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 3 of 6 · 104 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
Trazodone HydrochlorideTRAZODONE HYDROCHLORIDEZydus Lifesciences Limited43d4be17-5fae-4326-a5c4-9e25e2db6a432026-01-23Exact identifier
application number: ANDA205253
rxcui: 856377
rxcui: 856364
rxcui: 856369
rxcui: 856373
unii: 6E8ZO8LRNM
Trazodone HydrochlorideTRAZODONE HYDROCHLORIDEZydus Pharmaceuticals USA Inc.704aebf9-2fff-4ef3-8323-9ff0d7f0ffd92026-01-22Boxed warning, Warnings, Adverse reactionsExact identifier
application number: ANDA205253
ndc (product): 68382-805
rxcui: 856377
rxcui: 856364
rxcui: 856369
rxcui: 856373
spl id: 24cb2e4c-a9ba-4283-8396-343f6aa03121
spl set id: 704aebf9-2fff-4ef3-8323-9ff0d7f0ffd9
unii: 6E8ZO8LRNM
Trazodone HydrochlorideTRAZODONE HYDROCHLORIDEA-S Medication Solutions4fcd25d5-e34f-4eea-aeff-aa442651e6812026-01-20Boxed warning, Warnings, Adverse reactionsExact identifier
application number: ANDA205253
rxcui: 856364
unii: 6E8ZO8LRNM
Trazodone HydrochlorideTRAZODONE HYDROCHLORIDEAvKAREa382ac4d-9ab9-796a-e053-2a95a90a2c262026-01-15Boxed warning, Warnings, Adverse reactionsExact identifier
rxcui: 856364
unii: 6E8ZO8LRNM
Trazodone HydrochlorideTRAZODONE HYDROCHLORIDEAvPAK9f1c2bf1-5204-7306-e053-2a95a90a99032026-01-12Boxed warning, Warnings, Adverse reactionsExact identifier
application number: ANDA205253
rxcui: 856364
unii: 6E8ZO8LRNM
Trazodone HydrochlorideTRAZODONE HYDROCHLORIDEA-S Medication Solutions353e66cc-98ca-4500-97e7-00f23f1223492026-01-06Boxed warning, Warnings, Adverse reactionsExact identifier
application number: ANDA205253
rxcui: 856373
unii: 6E8ZO8LRNM
Trazodone HydrochlorideTRAZODONE HYDROCHLORIDEAdvanced Rx Pharmacy of Tennessee, LLCf89ad429-0056-e4d6-e053-6294a90a7ab12026-01-05Boxed warning, Warnings, Adverse reactionsExact identifier
rxcui: 856373
unii: 6E8ZO8LRNM
Trazodone HydrochlorideTRAZODONE HYDROCHLORIDENorthwind Health Company, LLCf2f2290f-b53c-3b38-e053-2995a90a157d2026-01-01Boxed warning, Warnings, Adverse reactionsExact identifier
rxcui: 856377
unii: 6E8ZO8LRNM
Trazodone HydrochlorideTRAZODONE HYDROCHLORIDENorthwind Health Company, LLCe07d7ee3-776d-1fa3-e053-2a95a90a70192026-01-01Boxed warning, Warnings, Adverse reactionsExact identifier
rxcui: 856373
unii: 6E8ZO8LRNM
Trazodone HydrochlorideTRAZODONE HYDROCHLORIDEAdvanced Rx Pharmacy of Tennessee, LLCf98b1e8f-9c66-3e9c-e053-6294a90ab0572025-12-18Boxed warning, Warnings, Adverse reactionsExact identifier
rxcui: 856377
unii: 6E8ZO8LRNM
Trazodone HydrochlorideTRAZODONE HYDROCHLORIDEAccord Healthcare, Inc.ed3039d8-3d27-4b71-a4b0-812943c9457f2025-12-17Boxed warning, Warnings, Adverse reactionsExact identifier
rxcui: 856377
rxcui: 856364
rxcui: 856369
rxcui: 856373
unii: 6E8ZO8LRNM
TRAZODONE HYDROCHLORIDETRAZODONE HYDROCHLORIDEBryant Ranch Prepack470a98a2-4e68-4c98-b3c8-e5eba4e55cdc2025-12-04Boxed warning, Warnings, Adverse reactionsExact identifier
rxcui: 856369
unii: 6E8ZO8LRNM
TRAZODONE HYDROCHLORIDETRAZODONE HYDROCHLORIDEBryant Ranch Prepackfdd35113-5f51-49c5-a29c-ffdddd28ef382025-12-04Boxed warning, Warnings, Adverse reactionsExact identifier
rxcui: 856373
unii: 6E8ZO8LRNM
TRAZODONE HYDROCHLORIDETRAZODONE HYDROCHLORIDEBryant Ranch Prepackb57daea8-5a39-41c1-842e-b1d15115e36f2025-12-04Boxed warning, Warnings, Adverse reactionsExact identifier
rxcui: 856373
unii: 6E8ZO8LRNM
TRAZODONE HYDROCHLORIDETRAZODONE HYDROCHLORIDEBryant Ranch Prepack24b5eee4-4210-4b90-a695-11e6a58689882025-12-04Boxed warning, Warnings, Adverse reactionsExact identifier
rxcui: 856364
unii: 6E8ZO8LRNM
TRAZODONE HYDROCHLORIDETRAZODONE HYDROCHLORIDEBryant Ranch Prepack7baa8eef-3a5c-43b3-a5fe-0c449aacda2e2025-12-04Boxed warning, Warnings, Adverse reactionsExact identifier
rxcui: 856373
unii: 6E8ZO8LRNM
Trazodone HydrochlorideTRAZODONE HYDROCHLORIDEAphena Pharma Solutions - Tennessee, LLCb716575a-5b96-49c5-bcb2-56b05fbb79202025-10-29Boxed warning, Warnings, Adverse reactionsExact identifier
application number: ANDA205253
rxcui: 856373
unii: 6E8ZO8LRNM
Trazodone HydrochlorideTRAZODONE HYDROCHLORIDEAmerican Health Packaging094ca37b-3ae2-4889-9536-e7e5f20e31052025-10-14Boxed warning, Warnings, Adverse reactionsExact identifier
application number: ANDA205253
rxcui: 856377
rxcui: 856364
rxcui: 856373
unii: 6E8ZO8LRNM
Trazodone HydrochlorideTRAZODONE HYDROCHLORIDEPD-Rx Pharmaceuticals, Inc.9b022ae9-dd52-43ae-804b-ddf8e7cfd5302025-10-01Boxed warning, Warnings, Adverse reactionsExact identifier
rxcui: 856364
unii: 6E8ZO8LRNM
Trazodone HydrochlorideTRAZODONE HYDROCHLORIDEPreferred Pharmaceuticals Inc.bb3ecde6-72ca-450c-ba88-9cf45c808d902025-10-01Boxed warning, Warnings, Adverse reactionsExact identifier
application number: ANDA205253
rxcui: 856364
unii: 6E8ZO8LRNM

Reported adverse events (FAERS/openFDA)#

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