Home NDC 60505-4089 Trazodone Hydrochloride
Product NDC 60505-4089
11-digit product format 605054089
Labeler code 60505
Product ID 60505-4089_a014d870-1a59-8026-826e-7acd952b4478
Type HUMAN PRESCRIPTION DRUG
Nonproprietary name Trazodone Hydrochloride
Dosage form TABLET
Route ORAL
Labeler Apotex Corp
Application ANDA071196
Marketing category ANDA
Marketing start 2014-12-31
Marketing end 0000-00-00
Substance TRAZODONE HYDROCHLORIDE
Active strength 150 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 · 24 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 60505-4089-3 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 60505-4089-3 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 60505-4089-3 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 60505-4089-3 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 60505-4089-3 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 60505-4089-3 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 60505-4089-3 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 60505-4089-3 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 60505-4089-3 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 60505-4089-3 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 60505-4089-3 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 60505-4089-3 557ba5c1ecfa…9c80585c8c6e…
Source provenance: Browse the complete Orange Book source catalog · source snapshot 42 .
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 A071196-001 TRAZODONE HYDROCHLORIDE TRAZODONE HYDROCHLORIDE 100MG TABLET / ORAL AB RS 1987-03-25 A071196-002 TRAZODONE HYDROCHLORIDE TRAZODONE HYDROCHLORIDE 150MG TABLET / ORAL AB 1999-04-26 A071196-003 TRAZODONE HYDROCHLORIDE TRAZODONE HYDROCHLORIDE 300MG TABLET / ORAL AB 1999-04-26
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 · 126 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 A071196-001 TRAZODONE HYDROCHLORIDE 100MG TABLET / ORAL AB RS 1987-03-25 caaa826d4ba7…2026-08-18 06:07:40 2026-07 A071196-002 TRAZODONE HYDROCHLORIDE 150MG TABLET / ORAL AB 1999-04-26 caaa826d4ba7…2026-08-18 06:07:40 2026-07 A071196-003 TRAZODONE HYDROCHLORIDE 300MG TABLET / ORAL AB 1999-04-26 caaa826d4ba7…2026-02-19 14:30 UTC 2026-02 A071196-001 TRAZODONE HYDROCHLORIDE 100MG TABLET / ORAL AB RS 1987-03-25 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 A071196-002 TRAZODONE HYDROCHLORIDE 150MG TABLET / ORAL AB 1999-04-26 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 A071196-003 TRAZODONE HYDROCHLORIDE 300MG TABLET / ORAL AB 1999-04-26 011fe1cb6892…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 A071196-001 TRAZODONE HYDROCHLORIDE 100MG TABLET / ORAL AB RS 1987-03-25 31067a03dcf5…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 A071196-002 TRAZODONE HYDROCHLORIDE 150MG TABLET / ORAL AB 1999-04-26 31067a03dcf5…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 A071196-003 TRAZODONE HYDROCHLORIDE 300MG TABLET / ORAL AB 1999-04-26 31067a03dcf5…2025-08-23 18:47 UTC 2025-08 A071196-001 TRAZODONE HYDROCHLORIDE 100MG TABLET / ORAL AB RS 1987-03-25 6a471c1ec25d…2025-08-23 18:47 UTC 2025-08 A071196-002 TRAZODONE HYDROCHLORIDE 150MG TABLET / ORAL AB 1999-04-26 6a471c1ec25d…2025-08-23 18:47 UTC 2025-08 A071196-003 TRAZODONE HYDROCHLORIDE 300MG TABLET / ORAL AB 1999-04-26 6a471c1ec25d…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 A071196-001 TRAZODONE HYDROCHLORIDE 100MG TABLET / ORAL AB RS 1987-03-25 fd3edfee7708…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 A071196-002 TRAZODONE HYDROCHLORIDE 150MG TABLET / ORAL AB 1999-04-26 fd3edfee7708…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 A071196-003 TRAZODONE HYDROCHLORIDE 300MG TABLET / ORAL AB 1999-04-26 fd3edfee7708…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 A071196-001 TRAZODONE HYDROCHLORIDE 100MG TABLET / ORAL AB RS 1987-03-25 b8a1b40f171c…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 A071196-002 TRAZODONE HYDROCHLORIDE 150MG TABLET / ORAL AB 1999-04-26 b8a1b40f171c…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 A071196-003 TRAZODONE HYDROCHLORIDE 300MG TABLET / ORAL AB 1999-04-26 b8a1b40f171c…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 A071196-001 TRAZODONE HYDROCHLORIDE 100MG TABLET / ORAL AB RS 1987-03-25 03ed91905a0d…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 A071196-002 TRAZODONE HYDROCHLORIDE 150MG TABLET / ORAL AB 1999-04-26 03ed91905a0d…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 A071196-003 TRAZODONE HYDROCHLORIDE 300MG TABLET / ORAL AB 1999-04-26 03ed91905a0d…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 A071196-001 TRAZODONE HYDROCHLORIDE 100MG TABLET / ORAL AB