Sumatriptan

Product NDC
55700-918
Requested package NDC
55700-918-09
11-digit product format
557000918
Labeler code
55700
Product ID
55700-918_8689443c-5dc1-4338-bb5d-7406930518ea
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Sumatriptan
Dosage form
TABLET, FILM COATED
Route
ORAL
Labeler
Quality Care Products, LLC
Application
ANDA078284
Marketing category
ANDA
Marketing start
2021-07-22
Marketing end
0000-00-00
Substance
SUMATRIPTAN SUCCINATE
Active strength
100 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
2022-12-31
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 packagepackage55700-91855700-918-09DDiscontinued by firm2026-08-03

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 · 15 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 2025-12-05DDiscontinued by firmd630ba8d3edf…732f749b63fb…
2025-08-27 00:01 UTC · source 2025-08-26DDiscontinued by firmf5e01cc5f278…a2eaf40c39c3…
2025-04-01 02:39 UTC · source 2025-03-31DDiscontinued by firm2ef7874e63bc…57b86245f4fa…
2025-03-28 20:22 UTC · source 2025-03-28DDiscontinued by firma1b67e2a42f9…c4cf2c586c0d…
2025-03-22 03:12 UTC · source 2025-03-21DDiscontinued by firmcfe11265f3b6…090c488252e2…
2025-03-10 12:48 UTC · source 2025-03-10DDiscontinued by firmcdf11ea48f46…ba0047e9e063…
2025-02-02 03:52 UTC · source 2025-01-31DDiscontinued by firm302b2466d912…e7b80fea0513…
2025-01-20 13:05 UTC · source 2025-01-20DDiscontinued by firmed331223b511…672a5bd82f5f…
2025-01-11 03:41 UTC · source 2025-01-10IInactivated by FDA0efc9e666f02…f202fb6c5f17…
2024-11-09 02:27 UTC · source 2024-11-08IInactivated by FDAad56d346431e…cc804d4bbf1e…
2024-10-04 04:10 UTC · source 2024-10-03IInactivated by FDA367a005e9d99…383a685ebd0f…
2024-07-10 04:00 UTC · source 2024-07-09IInactivated by FDA557ba5c1ecfa…9c80585c8c6e…
2024-05-28 21:12 UTC · source 2024-05-28IInactivated by FDA8af77b9d5b6f…d9bbb34c5368…
2024-05-15 03:39 UTC · source 2024-05-14IInactivated by FDA834df4deac94…adcc014656a3…
2024-03-11 06:39 UTC · source 2024-03-08IInactivated by FDA1332a3947898…d4bfe170f9cd…

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
A078284-001SUMATRIPTAN SUCCINATESUMATRIPTAN SUCCINATEEQ 25MG BASETABLET / ORALAB2009-08-10
A078284-002SUMATRIPTAN SUCCINATESUMATRIPTAN SUCCINATEEQ 50MG BASETABLET / ORALAB2009-08-10
A078284-003SUMATRIPTAN 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
A078284-001AB
A078284-002AB
A078284-003AB

