIPTAN SUCCINATEEQ 100MG BASETABLET / ORALAB2009-08-1079d66fd596c7…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07A076847-001SUMATRIPTAN SUCCINATEEQ 25MG BASETABLET / ORALAB2009-08-10301d65b070ca…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07A076847-002SUMATRIPTAN SUCCINATEEQ 50MG BASETABLET / ORALAB2009-08-10301d65b070ca…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07A076847-003SUMATRIPTAN SUCCINATEEQ 100MG BASETABLET / ORALAB2009-08-10301d65b070ca…
2024-06-18 03:08 UTC · 5 captures of this ZIP2024-06A076847-001SUMATRIPTAN SUCCINATEEQ 25MG BASETABLET / ORALAB2009-08-101e350fbaab3a…
2024-06-18 03:08 UTC · 5 captures of this ZIP2024-06A076847-002SUMATRIPTAN SUCCINATEEQ 50MG BASETABLET / ORALAB2009-08-101e350fbaab3a…
2024-06-18 03:08 UTC · 5 captures of this ZIP2024-06A076847-003SUMATRIPTAN SUCCINATEEQ 100MG BASETABLET / ORALAB2009-08-101e350fbaab3a…
2024-05-31 18:47 UTC2024-05A076847-001SUMATRIPTAN SUCCINATEEQ 25MG BASETABLET / ORALAB2009-08-108072bd15b7f6…

Observed Orange Book normalized TE history#

Normalized TE history page 1 of 4 · 123 observed states.

Captured, Edition, Application-product table
CapturedEditionApplication-productTE codeOrderSource SHA-256
2026-02-19 14:30 UTC2026-02A076847-001AB1011fe1cb6892…
2026-02-19 14:30 UTC2026-02A076847-002AB1011fe1cb6892…
2026-02-19 14:30 UTC2026-02A076847-003AB1011fe1cb6892…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A076847-001AB131067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A076847-002AB131067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A076847-003AB131067a03dcf5…
2025-08-23 18:47 UTC2025-08A076847-001AB16a471c1ec25d…
2025-08-23 18:47 UTC2025-08A076847-002AB16a471c1ec25d…
2025-08-23 18:47 UTC2025-08A076847-003AB16a471c1ec25d…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A076847-001AB1fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A076847-002AB1fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A076847-003AB1fd3edfee7708…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A076847-001AB1b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A076847-002AB1b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A076847-003AB1b8a1b40f171c…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A076847-001AB103ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A076847-002AB103ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A076847-003AB103ed91905a0d…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A076847-001AB12680178bc6a6…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A076847-002AB12680178bc6a6…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A076847-003AB12680178bc6a6…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A076847-001AB15bbf6a4d5a75…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A076847-002AB15bbf6a4d5a75…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A076847-003AB15bbf6a4d5a75…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A076847-001AB1d8e5a09893c0…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A076847-002AB1d8e5a09893c0…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A076847-003AB1d8e5a09893c0…
2024-10-29 15:01 UTC2024-10A076847-001AB1d06236e962d9…
2024-10-29 15:01 UTC2024-10A076847-002AB1d06236e962d9…
2024-10-29 15:01 UTC2024-10A076847-003AB1d06236e962d9…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08A076847-001AB179d66fd596c7…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08A076847-002AB179d66fd596c7…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08A076847-003AB179d66fd596c7…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07A076847-001AB1301d65b070ca…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07A076847-002AB1301d65b070ca…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07A076847-003AB1301d65b070ca…
2024-06-18 03:08 UTC · 5 captures of this ZIP2024-06A076847-001AB11e350fbaab3a…
2024-06-18 03:08 UTC · 5 captures of this ZIP2024-06A076847-002AB11e350fbaab3a…
2024-06-18 03:08 UTC · 5 captures of this ZIP2024-06A076847-003AB11e350fbaab3a…
2024-05-31 18:47 UTC2024-05A076847-001AB18072bd15b7f6…

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
a62a50ac-1535-4461-9768-8ae703e2e9fbProduct name120210525
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
9514609b-a2a9-f8ec-6ba6-3f8e5ee89877Product name120140508
bc07ef78-e82d-0c19-31f4-31f263780582Product name120140508
f6199b09-e585-7ceb-4b09-803cf5ce1ed1Product name120140508

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
35356-439-09EA - Each35356-43933594ec2-eb98-4ae1-84f4-88d9989fd2f812013-02-13
35356-439-36EA - Each35356-439ab079277-4002-41f6-bbb5-ae4407c2947512022-12-07

DailyMed Socrata Ingredients#

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
35356-439SUMATRIPTAN SUCCINATE TABLET [QUALITY CARE PRODUCTS, LLC]9Legacy NDC20241213_18d69b78-0725-4720-9118-1f106ca360cb.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 · 7 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
Sumatriptan SuccinateSUMATRIPTAN SUCCINATEDr. Reddy's Laboratories Limitedac80d018-6abf-2e41-ddea-90b4ff9e90132026-03-21Warnings, Adverse reactionsExact identifier
application applno (ANDA): 076847
application number: ANDA076847
Sumatriptan SuccinateSUMATRIPTAN SUCCINATENuCare Pharmaceuticals,Inc.7628caf4-5272-4e42-e053-2a91aa0a2f242025-01-08Warnings, Adverse reactionsExact identifier
application applno (ANDA): 076847
application number: ANDA076847
Sumatriptan SuccinateSUMATRIPTAN SUCCINATENuCare Pharmaceuticals,Inc.b297a466-7d24-9ebd-e053-2a95a90af4d12024-07-17Warnings, Adverse reactionsExact identifier
application applno (ANDA): 076847
application number: ANDA076847
Sumatriptan SuccinateSUMATRIPTAN SUCCINATEAsclemed USA, Inc.b16886d0-224b-4d83-85c4-bc3eb3606c172020-10-24Warnings, Adverse reactionsExact identifier
application applno (ANDA): 076847
application number: ANDA076847
Sumatriptan SuccinateSUMATRIPTAN SUCCINATEProficient Rx LP68daf82a-334e-43ca-b4bb-5c66a82f52c82020-02-01Warnings, Adverse reactionsExact identifier
application applno (ANDA): 076847
application number: ANDA076847
Sumatriptan SuccinateSUMATRIPTAN SUCCINATEProficient Rx LP77a41cca-02d2-4b84-975e-d1925f0fca802019-11-01Warnings, Adverse reactionsExact identifier
application applno (ANDA): 076847
application number: ANDA076847
Sumatriptan SuccinateSUMATRIPTAN SUCCINATEProficient Rx LPd9c78ac5-7328-4204-8f66-96606d7db5c32019-11-01Warnings, Adverse reactionsExact identifier
application applno (ANDA): 076847
application number: ANDA076847

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
35356-439-363535604393636 TABLET in 1 BOTTLE (35356-439-36) 36 tablet2022-11-080000-00-00NoNoCurrent