Home NDC 55700-759 Sumatriptan
Product NDC 55700-759
11-digit product format 557000759
Labeler code 55700
Product ID 55700-759_c7356307-4040-4541-aeb4-b8ebc9515c2c
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 2019-05-24
Marketing end 0000-00-00
Substance SUMATRIPTAN SUCCINATE
Active strength 25 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 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 · 18 matching rows.
View current auxiliary records. · View the auxiliary file history.
Captured / source date, Dataset, Scope table Captured / source date Dataset Scope Package NDC Snapshot Source SHA-256 2025-12-14 17:58 UTC · source 2025-12-05 excluded product product d630ba8d3edf…732f749b63fb…2025-12-14 17:58 UTC · source 2025-12-05 excluded package package 55700-759-09 d630ba8d3edf…732f749b63fb…2025-08-27 00:01 UTC · source 2025-08-26 excluded product product f5e01cc5f278…a2eaf40c39c3…2025-08-27 00:01 UTC · source 2025-08-26 excluded package package 55700-759-09 f5e01cc5f278…a2eaf40c39c3…2025-04-01 02:39 UTC · source 2025-03-31 excluded product product 2ef7874e63bc…57b86245f4fa…2025-04-01 02:39 UTC · source 2025-03-31 excluded package package 55700-759-09 2ef7874e63bc…57b86245f4fa…2025-03-28 20:22 UTC · source 2025-03-28 excluded product product a1b67e2a42f9…c4cf2c586c0d…2025-03-28 20:22 UTC · source 2025-03-28 excluded package package 55700-759-09 a1b67e2a42f9…c4cf2c586c0d…2025-03-22 03:12 UTC · source 2025-03-21 excluded product product cfe11265f3b6…090c488252e2…2025-03-22 03:12 UTC · source 2025-03-21 excluded package package 55700-759-09 cfe11265f3b6…090c488252e2…2025-03-10 12:48 UTC · source 2025-03-10 excluded product product cdf11ea48f46…ba0047e9e063…2025-03-10 12:48 UTC · source 2025-03-10 excluded package package 55700-759-09 cdf11ea48f46…ba0047e9e063…2025-02-02 03:52 UTC · source 2025-01-31 excluded product product 302b2466d912…e7b80fea0513…2025-02-02 03:52 UTC · source 2025-01-31 excluded package package 55700-759-09 302b2466d912…e7b80fea0513…2025-01-20 13:05 UTC · source 2025-01-20 excluded product product ed331223b511…672a5bd82f5f…2025-01-20 13:05 UTC · source 2025-01-20 excluded package package 55700-759-09 ed331223b511…672a5bd82f5f…2025-01-11 03:41 UTC · source 2025-01-10 excluded product product 0efc9e666f02…f202fb6c5f17…2025-01-11 03:41 UTC · source 2025-01-10 excluded package package 55700-759-09 0efc9e666f02…f202fb6c5f17…
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-product Trade name Ingredient Strength Dosage form / route TE codes RLD / RS Approval date A078327-001 SUMATRIPTAN SUCCINATE SUMATRIPTAN SUCCINATE EQ 25MG BASE TABLET / ORAL AB 2009-08-10 A078327-002 SUMATRIPTAN SUCCINATE SUMATRIPTAN SUCCINATE EQ 50MG BASE TABLET / ORAL AB 2009-08-10 A078327-003 SUMATRIPTAN SUCCINATE SUMATRIPTAN SUCCINATE EQ 100MG BASE TABLET / ORAL AB 2009-08-10
Therapeutic equivalence codes# Current TE-code rows page 1 of 1 · 3 matching rows.
