Home NDC 0245-0809 ZEMBRACE SYMTOUCH
Product NDC 0245-0809
11-digit product format 002450809
Labeler code 0245
Product ID 0245-0809_47f6d684-3580-1929-e063-6394a90ac772
Type HUMAN PRESCRIPTION DRUG
Nonproprietary name Sumatriptan Succinate
Dosage form INJECTION, SOLUTION
Route SUBCUTANEOUS
Labeler Upsher-Smith laboratories, LLC
Application NDA208223
Marketing category NDA
Marketing start 2016-02-22
Marketing end 2026-08-31
Substance SUMATRIPTAN SUCCINATE
Active strength 3 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
Current FDA listing Yes Source provenance: Browse the complete Orange Book source catalog · source snapshot 42 .
Orange Book products# Current product rows page 1 of 1 · 1 matching rows.
Application-product, Trade name, Ingredient table Application-product Trade name Ingredient Strength Dosage form / route TE codes RLD / RS Approval date N208223-001 ZEMBRACE SYMTOUCH SUMATRIPTAN SUCCINATE EQ 3MG BASE/0.5ML (EQ 3MG BASE/0.5ML) SOLUTION / SUBCUTANEOUS RLD 2016-01-28
Orange Book patents# Current patent rows page 1 of 1 · 3 matching rows.
Application-product, Patent, Expiration table Application-product Patent Expiration Use code Coverage / status Submission date N208223-001 10537554 2036-01-29 U-72 2020-01-21 N208223-001 11364224 2036-01-29 U-72 2022-06-21 N208223-001 12097183 2036-01-29 Drug product 2024-10-24
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 2 · 42 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 2026-08-18 06:07:40 2026-07 N208223-001 ZEMBRACE SYMTOUCH EQ 3MG BASE/0.5ML (EQ 3MG BASE/0.5ML) SOLUTION / SUBCUTANEOUS RLD 2016-01-28 caaa826d4ba7…2026-02-19 14:30 UTC 2026-02 N208223-001 ZEMBRACE SYMTOUCH EQ 3MG BASE/0.5ML (EQ 3MG BASE/0.5ML) SOLUTION / SUBCUTANEOUS RLD 2016-01-28 011fe1cb6892…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 N208223-001 ZEMBRACE SYMTOUCH EQ 3MG BASE/0.5ML (EQ 3MG BASE/0.5ML) SOLUTION / SUBCUTANEOUS RLD 2016-01-28 31067a03dcf5…2025-08-23 18:47 UTC 2025-08 N208223-001 ZEMBRACE SYMTOUCH EQ 3MG BASE/0.5ML (EQ 3MG BASE/0.5ML) SOLUTION / SUBCUTANEOUS RLD 2016-01-28 6a471c1ec25d…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 N208223-001 ZEMBRACE SYMTOUCH EQ 3MG BASE/0.5ML (EQ 3MG BASE/0.5ML) SOLUTION / SUBCUTANEOUS RLD 2016-01-28 fd3edfee7708…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 N208223-001 ZEMBRACE SYMTOUCH EQ 3MG BASE/0.5ML (EQ 3MG BASE/0.5ML) SOLUTION / SUBCUTANEOUS RLD 2016-01-28 b8a1b40f171c…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 N208223-001 ZEMBRACE SYMTOUCH EQ 3MG BASE/0.5ML (EQ 3MG BASE/0.5ML) SOLUTION / SUBCUTANEOUS RLD 2016-01-28 03ed91905a0d…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 N208223-001 ZEMBRACE SYMTOUCH EQ 3MG BASE/0.5ML (EQ 3MG