Home NDC 63187-377 Trazodone Hydrochloride
Product NDC 63187-377
11-digit product format 631870377
Labeler code 63187
Product ID 63187-377_e105235b-f15a-4154-a420-0bb77657d781
Type HUMAN PRESCRIPTION DRUG
Nonproprietary name Trazodone Hydrochloride
Dosage form TABLET, FILM COATED
Route ORAL
Labeler Proficient Rx LP
Application ANDA072193
Marketing category ANDA
Marketing start 2010-05-30
Marketing end 0000-00-00
Substance TRAZODONE HYDROCHLORIDE
Active strength 100 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 · 8 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 63187-377-90 d630ba8d3edf…732f749b63fb…2025-12-14 17:58 UTC · source 2025-12-05 excluded package package 63187-377-30 d630ba8d3edf…732f749b63fb…2025-12-14 17:58 UTC · source 2025-12-05 excluded package package 63187-377-60 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 63187-377-90 f5e01cc5f278…a2eaf40c39c3…2025-08-27 00:01 UTC · source 2025-08-26 excluded package package 63187-377-30 f5e01cc5f278…a2eaf40c39c3…2025-08-27 00:01 UTC · source 2025-08-26 excluded package package 63187-377-60 f5e01cc5f278…a2eaf40c39c3…
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 A072193-001 TRAZODONE HYDROCHLORIDE TRAZODONE HYDROCHLORIDE 100MG 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 A072193-001 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 · 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 A072193-001 TRAZODONE HYDROCHLORIDE 100MG TABLET / ORAL AB 1989-02-02 caaa826d4ba7…2026-02-19 14:30 UTC 2026-02 A072193-001 TRAZODONE HYDROCHLORIDE 100MG TABLET / ORAL AB 1989-02-02 011fe1cb6892…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 A072193-001 TRAZODONE HYDROCHLORIDE 100MG TABLET / ORAL AB 1989-02-02 31067a03dcf5…2025-08-23 18:47 UTC 2025-08 A072193-001 TRAZODONE HYDROCHLORIDE 100MG TABLET / ORAL AB 1989-02-02 6a471c1ec25d…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 A072193-001 TRAZODONE HYDROCHLORIDE 100MG TABLET / ORAL AB 1989-02-02 fd3edfee7708…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 A072193-001 TRAZODONE HYDROCHLORIDE 100MG TABLET / ORAL AB 1989-02-02 b8a1b40f171c…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 A072193-001 TRAZODONE HYDROCHLORIDE 100MG TABLET / ORAL AB 1989-02-02 03ed91905a0d…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 A072193-001 TRAZODONE HYDROCHLORIDE 100MG TABLET / ORAL AB 1989-02-02 2680178bc6a6…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 A072193-001 TRAZODONE HYDROCHLORIDE 100MG TABLET / ORAL AB 1989-02-02 5bbf6a4d5a75…2024-11-08 22:44 UTC · 3 captures of this ZIP 2024-11 A072193-001 TRAZODONE HYDROCHLORIDE 100MG TABLET / ORAL AB 1989-02-02 d8e5a09893c0…2024-10-29 15:01 UTC 2024-10 A072193-001 TRAZODONE HYDROCHLORIDE 100MG TABLET / ORAL AB 1989-02-02 d06236e962d9…2024-08-13 05:28 UTC · 3 captures of this ZIP 2024-08 A072193-001 TRAZODONE HYDROCHLORIDE 100MG TABLET / ORAL AB 1989-02-02 79d66fd596c7…2024-07-13 05:37 UTC · 2 captures of this ZIP 2024-07 A072193-001 TRAZODONE HYDROCHLORIDE 100MG TABLET / ORAL AB 1989-02-02 301d65b070ca…2024-06-18 03:08 UTC · 5 captures of this ZIP 2024-06 A072193-001 TRAZODONE HYDROCHLORIDE 100MG TABLET / ORAL AB 1989-02-02 1e350fbaab3a…2024-05-31 18:47 UTC 2024-05 A072193-001 TRAZODONE HYDROCHLORIDE 100MG TABLET / ORAL AB 1989-02-02 8072bd15b7f6…2022-06-29 02:47 UTC · 2 captures of this ZIP 2022-06 A072193-001 TRAZODONE HYDROCHLORIDE 100MG TABLET / ORAL AB 1989-02-02 5c6f7cd8ea54…2022-04-08 23:34 UTC 2022-04 A072193-001 TRAZODONE HYDROCHLORIDE 100MG TABLET / ORAL AB 1989-02-02 5d02ea3f76ae…2022-04-04 05:41 UTC 2022-04 A072193-001 TRAZODONE HYDROCHLORIDE 