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 5 of 6 · 104 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
Trazodone HydrochlorideTRAZODONE HYDROCHLORIDEAphena Pharma Solutions - Tennessee, LLC2d3f1d0b-3686-f4d7-e063-6394a90a1a762025-02-03Boxed warning, Warnings, Adverse reactionsExact identifier
application number: ANDA205253
rxcui: 856377
unii: 6E8ZO8LRNM
Trazodone HydrochlorideTRAZODONE HYDROCHLORIDECoupler LLC2c7dca0c-8313-7d85-e063-6294a90aca612025-01-27Boxed warning, Warnings, Adverse reactionsExact identifier
rxcui: 856377
unii: 6E8ZO8LRNM
TRAZODONE HCLTRAZODONE HCLAdvanced Rx Pharmacy of Tennessee, LLCd27e4473-6f62-ddfe-e053-2a95a90a9a2c2024-12-31Boxed warning, Warnings, Adverse reactionsExact identifier
application number: ANDA205253
ndc (package): 80425-0176-2
ndc (package): 80425-0176-1
ndc (product): 80425-0176
ndc11 (package): 80425017601
rxcui: 856377
spl id: 2a99a7c1-c4c3-2b01-e063-6294a90aa3b8
spl set id: d27e4473-6f62-ddfe-e053-2a95a90a9a2c
unii: 6E8ZO8LRNM
Trazodone HydrochlorideTRAZODONE HYDROCHLORIDEAdvanced Rx Pharmacy of Tennessee, LLCf8fc1f03-cd9d-9fa9-e053-6294a90a86652024-12-31Boxed warning, Warnings, Adverse reactionsExact identifier
rxcui: 856364
unii: 6E8ZO8LRNM
Trazodone HydrochlorideTRAZODONE HYDROCHLORIDEAdvanced Rx of Tennessee, LLC29ac7183-e574-506e-e063-6394a90a77c92024-12-19Boxed warning, Warnings, Adverse reactionsExact identifier
rxcui: 856364
unii: 6E8ZO8LRNM
Trazodone HydrochlorideTRAZODONE HYDROCHLORIDEA-S Medication Solutionsbe0dc037-d30a-4f07-ab7c-1695637b37402024-11-08Boxed warning, Warnings, Adverse reactionsExact identifier
rxcui: 856364
unii: 6E8ZO8LRNM
Trazodone HydrochlorideTRAZODONE HYDROCHLORIDEBryant Ranch Prepacka71063f9-cdc6-46bc-9eb4-626f288e46d92024-10-31Boxed warning, Warnings, Adverse reactionsExact identifier
rxcui: 856364
unii: 6E8ZO8LRNM
Trazodone HCLTRAZODONE HCLDirect_Rx1fd0fc6d-5b1c-9f6a-e063-6394a90a3b7c2024-08-16Boxed warning, Warnings, Adverse reactionsExact identifier
rxcui: 856369
unii: 6E8ZO8LRNM
Trazodone HydrochlorideTRAZODONE HYDROCHLORIDEBryant Ranch Prepack9df17765-5d41-4e26-98de-8506581145342024-08-08Boxed warning, Warnings, Adverse reactionsExact identifier
application number: ANDA205253
rxcui: 856373
unii: 6E8ZO8LRNM
Trazodone HydrochlorideTRAZODONE HYDROCHLORIDENuCare Pharmaceuticals,Inc.85bb3f78-5cf2-1319-e053-2991aa0ade752024-06-14Boxed warning, Warnings, Adverse reactionsExact identifier
application number: ANDA205253
rxcui: 856373
unii: 6E8ZO8LRNM
Trazodone HydrochlorideTRAZODONE HYDROCHLORIDENuCare Pharmaceuticals,Inc.6adb446d-cd2f-3d6b-e053-2991aa0a21142024-06-10Boxed warning, Warnings, Adverse reactionsExact identifier
application number: ANDA205253
rxcui: 856377
unii: 6E8ZO8LRNM
Trazodone HydrochlorideTRAZODONE HYDROCHLORIDEProficient Rx LP88ac1a9d-8483-4b29-9fe6-2e60e51f30052024-05-01Boxed warning, Warnings, Adverse reactionsExact identifier
application number: ANDA205253
rxcui: 856377
unii: 6E8ZO8LRNM
Trazodone HydrochlorideTRAZODONE HYDROCHLORIDEMedsource Pharmaceuticals138fef7b-db83-88c4-e063-6394a90ab0ac2024-03-13Boxed warning, Warnings, Adverse reactionsExact identifier
rxcui: 856373
unii: 6E8ZO8LRNM
Trazodone HydrochlorideTRAZODONE HYDROCHLORIDEMedsource Pharmaceuticals12f1737b-c021-d0f2-e063-6294a90a6f292024-03-05Boxed warning, Warnings, Adverse reactionsExact identifier
application number: ANDA205253
rxcui: 856377
unii: 6E8ZO8LRNM
Trazodone HydrochlorideTRAZODONE HYDROCHLORIDEAsclemed USA, Inc.04a676ee-358e-484d-9de4-a9a88d908ba82024-02-26Boxed warning, Warnings, Adverse reactionsExact identifier
application number: ANDA205253
rxcui: 856377
rxcui: 856364
rxcui: 856369
rxcui: 856373
unii: 6E8ZO8LRNM
Trazodone HydrochlorideTRAZODONE HYDROCHLORIDEA-S Medication Solutions3df90104-ef2c-4a82-b007-9843c43969ae2023-12-16Boxed warning, Warnings, Adverse reactionsExact identifier
application number: ANDA205253
rxcui: 856377
unii: 6E8ZO8LRNM
Trazodone HydrochlorideTRAZODONE HYDROCHLORIDEA-S Medication Solutionsac678c51-b1d3-4d6b-9599-7ef565b469d22023-10-16Boxed warning, Warnings, Adverse reactionsExact identifier
application number: ANDA205253
rxcui: 856373
unii: 6E8ZO8LRNM
Trazodone HydrochlorideTRAZODONE HYDROCHLORIDEProficient Rx LP3c8c3d2b-9108-40fa-90d9-6ed545cf65492023-06-01Boxed warning, Warnings, Adverse reactionsExact identifier
rxcui: 856364
unii: 6E8ZO8LRNM
Trazodone HydrochlorideTRAZODONE HYDROCHLORIDEProficient Rx LP203881a3-37d0-41dd-86c5-1e53fb7843262023-05-01Boxed warning, Warnings, Adverse reactionsExact identifier
rxcui: 856373
unii: 6E8ZO8LRNM
Trazodone HydrochlorideTRAZODONE HYDROCHLORIDEProficient Rx LPa90caa68-b28e-425f-b77c-7b566ac17dc22022-08-01Boxed warning, Warnings, Adverse reactionsExact identifier
rxcui: 856373
unii: 6E8ZO8LRNM

Reported adverse events (FAERS/openFDA)#

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