Home NDC 0555-0711 Trazodone Hydrochloride
Product NDC 0555-0711
11-digit product format 005550711
Labeler code 0555
Product ID 0555-0711_3902eb87-aa22-4775-b56a-7cb86c5f920e
Type HUMAN PRESCRIPTION DRUG
Nonproprietary name Trazodone Hydrochloride
Dosage form TABLET
Route ORAL
Labeler Teva Pharmaceuticals USA, Inc.
Application ANDA071196
Marketing category ANDA
Marketing start 2021-12-09
Substance TRAZODONE HYDROCHLORIDE
Active strength 300 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 · 3 matching rows.
Application-product, Trade name, Ingredient table Application-product Trade name Ingredient Strength Dosage form / route TE codes RLD / RS Approval date A071196-001 TRAZODONE HYDROCHLORIDE TRAZODONE HYDROCHLORIDE 100MG TABLET / ORAL AB RS 1987-03-25 A071196-002 TRAZODONE HYDROCHLORIDE TRAZODONE HYDROCHLORIDE 150MG TABLET / ORAL AB 1999-04-26 A071196-003 TRAZODONE HYDROCHLORIDE TRAZODONE HYDROCHLORIDE 300MG TABLET / ORAL AB 1999-04-26
Therapeutic equivalence codes# Current TE-code rows page 1 of 1 · 3 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 4 · 126 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 A071196-001 TRAZODONE HYDROCHLORIDE 100MG TABLET / ORAL AB RS 1987-03-25 caaa826d4ba7…2026-08-18 06:07:40 2026-07 A071196-002 TRAZODONE HYDROCHLORIDE 150MG TABLET / ORAL AB 1999-04-26 caaa826d4ba7…2026-08-18 06:07:40 2026-07 A071196-003 TRAZODONE HYDROCHLORIDE 300MG TABLET / ORAL AB 1999-04-26 caaa826d4ba7…2026-02-19 14:30 UTC 2026-02 A071196-001 TRAZODONE HYDROCHLORIDE 100MG TABLET / ORAL AB RS 1987-03-25 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 A071196-002 TRAZODONE HYDROCHLORIDE 150MG TABLET / ORAL AB 1999-04-26 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 A071196-003 TRAZODONE HYDROCHLORIDE 300MG TABLET / ORAL AB 1999-04-26 011fe1cb6892…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 A071196-001 TRAZODONE HYDROCHLORIDE 100MG TABLET / ORAL AB RS 1987-03-25 31067a03dcf5…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 A071196-002 TRAZODONE HYDROCHLORIDE 150MG TABLET / ORAL AB 1999-04-26 31067a03dcf5…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 A071196-003 TRAZODONE HYDROCHLORIDE 300MG TABLET / ORAL AB 1999-04-26 31067a03dcf5…2025-08-23 18:47 UTC 2025-08 A071196-001 TRAZODONE HYDROCHLORIDE 100MG TABLET / ORAL AB RS 1987-03-25 6a471c1ec25d…2025-08-23 18:47 UTC 2025-08 A071196-002 TRAZODONE HYDROCHLORIDE 150MG TABLET / ORAL AB 1999-04-26 6a471c1ec25d…2025-08-23 18:47 UTC 2025-08 A071196-003 TRAZODONE HYDROCHLORIDE 300MG TABLET / ORAL AB 1999-04-26 6a471c1ec25d…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 A071196-001 TRAZODONE HYDROCHLORIDE 100MG TABLET / ORAL AB RS 1987-03-25 fd3edfee7708…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 A071196-002 TRAZODONE HYDROCHLORIDE 150MG TABLET / ORAL AB 1999-04-26 fd3edfee7708…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 A071196-003 TRAZODONE HYDROCHLORIDE 300MG TABLET / ORAL AB 1999-04-26 fd3edfee7708…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 A071196-001 TRAZODONE HYDROCHLORIDE 100MG TABLET / ORAL AB RS 1987-03-25 b8a1b40f171c…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 A071196-002 TRAZODONE HYDROCHLORIDE 150MG TABLET / ORAL AB 1999-04-26 b8a1b40f171c…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 A071196-003 TRAZODONE HYDROCHLORIDE 300MG TABLET / ORAL AB 1999-04-26 b8a1b40f171c…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 A071196-001 TRAZODONE HYDROCHLORIDE 100MG TABLET / ORAL AB RS 1987-03-25 03ed91905a0d…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 A071196-002 TRAZODONE HYDROCHLORIDE 150MG TABLET / ORAL AB 1999-04-26 03ed91905a0d…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 A071196-003 TRAZODONE HYDROCHLORIDE 300MG TABLET / ORAL AB 1999-04-26 03ed91905a0d…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 A071196-001 TRAZODONE HYDROCHLORIDE 100MG TABLET / ORAL AB RS 1987-03-25 2680178bc6a6…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 A071196-002 TRAZODONE HYDROCHLORIDE 150MG TABLET / ORAL AB 1999-04-26 