Home NDC 71335-1483-5 Trazodone Hydrochloride
Product NDC 71335-1483
Requested package NDC 71335-1483-5
11-digit product format 713351483
Labeler code 71335
Product ID 71335-1483_4fe0cdc9-bc0d-45ae-a3bf-b4ae5e4f55ce
Type HUMAN PRESCRIPTION DRUG
Nonproprietary name Trazodone Hydrochloride
Dosage form TABLET
Route ORAL
Labeler Bryant Ranch Prepack
Application ANDA206923
Marketing category ANDA
Marketing start 2018-10-17
Substance TRAZODONE HYDROCHLORIDE
Active strength 150 mg/1
Pharmacologic classes Serotonin Reuptake Inhibitor [EPC]
NDC exclude flag No
Listing certified through 2026-12-31
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 · 2 matching rows.
View current auxiliary records. · View the auxiliary file history.
Captured / source date, Dataset, Scope table Captured / source date Dataset Scope Product NDC Package NDC Code Status Reporting period Archive Snapshot Source SHA-256 2024-05-15 03:39 UTC · source 2024-05-14 excluded package package 71335-1483 71335-1483-5 I Inactivated by FDA excluded / ndc_excluded.zip 834df4deac94…adcc014656a3…2024-03-11 06:39 UTC · source 2024-03-08 excluded package package 71335-1483 71335-1483-5 I Inactivated by FDA excluded / ndc_excluded.zip 1332a3947898…d4bfe170f9cd…
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 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# FDA-Initiated Inactive NDC Indexing# NDC, Effective, Related label table NDC Effective Related label 71335-1483-1 2024-05-20 These highlights do not include all the information needed to use TRAZODONE HYDROCHLORIDE TABLETS safely and effectively. See full prescribing information for TRAZODONE HYDROCHLORIDE TABLETS. TRAZODONE HYDROCHLORIDE tablets, for oral use Initial U.S. Approval: 1981 71335-1483-1 2024-05-20 These highlights do not include all the information needed to use TRAZODONE HYDROCHLORIDE TABLETS safely and effectively. See full prescribing information for TRAZODONE HYDROCHLORIDE TABLETS. TRAZODONE HYDROCHLORIDE tablets, for oral use Initial U.S. Approval: 1981 71335-1483-2 2024-05-20 These highlights do not include all the information needed to use TRAZODONE HYDROCHLORIDE TABLETS safely and effectively. See full prescribing information for TRAZODONE HYDROCHLORIDE TABLETS. TRAZODONE HYDROCHLORIDE tablets, for oral use Initial U.S. Approval: 1981 71335-1483-2 2024-05-20 These highlights do not include all the information needed to use TRAZODONE HYDROCHLORIDE TABLETS safely and effectively. See full prescribing information for TRAZODONE HYDROCHLORIDE TABLETS. TRAZODONE HYDROCHLORIDE tablets, for oral use Initial U.S. Approval: 1981 71335-1483-3 2024-05-20 These highlights do not include all the information needed to use TRAZODONE HYDROCHLORIDE TABLETS safely and effectively. See full prescribing information for TRAZODONE HYDROCHLORIDE TABLETS. TRAZODONE HYDROCHLORIDE tablets, for oral use Initial U.S. Approval: 1981 71335-1483-3 2024-05-20 These highlights do not include all the information needed to use TRAZODONE HYDROCHLORIDE TABLETS safely and effectively. See full prescribing information for TRAZODONE HYDROCHLORIDE TABLETS. TRAZODONE HYDROCHLORIDE tablets, for oral use Initial U.S. Approval: 1981 71335-1483-4 2024-05-20 These highlights do not include all the information needed to use TRAZODONE HYDROCHLORIDE TABLETS safely and effectively. See full prescribing information for TRAZODONE HYDROCHLORIDE TABLETS. TRAZODONE HYDROCHLORIDE tablets, for oral use Initial U.S. Approval: 1981 71335-1483-4 2024-05-20 These highlights do not include all the information needed to use TRAZODONE HYDROCHLORIDE TABLETS