BASE/0.5ML) SOLUTION / SUBCUTANEOUS RLD 2016-01-28 2680178bc6a6…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 N208223-001 ZEMBRACE SYMTOUCH EQ 3MG BASE/0.5ML (EQ 3MG BASE/0.5ML) SOLUTION / SUBCUTANEOUS RLD 2016-01-28 5bbf6a4d5a75…2024-11-08 22:44 UTC · 3 captures of this ZIP 2024-11 N208223-001 ZEMBRACE SYMTOUCH EQ 3MG BASE/0.5ML (EQ 3MG BASE/0.5ML) SOLUTION / SUBCUTANEOUS RLD 2016-01-28 d8e5a09893c0…2024-10-29 15:01 UTC 2024-10 N208223-001 ZEMBRACE SYMTOUCH EQ 3MG BASE/0.5ML (EQ 3MG BASE/0.5ML) SOLUTION / SUBCUTANEOUS RLD 2016-01-28 d06236e962d9…2024-08-13 05:28 UTC · 3 captures of this ZIP 2024-08 N208223-001 ZEMBRACE SYMTOUCH EQ 3MG BASE/0.5ML (EQ 3MG BASE/0.5ML) SOLUTION / SUBCUTANEOUS RLD 2016-01-28 79d66fd596c7…2024-07-13 05:37 UTC · 2 captures of this ZIP 2024-07 N208223-001 ZEMBRACE SYMTOUCH EQ 3MG BASE/0.5ML (EQ 3MG BASE/0.5ML) SOLUTION / SUBCUTANEOUS RLD 2016-01-28 301d65b070ca…2024-06-18 03:08 UTC · 5 captures of this ZIP 2024-06 N208223-001 ZEMBRACE SYMTOUCH EQ 3MG BASE/0.5ML (EQ 3MG BASE/0.5ML) SOLUTION / SUBCUTANEOUS RLD 2016-01-28 1e350fbaab3a…2024-05-31 18:47 UTC 2024-05 N208223-001 ZEMBRACE SYMTOUCH EQ 3MG BASE/0.5ML (EQ 3MG BASE/0.5ML) SOLUTION / SUBCUTANEOUS RLD 2016-01-28 8072bd15b7f6…2022-06-29 02:47 UTC · 2 captures of this ZIP 2022-06 N208223-001 ZEMBRACE SYMTOUCH EQ 3MG BASE/0.5ML (EQ 3MG BASE/0.5ML) SOLUTION / SUBCUTANEOUS RLD 2016-01-28 5c6f7cd8ea54…2022-04-08 23:34 UTC 2022-04 N208223-001 ZEMBRACE SYMTOUCH EQ 3MG BASE/0.5ML (EQ 3MG BASE/0.5ML) SOLUTION / SUBCUTANEOUS RLD 2016-01-28 5d02ea3f76ae…2022-04-04 05:41 UTC 2022-04 N208223-001 ZEMBRACE SYMTOUCH EQ 3MG BASE/0.5ML (EQ 3MG BASE/0.5ML) SOLUTION / SUBCUTANEOUS RLD 2016-01-28 4b0b4de00fa7…2019-12-13 00:20 UTC 2019-12 N208223-001 ZEMBRACE SYMTOUCH EQ 3MG BASE/0.5ML (EQ 3MG BASE/0.5ML) SOLUTION / SUBCUTANEOUS RLD 2016-01-28 74a2ff9319b5…2022-03-09 01:35 UTC 2022-03 N208223-001 ZEMBRACE SYMTOUCH EQ 3MG BASE/0.5ML (EQ 3MG BASE/0.5ML) SOLUTION / SUBCUTANEOUS RLD 2016-01-28 bb7c543d1eb4…2021-12-28 21:50 UTC 2021-12 N208223-001 ZEMBRACE SYMTOUCH EQ 3MG BASE/0.5ML (EQ 3MG BASE/0.5ML) SOLUTION / SUBCUTANEOUS RLD 2016-01-28 782e0a99824c…2021-05-05 16:15 UTC · 3 captures of this ZIP 2021-05 N208223-001 ZEMBRACE SYMTOUCH EQ 3MG BASE/0.5ML (EQ 3MG BASE/0.5ML) SOLUTION / SUBCUTANEOUS RLD 2016-01-28 87673890dc5c…2021-03-12 10:30 UTC 2021-03 N208223-001 ZEMBRACE SYMTOUCH EQ 3MG BASE/0.5ML (EQ 3MG BASE/0.5ML) SOLUTION / SUBCUTANEOUS RLD 2016-01-28 5aa47cf7b7d7…2020-12-22 03:56 UTC 2020-12 N208223-001 ZEMBRACE SYMTOUCH EQ 3MG BASE/0.5ML (EQ 3MG BASE/0.5ML) SOLUTION / SUBCUTANEOUS RLD 2016-01-28 8869cabd3fbd…2020-11-12 02:37 UTC 2020-11 N208223-001 ZEMBRACE SYMTOUCH EQ 3MG BASE/0.5ML (EQ 3MG