Home NDC 16729-300 Trazodone Hydrochloride
Product NDC 16729-300
11-digit product format 167290300
Labeler code 16729
Product ID 16729-300_4629674c-30f5-3709-e063-6394a90a3dc1
Type HUMAN PRESCRIPTION DRUG
Nonproprietary name Trazodone Hydrochloride
Dosage form TABLET
Route ORAL
Labeler Accord Healthcare, Inc.
Application ANDA206923
Marketing category ANDA
Marketing start 2018-10-05
Substance TRAZODONE HYDROCHLORIDE
Active strength 100 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 · 4 matching rows.
Application-product, Trade name, Ingredient table Application-product Trade name Ingredient Strength Dosage form / route TE codes RLD / RS Approval date A206923-001 TRAZODONE HYDROCHLORIDE TRAZODONE HYDROCHLORIDE 50MG TABLET / ORAL AB 2017-09-08 A206923-002 TRAZODONE HYDROCHLORIDE TRAZODONE HYDROCHLORIDE 100MG TABLET / ORAL AB 2017-09-08 A206923-003 TRAZODONE HYDROCHLORIDE TRAZODONE HYDROCHLORIDE 150MG TABLET / ORAL AB 2017-09-08 A206923-004 TRAZODONE HYDROCHLORIDE TRAZODONE HYDROCHLORIDE 300MG TABLET / ORAL AB 2017-09-08
Therapeutic equivalence codes# Current TE-code rows page 1 of 1 · 4 matching rows.
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 5 · 168 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 A206923-001 TRAZODONE HYDROCHLORIDE 50MG TABLET / ORAL AB 2017-09-08 caaa826d4ba7…2026-08-18 06:07:40 2026-07 A206923-002 TRAZODONE HYDROCHLORIDE 100MG TABLET / ORAL AB 2017-09-08 caaa826d4ba7…2026-08-18 06:07:40 2026-07 A206923-003 TRAZODONE HYDROCHLORIDE 150MG TABLET / ORAL AB 2017-09-08 caaa826d4ba7…2026-08-18 06:07:40 2026-07 A206923-004 TRAZODONE HYDROCHLORIDE 300MG TABLET / ORAL AB 2017-09-08 caaa826d4ba7…2026-02-19 14:30 UTC 2026-02 A206923-001 TRAZODONE HYDROCHLORIDE 50MG TABLET / ORAL AB 2017-09-08 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 A206923-002 TRAZODONE HYDROCHLORIDE 100MG TABLET / ORAL AB 2017-09-08 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 A206923-003 TRAZODONE HYDROCHLORIDE 150MG TABLET / ORAL AB 2017-09-08 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 A206923-004 TRAZODONE HYDROCHLORIDE 300MG TABLET / ORAL AB 2017-09-08 011fe1cb6892…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 A206923-001 TRAZODONE HYDROCHLORIDE 50MG TABLET / ORAL AB 2017-09-08 31067a03dcf5…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 A206923-002 TRAZODONE HYDROCHLORIDE 100MG TABLET / ORAL AB 2017-09-08 31067a03dcf5…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 A206923-003 TRAZODONE HYDROCHLORIDE 150MG TABLET / ORAL AB 2017-09-08 31067a03dcf5…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 A206923-004 TRAZODONE HYDROCHLORIDE 300MG TABLET / ORAL AB 2017-09-08 31067a03dcf5…2025-08-23 18:47 UTC 2025-08 A206923-001 TRAZODONE HYDROCHLORIDE 50MG TABLET / ORAL AB 2017-09-08 6a471c1ec25d…2025-08-23 18:47 UTC 2025-08 A206923-002 TRAZODONE HYDROCHLORIDE 100MG TABLET / ORAL AB 2017-09-08 6a471c1ec25d…2025-08-23 18:47 UTC 2025-08 A206923-003 TRAZODONE HYDROCHLORIDE 150MG TABLET / ORAL AB 2017-09-08 6a471c1ec25d…2025-08-23 18:47 UTC 2025-08 A206923-004 TRAZODONE HYDROCHLORIDE 300MG TABLET / ORAL AB 2017-09-08 6a471c1ec25d…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 A206923-001 TRAZODONE HYDROCHLORIDE 50MG TABLET / ORAL AB 2017-09-08 fd3edfee7708…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 A206923-002 TRAZODONE HYDROCHLORIDE 100MG TABLET / ORAL AB 2017-09-08 fd3edfee7708…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 A206923-003 TRAZODONE HYDROCHLORIDE 150MG TABLET / ORAL AB 2017-09-08 fd3edfee7708…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 A206923-004 TRAZODONE HYDROCHLORIDE 300MG TABLET / ORAL AB 2017-09-08 fd3edfee7708…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 A206923-001 TRAZODONE HYDROCHLORIDE 50MG TABLET / ORAL AB 2017-09-08 b8a1b40f171c…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 A206923-002 TRAZODONE HYDROCHLORIDE 100MG TABLET / ORAL AB 2017-09-08 b8a1b40f171c…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 A206923-003 TRAZODONE HYDROCHLORIDE 150MG TABLET / ORAL AB 2017-09-08 b8a1b40f171c…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 A206923-004 TRAZODONE HYDROCHLORIDE 300MG TABLET / ORAL AB 2017-09-08 b8a1b40f171c…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 A206923-001 TRAZODONE HYDROCHLORIDE 50MG TABLET / ORAL