Home NDC 61919-386-90 TRAZODONE HYDROCHLORIDE
Product NDC 61919-386
Requested package NDC 61919-386-90
11-digit product format 619190386
Labeler code 61919
Product ID 61919-386_875b4218-beb7-c7c2-e053-2995a90a897b
Type HUMAN PRESCRIPTION DRUG
Nonproprietary name TRAZODONE HYDROCHLORIDE
Dosage form TABLET, FILM COATED
Route ORAL
Labeler DIRECT RX
Application ANDA072192
Marketing category ANDA
Marketing start 2019-04-25
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 2020-12-31
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 · 15 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…2024-05-28 21:12 UTC · source 2024-05-28 8af77b9d5b6f…d9bbb34c5368…2024-05-15 03:39 UTC · source 2024-05-14 834df4deac94…adcc014656a3…2024-03-11 06:39 UTC · source 2024-03-08 1332a3947898…d4bfe170f9cd…
Source provenance: Browse the complete Orange Book source catalog · source snapshot 43 .
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 A072192-001 TRAZODONE HYDROCHLORIDE TRAZODONE HYDROCHLORIDE 50MG TABLET / ORAL AB 1989-02-02
Therapeutic equivalence codes# Current TE-code rows page 1 of 1 · 1 matching rows.
Application-product, TE code table Application-product TE code A072192-001 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 · 43 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 A072192-001 TRAZODONE HYDROCHLORIDE 50MG TABLET / ORAL AB 1989-02-02 84e616aacf4f…2026-08-18 06:07:40 2026-07 A072192-001 TRAZODONE HYDROCHLORIDE 50MG TABLET / ORAL AB 1989-02-02 caaa826d4ba7…2026-02-19 14:30 UTC 2026-02 A072192-001 TRAZODONE HYDROCHLORIDE 50MG TABLET / ORAL AB 1989-02-02 011fe1cb6892…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 A072192-001 TRAZODONE HYDROCHLORIDE 50MG TABLET / ORAL AB 1989-02-02 31067a03dcf5…2025-08-23 18:47 UTC 2025-08 A072192-001 TRAZODONE HYDROCHLORIDE 50MG TABLET / ORAL AB 1989-02-02 6a471c1ec25d…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 A072192-001 TRAZODONE HYDROCHLORIDE 50MG TABLET / ORAL AB 1989-02-02 fd3edfee7708…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 A072192-001 TRAZODONE HYDROCHLORIDE 50MG TABLET / ORAL AB 1989-02-02 b8a1b40f171c…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 A072192-001 TRAZODONE HYDROCHLORIDE 50MG TABLET / ORAL AB 1989-02-02 03ed91905a0d…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 A072192-001 TRAZODONE HYDROCHLORIDE 50MG TABLET / ORAL AB 1989-02-02 2680178bc6a6…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 A072192-001 TRAZODONE HYDROCHLORIDE 50MG TABLET / ORAL AB 1989-02-02 5bbf6a4d5a75…2024-11-08 22:44 UTC · 3 captures of this ZIP 2024-11 A072192-001 TRAZODONE HYDROCHLORIDE 50MG TABLET / ORAL AB 1989-02-02 d8e5a09893c0…2024-10-29 15:01 UTC 2024-10 A072192-001 TRAZODONE HYDROCHLORIDE 50MG TABLET / ORAL AB 1989-02-02 d06236e962d9…2024-08-13 05:28 UTC · 3 captures of this ZIP 2024-08 A072192-001 TRAZODONE HYDROCHLORIDE 50MG TABLET / ORAL AB 1989-02-02 79d66fd596c7…2024-07-13 05:37 UTC · 2 captures of this ZIP 2024-07 A072192-001 TRAZODONE HYDROCHLORIDE 50MG TABLET / ORAL AB 1989-02-02 301d65b070ca…2024-06-18 03:08 UTC · 5 captures of this ZIP 2024-06 A072192-001 TRAZODONE HYDROCHLORIDE 50MG TABLET / ORAL AB 1989-02-02 1e350fbaab3a…2024-05-31 18:47 UTC 2024-05 A072192-001 TRAZODONE HYDROCHLORIDE 50MG TABLET / ORAL AB 1989-02-02 8072bd15b7f6…2022-06-29 02:47 UTC · 2 captures of this ZIP 2022-06 A072192-001 TRAZODONE HYDROCHLORIDE 50MG TABLET / ORAL AB 1989-02-02 5c6f7cd8ea54…2022-04-08 23:34 UTC 2022-04 