Sumatriptan Succinate

Product NDC
53002-1592
Requested package NDC
53002-1592-9
11-digit product format
530021592
Labeler code
53002
Product ID
53002-1592_e9546a84-769a-424b-9f13-a4c29cc7ed9d
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Sumatriptan Succinate
Dosage form
TABLET
Route
ORAL
Labeler
RPK Pharmaceuticals, Inc.
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 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 · 1 matching rows.

Dataset, Scope, Product NDC table
DatasetScopeProduct NDCPackage NDCCodeStatusReporting periodSource date
excluded packagepackage53002-159253002-1592-9IInactivated by FDA2026-08-03

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 · 10 matching rows.

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

Captured / source date, Code, Status table
Captured / source dateCodeStatusSnapshotSource SHA-256
2025-12-14 17:58 UTC · source 2025-12-05IInactivated by FDAd630ba8d3edf…732f749b63fb…
2025-08-27 00:01 UTC · source 2025-08-26IInactivated by FDAf5e01cc5f278…a2eaf40c39c3…
2025-04-01 02:39 UTC · source 2025-03-31IInactivated by FDA2ef7874e63bc…57b86245f4fa…
2025-03-28 20:22 UTC · source 2025-03-28IInactivated by FDAa1b67e2a42f9…c4cf2c586c0d…
2025-03-22 03:12 UTC · source 2025-03-21IInactivated by FDAcfe11265f3b6…090c488252e2…
2025-03-10 12:48 UTC · source 2025-03-10IInactivated by FDAcdf11ea48f46…ba0047e9e063…
2025-02-02 03:52 UTC · source 2025-01-31UExcluded because listing certification expired302b2466d912…e7b80fea0513…
2025-01-20 13:05 UTC · source 2025-01-20UExcluded because listing certification expireded331223b511…672a5bd82f5f…
2025-01-11 03:41 UTC · source 2025-01-10UExcluded because listing certification expired0efc9e666f02…f202fb6c5f17…
2020-06-10 20:45 UTC · source 2020-06-10EExcluded after deficient or non-compliant submission was not corrected9bebd1f3094a…5416666fcb17…

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
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 Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
53002-1592-9Sumatriptan Succinate9 in 1 CARTONTABLET99
53002-1592-9Sumatriptan Succinate9 in 1 BLISTER PACKTABLET99

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
53002-1592SUMATRIPTAN SUCCINATE (SUMATRIPTAN SUCCINATE ) TABLET [RPK PHARMACEUTICALS, INC.]9Legacy NDC, 2 package rows20230609_d3b61201-fb84-446b-83a6-b72e8e1d6d04.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

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
313160SUMAtriptan succinate 100 MG Oral TabletPSNd3b61201-fb84-446b-83a6-b72e8e1d6d049
315223SUMAtriptan succinate 25 MG Oral TabletPSNd3b61201-fb84-446b-83a6-b72e8e1d6d049
313161SUMAtriptan succinate 50 MG Oral TabletPSNd3b61201-fb84-446b-83a6-b72e8e1d6d049
313160sumatriptan 100 MG Oral TabletSCDd3b61201-fb84-446b-83a6-b72e8e1d6d049
315223sumatriptan 25 MG Oral TabletSCDd3b61201-fb84-446b-83a6-b72e8e1d6d049
313161sumatriptan 50 MG Oral TabletSCDd3b61201-fb84-446b-83a6-b72e8e1d6d049
313160sumatriptan 100 MG (as sumatriptan succinate 140 MG) Oral TabletSYd3b61201-fb84-446b-83a6-b72e8e1d6d049
315223sumatriptan 25 MG (as sumatriptan succinate 35 MG) Oral TabletSYd3b61201-fb84-446b-83a6-b72e8e1d6d049
313161sumatriptan 50 MG (as sumatriptan succinate 70 MG) Oral TabletSYd3b61201-fb84-446b-83a6-b72e8e1d6d049

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
53002-1592-9530021592099 BLISTER PACK in 1 CARTON (53002-1592-9) > 9 TABLET in 1 BLISTER PACK9 blister pack2017-09-010000-00-00NoNoCurrent