Home NDC 43353-652 Trazodone Hydrochloride
Product NDC 43353-652
11-digit product format 433530652
Labeler code 43353
Product ID 43353-652_79266f41-f728-4daa-9c57-b2a5f3881e17
Type HUMAN PRESCRIPTION DRUG
Nonproprietary name Trazodone Hydrochloride
Dosage form TABLET, FILM COATED
Route ORAL
Labeler Aphena Pharma Solutions - Tennessee, LLC
Application ANDA072192
Marketing category ANDA
Marketing start 2010-05-30
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 2019-12-31
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 3 · 147 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 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 · 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 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…2022-09-29 23:25 UTC 2022-09 A072192-001 TRAZODONE HYDROCHLORIDE 50MG TABLET / ORAL AB 1989-02-02 e64feba35796…
Observed Orange Book normalized TE history# Normalized TE history page 1 of 2 · 42 observed states.
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 43353-652-15 Trazodone Hydrochloride 15 in 1 BOTTLE, PLASTIC TABLET, FILM COATED 15 1 43353-652-30 Trazodone Hydrochloride 30 in 1 BOTTLE, PLASTIC TABLET, FILM COATED 30 1 43353-652-45 Trazodone Hydrochloride 45 in 1 BOTTLE, PLASTIC TABLET, FILM COATED 45 1 43353-652-53 Trazodone Hydrochloride 60 in 1 BOTTLE, PLASTIC TABLET, FILM COATED 60 1 43353-652-60 Trazodone Hydrochloride 90 in 1 BOTTLE, PLASTIC TABLET, FILM COATED 90 1 43353-652-70 Trazodone Hydrochloride 120 in 1 BOTTLE, PLASTIC TABLET, FILM COATED 120 1
DailyMed Socrata Ingredients# Ingredient, Type, UNII table Ingredient Type UNII DailyMed label SPL version Uploaded TRAZODONE HYDROCHLORIDE ACTIVE INGREDIENT 6E8ZO8LRNM TRAZODONE HYDROCHLORIDE TABLET, FILM COATED [APHENA PHARMA SOLUTIONS - TENNESSEE, LLC] 1 TRAZODONE ACTIVE MOIETY YBK48BXK30 TRAZODONE HYDROCHLORIDE TABLET, FILM COATED [APHENA PHARMA SOLUTIONS - TENNESSEE, LLC] 1 HYPROMELLOSES INACTIVE INGREDIENT 3NXW29V3WO TRAZODONE HYDROCHLORIDE TABLET, FILM COATED [APHENA PHARMA SOLUTIONS - TENNESSEE, LLC] 1 LACTOSE MONOHYDRATE INACTIVE INGREDIENT EWQ57Q8I5X TRAZODONE HYDROCHLORIDE TABLET, FILM COATED [APHENA PHARMA SOLUTIONS - TENNESSEE, LLC] 1 MAGNESIUM STEARATE INACTIVE INGREDIENT 70097M6I30 TRAZODONE HYDROCHLORIDE TABLET, FILM COATED [APHENA PHARMA SOLUTIONS - TENNESSEE, LLC] 1 POLYDEXTROSE INACTIVE INGREDIENT VH2XOU12IE TRAZODONE HYDROCHLORIDE TABLET, FILM COATED [APHENA PHARMA SOLUTIONS - TENNESSEE, LLC] 1 POLYETHYLENE GLYCOLS INACTIVE INGREDIENT 3WJQ0SDW1A TRAZODONE HYDROCHLORIDE TABLET, FILM COATED [APHENA PHARMA SOLUTIONS - TENNESSEE, LLC] 1 POVIDONES INACTIVE INGREDIENT FZ989GH94E TRAZODONE HYDROCHLORIDE TABLET, FILM COATED [APHENA PHARMA SOLUTIONS - TENNESSEE, LLC] 1 SILICON DIOXIDE INACTIVE INGREDIENT ETJ7Z6XBU4 TRAZODONE HYDROCHLORIDE TABLET, FILM COATED [APHENA PHARMA SOLUTIONS - TENNESSEE, LLC] 1 STARCH, CORN INACTIVE INGREDIENT O8232NY3SJ TRAZODONE HYDROCHLORIDE TABLET, FILM COATED [APHENA PHARMA SOLUTIONS - TENNESSEE, LLC] 1 TITANIUM DIOXIDE INACTIVE INGREDIENT 15FIX9V2JP TRAZODONE HYDROCHLORIDE TABLET, FILM COATED [APHENA PHARMA SOLUTIONS - TENNESSEE, LLC] 1
DailyMed Dashboard NDC Coverage# NDC, Dashboard title, SPL version table NDC Dashboard title SPL version Validation Dashboard ZIP 43353-652 TRAZODONE HYDROCHLORIDE TABLET, FILM COATED [APHENA PHARMA SOLUTIONS - TENNESSEE, LLC] 1 Legacy NDC, 6 package rows 20140513_26d30297-fda9-45a4-b94a-a9f401705818.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 Status 43353-652-15 43353065215 15 in 1 BOTTLE, PLASTIC Historical 43353-652-30 43353065230 30 in 1 BOTTLE, PLASTIC Historical 43353-652-45 43353065245 45 in 1 BOTTLE, PLASTIC Historical 43353-652-53 43353065253 60 in 1 BOTTLE, PLASTIC Historical 43353-652-60 43353065260 90 in 1 BOTTLE, PLASTIC Historical 43353-652-70 43353065270 120 in 1 BOTTLE, PLASTIC Historical