BASE/0.5ML) SOLUTION / SUBCUTANEOUS RLD 2016-01-28 c0c555d07b60…2019-12-14 00:12 UTC 2019-12 N208223-001 ZEMBRACE SYMTOUCH EQ 3MG BASE/0.5ML (EQ 3MG BASE/0.5ML) SOLUTION / SUBCUTANEOUS RLD 2016-01-28 3f01610625f2…2019-09-15 20:21 UTC 2019-09 N208223-001 ZEMBRACE SYMTOUCH EQ 3MG BASE/0.5ML (EQ 3MG BASE/0.5ML) SOLUTION / SUBCUTANEOUS RLD 2016-01-28 b00525d2431f…2019-07-19 19:46 UTC 2019-07 N208223-001 ZEMBRACE SYMTOUCH EQ 3MG BASE/0.5ML (EQ 3MG BASE/0.5ML) SOLUTION / SUBCUTANEOUS RLD 2016-01-28 ea99ee380514…2024-03-16 18:09 UTC · 4 captures of this ZIP 2024-03 N208223-001 ZEMBRACE SYMTOUCH EQ 3MG BASE/0.5ML (EQ 3MG BASE/0.5ML) SOLUTION / SUBCUTANEOUS RLD 2016-01-28 6a51e52b5d6a…2024-02-18 07:12 UTC 2024-02 N208223-001 ZEMBRACE SYMTOUCH EQ 3MG BASE/0.5ML (EQ 3MG BASE/0.5ML) SOLUTION / SUBCUTANEOUS RLD 2016-01-28 1c564ffb4f44…2023-12-20 04:57 UTC 2023-12 N208223-001 ZEMBRACE SYMTOUCH EQ 3MG BASE/0.5ML (EQ 3MG BASE/0.5ML) SOLUTION / SUBCUTANEOUS RLD 2016-01-28 ea1830bbd6c7…2023-11-28 05:40 UTC · 2 captures of this ZIP 2023-11 N208223-001 ZEMBRACE SYMTOUCH EQ 3MG BASE/0.5ML (EQ 3MG BASE/0.5ML) SOLUTION / SUBCUTANEOUS RLD 2016-01-28 a72a2bbeb626…2023-10-25 00:34 UTC · 2 captures of this ZIP 2023-10 N208223-001 ZEMBRACE SYMTOUCH EQ 3MG BASE/0.5ML (EQ 3MG BASE/0.5ML) SOLUTION / SUBCUTANEOUS RLD 2016-01-28 9b2671bbb829…2023-07-15 15:27 UTC · 2 captures of this ZIP 2023-07 N208223-001 ZEMBRACE SYMTOUCH EQ 3MG BASE/0.5ML (EQ 3MG BASE/0.5ML) SOLUTION / SUBCUTANEOUS RLD 2016-01-28 a67488948f0b…2023-06-13 01:57 UTC · 3 captures of this ZIP 2023-06 N208223-001 ZEMBRACE SYMTOUCH EQ 3MG BASE/0.5ML (EQ 3MG BASE/0.5ML) SOLUTION / SUBCUTANEOUS RLD 2016-01-28 3f0d92c62455…2023-05-13 08:27 UTC 2023-05 N208223-001 ZEMBRACE SYMTOUCH EQ 3MG BASE/0.5ML (EQ 3MG BASE/0.5ML) SOLUTION / SUBCUTANEOUS RLD 2016-01-28 053a50430f4f…2023-01-26 05:58 UTC 2023-01 N208223-001 ZEMBRACE SYMTOUCH EQ 3MG BASE/0.5ML (EQ 3MG BASE/0.5ML) SOLUTION / SUBCUTANEOUS RLD 2016-01-28 3bdfa0b2c4d7…2022-11-12 20:34 UTC · 5 captures of this ZIP 2022-11 N208223-001 ZEMBRACE SYMTOUCH EQ 3MG BASE/0.5ML (EQ 3MG BASE/0.5ML) SOLUTION / SUBCUTANEOUS RLD 2016-01-28 3a93d1ddd44b…2022-10-28 04:53 UTC 2022-10 N208223-001 ZEMBRACE SYMTOUCH EQ 3MG BASE/0.5ML (EQ 3MG BASE/0.5ML) SOLUTION / SUBCUTANEOUS RLD 2016-01-28 f41ea6bd6efb…2022-09-29 23:25 UTC 2022-09 N208223-001 ZEMBRACE SYMTOUCH EQ 3MG BASE/0.5ML (EQ 3MG BASE/0.5ML) SOLUTION / SUBCUTANEOUS RLD 2016-01-28 e64feba35796…
Observed Orange Book patent history# Patent history page 1 of 2 · 77 observed states.
