Sumatriptan

Product NDC
55700-936
11-digit product format
557000936
Labeler code
55700
Product ID
55700-936_95ea9dc9-6680-461d-8259-2d53a199ad85
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Sumatriptan Succinate
Dosage form
TABLET
Route
ORAL
Labeler
Quality Care Products, LLC
Application
ANDA078327
Marketing category
ANDA
Marketing start
2021-09-03
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 · 2 matching rows.

Dataset, Scope, Product NDC table
DatasetScopeProduct NDCPackage NDCCodeStatusReporting periodSource date
excluded productproduct55700-936DDiscontinued by firm2026-10-02
excluded packagepackage55700-93655700-936-09DDiscontinued by firm2026-10-02

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

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
A078327-001SUMATRIPTAN SUCCINATESUMATRIPTAN SUCCINATEEQ 25MG BASETABLET / ORALAB2009-08-10
A078327-002SUMATRIPTAN SUCCINATESUMATRIPTAN SUCCINATEEQ 50MG BASETABLET / ORALAB2009-08-10
A078327-003SUMATRIPTAN 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
A078327-001AB
A078327-002AB
A078327-003AB

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 · 129 observed states.

Captured, Edition, Application-product table
CapturedEditionApplication-productTrade nameStrengthDosage form / routeProduct TE source textRLD / RSApproval dateSource SHA-256
2026-09-14 22:38:342026-08A078327-001SUMATRIPTAN SUCCINATEEQ 25MG BASETABLET / ORALAB2009-08-1084e616aacf4f…
2026-09-14 22:38:342026-08A078327-002SUMATRIPTAN SUCCINATEEQ 50MG BASETABLET / ORALAB2009-08-1084e616aacf4f…
2026-09-14 22:38:342026-08A078327-003SUMATRIPTAN SUCCINATEEQ 100MG BASETABLET / ORALAB2009-08-1084e616aacf4f…
2026-08-18 06:07:402026-07A078327-001SUMATRIPTAN SUCCINATEEQ 25MG BASETABLET / ORALAB2009-08-10caaa826d4ba7…
2026-08-18 06:07:402026-07A078327-002SUMATRIPTAN SUCCINATEEQ 50MG BASETABLET / ORALAB2009-08-10caaa826d4ba7…
2026-08-18 06:07:402026-07A078327-003SUMATRIPTAN SUCCINATEEQ 100MG BASETABLET / ORALAB2009-08-10caaa826d4ba7…
2026-02-19 14:30 UTC2026-02A078327-001SUMATRIPTAN SUCCINATEEQ 25MG BASETABLET / ORALAB2009-08-10011fe1cb6892…
2026-02-19 14:30 UTC2026-02A078327-002SUMATRIPTAN SUCCINATEEQ 50MG BASETABLET / ORALAB2009-08-10011fe1cb6892…
2026-02-19 14:30 UTC2026-02A078327-003SUMATRIPTAN SUCCINATEEQ 100MG BASETABLET / ORALAB2009-08-10011fe1cb6892…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A078327-001SUMATRIPTAN SUCCINATEEQ 25MG BASETABLET / ORALAB2009-08-1031067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A078327-002SUMATRIPTAN SUCCINATEEQ 50MG BASETABLET / ORALAB2009-08-1031067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A078327-003SUMATRIPTAN SUCCINATEEQ 100MG BASETABLET / ORALAB2009-08-1031067a03dcf5…
2025-08-23 18:47 UTC2025-08A078327-001SUMATRIPTAN SUCCINATEEQ 25MG BASETABLET / ORALAB2009-08-106a471c1ec25d…
2025-08-23 18:47 UTC2025-08A078327-002SUMATRIPTAN SUCCINATEEQ 50MG BASETABLET / ORALAB2009-08-106a471c1ec25d…