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 UTC2026-02A078284-001SUMATRIPTAN SUCCINATEEQ 25MG BASETABLET / ORALAB2009-08-10011fe1cb6892…
2026-02-19 14:30 UTC2026-02A078284-002SUMATRIPTAN SUCCINATEEQ 50MG BASETABLET / ORALAB2009-08-10011fe1cb6892…
2026-02-19 14:30 UTC2026-02A078284-003SUMATRIPTAN SUCCINATEEQ 100MG BASETABLET / ORALAB2009-08-10011fe1cb6892…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A078284-001SUMATRIPTAN SUCCINATEEQ 25MG BASETABLET / ORALAB2009-08-1031067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A078284-002SUMATRIPTAN SUCCINATEEQ 50MG BASETABLET / ORALAB2009-08-1031067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A078284-003SUMATRIPTAN SUCCINATEEQ 100MG BASETABLET / ORALAB2009-08-1031067a03dcf5…
2025-08-23 18:47 UTC2025-08A078284-001SUMATRIPTAN SUCCINATEEQ 25MG BASETABLET / ORALAB2009-08-106a471c1ec25d…
2025-08-23 18:47 UTC2025-08A078284-002SUMATRIPTAN SUCCINATEEQ 50MG BASETABLET / ORALAB2009-08-106a471c1ec25d…
2025-08-23 18:47 UTC2025-08A078284-003SUMATRIPTAN SUCCINATEEQ 100MG BASETABLET / ORALAB2009-08-106a471c1ec25d…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A078284-001SUMATRIPTAN SUCCINATEEQ 25MG BASETABLET / ORALAB2009-08-10fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A078284-002SUMATRIPTAN SUCCINATEEQ 50MG BASETABLET / ORALAB2009-08-10fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A078284-003SUMATRIPTAN SUCCINATEEQ 100MG BASETABLET / ORALAB2009-08-10fd3edfee7708…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A078284-001SUMATRIPTAN SUCCINATEEQ 25MG BASETABLET / ORALAB2009-08-10b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A078284-002SUMATRIPTAN SUCCINATEEQ 50MG BASETABLET / ORALAB2009-08-10b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A078284-003SUMATRIPTAN SUCCINATEEQ 100MG BASETABLET / ORALAB2009-08-10b8a1b40f171c…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A078284-001SUMATRIPTAN SUCCINATEEQ 25MG BASETABLET / ORALAB2009-08-1003ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A078284-002SUMATRIPTAN SUCCINATEEQ 50MG BASETABLET / ORALAB2009-08-1003ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A078284-003SUMATRIPTAN SUCCINATEEQ 100MG BASETABLET / ORALAB2009-08-1003ed91905a0d…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A078284-001SUMATRIPTAN SUCCINATEEQ 25MG BASETABLET / ORALAB2009-08-102680178bc6a6…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A078284-002SUMATRIPTAN SUCCINATEEQ 50MG BASETABLET / ORALAB2009-08-102680178bc6a6…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A078284-003SUMATRIPTAN SUCCINATEEQ 100MG BASETABLET / ORALAB2009-08-102680178bc6a6…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A078284-001SUMATRIPTAN SUCCINATEEQ 25MG BASETABLET / ORALAB2009-08-105bbf6a4d5a75…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A078284-002SUMATRIPTAN SUCCINATEEQ 50MG BASETABLET / ORALAB2009-08-105bbf6a4d5a75…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A078284-003SUMATRIPTAN SUCCINATEEQ 100MG BASETABLET / ORALAB2009-08-105bbf6a4d5a75…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A078284-001SUMATRIPTAN SUCCINATEEQ 25MG BASETABLET / ORALAB2009-08-10d8e5a09893c0…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A078284-002SUMATRIPTAN SUCCINATEEQ 50MG BASETABLET / ORALAB2009-08-10d8e5a09893c0…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A078284-003SUMATRIPTAN SUCCINATEEQ 100MG BASETABLET / ORALAB2009-08-10d8e5a09893c0…
2024-10-29 15:01 UTC2024-10A078284-001SUMATRIPTAN SUCCINATEEQ 25MG BASETABLET / ORALAB2009-08-10d06236e962d9…
2024-10-29 15:01 UTC2024-10A078284-002SUMATRIPTAN SUCCINATEEQ 50MG BASETABLET / ORALAB2009-08-10d06236e962d9…
2024-10-29 15:01 UTC2024-10A078284-003SUMATRIPTAN SUCCINATEEQ 100MG BASETABLET / ORALAB2009-08-10d06236e962d9…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08A078284-001SUMATRIPTAN SUCCINATEEQ 25MG BASETABLET / ORALAB2009-08-1079d66fd596c7…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08A078284-002SUMATRIPTAN SUCCINATEEQ 50MG BASETABLET / ORALAB2009-08-1079d66fd596c7…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08A078284-003SUMATRIPTAN SUCCINATEEQ 100MG BASETABLET / ORALAB2009-08-1079d66fd596c7…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07A078284-001SUMATRIPTAN SUCCINATEEQ 25MG BASETABLET / ORALAB2009-08-10301d65b070ca…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07A078284-002SUMATRIPTAN SUCCINATEEQ 50MG BASETABLET / ORALAB2009-08-10301d65b070ca…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07A078284-003SUMATRIPTAN SUCCINATEEQ 100MG BASETABLET / ORALAB2009-08-10301d65b070ca…
2024-06-18 03:08 UTC · 5 captures of this ZIP2024-06A078284-001SUMATRIPTAN SUCCINATEEQ 25MG BASETABLET / ORALAB2009-08-101e350fbaab3a…
2024-06-18 03:08 UTC · 5 captures of this ZIP2024-06A078284-002SUMATRIPTAN SUCCINATEEQ 50MG BASETABLET / ORALAB2009-08-101e350fbaab3a…
2024-06-18 03:08 UTC · 5 captures of this ZIP2024-06A078284-003SUMATRIPTAN SUCCINATEEQ 100MG BASETABLET / ORALAB2009-08-101e350fbaab3a…
2024-05-31 18:47 UTC2024-05A078284-001SUMATRIPTAN 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 UTC2026-02A078284-001AB1011fe1cb6892…
2026-02-19 14:30 UTC2026-02A078284-002AB1011fe1cb6892…
2026-02-19 14:30 UTC2026-02A078284-003AB1011fe1cb6892…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A078284-001AB131067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A078284-002AB131067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A078284-003AB131067a03dcf5…
2025-08-23 18:47 UTC2025-08A078284-001AB16a471c1ec25d…
2025-08-23 18:47 UTC2025-08A078284-002AB16a471c1ec25d…
2025-08-23 18:47 UTC2025-08A078284-003AB16a471c1ec25d…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A078284-001AB1fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A078284-002AB1fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A078284-003AB1fd3edfee7708…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A078284-001AB1b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A078284-002AB1b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A078284-003AB1b8a1b40f171c…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A078284-001AB103ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A078284-002AB103ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A078284-003AB103ed91905a0d…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A078284-001AB12680178bc6a6…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A078284-002AB12680178bc6a6…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A078284-003AB12680178bc6a6…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A078284-001AB15bbf6a4d5a75…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A078284-002AB15bbf6a4d5a75…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A078284-003AB15bbf6a4d5a75…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A078284-001AB1d8e5a09893c0…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A078284-002AB1d8e5a09893c0…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A078284-003AB1d8e5a09893c0…
2024-10-29 15:01 UTC2024-10A078284-001AB1d06236e962d9…
2024-10-29 15:01 UTC2024-10A078284-002AB1d06236e962d9…
2024-10-29 15:01 UTC2024-10A078284-003AB1d06236e962d9…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08A078284-001AB179d66fd596c7…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08A078284-002AB179d66fd596c7…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08A078284-003AB179d66fd596c7…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07A078284-001AB1301d65b070ca…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07A078284-002AB1301d65b070ca…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07A078284-003AB1301d65b070ca…
2024-06-18 03:08 UTC · 5 captures of this ZIP2024-06A078284-001AB11e350fbaab3a…
2024-06-18 03:08 UTC · 5 captures of this ZIP2024-06A078284-002AB11e350fbaab3a…
2024-06-18 03:08 UTC · 5 captures of this ZIP2024-06A078284-003AB11e350fbaab3a…
2024-05-31 18:47 UTC2024-05A078284-001AB18072bd15b7f6…

