Home NDC 66116-413 Sumatriptan Succinate
Product NDC 66116-413
11-digit product format 661160413
Labeler code 66116
Product ID 66116-413_2fbc01fb-b787-4ff1-bb9f-280dfe975531
Type HUMAN PRESCRIPTION DRUG
Nonproprietary name Sumatriptan Succinate
Dosage form TABLET, FILM COATED
Route ORAL
Labeler MedVantx, Inc.
Application ANDA076840
Marketing category ANDA
Marketing start 2010-09-22
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 E
Listing certified through 2017-12-31
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 · 44 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 66116-413-09 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 66116-413-09 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 66116-413-09 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 66116-413-09 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 66116-413-09 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 66116-413-09 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 66116-413-09 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 66116-413-09 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 66116-413-09 0efc9e666f02…f202fb6c5f17…2024-11-09 02:27 UTC · source 2024-11-08 excluded product product ad56d346431e…cc804d4bbf1e…2024-11-09 02:27 UTC · source 2024-11-08 excluded package package 66116-413-09 ad56d346431e…cc804d4bbf1e…2024-10-04 04:10 UTC · source 2024-10-03 excluded product product 367a005e9d99…383a685ebd0f…2024-10-04 04:10 UTC · source 2024-10-03 excluded package package 66116-413-09 367a005e9d99…383a685ebd0f…2024-07-10 04:00 UTC · source 2024-07-09 excluded product product 557ba5c1ecfa…9c80585c8c6e…2024-07-10 04:00 UTC · source 2024-07-09 excluded package package 66116-413-09 557ba5c1ecfa…9c80585c8c6e…2024-05-28 21:12 UTC · source 2024-05-28 excluded product product 8af77b9d5b6f…d9bbb34c5368…2024-05-28 21:12 UTC · source 2024-05-28 excluded package package 66116-413-09 8af77b9d5b6f…d9bbb34c5368…2024-05-15 03:39 UTC · source 2024-05-14 excluded product product 834df4deac94…adcc014656a3…2024-05-15 03:39 UTC · source 2024-05-14 excluded package package 66116-413-09 834df4deac94…adcc014656a3…2024-03-11 06:39 UTC · source 2024-03-08 excluded product product 1332a3947898…d4bfe170f9cd…2024-03-11 06:39 UTC · source 2024-03-08 excluded package package 66116-413-09 1332a3947898…d4bfe170f9cd…2022-08-30 03:57 UTC · source 2022-08-29 excluded product product fb8cb913e6d1…eb8c232b6be0…2022-08-30 03:57 UTC · source 2022-08-29 excluded package package 66116-413-09 fb8cb913e6d1…eb8c232b6be0…2022-04-09 23:13 UTC · source 2022-04-08 excluded product product 86f5da6cb304…a595104c45d7…2022-04-09 23:13 UTC · source 2022-04-08 excluded package package 66116-413-09 86f5da6cb304…a595104c45d7…2022-04-04 05:40 UTC · source 2022-04-01 excluded product product bd6a592717d7…303034d00443…2022-04-04 05:40 UTC · source 2022-04-01 excluded package package 66116-413-09 bd6a592717d7…303034d00443…2021-12-27 23:28 UTC · source 2021-12-27 excluded product product 8dfbde2a14a4…c9ff85d89658…2021-12-27 23:28 UTC · source 2021-12-27 excluded package package 66116-413-09 8dfbde2a14a4…c9ff85d89658…2020-12-18 03:04 UTC · source 2020-12-17 excluded product product e2bbac7714bc…27bdfed8d636…2020-12-18 03:04 UTC · source 2020-12-17 excluded package package 66116-413-09 e2bbac7714bc…27bdfed8d636…2020-06-10 20:45 UTC · source 2020-06-10 excluded product product 9bebd1f3094a…5416666fcb17…2020-06-10 20:45 UTC · source 2020-06-10 excluded package package 66116-413-09 9bebd1f3094a…5416666fcb17…2019-12-08 06:16 UTC · source 2019-12-05 excluded product product 110d247fa046…a55b01930146…2019-12-08 06:16 UTC · source 2019-12-05 excluded package package 66116-413-09 110d247fa046…a55b01930146…