safely and effectively. See full prescribing information for TRAZODONE HYDROCHLORIDE TABLETS. TRAZODONE HYDROCHLORIDE tablets, for oral use Initial U.S. Approval: 1981 71335-1483-5 2024-05-20 These highlights do not include all the information needed to use TRAZODONE HYDROCHLORIDE TABLETS safely and effectively. See full prescribing information for TRAZODONE HYDROCHLORIDE TABLETS. TRAZODONE HYDROCHLORIDE tablets, for oral use Initial U.S. Approval: 1981 71335-1483-5 2024-05-20 These highlights do not include all the information needed to use TRAZODONE HYDROCHLORIDE TABLETS safely and effectively. See full prescribing information for TRAZODONE HYDROCHLORIDE TABLETS. TRAZODONE HYDROCHLORIDE tablets, for oral use Initial U.S. Approval: 1981 71335-1483-6 2024-05-20 These highlights do not include all the information needed to use TRAZODONE HYDROCHLORIDE TABLETS safely and effectively. See full prescribing information for TRAZODONE HYDROCHLORIDE TABLETS. TRAZODONE HYDROCHLORIDE tablets, for oral use Initial U.S. Approval: 1981 71335-1483-6 2024-05-20 These highlights do not include all the information needed to use TRAZODONE HYDROCHLORIDE TABLETS safely and effectively. See full prescribing information for TRAZODONE HYDROCHLORIDE TABLETS. TRAZODONE HYDROCHLORIDE tablets, for oral use Initial U.S. Approval: 1981 71335-1483-7 2024-05-20 These highlights do not include all the information needed to use TRAZODONE HYDROCHLORIDE TABLETS safely and effectively. See full prescribing information for TRAZODONE HYDROCHLORIDE TABLETS. TRAZODONE HYDROCHLORIDE tablets, for oral use Initial U.S. Approval: 1981 71335-1483-7 2024-05-20 These highlights do not include all the information needed to use TRAZODONE HYDROCHLORIDE TABLETS safely and effectively. See full prescribing information for TRAZODONE HYDROCHLORIDE TABLETS. TRAZODONE HYDROCHLORIDE tablets, for oral use Initial U.S. Approval: 1981 71335-1483-1 2024-01-30 These highlights do not include all the information needed to use TRAZODONE HYDROCHLORIDE TABLETS safely and effectively. See full prescribing information for TRAZODONE HYDROCHLORIDE TABLETS. TRAZODONE HYDROCHLORIDE tablets, for oral use Initial U.S. Approval: 1981 71335-1483-1 2024-01-30 These highlights do not include all the information needed to use TRAZODONE HYDROCHLORIDE TABLETS safely and effectively. See full prescribing information for TRAZODONE HYDROCHLORIDE TABLETS. TRAZODONE HYDROCHLORIDE tablets, for oral use Initial U.S. Approval: 1981 71335-1483-2 2024-01-30 These highlights do not include all the information needed to use TRAZODONE HYDROCHLORIDE TABLETS safely and effectively. See full prescribing information for TRAZODONE HYDROCHLORIDE TABLETS. TRAZODONE HYDROCHLORIDE tablets, for oral use Initial U.S. Approval: 1981 71335-1483-2 2024-01-30 These highlights do not include all the information needed to use TRAZODONE HYDROCHLORIDE TABLETS safely and effectively. See full prescribing information for TRAZODONE HYDROCHLORIDE TABLETS. TRAZODONE HYDROCHLORIDE tablets, for oral use Initial U.S. Approval: 1981 71335-1483-3 2024-01-30 These highlights do not include all the information needed to use TRAZODONE HYDROCHLORIDE TABLETS safely and effectively. See full prescribing information for TRAZODONE HYDROCHLORIDE TABLETS. TRAZODONE HYDROCHLORIDE tablets, for oral use Initial U.S. Approval: 1981 71335-1483-3 2024-01-30 These highlights do not include all the information needed to use TRAZODONE HYDROCHLORIDE TABLETS safely and effectively. See full prescribing information for TRAZODONE HYDROCHLORIDE TABLETS. TRAZODONE HYDROCHLORIDE