FDA-Initiated Inactive NDC Indexing#

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
55700-918-09EA - Each55700-918545bb976-0369-43da-b60e-4d1fe3a4801112021-10-08

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 · 10 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
SumatriptanSUMATRIPTANBionpharma Inc.e90b0eea-c424-4f00-98da-6ed6e80de1f62026-05-29Warnings, Adverse reactionsExact identifier
application applno (ANDA): 078284
application number: ANDA078284
SumatriptanSUMATRIPTANPreferred Pharmaceuticals Inc.0b9a0ab5-d8bd-4cae-b86c-45740ee1015a2025-09-25Warnings, Adverse reactionsExact identifier
application applno (ANDA): 078284
application number: ANDA078284
SumatriptanSUMATRIPTANPreferred Pharmaceuticals Inc.ff08b9ee-03bf-4f5b-930e-233a3b8866af2025-09-25Warnings, Adverse reactionsExact identifier
application applno (ANDA): 078284
application number: ANDA078284
SumatriptanSUMATRIPTANNuCare Pharmaceuticals,Inc.082d05f6-3850-0fa2-e063-6294a90a0c662025-02-03Warnings, Adverse reactionsExact identifier
application applno (ANDA): 078284
application number: ANDA078284
SumatriptanSUMATRIPTANDirect_Rxefb7ec4e-0a5d-2aae-e053-2a95a90aebf22025-01-22Warnings, Adverse reactionsExact identifier
application applno (ANDA): 078284
application number: ANDA078284
SumatriptanSUMATRIPTANProficient Rx LP85bf8e58-0984-427b-9ed4-7e0df4e444d22025-01-01Warnings, Adverse reactionsExact identifier
application applno (ANDA): 078284
application number: ANDA078284
SumatriptanSUMATRIPTANAdvanced Rx Pharmacy of Tennessee, LLCf27ca3c0-9de0-ff9c-e053-2a95a90ab8942024-12-31Warnings, Adverse reactionsExact identifier
application applno (ANDA): 078284
application number: ANDA078284
SumatriptanSUMATRIPTANAdvanced Rx of Tennessee, LLC2aab8786-b225-833a-e063-6394a90ac7ae2024-12-30Warnings, Adverse reactionsExact identifier
application applno (ANDA): 078284
application number: ANDA078284
Sumatriptan SuccinateSUMATRIPTAN SUCCINATEDirect_Rx284ee7ac-759e-b592-e063-6394a90a78ba2024-12-02Warnings, Adverse reactionsExact identifier
application applno (ANDA): 078284
application number: ANDA078284
SumatriptanSUMATRIPTANA-S Medication Solutions790acc89-81b3-4869-92e7-dc9f7fa6567b2024-11-08Warnings, Adverse reactionsExact identifier
application applno (ANDA): 078284
application number: ANDA078284

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionMarketing startMarketing endSampleExclude flagStatus
55700-918-09557000918099 TABLET, FILM COATED in 1 BLISTER PACK (55700-918-09) 2021-07-220000-00-00NoNoCurrent