Captured, Edition, Application-product table Captured Edition Application-product Patent Expiration Use code Coverage / status Submission date Source SHA-256 2026-08-18 06:07:40 2026-07 N208223-001 10537554 2036-01-29 U-72 2020-01-21 caaa826d4ba7…2026-08-18 06:07:40 2026-07 N208223-001 11364224 2036-01-29 U-72 2022-06-21 caaa826d4ba7…2026-08-18 06:07:40 2026-07 N208223-001 12097183 2036-01-29 Drug product 2024-10-24 caaa826d4ba7…2026-02-19 14:30 UTC 2026-02 N208223-001 10537554 2036-01-29 U-72 2020-01-21 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 N208223-001 11364224 2036-01-29 U-72 2022-06-21 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 N208223-001 12097183 2036-01-29 Drug product 2024-10-24 011fe1cb6892…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 N208223-001 10537554 2036-01-29 U-72 2020-01-21 31067a03dcf5…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 N208223-001 11364224 2036-01-29 U-72 2022-06-21 31067a03dcf5…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 N208223-001 12097183 2036-01-29 Drug product 2024-10-24 31067a03dcf5…2025-08-23 18:47 UTC 2025-08 N208223-001 10537554 2036-01-29 U-72 2020-01-21 6a471c1ec25d…2025-08-23 18:47 UTC 2025-08 N208223-001 11364224 2036-01-29 U-72 2022-06-21 6a471c1ec25d…2025-08-23 18:47 UTC 2025-08 N208223-001 12097183 2036-01-29 Drug product 2024-10-24 6a471c1ec25d…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 N208223-001 10537554 2036-01-29 U-72 2020-01-21 fd3edfee7708…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 N208223-001 11364224 2036-01-29 U-72 2022-06-21 fd3edfee7708…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 N208223-001 12097183 2036-01-29 Drug product 2024-10-24 fd3edfee7708…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 N208223-001 10537554 2036-01-29 U-72 2020-01-21 b8a1b40f171c…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 N208223-001 11364224 2036-01-29 U-72 2022-06-21 b8a1b40f171c…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 N208223-001 12097183 2036-01-29 Drug product 2024-10-24 b8a1b40f171c…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 N208223-001 10537554 2036-01-29 U-72 2020-01-21 03ed91905a0d…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 N208223-001 11364224 2036-01-29 U-72 2022-06-21 03ed91905a0d…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 N208223-001 12097183 2036-01-29 Drug product 2024-10-24 03ed91905a0d…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 N208223-001 10537554 2036-01-29 U-72 2020-01-21 2680178bc6a6…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 N208223-001 11364224 2036-01-29 U-72 2022-06-21 2680178bc6a6…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 N208223-001 12097183 2036-01-29 Drug product 2024-10-24 2680178bc6a6…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 N208223-001 10537554 2036-01-29 U-72 2020-01-21 