2025-08-23 18:47 UTC2025-08A078327-003SUMATRIPTAN SUCCINATEEQ 100MG BASETABLET / ORALAB2009-08-106a471c1ec25d…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A078327-001SUMATRIPTAN SUCCINATEEQ 25MG BASETABLET / ORALAB2009-08-10fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A078327-002SUMATRIPTAN SUCCINATEEQ 50MG BASETABLET / ORALAB2009-08-10fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A078327-003SUMATRIPTAN SUCCINATEEQ 100MG BASETABLET / ORALAB2009-08-10fd3edfee7708…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A078327-001SUMATRIPTAN SUCCINATEEQ 25MG BASETABLET / ORALAB2009-08-10b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A078327-002SUMATRIPTAN SUCCINATEEQ 50MG BASETABLET / ORALAB2009-08-10b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A078327-003SUMATRIPTAN SUCCINATEEQ 100MG BASETABLET / ORALAB2009-08-10b8a1b40f171c…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A078327-001SUMATRIPTAN SUCCINATEEQ 25MG BASETABLET / ORALAB2009-08-1003ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A078327-002SUMATRIPTAN SUCCINATEEQ 50MG BASETABLET / ORALAB2009-08-1003ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A078327-003SUMATRIPTAN SUCCINATEEQ 100MG BASETABLET / ORALAB2009-08-1003ed91905a0d…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A078327-001SUMATRIPTAN SUCCINATEEQ 25MG BASETABLET / ORALAB2009-08-102680178bc6a6…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A078327-002SUMATRIPTAN SUCCINATEEQ 50MG BASETABLET / ORALAB2009-08-102680178bc6a6…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A078327-003SUMATRIPTAN SUCCINATEEQ 100MG BASETABLET / ORALAB2009-08-102680178bc6a6…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A078327-001SUMATRIPTAN SUCCINATEEQ 25MG BASETABLET / ORALAB2009-08-105bbf6a4d5a75…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A078327-002SUMATRIPTAN SUCCINATEEQ 50MG BASETABLET / ORALAB2009-08-105bbf6a4d5a75…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A078327-003SUMATRIPTAN SUCCINATEEQ 100MG BASETABLET / ORALAB2009-08-105bbf6a4d5a75…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A078327-001SUMATRIPTAN SUCCINATEEQ 25MG BASETABLET / ORALAB2009-08-10d8e5a09893c0…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A078327-002SUMATRIPTAN SUCCINATEEQ 50MG BASETABLET / ORALAB2009-08-10d8e5a09893c0…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A078327-003SUMATRIPTAN SUCCINATEEQ 100MG BASETABLET / ORALAB2009-08-10d8e5a09893c0…
2024-10-29 15:01 UTC2024-10A078327-001SUMATRIPTAN SUCCINATEEQ 25MG BASETABLET / ORALAB2009-08-10d06236e962d9…
2024-10-29 15:01 UTC2024-10A078327-002SUMATRIPTAN SUCCINATEEQ 50MG BASETABLET / ORALAB2009-08-10d06236e962d9…
2024-10-29 15:01 UTC2024-10A078327-003SUMATRIPTAN SUCCINATEEQ 100MG BASETABLET / ORALAB2009-08-10d06236e962d9…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08A078327-001SUMATRIPTAN SUCCINATEEQ 25MG BASETABLET / ORALAB2009-08-1079d66fd596c7…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08A078327-002SUMATRIPTAN SUCCINATEEQ 50MG BASETABLET / ORALAB2009-08-1079d66fd596c7…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08A078327-003SUMATRIPTAN SUCCINATEEQ 100MG BASETABLET / ORALAB2009-08-1079d66fd596c7…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07A078327-001SUMATRIPTAN SUCCINATEEQ 25MG BASETABLET / ORALAB2009-08-10301d65b070ca…

Observed Orange Book normalized TE history#

Normalized TE history page 1 of 4 · 129 observed states.

