Home NDC 42291-829 Trazodone Hydrochloride
Product NDC 42291-829
11-digit product format 422910829
Labeler code 42291
Product ID 42291-829_4875c084-69f6-d254-e063-6294a90ada37
Type HUMAN PRESCRIPTION DRUG
Nonproprietary name Trazodone Hydrochloride
Dosage form TABLET
Route ORAL
Labeler AvKARE
Application ANDA071525
Marketing category ANDA
Marketing start 2020-04-17
Substance TRAZODONE HYDROCHLORIDE
Active strength 150 mg/1
Pharmacologic classes Serotonin Reuptake Inhibitor [EPC]
NDC exclude flag No
Listing certified through 2027-12-31
Current FDA listing Yes 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 A071525-001 TRAZODONE HYDROCHLORIDE TRAZODONE HYDROCHLORIDE 150MG TABLET / ORAL AB 1988-03-09
Therapeutic equivalence codes# Current TE-code rows page 1 of 1 · 1 matching rows.
Application-product, TE code table Application-product TE code A071525-001 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 A071525-001 TRAZODONE HYDROCHLORIDE 150MG TABLET / ORAL AB 1988-03-09 caaa826d4ba7…2026-02-19 14:30 UTC 2026-02 A071525-001 TRAZODONE HYDROCHLORIDE 150MG TABLET / ORAL AB 1988-03-09 011fe1cb6892…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 A071525-001 TRAZODONE HYDROCHLORIDE 150MG TABLET / ORAL AB 1988-03-09 31067a03dcf5…2025-08-23 18:47 UTC 2025-08 A071525-001 TRAZODONE HYDROCHLORIDE 150MG TABLET / ORAL AB 1988-03-09 6a471c1ec25d…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 A071525-001 TRAZODONE HYDROCHLORIDE 150MG TABLET / ORAL AB 1988-03-09 fd3edfee7708…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 A071525-001 TRAZODONE HYDROCHLORIDE 150MG TABLET / ORAL AB 1988-03-09 b8a1b40f171c…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 A071525-001 TRAZODONE HYDROCHLORIDE 150MG TABLET / ORAL AB 1988-03-09 03ed91905a0d…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 A071525-001 TRAZODONE HYDROCHLORIDE 150MG TABLET / ORAL AB 1988-03-09 2680178bc6a6…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 A071525-001 TRAZODONE HYDROCHLORIDE 150MG TABLET / ORAL AB 1988-03-09 5bbf6a4d5a75…2024-11-08 22:44 UTC · 3 captures of this ZIP 2024-11 A071525-001 TRAZODONE HYDROCHLORIDE 150MG TABLET / ORAL AB 1988-03-09 d8e5a09893c0…2024-10-29 15:01 UTC 2024-10 A071525-001 TRAZODONE HYDROCHLORIDE 150MG TABLET / ORAL AB 1988-03-09 d06236e962d9…2024-08-13 05:28 UTC · 3 captures of this ZIP 2024-08 A071525-001 TRAZODONE HYDROCHLORIDE 150MG TABLET / ORAL AB 1988-03-09 79d66fd596c7…2024-07-13 05:37 UTC · 2 captures of this ZIP 2024-07 A071525-001 TRAZODONE HYDROCHLORIDE 150MG TABLET / ORAL AB 1988-03-09 301d65b070ca…2024-06-18 03:08 UTC · 5 captures of this ZIP 2024-06 A071525-001 TRAZODONE HYDROCHLORIDE 150MG TABLET / ORAL AB 1988-03-09 1e350fbaab3a…2024-05-31 18:47 UTC 2024-05 A071525-001 TRAZODONE HYDROCHLORIDE 150MG TABLET / ORAL AB 1988-03-09 8072bd15b7f6…2022-06-29 02:47 UTC · 2 captures of this ZIP 2022-06 A071525-001 TRAZODONE HYDROCHLORIDE 150MG TABLET / ORAL AB 1988-03-09 5c6f7cd8ea54…2022-04-08 23:34 UTC 2022-04 A071525-001 TRAZODONE HYDROCHLORIDE 150MG TABLET / ORAL AB 1988-03-09 5d02ea3f76ae…2022-04-04 05:41 UTC 2022-04 A071525-001 TRAZODONE HYDROCHLORIDE 150MG TABLET / ORAL AB 1988-03-09 4b0b4de00fa7…2019-12-13 00:20 UTC 2019-12 A071525-001 TRAZODONE HYDROCHLORIDE 150MG TABLET / ORAL AB 1988-03-09 74a2ff9319b5…2022-03-09 01:35 UTC 2022-03 A071525-001 TRAZODONE HYDROCHLORIDE 150MG TABLET / ORAL AB 1988-03-09 bb7c543d1eb4…2021-12-28 21:50 UTC 2021-12 A071525-001 TRAZODONE HYDROCHLORIDE 150MG TABLET / ORAL AB 1988-03-09 782e0a99824c…2021-05-05 16:15 UTC · 3 captures of this ZIP 2021-05 A071525-001 TRAZODONE HYDROCHLORIDE 150MG TABLET / ORAL AB 1988-03-09 87673890dc5c…2021-03-12 10:30 UTC 2021-03 A071525-001 TRAZODONE HYDROCHLORIDE 150MG TABLET / ORAL AB 1988-03-09 5aa47cf7b7d7…2020-12-22 03:56 UTC 2020-12 A071525-001 TRAZODONE HYDROCHLORIDE 150MG TABLET / ORAL AB 1988-03-09 8869cabd3fbd…2020-11-12 