tablets, for oral use Initial U.S. Approval: 1981 71335-1483-4 2024-01-30 These highlights do not include all the information needed to use TRAZODONE HYDROCHLORIDE TABLETS safely and effectively. See full prescribing information for TRAZODONE HYDROCHLORIDE TABLETS. TRAZODONE HYDROCHLORIDE tablets, for oral use Initial U.S. Approval: 1981 71335-1483-4 2024-01-30 These highlights do not include all the information needed to use TRAZODONE HYDROCHLORIDE TABLETS safely and effectively. See full prescribing information for TRAZODONE HYDROCHLORIDE TABLETS. TRAZODONE HYDROCHLORIDE tablets, for oral use Initial U.S. Approval: 1981 71335-1483-5 2024-01-30 These highlights do not include all the information needed to use TRAZODONE HYDROCHLORIDE TABLETS safely and effectively. See full prescribing information for TRAZODONE HYDROCHLORIDE TABLETS. TRAZODONE HYDROCHLORIDE tablets, for oral use Initial U.S. Approval: 1981 71335-1483-5 2024-01-30 These highlights do not include all the information needed to use TRAZODONE HYDROCHLORIDE TABLETS safely and effectively. See full prescribing information for TRAZODONE HYDROCHLORIDE TABLETS. TRAZODONE HYDROCHLORIDE tablets, for oral use Initial U.S. Approval: 1981 71335-1483-6 2024-01-30 These highlights do not include all the information needed to use TRAZODONE HYDROCHLORIDE TABLETS safely and effectively. See full prescribing information for TRAZODONE HYDROCHLORIDE TABLETS. TRAZODONE HYDROCHLORIDE tablets, for oral use Initial U.S. Approval: 1981 71335-1483-6 2024-01-30 These highlights do not include all the information needed to use TRAZODONE HYDROCHLORIDE TABLETS safely and effectively. See full prescribing information for TRAZODONE HYDROCHLORIDE TABLETS. TRAZODONE HYDROCHLORIDE tablets, for oral use Initial U.S. Approval: 1981 71335-1483-7 2024-01-30 These highlights do not include all the information needed to use TRAZODONE HYDROCHLORIDE TABLETS safely and effectively. See full prescribing information for TRAZODONE HYDROCHLORIDE TABLETS. TRAZODONE HYDROCHLORIDE tablets, for oral use Initial U.S. Approval: 1981 71335-1483-7 2024-01-30 These highlights do not include all the information needed to use TRAZODONE HYDROCHLORIDE TABLETS safely and effectively. See full prescribing information for TRAZODONE HYDROCHLORIDE TABLETS. TRAZODONE HYDROCHLORIDE tablets, for oral use Initial U.S. Approval: 1981
DailyMed Package Descriptions# Package NDC, Product, Description table Package NDC Product Description Form Quantity Strength SPL version 71335-1483-1 Trazodone Hydrochloride 30 in 1 BOTTLE TABLET 30 5 71335-1483-2 Trazodone Hydrochloride 60 in 1 BOTTLE TABLET 60 5 71335-1483-3 Trazodone Hydrochloride 90 in 1 BOTTLE TABLET 90 5 71335-1483-4 Trazodone Hydrochloride 18 in 1 BOTTLE TABLET 18 5 71335-1483-5 Trazodone Hydrochloride 100 in 1 BOTTLE TABLET 100 5 71335-1483-6 Trazodone Hydrochloride 45 in 1 BOTTLE TABLET 45 5 71335-1483-7 Trazodone Hydrochloride 180 in 1 BOTTLE TABLET 180 5
DailyMed Dashboard NDC Coverage# NDC, Dashboard title, SPL version table NDC Dashboard title SPL version Validation Dashboard ZIP 71335-1483 TRAZODONE HYDROCHLORIDE TABLET [BRYANT RANCH PREPACK] 5 Current NDC, Legacy NDC, 7 package rows 20240522_5605e909-dc75-4578-94c6-41bb96ba3e2a.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 ndc (package): 71335-1483-5 ndc (product): 71335-1483 ndc11 (package): 71335148305 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 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 71335-1483-5 71335148305 100 TABLET in 1 BOTTLE (71335-1483-5) 100 tablet 2022-02-14 0000-00-00 No No Current