Home NDC 68071-3124-6 Trazodone Hydrochloride
Product NDC 68071-3124
Requested package NDC 68071-3124-6
11-digit product format 680713124
Labeler code 68071
Product ID 68071-3124_af857f13-398d-45b3-e053-2995a90aebbd
Type HUMAN PRESCRIPTION DRUG
Nonproprietary name Trazodone Hydrochloride
Dosage form TABLET
Route ORAL
Labeler NuCare Pharmaceuticals, Inc.
Application ANDA071524
Marketing category ANDA
Marketing start 1990-09-30
Marketing end 0000-00-00
Substance TRAZODONE HYDROCHLORIDE
Active strength 100 mg/1
Pharmacologic classes Serotonin Reuptake Inhibitor [EPC]
NDC exclude flag No
Listing certified through 2021-12-31
Current FDA listing Historical FDA.report record Source provenance: Browse the complete Orange Book source catalog · source snapshot 1 .
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 A071524-001 TRAZODONE HYDROCHLORIDE TRAZODONE HYDROCHLORIDE 100MG TABLET / ORAL AB 1987-12-11
Therapeutic equivalence codes# Current TE-code rows page 1 of 1 · 1 matching rows.
Application-product, TE code table Application-product TE code A071524-001 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.
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 2026-08-01 22:54:32 2026-06 A071524-001 TRAZODONE HYDROCHLORIDE 100MG TABLET / ORAL AB 1987-12-11 a50c72e98297…
Observed Orange Book normalized TE history# Captured, Edition, Application-product table Captured Edition Application-product TE code Order Source SHA-256 2026-08-01 22:54:32 2026-06 A071524-001 AB 1 a50c72e98297…
openFDA label cross-check# Cross-check layer: openFDA label JSON enriches search and identifies hydration gaps. The DailyMed Structured Product Label remains the canonical label presentation on FDA.report. Every label matching the complete exact-identifier union is deduplicated and paginated below.
Matched openFDA labels page 1 of 1 · 9 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 df17cec9-ad5e-4e57-8572-c927c9b955e2 2026-05-28 Boxed warning, Warnings, Adverse reactions Exact identifier application applno (ANDA): 071524 application number: ANDA071524 Trazodone Hydrochloride TRAZODONE HYDROCHLORIDE REMEDYREPACK INC. 7bba99e5-4096-4fcb-8591-dc4a9bfe975e 2026-04-22 Boxed warning, Warnings, Adverse reactions Exact identifier application applno (ANDA): 071524 application number: ANDA071524 Trazodone Hydrochloride TRAZODONE HYDROCHLORIDE AvKARE b3723265-7455-c25c-e053-2a95a90a379b 2026-03-11 Boxed warning, Warnings, Adverse reactions Exact identifier application applno (ANDA): 071524 application number: ANDA071524 Trazodone Hydrochloride TRAZODONE HYDROCHLORIDE PD-Rx Pharmaceuticals, Inc. b617348c-cb19-45df-b313-4ea6af6f1dda 2026-02-26 Boxed warning, Warnings, Adverse reactions Exact identifier application applno (ANDA): 071524 application number: ANDA071524 Trazodone Hydrochloride TRAZODONE HYDROCHLORIDE Northwind Health Company, LLC e07d7ee3-776d-1fa3-e053-2a95a90a7019 2026-01-01 Boxed warning, Warnings, Adverse reactions Exact identifier application applno (ANDA): 071524 application number: ANDA071524 Trazodone Hydrochloride TRAZODONE HYDROCHLORIDE Aphena Pharma Solutions - Tennessee, LLC d42fd0c8-3673-4f18-a6c0-cd276bbf9fef 2025-09-16 Boxed warning, Warnings, Adverse reactions Exact identifier application applno (ANDA): 071524 application number: ANDA071524 Trazodone Hydrochloride TRAZODONE HYDROCHLORIDE Aphena Pharma Solutions - Tennessee, LLC 5ab590d8-225f-43f4-bb68-1f2c86f9a886 2025-07-24 Boxed warning, Warnings, Adverse reactions Exact identifier application applno (ANDA): 071524 application number: ANDA071524 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): 071524 application number: ANDA071524 Trazodone Hydrochloride TRAZODONE HYDROCHLORIDE Proficient Rx LP 203881a3-37d0-41dd-86c5-1e53fb784326 2023-05-01 Boxed warning, Warnings, Adverse reactions Exact identifier application applno (ANDA): 071524 application number: ANDA071524
FDA-Initiated Inactive NDC Indexing# NDC, Effective, Action table NDC Effective Action Document Indexing SPL Related label 68071-3124-3 2024-07-19 C162847 48780-1 9d75b9d0-819a-f424-e053-dadaa90a57ce 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 68071-3124-5 2024-07-19 C162847 48780-1 9d75b9d0-819a-f424-e053-dadaa90a57ce 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 68071-3124-6 2024-07-19 C162847 48780-1 9d75b9d0-819a-f424-e053-dadaa90a57ce 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 68071-3124-9 2024-07-19 C162847 48780-1 9d75b9d0-819a-f424-e053-dadaa90a57ce 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 68071-3124-3 2022-01-28 C162847 48780-1 9d75b9d0-819a-f424-e053-dadaa90a57ce 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 68071-3124-5 2022-01-28 C162847 48780-1 9d75b9d0-819a-f424-e053-dadaa90a57ce 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 68071-3124-6 2022-01-28 C162847 48780-1 9d75b9d0-819a-f424-e053-dadaa90a57ce 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 68071-3124-9 2022-01-28 C162847 48780-1 9d75b9d0-819a-f424-e053-dadaa90a57ce 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 68071-3124-3 2020-09-17 C162847 48780-1 9d75b9d0-819a-f424-e053-dadaa90a57ce 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 68071-3124-5 2020-09-17 C162847 48780-1 9d75b9d0-819a-f424-e053-dadaa90a57ce 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 68071-3124-6 2020-09-17 C162847 48780-1 9d75b9d0-819a-f424-e053-dadaa90a57ce 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 68071-3124-9 2020-09-17 C162847 48780-1 9d75b9d0-819a-f424-e053-dadaa90a57ce 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 68071-3124-3 2020-01-31 C162847 48780-1 9d75b9d0-819a-f424-e053-dadaa90a57ce 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 68071-3124-5 2020-01-31 C162847 48780-1 9d75b9d0-819a-f424-e053-dadaa90a57ce 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 68071-3124-6 2020-01-31 C162847 48780-1 9d75b9d0-819a-f424-e053-dadaa90a57ce 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 68071-3124-9 2020-01-31 C162847 48780-1 9d75b9d0-819a-f424-e053-dadaa90a57ce 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
Packages# Package NDC, 11-digit format, Description table Package NDC 11-digit format Description Units Marketing start Marketing end Sample Exclude flag Status 68071-3124-6 68071312406 60 TABLET in 1 BOTTLE (68071-3124-6) 60 tablet 1990-09-30 0000-00-00 No No Current