A072192-001 TRAZODONE HYDROCHLORIDE 50MG TABLET / ORAL AB 1989-02-02 5d02ea3f76ae…2022-04-04 05:41 UTC 2022-04 A072192-001 TRAZODONE HYDROCHLORIDE 50MG TABLET / ORAL AB 1989-02-02 4b0b4de00fa7…2019-12-13 00:20 UTC 2019-12 A072192-001 TRAZODONE HYDROCHLORIDE 50MG TABLET / ORAL AB 1989-02-02 74a2ff9319b5…2022-03-09 01:35 UTC 2022-03 A072192-001 TRAZODONE HYDROCHLORIDE 50MG TABLET / ORAL AB 1989-02-02 bb7c543d1eb4…2021-12-28 21:50 UTC 2021-12 A072192-001 TRAZODONE HYDROCHLORIDE 50MG TABLET / ORAL AB 1989-02-02 782e0a99824c…2021-05-05 16:15 UTC · 3 captures of this ZIP 2021-05 A072192-001 TRAZODONE HYDROCHLORIDE 50MG TABLET / ORAL AB 1989-02-02 87673890dc5c…2021-03-12 10:30 UTC 2021-03 A072192-001 TRAZODONE HYDROCHLORIDE 50MG TABLET / ORAL AB 1989-02-02 5aa47cf7b7d7…2020-12-22 03:56 UTC 2020-12 A072192-001 TRAZODONE HYDROCHLORIDE 50MG TABLET / ORAL AB 1989-02-02 8869cabd3fbd…2020-11-12 02:37 UTC 2020-11 A072192-001 TRAZODONE HYDROCHLORIDE 50MG TABLET / ORAL AB 1989-02-02 c0c555d07b60…2019-12-14 00:12 UTC 2019-12 A072192-001 TRAZODONE HYDROCHLORIDE 50MG TABLET / ORAL AB 1989-02-02 3f01610625f2…2019-09-15 20:21 UTC 2019-09 A072192-001 TRAZODONE HYDROCHLORIDE 50MG TABLET / ORAL AB 1989-02-02 b00525d2431f…2019-07-19 19:46 UTC 2019-07 A072192-001 TRAZODONE HYDROCHLORIDE 50MG TABLET / ORAL AB 1989-02-02 ea99ee380514…2024-03-16 18:09 UTC · 4 captures of this ZIP 2024-03 A072192-001 TRAZODONE HYDROCHLORIDE 50MG TABLET / ORAL AB 1989-02-02 6a51e52b5d6a…2024-02-18 07:12 UTC 2024-02 A072192-001 TRAZODONE HYDROCHLORIDE 50MG TABLET / ORAL AB 1989-02-02 1c564ffb4f44…2023-12-20 04:57 UTC 2023-12 A072192-001 TRAZODONE HYDROCHLORIDE 50MG TABLET / ORAL AB 1989-02-02 ea1830bbd6c7…2023-11-28 05:40 UTC · 2 captures of this ZIP 2023-11 A072192-001 TRAZODONE HYDROCHLORIDE 50MG TABLET / ORAL AB 1989-02-02 a72a2bbeb626…2023-10-25 00:34 UTC · 2 captures of this ZIP 2023-10 A072192-001 TRAZODONE HYDROCHLORIDE 50MG TABLET / ORAL AB 1989-02-02 9b2671bbb829…2023-07-15 15:27 UTC · 2 captures of this ZIP 2023-07 A072192-001 TRAZODONE HYDROCHLORIDE 50MG TABLET / ORAL AB 1989-02-02 a67488948f0b…2023-06-13 01:57 UTC · 3 captures of this ZIP 2023-06 A072192-001 TRAZODONE HYDROCHLORIDE 50MG TABLET / ORAL AB 1989-02-02 3f0d92c62455…2023-05-13 08:27 UTC 2023-05 A072192-001 TRAZODONE HYDROCHLORIDE 50MG TABLET / ORAL AB 1989-02-02 053a50430f4f…2023-01-26 05:58 UTC 2023-01 A072192-001 TRAZODONE HYDROCHLORIDE 50MG TABLET / ORAL AB 1989-02-02 3bdfa0b2c4d7…2022-11-12 20:34 UTC · 5 captures of this ZIP 2022-11 A072192-001 TRAZODONE HYDROCHLORIDE 50MG TABLET / ORAL AB 1989-02-02 3a93d1ddd44b…2022-10-28 04:53 UTC 2022-10 A072192-001 TRAZODONE HYDROCHLORIDE 50MG TABLET / ORAL AB 1989-02-02 f41ea6bd6efb…
Observed Orange Book normalized TE history# Normalized TE history page 1 of 2 · 43 observed states.
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 61919-386-90 TRAZODONE HYDROCHLORIDE 90 in 1 BOTTLE TABLET, FILM COATED 90 3
DailyMed Dashboard NDC Coverage# NDC, Dashboard title, SPL version table NDC Dashboard title SPL version Validation Dashboard ZIP 61919-386 TRAZODONE HYDROCHLORIDE TABLET TRAZODONE HYDROCHLORIDE TABLET, FILM COATED [DIRECT RX] 3 Legacy NDC, 1 package rows 20190425_66da652a-72b4-c17f-e053-2a91aa0a8d69.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 · 1 matching rows.
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 61919-386-90 61919038690 90 TABLET, FILM COATED in 1 BOTTLE (61919-386-90) 2019-04-25 0000-00-00 No No Current