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 A076840-001 SUMATRIPTAN SUCCINATE SUMATRIPTAN SUCCINATE EQ 25MG BASE TABLET / ORAL 2009-02-09 A076840-002 SUMATRIPTAN SUCCINATE SUMATRIPTAN SUCCINATE EQ 50MG BASE TABLET / ORAL 2009-02-09 A076840-003 SUMATRIPTAN SUCCINATE SUMATRIPTAN SUCCINATE EQ 100MG BASE TABLET / ORAL 2009-02-09
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 A076840-001 SUMATRIPTAN SUCCINATE EQ 25MG BASE TABLET / ORAL 2009-02-09 84e616aacf4f…2026-09-14 22:38:34 2026-08 A076840-002 SUMATRIPTAN SUCCINATE EQ 50MG BASE TABLET / ORAL 2009-02-09 84e616aacf4f…2026-09-14 22:38:34 2026-08 A076840-003 SUMATRIPTAN SUCCINATE EQ 100MG BASE TABLET / ORAL 2009-02-09 84e616aacf4f…2026-08-18 06:07:40 2026-07 A076840-001 SUMATRIPTAN SUCCINATE EQ 25MG BASE TABLET / ORAL 2009-02-09 caaa826d4ba7…2026-08-18 06:07:40 2026-07 A076840-002 SUMATRIPTAN SUCCINATE EQ 50MG BASE TABLET / ORAL 2009-02-09 caaa826d4ba7…2026-08-18 06:07:40 2026-07 A076840-003 SUMATRIPTAN SUCCINATE EQ 100MG BASE TABLET / ORAL 2009-02-09 caaa826d4ba7…2026-02-19 14:30 UTC 2026-02 A076840-001 SUMATRIPTAN SUCCINATE EQ 25MG BASE TABLET / ORAL 2009-02-09 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 A076840-002 SUMATRIPTAN SUCCINATE EQ 50MG BASE TABLET / ORAL 2009-02-09 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 A076840-003 SUMATRIPTAN SUCCINATE EQ 100MG BASE TABLET / ORAL 2009-02-09 011fe1cb6892…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 A076840-001 SUMATRIPTAN SUCCINATE EQ 25MG BASE TABLET / ORAL 2009-02-09 31067a03dcf5…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 A076840-002 SUMATRIPTAN SUCCINATE EQ 50MG BASE TABLET / ORAL 2009-02-09 31067a03dcf5…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 A076840-003 SUMATRIPTAN SUCCINATE EQ 100MG BASE TABLET / ORAL 2009-02-09 31067a03dcf5…2025-08-23 18:47 UTC 2025-08 A076840-001 SUMATRIPTAN SUCCINATE EQ 25MG BASE TABLET / ORAL 2009-02-09 6a471c1ec25d…2025-08-23 18:47 UTC 2025-08 A076840-002 SUMATRIPTAN SUCCINATE EQ 50MG BASE TABLET / ORAL 2009-02-09 6a471c1ec25d…2025-08-23 18:47 UTC 2025-08 A076840-003 SUMATRIPTAN SUCCINATE EQ 100MG BASE TABLET / ORAL 2009-02-09 6a471c1ec25d…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 A076840-001 SUMATRIPTAN SUCCINATE EQ 25MG BASE TABLET / ORAL 2009-02-09 fd3edfee7708…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 A076840-002 SUMATRIPTAN SUCCINATE EQ 50MG BASE TABLET / ORAL 2009-02-09 fd3edfee7708…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 A076840-003 SUMATRIPTAN SUCCINATE EQ 100MG BASE TABLET / ORAL 2009-02-09 fd3edfee7708…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 A076840-001 SUMATRIPTAN SUCCINATE EQ 25MG BASE TABLET / ORAL 2009-02-09 b8a1b40f171c…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 A076840-002 SUMATRIPTAN SUCCINATE EQ 50MG BASE TABLET / ORAL 2009-02-09 b8a1b40f171c…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 A076840-003 SUMATRIPTAN SUCCINATE EQ 100MG BASE TABLET / ORAL 2009-02-09 b8a1b40f171c…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 A076840-001 SUMATRIPTAN SUCCINATE EQ 25MG BASE TABLET / ORAL 2009-02-09 03ed91905a0d…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 A076840-002 SUMATRIPTAN SUCCINATE EQ 50MG BASE TABLET / ORAL 2009-02-09 03ed91905a0d…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 A076840-003 SUMATRIPTAN SUCCINATE EQ 100MG BASE TABLET / ORAL 2009-02-09 03ed91905a0d…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 A076840-001 SUMATRIPTAN SUCCINATE EQ 25MG BASE TABLET / ORAL 2009-02-09 2680178bc6a6…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 A076840-002 SUMATRIPTAN SUCCINATE EQ 50MG BASE TABLET / ORAL 2009-02-09 2680178bc6a6…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 A076840-003 SUMATRIPTAN SUCCINATE EQ 100MG BASE TABLET / ORAL 2009-02-09 2680178bc6a6…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 