FDA.reportPublic FDA data

NDC 80425-0176-01 - TRAZODONE HCL

This NDC is not currently matched to an FDA NDC product listing in FDA.report, but it is a valid NDC-form code. FDA.report is showing the available DailyMed label context for the product root.

Product NDC
80425-0176
Requested NDC
80425-0176-01
Package NDCs from labels
80425-0176-1, 80425-0176-2, 80425-0176-01
Manufacturer
Advanced Rx Pharmacy of Tennessee, LLC
Effective date
2024-12-31
Current FDA listing
Not matched in FDA.report NDC product tables

DailyMed Labels#

Label, Manufacturer, Effective date table
LabelManufacturerEffective dateType
TRAZODONE HCL - Advanced Rx Pharmacy of Tennessee, LLCAdvanced Rx Pharmacy of Tennessee, LLC2024-12-31HUMAN PRESCRIPTION DRUG LABEL

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
80425-0176-1TRAZODONE HCL30 in 1 BOTTLETABLET305
80425-0176-2TRAZODONE HCL60 in 1 BOTTLETABLET605

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
80425-0176TRAZODONE HCL TABLET [ADVANCED RX PHARMACY OF TENNESSEE, LLC]5Current NDC, Legacy NDC, 2 package rows20250101_d27e4473-6f62-ddfe-e053-2a95a90a9a2c.zip

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
80425-0176-1EA - Each80425-01763e8678b7-acd7-47f2-9396-6551d4d9a9c912023-06-06
80425-0176-2EA - Each80425-0176fd65bc4c-1959-4534-84f3-8f1a8e0b3bdd12023-06-06