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 Captured Edition Application-product Trade name Strength Dosage form / route Product TE source text RLD / RS Approval date Source SHA-256 2026-09-14 22:38:34 2026-08 A078327-001 SUMATRIPTAN SUCCINATE EQ 25MG BASE TABLET / ORAL AB 2009-08-10 84e616aacf4f…2026-09-14 22:38:34 2026-08 A078327-002 SUMATRIPTAN SUCCINATE EQ 50MG BASE TABLET / ORAL AB 2009-08-10 84e616aacf4f…2026-09-14 22:38:34 2026-08 A078327-003 SUMATRIPTAN SUCCINATE EQ 100MG BASE TABLET / ORAL AB 2009-08-10 84e616aacf4f…2026-08-18 06:07:40 2026-07 A078327-001 SUMATRIPTAN SUCCINATE EQ 25MG BASE TABLET / ORAL AB 2009-08-10 caaa826d4ba7…2026-08-18 06:07:40 2026-07 A078327-002 SUMATRIPTAN SUCCINATE EQ 50MG BASE TABLET / ORAL AB 2009-08-10 caaa826d4ba7…2026-08-18 06:07:40 2026-07 A078327-003 SUMATRIPTAN SUCCINATE EQ 100MG BASE TABLET / ORAL AB 2009-08-10 caaa826d4ba7…2026-02-19 14:30 UTC 2026-02 A078327-001 SUMATRIPTAN SUCCINATE EQ 25MG BASE TABLET / ORAL AB 2009-08-10 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 A078327-002 SUMATRIPTAN SUCCINATE EQ 50MG BASE TABLET / ORAL AB 2009-08-10 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 A078327-003 SUMATRIPTAN SUCCINATE EQ 100MG BASE TABLET / ORAL AB 2009-08-10 011fe1cb6892…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 A078327-001 SUMATRIPTAN SUCCINATE EQ 25MG BASE TABLET / ORAL AB 2009-08-10 31067a03dcf5…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 A078327-002 SUMATRIPTAN SUCCINATE EQ 50MG BASE TABLET / ORAL AB 2009-08-10 31067a03dcf5…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 A078327-003 SUMATRIPTAN SUCCINATE EQ 100MG BASE TABLET / ORAL AB 2009-08-10 31067a03dcf5…2025-08-23 18:47 UTC 2025-08 A078327-001 SUMATRIPTAN SUCCINATE EQ 25MG BASE TABLET / ORAL AB 2009-08-10 6a471c1ec25d…2025-08-23 18:47 UTC 2025-08 A078327-002 SUMATRIPTAN SUCCINATE EQ 50MG BASE TABLET / ORAL AB 2009-08-10 6a471c1ec25d…2025-08-23 18:47 UTC 2025-08 A078327-003 SUMATRIPTAN SUCCINATE EQ 100MG BASE TABLET / ORAL AB 2009-08-10 6a471c1ec25d…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 A078327-001 SUMATRIPTAN SUCCINATE EQ 25MG BASE TABLET / ORAL AB 2009-08-10 fd3edfee7708…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 A078327-002 SUMATRIPTAN SUCCINATE EQ 50MG BASE TABLET / ORAL AB 2009-08-10 fd3edfee7708…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 A078327-003 SUMATRIPTAN SUCCINATE EQ 100MG BASE TABLET / ORAL AB 2009-08-10 fd3edfee7708…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 A078327-001 SUMATRIPTAN SUCCINATE EQ 25MG BASE TABLET / ORAL AB 2009-08-10 b8a1b40f171c…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 A078327-002 SUMATRIPTAN SUCCINATE EQ 50MG BASE TABLET / ORAL AB 2009-08-10 b8a1b40f171c…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 A078327-003 SUMATRIPTAN SUCCINATE EQ 100MG BASE TABLET / ORAL AB 2009-08-10 b8a1b40f171c…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 A078327-001 SUMATRIPTAN SUCCINATE EQ 25MG BASE TABLET / ORAL AB 2009-08-10 03ed91905a0d…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 