Home NDC 50090-2372-0 Trazodone Hydrochloride
Product NDC 50090-2372
Requested package NDC 50090-2372-0
11-digit product format 500902372
Labeler code 50090
Product ID 50090-2372_865e3e33-8879-4937-891b-aaf7117e47e1
Type HUMAN PRESCRIPTION DRUG
Nonproprietary name Trazodone Hydrochloride
Dosage form TABLET
Route ORAL
Labeler A-S Medication Solutions
Application ANDA071258
Marketing category ANDA
Marketing start 2008-11-17
Marketing end 0000-00-00
Substance TRAZODONE HYDROCHLORIDE
Active strength 50 mg/1
Pharmacologic classes Serotonin Reuptake Inhibitor [EPC]
NDC exclude flag No
Listing certified through 2023-12-31
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 · 12 matching rows.
View current auxiliary records. · View the auxiliary file history.
Captured / source date, Snapshot, Source SHA-256 table Captured / source date Snapshot Source SHA-256 2025-12-14 17:58 UTC · source 2025-12-05 d630ba8d3edf…732f749b63fb…2025-08-27 00:01 UTC · source 2025-08-26 f5e01cc5f278…a2eaf40c39c3…2025-04-01 02:39 UTC · source 2025-03-31 2ef7874e63bc…57b86245f4fa…2025-03-28 20:22 UTC · source 2025-03-28 a1b67e2a42f9…c4cf2c586c0d…2025-03-22 03:12 UTC · source 2025-03-21 cfe11265f3b6…090c488252e2…2025-03-10 12:48 UTC · source 2025-03-10 cdf11ea48f46…ba0047e9e063…2025-02-02 03:52 UTC · source 2025-01-31 302b2466d912…e7b80fea0513…2025-01-20 13:05 UTC · source 2025-01-20 ed331223b511…672a5bd82f5f…2025-01-11 03:41 UTC · source 2025-01-10 0efc9e666f02…f202fb6c5f17…2024-11-09 02:27 UTC · source 2024-11-08 ad56d346431e…cc804d4bbf1e…2024-10-04 04:10 UTC · source 2024-10-03 367a005e9d99…383a685ebd0f…2024-07-10 04:00 UTC · source 2024-07-09 557ba5c1ecfa…9c80585c8c6e…
Source provenance: Browse the complete Orange Book source catalog · source snapshot 1 .
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 A071258-001 TRAZODONE HYDROCHLORIDE TRAZODONE HYDROCHLORIDE 50MG TABLET / ORAL AB 1987-03-25
Therapeutic equivalence codes# Current TE-code rows page 1 of 1 · 1 matching rows.
Application-product, TE code table Application-product TE code A071258-001 AB
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 · 41 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 2026-02-19 14:30 UTC 2026-02 A071258-001 TRAZODONE HYDROCHLORIDE 50MG TABLET / ORAL AB 1987-03-25 011fe1cb6892…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 A071258-001 TRAZODONE HYDROCHLORIDE 50MG TABLET / ORAL AB 1987-03-25 31067a03dcf5…2025-08-23 18:47 UTC 2025-08 A071258-001 TRAZODONE HYDROCHLORIDE 50MG TABLET / ORAL AB 1987-03-25 6a471c1ec25d…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 A071258-001 TRAZODONE HYDROCHLORIDE 50MG TABLET / ORAL AB 1987-03-25 fd3edfee7708…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 A071258-001 TRAZODONE HYDROCHLORIDE 50MG TABLET / ORAL AB 1987-03-25 b8a1b40f171c…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 A071258-001 TRAZODONE HYDROCHLORIDE 50MG TABLET / ORAL AB 1987-03-25 03ed91905a0d…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 A071258-001 TRAZODONE HYDROCHLORIDE 50MG TABLET / ORAL AB 1987-03-25 2680178bc6a6…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 A071258-001 TRAZODONE HYDROCHLORIDE 50MG TABLET / ORAL AB 1987-03-25 5bbf6a4d5a75…2024-11-08 22:44 UTC · 3 captures of this ZIP 2024-11 A071258-001 TRAZODONE HYDROCHLORIDE 50MG TABLET / ORAL AB 1987-03-25 d8e5a09893c0…2024-10-29 15:01 UTC 2024-10 A071258-001 TRAZODONE HYDROCHLORIDE 50MG TABLET / ORAL AB 1987-03-25 d06236e962d9…2024-08-13 05:28 UTC · 3 captures of this ZIP 2024-08 A071258-001 TRAZODONE HYDROCHLORIDE 50MG TABLET / ORAL AB 1987-03-25 