Home NDC 71610-514 Trazodone Hydrochloride
Product NDC 71610-514
11-digit product format 716100514
Labeler code 71610
Product ID 71610-514_7309a57d-a286-4cde-82fe-5a84f5823572
Type HUMAN PRESCRIPTION DRUG
Nonproprietary name Trazodone Hydrochloride
Dosage form TABLET
Route ORAL
Labeler Aphena Pharma Solutions - Tennessee, LLC
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 2026-12-31
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 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 2026-12-31 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 · 2 matching rows.
Identifier, FDA.report destination table Identifier FDA.report destination 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 71610-514-30 Trazodone Hydrochloride 30 in 1 BOTTLE TABLET 30 1 71610-514-53 Trazodone Hydrochloride 60 in 1 BOTTLE TABLET 60 1
DailyMed Dashboard NDC Coverage# NDC, Dashboard title, SPL version table NDC Dashboard title SPL version Validation Dashboard ZIP 71610-514 TRAZODONE HYDROCHLORIDE TABLET [APHENA PHARMA SOLUTIONS - TENNESSEE, LLC] 1 Current NDC, Legacy NDC, 2 package rows 20210313_5d22a06c-9cb8-4b49-8d67-769d181ad70c.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 71610-514-30 71610051430 30 TABLET in 1 BOTTLE (71610-514-30) 30 tablet 2021-01-06 0000-00-00 No No Current 71610-514-53 71610051453 60 TABLET in 1 BOTTLE (71610-514-53) 60 tablet 2021-02-12 0000-00-00 No No Current