02:37 UTC 2020-11 A071525-001 TRAZODONE HYDROCHLORIDE 150MG TABLET / ORAL AB 1988-03-09 c0c555d07b60…2019-12-14 00:12 UTC 2019-12 A071525-001 TRAZODONE HYDROCHLORIDE 150MG TABLET / ORAL AB 1988-03-09 3f01610625f2…2019-09-15 20:21 UTC 2019-09 A071525-001 TRAZODONE HYDROCHLORIDE 150MG TABLET / ORAL AB 1988-03-09 b00525d2431f…2019-07-19 19:46 UTC 2019-07 A071525-001 TRAZODONE HYDROCHLORIDE 150MG TABLET / ORAL AB 1988-03-09 ea99ee380514…2024-03-16 18:09 UTC · 4 captures of this ZIP 2024-03 A071525-001 TRAZODONE HYDROCHLORIDE 150MG TABLET / ORAL AB 1988-03-09 6a51e52b5d6a…2024-02-18 07:12 UTC 2024-02 A071525-001 TRAZODONE HYDROCHLORIDE 150MG TABLET / ORAL AB 1988-03-09 1c564ffb4f44…2023-12-20 04:57 UTC 2023-12 A071525-001 TRAZODONE HYDROCHLORIDE 150MG TABLET / ORAL AB 1988-03-09 ea1830bbd6c7…2023-11-28 05:40 UTC · 2 captures of this ZIP 2023-11 A071525-001 TRAZODONE HYDROCHLORIDE 150MG TABLET / ORAL AB 1988-03-09 a72a2bbeb626…2023-10-25 00:34 UTC · 2 captures of this ZIP 2023-10 A071525-001 TRAZODONE HYDROCHLORIDE 150MG TABLET / ORAL AB 1988-03-09 9b2671bbb829…2023-07-15 15:27 UTC · 2 captures of this ZIP 2023-07 A071525-001 TRAZODONE HYDROCHLORIDE 150MG TABLET / ORAL AB 1988-03-09 a67488948f0b…2023-06-13 01:57 UTC · 3 captures of this ZIP 2023-06 A071525-001 TRAZODONE HYDROCHLORIDE 150MG TABLET / ORAL AB 1988-03-09 3f0d92c62455…2023-05-13 08:27 UTC 2023-05 A071525-001 TRAZODONE HYDROCHLORIDE 150MG TABLET / ORAL AB 1988-03-09 053a50430f4f…2023-01-26 05:58 UTC 2023-01 A071525-001 TRAZODONE HYDROCHLORIDE 150MG TABLET / ORAL AB 1988-03-09 3bdfa0b2c4d7…2022-11-12 20:34 UTC · 5 captures of this ZIP 2022-11 A071525-001 TRAZODONE HYDROCHLORIDE 150MG TABLET / ORAL AB 1988-03-09 3a93d1ddd44b…2022-10-28 04:53 UTC 2022-10 A071525-001 TRAZODONE HYDROCHLORIDE 150MG TABLET / ORAL AB 1988-03-09 f41ea6bd6efb…2022-09-29 23:25 UTC 2022-09 A071525-001 TRAZODONE HYDROCHLORIDE 150MG TABLET / ORAL AB 1988-03-09 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 150 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 · 1 matching rows.
Identifier, FDA.report destination table Identifier FDA.report destination 856364 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 42291-829-50 Trazodone Hydrochloride 500 in 1 BOTTLE TABLET 500 4 42291-829-90 Trazodone Hydrochloride 90 in 1 BOTTLE TABLET 90 4
DailyMed Dashboard NDC Coverage# NDC, Dashboard title, SPL version table NDC Dashboard title SPL version Validation Dashboard ZIP 42291-829 TRAZODONE HYDROCHLORIDE TABLET [AVKARE] 3 Current NDC, Legacy NDC, 2 package rows 20240111_a382ac4d-9ab9-796a-e053-2a95a90a2c26.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 NCS HealthCare of KY, LLC dba Vangard Labs 310c4b81-d2cf-4014-873d-e71d036105de 2026-05-28 Boxed warning, Warnings, Adverse reactions Exact identifier application applno (ANDA): 071525 application number: ANDA071525 Trazodone Hydrochloride TRAZODONE HYDROCHLORIDE AvKARE a382ac4d-9ab9-796a-e053-2a95a90a2c26 2026-01-15 Boxed warning, Warnings, Adverse reactions Exact identifier application applno (ANDA): 071525 application number: ANDA071525 ndc (product): 42291-829 Trazodone Hydrochloride TRAZODONE HYDROCHLORIDE PD-Rx Pharmaceuticals, Inc. 9b022ae9-dd52-43ae-804b-ddf8e7cfd530 2025-10-01 Boxed warning, Warnings, Adverse reactions Exact identifier application applno (ANDA): 071525 application number: ANDA071525 Trazodone Hydrochloride TRAZODONE HYDROCHLORIDE Teva Pharmaceuticals USA, Inc. 4006d439-e2de-4590-82e9-fc9d56e3ec1b 2025-07-09 Boxed warning, Warnings, Adverse reactions Exact identifier application applno (ANDA): 071525 application number: ANDA071525
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 42291-829-50 42291082950 500 TABLET in 1 BOTTLE (42291-829-50) 500 tablet 2020-04-17 0000-00-00 No No Current 42291-829-90 42291082990 90 TABLET in 1 BOTTLE (42291-829-90) 90 tablet 2020-04-17 0000-00-00 No No Current