Home NDC 50090-8109-0 sumatriptan
Product NDC 50090-8109
Requested package NDC 50090-8109-0
11-digit product format 500908109
Labeler code 50090
Product ID 50090-8109_eafe5699-1ee8-45bf-90cd-574035defd76
Type HUMAN PRESCRIPTION DRUG
Nonproprietary name sumatriptan
Dosage form TABLET, FILM COATED
Route ORAL
Labeler A-S Medication Solutions
Application ANDA219036
Marketing category ANDA
Marketing start 2025-05-05
Substance SUMATRIPTAN SUCCINATE
Active strength 25 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 2027-12-31
Current FDA listing Yes Source provenance: Browse the complete Orange Book source catalog · source snapshot 44 .
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 A219036-001 SUMATRIPTAN SUCCINATE SUMATRIPTAN SUCCINATE EQ 25MG BASE TABLET / ORAL AB 2024-12-31 A219036-002 SUMATRIPTAN SUCCINATE SUMATRIPTAN SUCCINATE EQ 50MG BASE TABLET / ORAL AB 2024-12-31 A219036-003 SUMATRIPTAN SUCCINATE SUMATRIPTAN SUCCINATE EQ 100MG BASE TABLET / ORAL AB 2024-12-31
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.
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 2026-10-15 13:18:30 2026-09 A219036-001 SUMATRIPTAN SUCCINATE EQ 25MG BASE TABLET / ORAL AB 2024-12-31 c2088c7a36db…2026-10-15 13:18:30 2026-09 A219036-002 SUMATRIPTAN SUCCINATE EQ 50MG BASE TABLET / ORAL AB 2024-12-31 c2088c7a36db…2026-10-15 13:18:30 2026-09 A219036-003 SUMATRIPTAN SUCCINATE EQ 100MG BASE TABLET / ORAL AB 2024-12-31 c2088c7a36db…2026-09-14 22:38:34 2026-08 A219036-001 SUMATRIPTAN SUCCINATE EQ 25MG BASE TABLET / ORAL AB 2024-12-31 84e616aacf4f…2026-09-14 22:38:34 2026-08 A219036-002 SUMATRIPTAN SUCCINATE EQ 50MG BASE TABLET / ORAL AB 2024-12-31 84e616aacf4f…2026-09-14 22:38:34 2026-08 A219036-003 SUMATRIPTAN SUCCINATE EQ 100MG BASE TABLET / ORAL AB 2024-12-31 84e616aacf4f…2026-08-18 06:07:40 2026-07 A219036-001 SUMATRIPTAN SUCCINATE EQ 25MG BASE TABLET / ORAL AB 2024-12-31 caaa826d4ba7…2026-08-18 06:07:40 2026-07 A219036-002 SUMATRIPTAN SUCCINATE EQ 50MG BASE TABLET / ORAL AB 2024-12-31 caaa826d4ba7…2026-08-18 06:07:40 2026-07 A219036-003 SUMATRIPTAN SUCCINATE EQ 100MG BASE TABLET / ORAL AB 2024-12-31 caaa826d4ba7…2026-02-19 14:30 UTC 2026-02 A219036-001 SUMATRIPTAN SUCCINATE EQ 25MG BASE TABLET / ORAL AB 2024-12-31 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 A219036-002 SUMATRIPTAN SUCCINATE EQ 50MG BASE TABLET / ORAL AB 2024-12-31 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 A219036-003 SUMATRIPTAN SUCCINATE EQ 100MG BASE TABLET / ORAL AB 2024-12-31 011fe1cb6892…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 A219036-001 SUMATRIPTAN SUCCINATE EQ 25MG BASE TABLET / ORAL AB 2024-12-31 31067a03dcf5…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 A219036-002 SUMATRIPTAN SUCCINATE EQ 50MG BASE TABLET / ORAL AB 2024-12-31 31067a03dcf5…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 A219036-003 SUMATRIPTAN SUCCINATE EQ 100MG BASE TABLET / ORAL AB 2024-12-31 31067a03dcf5…2025-08-23 18:47 UTC 2025-08 A219036-001 SUMATRIPTAN SUCCINATE EQ 25MG BASE TABLET / ORAL AB 2024-12-31 6a471c1ec25d…2025-08-23 18:47 UTC 2025-08 A219036-002 SUMATRIPTAN SUCCINATE EQ 50MG BASE TABLET / ORAL AB 2024-12-31 6a471c1ec25d…2025-08-23 18:47 UTC 2025-08 A219036-003 SUMATRIPTAN SUCCINATE EQ 100MG BASE TABLET / ORAL AB 2024-12-31 6a471c1ec25d…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 A219036-001 SUMATRIPTAN SUCCINATE EQ 25MG BASE TABLET / ORAL AB 2024-12-31 fd3edfee7708…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 A219036-002 SUMATRIPTAN SUCCINATE EQ 50MG BASE TABLET / ORAL AB 2024-12-31 fd3edfee7708…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 A219036-003 SUMATRIPTAN SUCCINATE EQ 100MG BASE TABLET / ORAL AB 2024-12-31 fd3edfee7708…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 A219036-001 SUMATRIPTAN SUCCINATE EQ 25MG BASE TABLET / ORAL AB 2024-12-31 b8a1b40f171c…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 A219036-002 SUMATRIPTAN SUCCINATE EQ 50MG BASE TABLET / ORAL AB 2024-12-31 b8a1b40f171c…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 A219036-003 SUMATRIPTAN SUCCINATE EQ 100MG BASE TABLET / ORAL AB 2024-12-31 b8a1b40f171c…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 A219036-001 SUMATRIPTAN SUCCINATE EQ 25MG BASE TABLET / ORAL AB 2024-12-31 03ed91905a0d…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 A219036-002 SUMATRIPTAN SUCCINATE EQ 50MG BASE TABLET / ORAL AB 2024-12-31 03ed91905a0d…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 A219036-003 SUMATRIPTAN SUCCINATE EQ 100MG BASE TABLET / ORAL AB 2024-12-31 03ed91905a0d…2026-07-26 02:55 UTC · 3 captures of this ZIP 2026-06 A219036-001 SUMATRIPTAN SUCCINATE EQ 25MG BASE TABLET / ORAL AB 2024-12-31 a50c72e98297…2026-07-26 02:55 UTC · 3 captures of this ZIP 2026-06 A219036-002 SUMATRIPTAN SUCCINATE EQ 50MG BASE TABLET / ORAL AB 2024-12-31 a50c72e98297…2026-07-26 02:55 UTC · 3 captures of this ZIP 2026-06 A219036-003 SUMATRIPTAN SUCCINATE EQ 100MG BASE TABLET / ORAL AB 2024-12-31 a50c72e98297…
Observed Orange Book normalized TE history# Reported adverse events (FAERS/openFDA)# Adverse event summaries are temporarily unavailable. Other product information remains available.
Additional Listing Data#
Finished product Yes
Brand name base sumatriptan
Listing expiration 2027-12-31 Active Ingredients# Ingredient, Strength table Ingredient Strength SUMATRIPTAN SUCCINATE 25 mg/1
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 · 1 matching rows.
Packages# Package NDC, 11-digit format, Description table Package NDC 11-digit format Description Units Marketing start Sample Exclude flag Status 50090-8109-0 50090810900 1 BLISTER PACK in 1 CARTON (50090-8109-0) / 9 TABLET, FILM COATED in 1 BLISTER PACK 1 blister pack 2026-10-08 No No Current