Captured, Edition, Application-product table
CapturedEditionApplication-productTE codeOrderSource SHA-256
2026-09-14 22:38:342026-08A078327-001AB184e616aacf4f…
2026-09-14 22:38:342026-08A078327-002AB184e616aacf4f…
2026-09-14 22:38:342026-08A078327-003AB184e616aacf4f…
2026-08-18 06:07:402026-07A078327-001AB1caaa826d4ba7…
2026-08-18 06:07:402026-07A078327-002AB1caaa826d4ba7…
2026-08-18 06:07:402026-07A078327-003AB1caaa826d4ba7…
2026-02-19 14:30 UTC2026-02A078327-001AB1011fe1cb6892…
2026-02-19 14:30 UTC2026-02A078327-002AB1011fe1cb6892…
2026-02-19 14:30 UTC2026-02A078327-003AB1011fe1cb6892…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A078327-001AB131067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A078327-002AB131067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A078327-003AB131067a03dcf5…
2025-08-23 18:47 UTC2025-08A078327-001AB16a471c1ec25d…
2025-08-23 18:47 UTC2025-08A078327-002AB16a471c1ec25d…
2025-08-23 18:47 UTC2025-08A078327-003AB16a471c1ec25d…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A078327-001AB1fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A078327-002AB1fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A078327-003AB1fd3edfee7708…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A078327-001AB1b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A078327-002AB1b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A078327-003AB1b8a1b40f171c…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A078327-001AB103ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A078327-002AB103ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A078327-003AB103ed91905a0d…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A078327-001AB12680178bc6a6…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A078327-002AB12680178bc6a6…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A078327-003AB12680178bc6a6…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A078327-001AB15bbf6a4d5a75…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A078327-002AB15bbf6a4d5a75…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A078327-003AB15bbf6a4d5a75…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A078327-001AB1d8e5a09893c0…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A078327-002AB1d8e5a09893c0…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A078327-003AB1d8e5a09893c0…
2024-10-29 15:01 UTC2024-10A078327-001AB1d06236e962d9…
2024-10-29 15:01 UTC2024-10A078327-002AB1d06236e962d9…
2024-10-29 15:01 UTC2024-10A078327-003AB1d06236e962d9…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08A078327-001AB179d66fd596c7…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08A078327-002AB179d66fd596c7…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08A078327-003AB179d66fd596c7…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07A078327-001AB1301d65b070ca…

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

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
55700-936-09Sumatriptan1 in 1 CARTONTABLET13
55700-936-09Sumatriptan9 in 1 BLISTER PACKTABLET93

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
55700-936-09EA - Each55700-93685e639ba-4c66-47e6-8d51-755d9ab990a212021-10-08