2680178bc6a6…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 A071196-003 TRAZODONE HYDROCHLORIDE 300MG TABLET / ORAL AB 1999-04-26 2680178bc6a6…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 A071196-001 TRAZODONE HYDROCHLORIDE 100MG TABLET / ORAL AB RS 1987-03-25 5bbf6a4d5a75…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 A071196-002 TRAZODONE HYDROCHLORIDE 150MG TABLET / ORAL AB 1999-04-26 5bbf6a4d5a75…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 A071196-003 TRAZODONE HYDROCHLORIDE 300MG TABLET / ORAL AB 1999-04-26 5bbf6a4d5a75…2024-11-08 22:44 UTC · 3 captures of this ZIP 2024-11 A071196-001 TRAZODONE HYDROCHLORIDE 100MG TABLET / ORAL AB RS 1987-03-25 d8e5a09893c0…2024-11-08 22:44 UTC · 3 captures of this ZIP 2024-11 A071196-002 TRAZODONE HYDROCHLORIDE 150MG TABLET / ORAL AB 1999-04-26 d8e5a09893c0…2024-11-08 22:44 UTC · 3 captures of this ZIP 2024-11 A071196-003 TRAZODONE HYDROCHLORIDE 300MG TABLET / ORAL AB 1999-04-26 d8e5a09893c0…2024-10-29 15:01 UTC 2024-10 A071196-001 TRAZODONE HYDROCHLORIDE 100MG TABLET / ORAL AB RS 1987-03-25 d06236e962d9…2024-10-29 15:01 UTC 2024-10 A071196-002 TRAZODONE HYDROCHLORIDE 150MG TABLET / ORAL AB 1999-04-26 d06236e962d9…2024-10-29 15:01 UTC 2024-10 A071196-003 TRAZODONE HYDROCHLORIDE 300MG TABLET / ORAL AB 1999-04-26 d06236e962d9…2024-08-13 05:28 UTC · 3 captures of this ZIP 2024-08 A071196-001 TRAZODONE HYDROCHLORIDE 100MG TABLET / ORAL AB RS 1987-03-25 79d66fd596c7…2024-08-13 05:28 UTC · 3 captures of this ZIP 2024-08 A071196-002 TRAZODONE HYDROCHLORIDE 150MG TABLET / ORAL AB 1999-04-26 79d66fd596c7…2024-08-13 05:28 UTC · 3 captures of this ZIP 2024-08 A071196-003 TRAZODONE HYDROCHLORIDE 300MG TABLET / ORAL AB 1999-04-26 79d66fd596c7…2024-07-13 05:37 UTC · 2 captures of this ZIP 2024-07 A071196-001 TRAZODONE HYDROCHLORIDE 100MG TABLET / ORAL AB RS 1987-03-25 301d65b070ca…2024-07-13 05:37 UTC · 2 captures of this ZIP 2024-07 A071196-002 TRAZODONE HYDROCHLORIDE 150MG TABLET / ORAL AB 1999-04-26 301d65b070ca…2024-07-13 05:37 UTC · 2 captures of this ZIP 2024-07 A071196-003 TRAZODONE HYDROCHLORIDE 300MG TABLET / ORAL AB 1999-04-26 301d65b070ca…2024-06-18 03:08 UTC · 5 captures of this ZIP 2024-06 A071196-001 TRAZODONE HYDROCHLORIDE 100MG TABLET / ORAL AB RS 1987-03-25 1e350fbaab3a…
Observed Orange Book normalized TE history# Normalized TE history page 1 of 4 · 126 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 300 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 856369 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 0555-0711-02 Trazodone Hydrochloride 100 in 1 BOTTLE TABLET 100 3
DailyMed Dashboard NDC Coverage# NDC, Dashboard title, SPL version table NDC Dashboard title SPL version Validation Dashboard ZIP 0555-0711 TRAZODONE HYDROCHLORIDE TABLET [TEVA PHARMACEUTICALS USA, INC.] 3 Current NDC, Legacy NDC, 1 package rows 20221029_9c4da6ad-d4d1-4e8c-918d-8ac48512a93f.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 REMEDYREPACK INC. dc1f347e-1acb-4c06-b36e-f15fecb7ac93 2026-08-07 Boxed warning, Warnings, Adverse reactions Exact identifier application applno (ANDA): 071196 application number: ANDA071196 Trazodone Hydrochloride TRAZODONE HYDROCHLORIDE Apotex Corp 71961ab1-951d-1493-f76c-2ff25cca2a85 2026-03-24 Boxed warning, Warnings, Adverse reactions Exact identifier application applno (ANDA): 071196 application number: ANDA071196 Trazodone Hydrochloride TRAZODONE HYDROCHLORIDE Aphena Pharma Solutions - Tennessee, LLC 5d22a06c-9cb8-4b49-8d67-769d181ad70c 2021-03-10 Boxed warning, Warnings, Adverse reactions Exact identifier application applno (ANDA): 071196 application number: ANDA071196 Trazodone Hydrochloride TRAZODONE HYDROCHLORIDE Teva Pharmaceuticals USA, Inc. 9c4da6ad-d4d1-4e8c-918d-8ac48512a93f 2020-06-30 Boxed warning, Warnings, Adverse reactions Exact identifier application applno (ANDA): 071196 application number: ANDA071196 ndc (product): 0555-0711
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 0555-0711-02 00555071102 100 TABLET in 1 BOTTLE (0555-0711-02) 100 tablet 2021-12-09 0000-00-00 No No Current