A078327-002 SUMATRIPTAN SUCCINATE EQ 50MG BASE TABLET / ORAL AB 2009-08-10 03ed91905a0d…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 A078327-003 SUMATRIPTAN SUCCINATE EQ 100MG BASE TABLET / ORAL AB 2009-08-10 03ed91905a0d…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 A078327-001 SUMATRIPTAN SUCCINATE EQ 25MG BASE TABLET / ORAL AB 2009-08-10 2680178bc6a6…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 A078327-002 SUMATRIPTAN SUCCINATE EQ 50MG BASE TABLET / ORAL AB 2009-08-10 2680178bc6a6…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 A078327-003 SUMATRIPTAN SUCCINATE EQ 100MG BASE TABLET / ORAL AB 2009-08-10 2680178bc6a6…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 A078327-001 SUMATRIPTAN SUCCINATE EQ 25MG BASE TABLET / ORAL AB 2009-08-10 5bbf6a4d5a75…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 A078327-002 SUMATRIPTAN SUCCINATE EQ 50MG BASE TABLET / ORAL AB 2009-08-10 5bbf6a4d5a75…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 A078327-003 SUMATRIPTAN SUCCINATE EQ 100MG BASE TABLET / ORAL AB 2009-08-10 5bbf6a4d5a75…2024-11-08 22:44 UTC · 3 captures of this ZIP 2024-11 A078327-001 SUMATRIPTAN SUCCINATE EQ 25MG BASE TABLET / ORAL AB 2009-08-10 d8e5a09893c0…2024-11-08 22:44 UTC · 3 captures of this ZIP 2024-11 A078327-002 SUMATRIPTAN SUCCINATE EQ 50MG BASE TABLET / ORAL AB 2009-08-10 d8e5a09893c0…2024-11-08 22:44 UTC · 3 captures of this ZIP 2024-11 A078327-003 SUMATRIPTAN SUCCINATE EQ 100MG BASE TABLET / ORAL AB 2009-08-10 d8e5a09893c0…2024-10-29 15:01 UTC 2024-10 A078327-001 SUMATRIPTAN SUCCINATE EQ 25MG BASE TABLET / ORAL AB 2009-08-10 d06236e962d9…2024-10-29 15:01 UTC 2024-10 A078327-002 SUMATRIPTAN SUCCINATE EQ 50MG BASE TABLET / ORAL AB 2009-08-10 d06236e962d9…2024-10-29 15:01 UTC 2024-10 A078327-003 SUMATRIPTAN SUCCINATE EQ 100MG BASE TABLET / ORAL AB 2009-08-10 d06236e962d9…2024-08-13 05:28 UTC · 3 captures of this ZIP 2024-08 A078327-001 SUMATRIPTAN SUCCINATE EQ 25MG BASE TABLET / ORAL AB 2009-08-10 79d66fd596c7…2024-08-13 05:28 UTC · 3 captures of this ZIP 2024-08 A078327-002 SUMATRIPTAN SUCCINATE EQ 50MG BASE TABLET / ORAL AB 2009-08-10 79d66fd596c7…2024-08-13 05:28 UTC · 3 captures of this ZIP 2024-08 A078327-003 SUMATRIPTAN SUCCINATE EQ 100MG BASE TABLET / ORAL AB 2009-08-10 79d66fd596c7…2024-07-13 05:37 UTC · 2 captures of this ZIP 2024-07 A078327-001 SUMATRIPTAN SUCCINATE EQ 25MG BASE TABLET / ORAL AB 2009-08-10 301d65b070ca…
Observed Orange Book normalized TE history# Normalized TE history page 1 of 4 · 129 observed states.
Reported adverse events (FAERS/openFDA)# Adverse event summaries are temporarily unavailable. Other product information remains available.
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 2 of 2 · 21 matching rows.
Packages# Package NDC, 11-digit format, Description table Package NDC 11-digit format Description Units Marketing start Marketing end Sample Exclude flag Status 55700-759-09 55700075909 1 BLISTER PACK in 1 CARTON (55700-759-09) > 9 TABLET in 1 BLISTER PACK 1 blister pack 2019-05-24 0000-00-00 No No Current