Home NDC 60505-2653 Trazodone Hydrochloride
Product NDC 60505-2653
11-digit product format 605052653
Labeler code 60505
Product ID 60505-2653_6761bdb4-2041-118d-35a8-4c39a8b20539
Type HUMAN PRESCRIPTION DRUG
Nonproprietary name Trazodone Hydrochloride
Dosage form TABLET
Route ORAL
Labeler Apotex Corp
Application ANDA071258
Marketing category ANDA
Marketing start 2008-11-17
Substance TRAZODONE HYDROCHLORIDE
Active strength 50 mg/1
Pharmacologic classes Serotonin Reuptake Inhibitor [EPC]
NDC exclude flag No
Listing certified through 2027-12-31
Current FDA listing Yes 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.
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 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 · 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 A071258-001 TRAZODONE HYDROCHLORIDE 50MG TABLET / ORAL AB 1987-03-25 caaa826d4ba7…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…
Observed Orange Book normalized TE history# Normalized TE history page 1 of 2 · 42 observed states.
Additional Listing Data#
Finished product Yes
Brand name base Trazodone Hydrochloride
Listing expiration 2027-12-31 Active Ingredients# Ingredient, Strength table Ingredient Strength TRAZODONE HYDROCHLORIDE 50 mg/1
Harmonized UNII identifiers# UNII identifiers page 1 of 1 · 1 matching rows.
Identifier, FDA.report destination table Identifier FDA.report destination 6E8ZO8LRNM Internal UNII lookup
Harmonized RxCUI identifiers# RxCUI identifiers page 1 of 1 · 4 matching rows.
Identifier, FDA.report destination table Identifier FDA.report destination 856364 Internal RxNorm lookup 856369 Internal RxNorm lookup 856373 Internal RxNorm lookup 856377 Internal RxNorm lookup
Harmonized SPL set identifiers# SPL set identifiers page 1 of 1 · 1 matching rows.
DailyMed Product Concepts# DailyMed Package Descriptions# Package NDC, Product, Description table Package NDC Product Description Form Quantity Strength SPL version 60505-2653-0 Trazodone Hydrochloride 10 in 1 BLISTER PACK TABLET 10 22 60505-2653-0 Trazodone Hydrochloride 10 in 1 CARTON TABLET 10 22 60505-2653-1 Trazodone Hydrochloride 100 in 1 BOTTLE TABLET 100 22 60505-2653-5 Trazodone Hydrochloride 500 in 1 BOTTLE TABLET 500 22 60505-2653-7 Trazodone Hydrochloride 17000 in 1 BOTTLE TABLET 17000 22
DailyMed Socrata Ingredients# DailyMed Dashboard NDC Coverage# NDC, Dashboard title, SPL version table NDC Dashboard title SPL version Validation Dashboard ZIP 60505-2653 TRAZODONE HYDROCHLORIDE TABLET [APOTEX CORP] 20 Current NDC, Legacy NDC, 5 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 · 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 60505-2653-0 60505265300 10 BLISTER PACK in 1 CARTON (60505-2653-0) / 10 TABLET in 1 BLISTER PACK 10 blister pack 2008-11-17 0000-00-00 No No Current 60505-2653-1 60505265301 100 TABLET in 1 BOTTLE (60505-2653-1) 100 tablet 2008-11-17 0000-00-00 No No Current 60505-2653-5 60505265305 500 TABLET in 1 BOTTLE (60505-2653-5) 500 tablet 2008-11-17 0000-00-00 No No Current 60505-2653-7 60505265307 17000 TABLET in 1 BOTTLE (60505-2653-7) 17000 tablet 2008-11-17 0000-00-00 No No Current