AB 2017-09-08 03ed91905a0d…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 A206923-002 TRAZODONE HYDROCHLORIDE 100MG TABLET / ORAL AB 2017-09-08 03ed91905a0d…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 A206923-003 TRAZODONE HYDROCHLORIDE 150MG TABLET / ORAL AB 2017-09-08 03ed91905a0d…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 A206923-004 TRAZODONE HYDROCHLORIDE 300MG TABLET / ORAL AB 2017-09-08 03ed91905a0d…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 A206923-001 TRAZODONE HYDROCHLORIDE 50MG TABLET / ORAL AB 2017-09-08 2680178bc6a6…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 A206923-002 TRAZODONE HYDROCHLORIDE 100MG TABLET / ORAL AB 2017-09-08 2680178bc6a6…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 A206923-003 TRAZODONE HYDROCHLORIDE 150MG TABLET / ORAL AB 2017-09-08 2680178bc6a6…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 A206923-004 TRAZODONE HYDROCHLORIDE 300MG TABLET / ORAL AB 2017-09-08 2680178bc6a6…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 A206923-001 TRAZODONE HYDROCHLORIDE 50MG TABLET / ORAL AB 2017-09-08 5bbf6a4d5a75…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 A206923-002 TRAZODONE HYDROCHLORIDE 100MG TABLET / ORAL AB 2017-09-08 5bbf6a4d5a75…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 A206923-003 TRAZODONE HYDROCHLORIDE 150MG TABLET / ORAL AB 2017-09-08 5bbf6a4d5a75…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 A206923-004 TRAZODONE HYDROCHLORIDE 300MG TABLET / ORAL AB 2017-09-08 5bbf6a4d5a75…2024-11-08 22:44 UTC · 3 captures of this ZIP 2024-11 A206923-001 TRAZODONE HYDROCHLORIDE 50MG TABLET / ORAL AB 2017-09-08 d8e5a09893c0…2024-11-08 22:44 UTC · 3 captures of this ZIP 2024-11 A206923-002 TRAZODONE HYDROCHLORIDE 100MG TABLET / ORAL AB 2017-09-08 d8e5a09893c0…2024-11-08 22:44 UTC · 3 captures of this ZIP 2024-11 A206923-003 TRAZODONE HYDROCHLORIDE 150MG TABLET / ORAL AB 2017-09-08 d8e5a09893c0…2024-11-08 22:44 UTC · 3 captures of this ZIP 2024-11 A206923-004 TRAZODONE HYDROCHLORIDE 300MG TABLET / ORAL AB 2017-09-08 d8e5a09893c0…
Observed Orange Book normalized TE history# Normalized TE history page 1 of 5 · 168 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 100 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 16729-300-01 Trazodone Hydrochloride 100 in 1 BOTTLE TABLET 100 12 16729-300-16 Trazodone Hydrochloride 500 in 1 BOTTLE TABLET 500 12 16729-300-17 Trazodone Hydrochloride 1000 in 1 BOTTLE TABLET 1000 12 16729-300-43 Trazodone Hydrochloride 10 in 1 CARTON TABLET 10 12 16729-300-44 Trazodone Hydrochloride 10 in 1 BLISTER PACK TABLET 10 12
DailyMed Dashboard NDC Coverage# NDC, Dashboard title, SPL version table NDC Dashboard title SPL version Validation Dashboard ZIP 16729-300 TRAZODONE HYDROCHLORIDE TABLET [ACCORD HEALTHCARE, INC.] 10 Current NDC, Legacy NDC, 5 package rows 20240221_ed3039d8-3d27-4b71-a4b0-812943c9457f.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 Bryant Ranch Prepack 5605e909-dc75-4578-94c6-41bb96ba3e2a 2026-06-19 Boxed warning, Warnings, Adverse reactions Exact identifier application applno (ANDA): 206923 application number: ANDA206923 Trazodone Hydrochloride TRAZODONE HYDROCHLORIDE Bryant Ranch Prepack 78c3188c-d42f-4d3d-aa42-3c146dfe08ee 2026-05-13 Boxed warning, Warnings, Adverse reactions Exact identifier application applno (ANDA): 206923 application number: ANDA206923 Trazodone Hydrochloride TRAZODONE HYDROCHLORIDE Accord Healthcare, Inc. ed3039d8-3d27-4b71-a4b0-812943c9457f 2025-12-17 Boxed warning, Warnings, Adverse reactions Exact identifier application applno (ANDA): 206923 application number: ANDA206923 ndc (product): 16729-300 Trazodone Hydrochloride TRAZODONE HYDROCHLORIDE Proficient Rx LP a90caa68-b28e-425f-b77c-7b566ac17dc2 2022-08-01 Boxed warning, Warnings, Adverse reactions Exact identifier application applno (ANDA): 206923 application number: ANDA206923
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 16729-300-01 16729030001 100 TABLET in 1 BOTTLE (16729-300-01) 100 tablet 2018-10-05 0000-00-00 No No Current 16729-300-16 16729030016 500 in 1 BOTTLE Historical 16729-300-17 16729030017 1000 TABLET in 1 BOTTLE (16729-300-17) 1000 tablet 2018-10-09 0000-00-00 No No Current 16729-300-43 16729030043 10 in 1 CARTON Historical 16729-300-44 16729030044 10 in 1 BLISTER PACK Historical