79d66fd596c7…2024-07-13 05:37 UTC · 2 captures of this ZIP 2024-07 A071258-001 TRAZODONE HYDROCHLORIDE 50MG TABLET / ORAL AB 1987-03-25 301d65b070ca…2024-06-18 03:08 UTC · 5 captures of this ZIP 2024-06 A071258-001 TRAZODONE HYDROCHLORIDE 50MG TABLET / ORAL AB 1987-03-25 1e350fbaab3a…2024-05-31 18:47 UTC 2024-05 A071258-001 TRAZODONE HYDROCHLORIDE 50MG TABLET / ORAL AB 1987-03-25 8072bd15b7f6…2022-06-29 02:47 UTC · 2 captures of this ZIP 2022-06 A071258-001 TRAZODONE HYDROCHLORIDE 50MG TABLET / ORAL AB 1987-03-25 5c6f7cd8ea54…2022-04-08 23:34 UTC 2022-04 A071258-001 TRAZODONE HYDROCHLORIDE 50MG TABLET / ORAL AB 1987-03-25 5d02ea3f76ae…2022-04-04 05:41 UTC 2022-04 A071258-001 TRAZODONE HYDROCHLORIDE 50MG TABLET / ORAL AB 1987-03-25 4b0b4de00fa7…2019-12-13 00:20 UTC 2019-12 A071258-001 TRAZODONE HYDROCHLORIDE 50MG TABLET / ORAL AB 1987-03-25 74a2ff9319b5…2022-03-09 01:35 UTC 2022-03 A071258-001 TRAZODONE HYDROCHLORIDE 50MG TABLET / ORAL AB 1987-03-25 bb7c543d1eb4…2021-12-28 21:50 UTC 2021-12 A071258-001 TRAZODONE HYDROCHLORIDE 50MG TABLET / ORAL AB 1987-03-25 782e0a99824c…2021-05-05 16:15 UTC · 3 captures of this ZIP 2021-05 A071258-001 TRAZODONE HYDROCHLORIDE 50MG TABLET / ORAL AB 1987-03-25 87673890dc5c…2021-03-12 10:30 UTC 2021-03 A071258-001 TRAZODONE HYDROCHLORIDE 50MG TABLET / ORAL AB 1987-03-25 5aa47cf7b7d7…2020-12-22 03:56 UTC 2020-12 A071258-001 TRAZODONE HYDROCHLORIDE 50MG TABLET / ORAL AB 1987-03-25 8869cabd3fbd…2020-11-12 02:37 UTC 2020-11 A071258-001 TRAZODONE HYDROCHLORIDE 50MG TABLET / ORAL AB 1987-03-25 c0c555d07b60…2019-12-14 00:12 UTC 2019-12 A071258-001 TRAZODONE HYDROCHLORIDE 50MG TABLET / ORAL AB 1987-03-25 3f01610625f2…2019-09-15 20:21 UTC 2019-09 A071258-001 TRAZODONE HYDROCHLORIDE 50MG TABLET / ORAL AB 1987-03-25 b00525d2431f…2019-07-19 19:46 UTC 2019-07 A071258-001 TRAZODONE HYDROCHLORIDE 50MG TABLET / ORAL AB 1987-03-25 ea99ee380514…2024-03-16 18:09 UTC · 4 captures of this ZIP 2024-03 A071258-001 TRAZODONE HYDROCHLORIDE 50MG TABLET / ORAL AB 1987-03-25 6a51e52b5d6a…2024-02-18 07:12 UTC 2024-02 A071258-001 TRAZODONE HYDROCHLORIDE 50MG TABLET / ORAL AB 1987-03-25 1c564ffb4f44…2023-12-20 04:57 UTC 2023-12 A071258-001 TRAZODONE HYDROCHLORIDE 50MG TABLET / ORAL AB 1987-03-25 ea1830bbd6c7…2023-11-28 05:40 UTC · 2 captures of this ZIP 2023-11 A071258-001 TRAZODONE HYDROCHLORIDE 50MG TABLET / ORAL AB 1987-03-25 a72a2bbeb626…2023-10-25 00:34 UTC · 2 captures of this ZIP 2023-10 A071258-001 TRAZODONE HYDROCHLORIDE 50MG TABLET / ORAL AB 1987-03-25 9b2671bbb829…2023-07-15 15:27 UTC · 2 captures of this ZIP 2023-07 A071258-001 TRAZODONE HYDROCHLORIDE 50MG TABLET / ORAL AB 1987-03-25 a67488948f0b…2023-06-13 01:57 UTC · 3 captures of this ZIP 2023-06 A071258-001 TRAZODONE HYDROCHLORIDE 50MG TABLET / ORAL AB 1987-03-25 3f0d92c62455…2023-05-13 08:27 UTC 2023-05 A071258-001 TRAZODONE HYDROCHLORIDE 50MG TABLET / ORAL AB 1987-03-25 053a50430f4f…2023-01-26 05:58 UTC 2023-01 A071258-001 TRAZODONE HYDROCHLORIDE 50MG TABLET / ORAL AB 1987-03-25 3bdfa0b2c4d7…2022-11-12 20:34 UTC · 5 captures of this ZIP 2022-11 A071258-001 TRAZODONE HYDROCHLORIDE 50MG TABLET / ORAL AB 1987-03-25 3a93d1ddd44b…2022-10-28 04:53 UTC 2022-10 A071258-001 TRAZODONE HYDROCHLORIDE 50MG TABLET / ORAL AB 1987-03-25 f41ea6bd6efb…2022-09-29 23:25 UTC 2022-09 A071258-001 TRAZODONE HYDROCHLORIDE 50MG TABLET / ORAL AB 1987-03-25 e64feba35796…2022-07-09 03:26 UTC · 3 captures of this ZIP 2022-07 A071258-001 TRAZODONE HYDROCHLORIDE 50MG TABLET / ORAL AB 1987-03-25 cb3db0bc1861…
Observed Orange Book normalized TE history# Normalized TE history page 1 of 2 · 41 observed states.