RS 1987-03-25 2680178bc6a6…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 A071196-002 TRAZODONE HYDROCHLORIDE 150MG TABLET / ORAL AB 1999-04-26 2680178bc6a6…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 A071196-003 TRAZODONE HYDROCHLORIDE 300MG TABLET / ORAL AB 1999-04-26 2680178bc6a6…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 A071196-001 TRAZODONE HYDROCHLORIDE 100MG TABLET / ORAL AB RS 1987-03-25 5bbf6a4d5a75…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 A071196-002 TRAZODONE HYDROCHLORIDE 150MG TABLET / ORAL AB 1999-04-26 5bbf6a4d5a75…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 A071196-003 TRAZODONE HYDROCHLORIDE 300MG TABLET / ORAL AB 1999-04-26 5bbf6a4d5a75…2024-11-08 22:44 UTC · 3 captures of this ZIP 2024-11 A071196-001 TRAZODONE HYDROCHLORIDE 100MG TABLET / ORAL AB RS 1987-03-25 d8e5a09893c0…2024-11-08 22:44 UTC · 3 captures of this ZIP 2024-11 A071196-002 TRAZODONE HYDROCHLORIDE 150MG TABLET / ORAL AB 1999-04-26 d8e5a09893c0…2024-11-08 22:44 UTC · 3 captures of this ZIP 2024-11 A071196-003 TRAZODONE HYDROCHLORIDE 300MG TABLET / ORAL AB 1999-04-26 d8e5a09893c0…2024-10-29 15:01 UTC 2024-10 A071196-001 TRAZODONE HYDROCHLORIDE 100MG TABLET / ORAL AB RS 1987-03-25 d06236e962d9…2024-10-29 15:01 UTC 2024-10 A071196-002 TRAZODONE HYDROCHLORIDE 150MG TABLET / ORAL AB 1999-04-26 d06236e962d9…2024-10-29 15:01 UTC 2024-10 A071196-003 TRAZODONE HYDROCHLORIDE 300MG TABLET / ORAL AB 1999-04-26 d06236e962d9…2024-08-13 05:28 UTC · 3 captures of this ZIP 2024-08 A071196-001 TRAZODONE HYDROCHLORIDE 100MG TABLET / ORAL AB RS 1987-03-25 79d66fd596c7…2024-08-13 05:28 UTC · 3 captures of this ZIP 2024-08 A071196-002 TRAZODONE HYDROCHLORIDE 150MG TABLET / ORAL AB 1999-04-26 79d66fd596c7…2024-08-13 05:28 UTC · 3 captures of this ZIP 2024-08 A071196-003 TRAZODONE HYDROCHLORIDE 300MG TABLET / ORAL AB 1999-04-26 79d66fd596c7…2024-07-13 05:37 UTC · 2 captures of this ZIP 2024-07 A071196-001 TRAZODONE HYDROCHLORIDE 100MG TABLET / ORAL AB RS 1987-03-25 301d65b070ca…2024-07-13 05:37 UTC · 2 captures of this ZIP 2024-07 A071196-002 TRAZODONE HYDROCHLORIDE 150MG TABLET / ORAL AB 1999-04-26 301d65b070ca…2024-07-13 05:37 UTC · 2 captures of this ZIP 2024-07 A071196-003 TRAZODONE HYDROCHLORIDE 300MG TABLET / ORAL AB 1999-04-26 301d65b070ca…2024-06-18 03:08 UTC · 5 captures of this ZIP 2024-06 A071196-001 TRAZODONE HYDROCHLORIDE 100MG TABLET / ORAL AB RS 1987-03-25 1e350fbaab3a…
Observed Orange Book normalized TE history# Normalized TE history page 1 of 4 · 126 observed states.
DailyMed Product Concepts# DailyMed Package Descriptions# Package NDC, Product, Description table Package NDC Product Description Form Quantity Strength SPL version 60505-4089-3 Trazodone Hydrochloride 12 in 1 CARTON TABLET 12 22 60505-4089-3 Trazodone Hydrochloride 30 in 1 BOTTLE, DISPENSING TABLET 30 22
DailyMed Socrata Ingredients# DailyMed Dashboard NDC Coverage# NDC, Dashboard title, SPL version table NDC Dashboard title SPL version Validation Dashboard ZIP 60505-4089 TRAZODONE HYDROCHLORIDE TABLET [APOTEX CORP] 20 Legacy NDC, 2 package rows 20250322_71961ab1-951d-1493-f76c-2ff25cca2a85.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 · 4 matching rows.
Brand, Generic, Manufacturer table Brand Generic Manufacturer SPL set ID Effective date Available safety fields Join Trazodone Hydrochloride TRAZODONE HYDROCHLORIDE REMEDYREPACK INC. dc1f347e-1acb-4c06-b36e-f15fecb7ac93 2026-08-07 Boxed warning, Warnings, Adverse reactions Exact identifier application applno (ANDA): 071196 application number: ANDA071196 Trazodone Hydrochloride TRAZODONE HYDROCHLORIDE Apotex Corp 71961ab1-951d-1493-f76c-2ff25cca2a85 2026-03-24 Boxed warning, Warnings, Adverse reactions Exact identifier application applno (ANDA): 071196 application number: ANDA071196 ndc (product): 60505-4089 Trazodone Hydrochloride TRAZODONE HYDROCHLORIDE Aphena Pharma Solutions - Tennessee, LLC 5d22a06c-9cb8-4b49-8d67-769d181ad70c 2021-03-10 Boxed warning, Warnings, Adverse reactions Exact identifier application applno (ANDA): 071196 application number: ANDA071196 Trazodone Hydrochloride TRAZODONE HYDROCHLORIDE Teva Pharmaceuticals USA, Inc. 9c4da6ad-d4d1-4e8c-918d-8ac48512a93f 2020-06-30 Boxed warning, Warnings, Adverse reactions Exact identifier application applno (ANDA): 071196 application number: ANDA071196
DailyMed RxNorm Mappings# Packages# Package NDC, 11-digit format, Description table Package NDC 11-digit format Description Marketing start Marketing end Sample Exclude flag Status 60505-4089-3 60505408903 12 BOTTLE, DISPENSING in 1 CARTON (60505-4089-3) > 30 TABLET in 1 BOTTLE, DISPENSING 2014-12-31 0000-00-00 No No Current