100MG TABLET / ORAL AB 1989-02-02 4b0b4de00fa7…2019-12-13 00:20 UTC 2019-12 A072193-001 TRAZODONE HYDROCHLORIDE 100MG TABLET / ORAL AB 1989-02-02 74a2ff9319b5…2022-03-09 01:35 UTC 2022-03 A072193-001 TRAZODONE HYDROCHLORIDE 100MG TABLET / ORAL AB 1989-02-02 bb7c543d1eb4…2021-12-28 21:50 UTC 2021-12 A072193-001 TRAZODONE HYDROCHLORIDE 100MG TABLET / ORAL AB 1989-02-02 782e0a99824c…2021-05-05 16:15 UTC · 3 captures of this ZIP 2021-05 A072193-001 TRAZODONE HYDROCHLORIDE 100MG TABLET / ORAL AB 1989-02-02 87673890dc5c…2021-03-12 10:30 UTC 2021-03 A072193-001 TRAZODONE HYDROCHLORIDE 100MG TABLET / ORAL AB 1989-02-02 5aa47cf7b7d7…2020-12-22 03:56 UTC 2020-12 A072193-001 TRAZODONE HYDROCHLORIDE 100MG TABLET / ORAL AB 1989-02-02 8869cabd3fbd…2020-11-12 02:37 UTC 2020-11 A072193-001 TRAZODONE HYDROCHLORIDE 100MG TABLET / ORAL AB 1989-02-02 c0c555d07b60…2019-12-14 00:12 UTC 2019-12 A072193-001 TRAZODONE HYDROCHLORIDE 100MG TABLET / ORAL AB 1989-02-02 3f01610625f2…2019-09-15 20:21 UTC 2019-09 A072193-001 TRAZODONE HYDROCHLORIDE 100MG TABLET / ORAL AB 1989-02-02 b00525d2431f…2019-07-19 19:46 UTC 2019-07 A072193-001 TRAZODONE HYDROCHLORIDE 100MG TABLET / ORAL AB 1989-02-02 ea99ee380514…2024-03-16 18:09 UTC · 4 captures of this ZIP 2024-03 A072193-001 TRAZODONE HYDROCHLORIDE 100MG TABLET / ORAL AB 1989-02-02 6a51e52b5d6a…2024-02-18 07:12 UTC 2024-02 A072193-001 TRAZODONE HYDROCHLORIDE 100MG TABLET / ORAL AB 1989-02-02 1c564ffb4f44…2023-12-20 04:57 UTC 2023-12 A072193-001 TRAZODONE HYDROCHLORIDE 100MG TABLET / ORAL AB 1989-02-02 ea1830bbd6c7…2023-11-28 05:40 UTC · 2 captures of this ZIP 2023-11 A072193-001 TRAZODONE HYDROCHLORIDE 100MG TABLET / ORAL AB 1989-02-02 a72a2bbeb626…2023-10-25 00:34 UTC · 2 captures of this ZIP 2023-10 A072193-001 TRAZODONE HYDROCHLORIDE 100MG TABLET / ORAL AB 1989-02-02 9b2671bbb829…2023-07-15 15:27 UTC · 2 captures of this ZIP 2023-07 A072193-001 TRAZODONE HYDROCHLORIDE 100MG TABLET / ORAL AB 1989-02-02 a67488948f0b…2023-06-13 01:57 UTC · 3 captures of this ZIP 2023-06 A072193-001 TRAZODONE HYDROCHLORIDE 100MG TABLET / ORAL AB 1989-02-02 3f0d92c62455…2023-05-13 08:27 UTC 2023-05 A072193-001 TRAZODONE HYDROCHLORIDE 100MG TABLET / ORAL AB 1989-02-02 053a50430f4f…2023-01-26 05:58 UTC 2023-01 A072193-001 TRAZODONE HYDROCHLORIDE 100MG TABLET / ORAL AB 1989-02-02 3bdfa0b2c4d7…2022-11-12 20:34 UTC · 5 captures of this ZIP 2022-11 A072193-001 TRAZODONE HYDROCHLORIDE 100MG TABLET / ORAL AB 1989-02-02 3a93d1ddd44b…2022-10-28 04:53 UTC 2022-10 A072193-001 TRAZODONE HYDROCHLORIDE 100MG TABLET / ORAL AB 1989-02-02 f41ea6bd6efb…2022-09-29 23:25 UTC 2022-09 A072193-001 TRAZODONE HYDROCHLORIDE 100MG TABLET / ORAL AB 1989-02-02 e64feba35796…
Observed Orange Book normalized TE history# Normalized TE history page 1 of 2 · 42 observed states.
DailyMed Dashboard NDC Coverage# NDC, Dashboard title, SPL version table NDC Dashboard title SPL version Validation Dashboard ZIP 63187-377 TRAZODONE HYDROCHLORIDE TABLET, FILM COATED [PROFICIENT RX LP] 3 Legacy NDC 20191121_de2aa5b8-c443-476f-abb1-69e1a8e29595.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.
Packages# Package NDC, 11-digit format, Description table Package NDC 11-digit format Description Marketing start Marketing end Sample Exclude flag Status 63187-377-30 63187037730 30 TABLET, FILM COATED in 1 BOTTLE, PLASTIC (63187-377-30) 2016-09-01 0000-00-00 No No Current 63187-377-60 63187037760 60 TABLET, FILM COATED in 1 BOTTLE, PLASTIC (63187-377-60) 2016-09-01 0000-00-00 No No Current 63187-377-90 63187037790 90 TABLET, FILM COATED in 1 BOTTLE, PLASTIC (63187-377-90) 2016-09-01 0000-00-00 No No Current