FDA-Initiated Inactive NDC Indexing# NDC, Effective, Related label table NDC Effective Related label 50090-2372-0 2020-02-17 These highlights do not include all the information needed to use TRAZODONE HYDROCHLORIDE TABLETS safely and effectively. See full prescribing information for TRAZODONE HYDROCHLORIDE TABLETS. TRAZODONE HYDROCHLORIDE tablets, for oral use Initial U.S. Approval: 1981 50090-2372-1 2020-02-17 These highlights do not include all the information needed to use TRAZODONE HYDROCHLORIDE TABLETS safely and effectively. See full prescribing information for TRAZODONE HYDROCHLORIDE TABLETS. TRAZODONE HYDROCHLORIDE tablets, for oral use Initial U.S. Approval: 1981 50090-2372-6 2020-02-17 These highlights do not include all the information needed to use TRAZODONE HYDROCHLORIDE TABLETS safely and effectively. See full prescribing information for TRAZODONE HYDROCHLORIDE TABLETS. TRAZODONE HYDROCHLORIDE tablets, for oral use Initial U.S. Approval: 1981 50090-2372-8 2020-02-17 These highlights do not include all the information needed to use TRAZODONE HYDROCHLORIDE TABLETS safely and effectively. See full prescribing information for TRAZODONE HYDROCHLORIDE TABLETS. TRAZODONE HYDROCHLORIDE tablets, for oral use Initial U.S. Approval: 1981 50090-2372-9 2020-02-17 These highlights do not include all the information needed to use TRAZODONE HYDROCHLORIDE TABLETS safely and effectively. See full prescribing information for TRAZODONE HYDROCHLORIDE TABLETS. TRAZODONE HYDROCHLORIDE tablets, for oral use Initial U.S. Approval: 1981 50090-2372-0 2020-01-31 These highlights do not include all the information needed to use TRAZODONE HYDROCHLORIDE TABLETS safely and effectively. See full prescribing information for TRAZODONE HYDROCHLORIDE TABLETS. TRAZODONE HYDROCHLORIDE tablets, for oral use Initial U.S. Approval: 1981 50090-2372-1 2020-01-31 These highlights do not include all the information needed to use TRAZODONE HYDROCHLORIDE TABLETS safely and effectively. See full prescribing information for TRAZODONE HYDROCHLORIDE TABLETS. TRAZODONE HYDROCHLORIDE tablets, for oral use Initial U.S. Approval: 1981 50090-2372-6 2020-01-31 These highlights do not include all the information needed to use TRAZODONE HYDROCHLORIDE TABLETS safely and effectively. See full prescribing information for TRAZODONE HYDROCHLORIDE TABLETS. TRAZODONE HYDROCHLORIDE tablets, for oral use Initial U.S. Approval: 1981 50090-2372-8 2020-01-31 These highlights do not include all the information needed to use TRAZODONE HYDROCHLORIDE TABLETS safely and effectively. See full prescribing information for TRAZODONE HYDROCHLORIDE TABLETS. TRAZODONE HYDROCHLORIDE tablets, for oral use Initial U.S. Approval: 1981 50090-2372-9 2020-01-31 These highlights do not include all the information needed to use TRAZODONE HYDROCHLORIDE TABLETS safely and effectively. See full prescribing information for TRAZODONE HYDROCHLORIDE TABLETS. TRAZODONE HYDROCHLORIDE tablets, for oral use Initial U.S. Approval: 1981
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.
Packages# Package NDC, 11-digit format, Description table Package NDC 11-digit format Description Units Marketing start Marketing end Sample Exclude flag Status 50090-2372-0 50090237200 30 TABLET in 1 BOTTLE (50090-2372-0) 30 tablet 2016-04-26 0000-00-00 No No Current