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
55700-936SUMATRIPTAN (SUMATRIPTAN SUCCINATE) TABLET [QUALITY CARE PRODUCTS, LLC]3Legacy NDC, 2 package rows20241220_da77dfc4-551c-4e0e-a65e-cb478f193cd9.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 2 · 21 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
SumatriptanSUMATRIPTAN SUCCINATEPreferred Pharmaceuticals, Inc.bf9fd9fe-095b-4478-bd2e-a5534af077612026-09-03Warnings, Adverse reactionsExact identifier
application applno (ANDA): 078327
application number: ANDA078327
SumatriptanSUMATRIPTAN SUCCINATEPreferred Pharmaceuticals Inc.baf37e8c-d414-4ca7-a366-97dc202372ff2026-09-02Warnings, Adverse reactionsExact identifier
application applno (ANDA): 078327
application number: ANDA078327
SumatriptanSUMATRIPTAN SUCCINATEREMEDYREPACK INC.73c9ac06-b55e-41e0-90ec-deb250f37eb52026-05-19Warnings, Adverse reactionsExact identifier
application applno (ANDA): 078327
application number: ANDA078327
SumatriptanSUMATRIPTAN SUCCINATEAurobindo Pharma Limitedb2503fff-c978-4efa-b1b4-d7740b6b26f22026-05-12Warnings, Adverse reactionsExact identifier
application applno (ANDA): 078327
application number: ANDA078327
SumatriptanSUMATRIPTAN SUCCINATESportpharm LLCd071aef6-a5bd-4f68-ba6d-03004466897c2026-04-24Warnings, Adverse reactionsExact identifier
application applno (ANDA): 078327
application number: ANDA078327
SumatriptanSUMATRIPTAN SUCCINATEA-S Medication Solutions62ba6fef-467a-4500-993c-51907f12a67c2026-02-14Warnings, Adverse reactionsExact identifier
application applno (ANDA): 078327
application number: ANDA078327
SumatriptanSUMATRIPTAN SUCCINATENorthStar Rx LLC84bfc4ba-4172-4adb-b963-4e0eb438c07a2026-02-13Warnings, Adverse reactionsExact identifier
application applno (ANDA): 078327
application number: ANDA078327
SumatriptanSUMATRIPTAN SUCCINATEPreferred Pharmaceuticals, Inc.f2e7d756-1e12-462a-a43f-a9d860b11ee82025-09-25Warnings, Adverse reactionsExact identifier
application applno (ANDA): 078327
application number: ANDA078327
SumatriptanSUMATRIPTAN SUCCINATENuCare Pharmaceuticals, Inc.2efd4269-5657-9669-e063-6394a90a583a2025-02-25Warnings, Adverse reactionsExact identifier
application applno (ANDA): 078327
application number: ANDA078327
SumatriptanSUMATRIPTAN SUCCINATENuCare Pharmaceuticals, Inc.2a96f37d-03f6-678c-e063-6394a90ae0c62024-12-31Warnings, Adverse reactionsExact identifier
application applno (ANDA): 078327
application number: ANDA078327
SumatriptanSUMATRIPTANAdvanced Rx of Tennessee, LLCf1a118cf-2179-572a-e053-2995a90acbb02024-12-31Warnings, Adverse reactionsExact identifier
application applno (ANDA): 078327
application number: ANDA078327
SumatriptanSUMATRIPTAN SUCCINATEQuality Care Products, LLC5d1f3de0-684a-4092-be30-aa325ff20d042024-12-18Warnings, Adverse reactionsExact identifier
application applno (ANDA): 078327
application number: ANDA078327
SumatriptanSUMATRIPTAN SUCCINATEQuality Care Products, LLCda77dfc4-551c-4e0e-a65e-cb478f193cd92024-12-18Warnings, Adverse reactionsExact identifier
application applno (ANDA): 078327
application number: ANDA078327
ndc (product): 55700-936
SumatriptanSUMATRIPTANAdvanced Rx Pharmacy of Tennessee, LLCf8c4bbfb-1586-4610-e053-6394a90a8f092024-08-27Warnings, Adverse reactionsExact identifier
application applno (ANDA): 078327
application number: ANDA078327
SumatriptanSUMATRIPTAN SUCCINATENuCare Pharmaceuticals,Inc.54c6f8f4-5466-3988-e054-00144ff8d46c2024-07-10Warnings, Adverse reactionsExact identifier
application applno (ANDA): 078327
application number: ANDA078327
SumatriptanSUMATRIPTAN SUCCINATENuCare Pharmaceuticals,Inc.933f6575-a4c4-0f65-e053-2a95a90ab9672024-06-19Exact identifier
application applno (ANDA): 078327
application number: ANDA078327
SumatriptanSUMATRIPTAN SUCCINATENuCare Pharmaceuticals,Inc.85295be9-852d-4e21-e053-2991aa0a8a782024-06-14Warnings, Adverse reactionsExact identifier
application applno (ANDA): 078327
application number: ANDA078327
SumatriptanSUMATRIPTAN SUCCINATEProficient Rx LPfe09fab6-b9e3-469c-9a38-bcc343dcc8992023-01-01Warnings, Adverse reactionsExact identifier
application applno (ANDA): 078327
application number: ANDA078327
SumatriptanSUMATRIPTAN SUCCINATEAsclemed USA, Inc.77f9f135-e840-48f0-81e8-73e08433e7682022-10-11Warnings, Adverse reactionsExact identifier
application applno (ANDA): 078327
application number: ANDA078327
SumatriptanSUMATRIPTAN SUCCINATEProficient Rx LPabbd2168-1523-4eb6-a75c-dc4d7d1b1c9b2022-06-01Warnings, Adverse reactionsExact identifier
application applno (ANDA): 078327
application number: ANDA078327

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
313161SUMAtriptan succinate 50 MG Oral TabletPSNda77dfc4-551c-4e0e-a65e-cb478f193cd93
313161sumatriptan 50 MG Oral TabletSCDda77dfc4-551c-4e0e-a65e-cb478f193cd93
313161sumatriptan 50 MG (as sumatriptan succinate 70 MG) Oral TabletSYda77dfc4-551c-4e0e-a65e-cb478f193cd93

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
55700-936-09557000936091 BLISTER PACK in 1 CARTON (55700-936-09) > 9 TABLET in 1 BLISTER PACK1 blister pack2021-09-030000-00-00NoNoCurrent