5bbf6a4d5a75…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 N208223-001 11364224 2036-01-29 U-72 2022-06-21 5bbf6a4d5a75…2024-11-08 22:44 UTC · 3 captures of this ZIP 2024-11 N208223-001 10537554 2036-01-29 U-72 2020-01-21 d8e5a09893c0…2024-11-08 22:44 UTC · 3 captures of this ZIP 2024-11 N208223-001 11364224 2036-01-29 U-72 2022-06-21 d8e5a09893c0…2024-11-08 22:44 UTC · 3 captures of this ZIP 2024-11 N208223-001 12097183 2036-01-29 Drug product 2024-10-24 d8e5a09893c0…2024-10-29 15:01 UTC 2024-10 N208223-001 10537554 2036-01-29 U-72 2020-01-21 d06236e962d9…2024-10-29 15:01 UTC 2024-10 N208223-001 11364224 2036-01-29 U-72 2022-06-21 d06236e962d9…2024-08-13 05:28 UTC · 3 captures of this ZIP 2024-08 N208223-001 10537554 2036-01-29 U-72 2020-01-21 79d66fd596c7…2024-08-13 05:28 UTC · 3 captures of this ZIP 2024-08 N208223-001 11364224 2036-01-29 U-72 2022-06-21 79d66fd596c7…2024-07-13 05:37 UTC · 2 captures of this ZIP 2024-07 N208223-001 10537554 2036-01-29 U-72 2020-01-21 301d65b070ca…2024-07-13 05:37 UTC · 2 captures of this ZIP 2024-07 N208223-001 11364224 2036-01-29 U-72 2022-06-21 301d65b070ca…2024-06-18 03:08 UTC · 5 captures of this ZIP 2024-06 N208223-001 10537554 2036-01-29 U-72 2020-01-21 1e350fbaab3a…2024-06-18 03:08 UTC · 5 captures of this ZIP 2024-06 N208223-001 11364224 2036-01-29 U-72 2022-06-21 1e350fbaab3a…2024-05-31 18:47 UTC 2024-05 N208223-001 10537554 2036-01-29 U-72 2020-01-21 8072bd15b7f6…2024-05-31 18:47 UTC 2024-05 N208223-001 11364224 2036-01-29 U-72 2022-06-21 8072bd15b7f6…2022-06-29 02:47 UTC · 2 captures of this ZIP 2022-06 N208223-001 10537554 2036-01-29 U-72 2020-01-21 5c6f7cd8ea54…
DailyMed Product Concepts# DailyMed Package Descriptions# Package NDC, Product, Description table Package NDC Product Description Form Quantity Strength SPL version 0245-0809-38 ZEMBRACE SYMTOUCH 4 in 1 CARTON INJECTION, SOLUTION 4 8 0245-0809-89 ZEMBRACE SYMTOUCH 1 in 1 SYRINGE INJECTION, SOLUTION 1 8
DailyMed Dashboard NDC Coverage# NDC, Dashboard title, SPL version table NDC Dashboard title SPL version Validation Dashboard ZIP 0245-0809 ZEMBRACE SYMTOUCH (SUMATRIPTAN SUCCINATE) INJECTION, SOLUTION [UPSHER-SMITH LABORATORIES, LLC] 7 Current NDC, Legacy NDC, 2 package rows 20241120_6e5b104f-2b9e-416e-92fb-ef1bdaea867d.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 1 · 2 matching rows.
DailyMed RxNorm Mappings# Packages# Package NDC, 11-digit format, Description table Package NDC 11-digit format Description Units Marketing start Marketing end Sample Exclude flag Status 0245-0809-38 00245080938 4 SYRINGE in 1 CARTON (0245-0809-38) / 1 INJECTION, SOLUTION in 1 SYRINGE (0245-0809-89) 4 syringe 2021-01-04 2026-08-31 No No Current 0245-0809-89 00245080989 1 in 1 SYRINGE Historical