A076840-001 SUMATRIPTAN SUCCINATE EQ 25MG BASE TABLET / ORAL 2009-02-09 5bbf6a4d5a75…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 A076840-002 SUMATRIPTAN SUCCINATE EQ 50MG BASE TABLET / ORAL 2009-02-09 5bbf6a4d5a75…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 A076840-003 SUMATRIPTAN SUCCINATE EQ 100MG BASE TABLET / ORAL 2009-02-09 5bbf6a4d5a75…2024-11-08 22:44 UTC · 3 captures of this ZIP 2024-11 A076840-001 SUMATRIPTAN SUCCINATE EQ 25MG BASE TABLET / ORAL 2009-02-09 d8e5a09893c0…2024-11-08 22:44 UTC · 3 captures of this ZIP 2024-11 A076840-002 SUMATRIPTAN SUCCINATE EQ 50MG BASE TABLET / ORAL 2009-02-09 d8e5a09893c0…2024-11-08 22:44 UTC · 3 captures of this ZIP 2024-11 A076840-003 SUMATRIPTAN SUCCINATE EQ 100MG BASE TABLET / ORAL 2009-02-09 d8e5a09893c0…2024-10-29 15:01 UTC 2024-10 A076840-001 SUMATRIPTAN SUCCINATE EQ 25MG BASE TABLET / ORAL 2009-02-09 d06236e962d9…2024-10-29 15:01 UTC 2024-10 A076840-002 SUMATRIPTAN SUCCINATE EQ 50MG BASE TABLET / ORAL 2009-02-09 d06236e962d9…2024-10-29 15:01 UTC 2024-10 A076840-003 SUMATRIPTAN SUCCINATE EQ 100MG BASE TABLET / ORAL 2009-02-09 d06236e962d9…2024-08-13 05:28 UTC · 3 captures of this ZIP 2024-08 A076840-001 SUMATRIPTAN SUCCINATE EQ 25MG BASE TABLET / ORAL 2009-02-09 79d66fd596c7…2024-08-13 05:28 UTC · 3 captures of this ZIP 2024-08 A076840-002 SUMATRIPTAN SUCCINATE EQ 50MG BASE TABLET / ORAL 2009-02-09 79d66fd596c7…2024-08-13 05:28 UTC · 3 captures of this ZIP 2024-08 A076840-003 SUMATRIPTAN SUCCINATE EQ 100MG BASE TABLET / ORAL 2009-02-09 79d66fd596c7…2024-07-13 05:37 UTC · 2 captures of this ZIP 2024-07 A076840-001 SUMATRIPTAN SUCCINATE EQ 25MG BASE TABLET / ORAL 2009-02-09 301d65b070ca…
Reported adverse events (FAERS/openFDA)# Adverse event summaries are temporarily unavailable. Other product information remains available.
DailyMed Product Concepts# FDA-Initiated Inactive NDC Indexing# DailyMed Package Descriptions# Package NDC, Product, Description table Package NDC Product Description Form Quantity Strength SPL version 66116-413-09 Sumatriptan Succinate 9 in 1 BLISTER PACK TABLET, FILM COATED 9 1
DailyMed Socrata Ingredients# Ingredient, Type, UNII table Ingredient Type UNII DailyMed label SPL version Uploaded SUMATRIPTAN SUCCINATE ACTIVE INGREDIENT J8BDZ68989 SUMATRIPTAN SUCCINATE TABLET, FILM COATED [MEDVANTX, INC.] 1 SUMATRIPTAN ACTIVE MOIETY 8R78F6L9VO SUMATRIPTAN SUCCINATE TABLET, FILM COATED [MEDVANTX, INC.] 1 ANHYDROUS LACTOSE INACTIVE INGREDIENT 3SY5LH9PMK SUMATRIPTAN SUCCINATE TABLET, FILM COATED [MEDVANTX, INC.] 1 CELLULOSE, MICROCRYSTALLINE INACTIVE INGREDIENT OP1R32D61U SUMATRIPTAN SUCCINATE TABLET, FILM COATED [MEDVANTX, INC.] 1 CROSCARMELLOSE SODIUM INACTIVE INGREDIENT M28OL1HH48 SUMATRIPTAN SUCCINATE TABLET, FILM COATED [MEDVANTX, INC.] 1 HYPROMELLOSE 2910 (6 MPA.S) INACTIVE INGREDIENT 0WZ8WG20P6 SUMATRIPTAN SUCCINATE TABLET, FILM COATED [MEDVANTX, INC.] 1 LACTOSE MONOHYDRATE INACTIVE INGREDIENT EWQ57Q8I5X SUMATRIPTAN SUCCINATE TABLET, FILM COATED [MEDVANTX, INC.] 1 MAGNESIUM STEARATE INACTIVE INGREDIENT 70097M6I30 SUMATRIPTAN SUCCINATE TABLET, FILM COATED [MEDVANTX, INC.] 1 POLYETHYLENE GLYCOL INACTIVE INGREDIENT 3WJQ0SDW1A SUMATRIPTAN SUCCINATE TABLET, FILM COATED [MEDVANTX, INC.] 1 TITANIUM DIOXIDE INACTIVE INGREDIENT 15FIX9V2JP SUMATRIPTAN SUCCINATE TABLET, FILM COATED [MEDVANTX, INC.] 1
DailyMed Dashboard NDC Coverage# NDC, Dashboard title, SPL version table NDC Dashboard title SPL version Validation Dashboard ZIP 66116-413 SUMATRIPTAN SUCCINATE TABLET, FILM COATED [MEDVANTX, INC.] 1 Legacy NDC, 1 package rows 20111212_2fbc01fb-b787-4ff1-bb9f-280dfe975531.zip
DailyMed RxNorm Mappings# Packages# Package NDC, 11-digit format, Description table Package NDC 11-digit format Description Status 66116-413-09 66116041309 9 in 1 BLISTER PACK Historical