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 4 of 6 · 104 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
Trazodone HydrochlorideTRAZODONE HYDROCHLORIDEPreferred Pharmaceuticals Inc.67d2a90a-3036-409c-aa32-937c550765472025-10-01Boxed warning, Warnings, Adverse reactionsExact identifier
application number: ANDA205253
rxcui: 856373
unii: 6E8ZO8LRNM
Trazodone HydrochlorideTRAZODONE HYDROCHLORIDEPreferred Pharmaceuticals Inc.9962589c-ee1f-4d5e-bd49-b7807bb60ace2025-10-01Boxed warning, Warnings, Adverse reactionsExact identifier
application number: ANDA205253
rxcui: 856377
unii: 6E8ZO8LRNM
TRAZODONE HYDROCHLORIDETRAZODONE HYDROCHLORIDEBryant Ranch Prepack4370fe5c-1c40-499b-abb5-bca0a39834c62025-09-19Boxed warning, Warnings, Adverse reactionsExact identifier
rxcui: 856373
unii: 6E8ZO8LRNM
TRAZODONE HYDROCHLORIDETRAZODONE HYDROCHLORIDEBryant Ranch Prepacka343910a-bf4c-4a41-b0ee-0e90e83558152025-09-19Boxed warning, Warnings, Adverse reactionsExact identifier
rxcui: 856364
unii: 6E8ZO8LRNM
TRAZODONE HYDROCHLORIDETRAZODONE HYDROCHLORIDEBryant Ranch Prepack1514b3b0-7742-4247-b9fd-ea14849d3fdd2025-09-19Boxed warning, Warnings, Adverse reactionsExact identifier
rxcui: 856369
unii: 6E8ZO8LRNM
Trazodone HydrochlorideTRAZODONE HYDROCHLORIDEAphena Pharma Solutions - Tennessee, LLCd42fd0c8-3673-4f18-a6c0-cd276bbf9fef2025-09-16Boxed warning, Warnings, Adverse reactionsExact identifier
rxcui: 856377
rxcui: 856373
unii: 6E8ZO8LRNM
Trazodone HydrochlorideTRAZODONE HYDROCHLORIDENuCare Pharmaceuticals,Inc.f7e6a78e-7ac3-35b9-e053-6294a90aabd02025-08-20Boxed warning, Warnings, Adverse reactionsExact identifier
rxcui: 856373
unii: 6E8ZO8LRNM
Trazodone HydrochlorideTRAZODONE HYDROCHLORIDEAphena Pharma Solutions - Tennessee, LLC5ab590d8-225f-43f4-bb68-1f2c86f9a8862025-07-24Boxed warning, Warnings, Adverse reactionsExact identifier
rxcui: 856377
rxcui: 856373
unii: 6E8ZO8LRNM
Trazodone HydrochlorideTRAZODONE HYDROCHLORIDEMajor Pharmaceuticals8eb85c26-a6cb-4a10-a990-ccc0b20aff082025-07-21Boxed warning, Warnings, Adverse reactionsExact identifier
application number: ANDA205253
rxcui: 856377
rxcui: 856364
rxcui: 856373
unii: 6E8ZO8LRNM
Trazodone HydrochlorideTRAZODONE HYDROCHLORIDETeva Pharmaceuticals USA, Inc.4006d439-e2de-4590-82e9-fc9d56e3ec1b2025-07-09Boxed warning, Warnings, Adverse reactionsExact identifier
rxcui: 856377
rxcui: 856364
rxcui: 856373
unii: 6E8ZO8LRNM
Trazodone HydrochlorideTRAZODONE HYDROCHLORIDECardinal Health 107, LLC9265f4f6-df24-4495-9dbf-e3fcfa4c864d2025-07-02Boxed warning, Warnings, Adverse reactionsExact identifier
application number: ANDA205253
rxcui: 856377
rxcui: 856373
unii: 6E8ZO8LRNM
Trazodone HydrochlorideTRAZODONE HYDROCHLORIDEBryant Ranch Prepack42ecd35c-4300-4cd3-942a-f3efb872fa992025-06-12Boxed warning, Warnings, Adverse reactionsExact identifier
application number: ANDA205253
rxcui: 856377
unii: 6E8ZO8LRNM
Trazodone HydrochlorideTRAZODONE HYDROCHLORIDEBryant Ranch Prepackadc7427e-3553-4805-b063-eeda840490292025-06-03Boxed warning, Warnings, Adverse reactionsExact identifier
rxcui: 856377
unii: 6E8ZO8LRNM
Trazodone HydrochlorideTRAZODONE HYDROCHLORIDEBryant Ranch Prepack65ef34fb-8fe4-4e9d-9068-98702515ffeb2025-04-23Boxed warning, Warnings, Adverse reactionsExact identifier
application number: ANDA205253
rxcui: 856364
unii: 6E8ZO8LRNM
Trazodone HydrochlorideTRAZODONE HYDROCHLORIDESun Pharmaceutical Industries, Inc.f291b905-a739-5e43-e053-2995a90ac40c2025-04-08Boxed warning, Warnings, Adverse reactionsExact identifier
rxcui: 856377
rxcui: 856364
rxcui: 856373
unii: 6E8ZO8LRNM
TRAZODONE HYDROCHLORIDETRAZODONE HYDROCHLORIDERising Pharma Holdings, Inc.ef26e4f0-f31f-4efa-9938-28c886cf3d1d2025-04-02Boxed warning, Warnings, Adverse reactionsExact identifier
rxcui: 856377
rxcui: 856364
rxcui: 856369
rxcui: 856373
unii: 6E8ZO8LRNM
TRAZODONE HYDROCHLORIDETRAZODONE HYDROCHLORIDEAurolife Pharma LLC295e92a9-bcb0-4d53-ba62-e30020e9834b2025-04-02Boxed warning, Warnings, Adverse reactionsExact identifier
rxcui: 856377
rxcui: 856364
rxcui: 856369
rxcui: 856373
unii: 6E8ZO8LRNM
Trazodone HydrochlorideTRAZODONE HYDROCHLORIDECoupler LLC31356804-951b-68c7-e063-6294a90a64102025-03-25Boxed warning, Warnings, Adverse reactionsExact identifier
rxcui: 856373
unii: 6E8ZO8LRNM
TRAZODONE HYDROCHLORIDETRAZODONE HYDROCHLORIDEAdvanced Rx of Tennessee, LLC30ca6faa-316d-5754-e063-6394a90a7eff2025-03-20Boxed warning, Warnings, Adverse reactionsExact identifier
rxcui: 856377
unii: 6E8ZO8LRNM
Trazodone HydrochlorideTRAZODONE HYDROCHLORIDENuCare Pharmaceuticals,Inc.fc9b90d1-7da5-efc1-e053-6294a90a02232025-02-04Boxed warning, Warnings, Adverse reactionsExact identifier
rxcui: 856377
unii: 6E8ZO8LRNM

Reported adverse events (FAERS/openFDA)#

Adverse event summaries are temporarily unavailable. Other product information remains available.