FDA.reportPublic FDA data

NDC 80425-0502-01 - TRAZODONE HYDROCHLORIDE

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
80425-0502
Requested NDC
80425-0502-01
Package NDCs from labels
80425-0502-1, 80425-0502-2, 80425-0502-3, 80425-0502-01
Manufacturer
Advanced Rx of Tennessee, LLC
Effective date
2025-03-20
Current FDA listing
Not matched in FDA.report NDC product tables

DailyMed Labels#

Label, Manufacturer, Effective date table
LabelManufacturerEffective dateType
TRAZODONE HYDROCHLORIDE - Advanced Rx of Tennessee, LLCAdvanced Rx of Tennessee, LLC2025-03-20HUMAN PRESCRIPTION DRUG LABEL

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
80425-0502-1TRAZODONE HYDROCHLORIDE30 in 1 BOTTLETABLET301
80425-0502-2TRAZODONE HYDROCHLORIDE60 in 1 BOTTLETABLET601
80425-0502-3TRAZODONE HYDROCHLORIDE90 in 1 BOTTLETABLET901

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
80425-0502TRAZODONE HYDROCHLORIDE TABLET [ADVANCED RX OF TENNESSEE, LLC]1Current NDC, 3 package rows20250322_30ca6faa-316d-5754-e063-6394a90a7eff.zip

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
80425-0502-1EA - Each80425-050211d06bbe-2dac-4853-b7e0-5c774000e43a12025-05-14
80425-0502-2EA - Each80425-0502d9f5d1fc-2f95-4f7f-99e8-388f82e77ab612025-05-14
80425-0502-3EA - Each80425-05024c792925-389f-4551-bb69-e8ec5731026d12025-05-14

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 19 of 36 · 714 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
Sinus TonicECHINACEA (ANGUSTIFOLIA), BAPTISIA TINCTORIA, THIAMINUM HYDROCHLORICUM, HYDRASTIS CANADENSIS, PYRIDOXINUM HYDROCHLORICUM, SPONGIA TOSTA, APIS MELLIFICA, ASCORBIC ACID, HEPAR SULPHURIS CALCAREUM, KALI BICHROMICUM, LACHESIS MUTUS, MERCURIUS IODATUS RUBER, MERCURIUS SULPHURATUS RUBER, PULSATILLA (PRATENSIS), SILICEA, SINUSITISINUM, PANTOTHENIC ACIDBioActive Nutritional, Inc.63234fdc-7456-42c6-8996-fef372dd4a532025-05-20WarningsExact identifier
unii: ETJ7Z6XBU4
Inflammation IECHINACEA (ANGUSTIFOLIA), NASTURTIUM AQUATICUM, PHYTOLACCA DECANDRA, HYDRASTIS CANADENSIS, APIS MELLIFICA, BELLADONNA, FERRUM PHOSPHORICUM, NITRICUM ACIDUM, OLEANDER, SILICEABioActive Nutritional, Inc.ddfad5cd-c928-42c0-9562-9feebb73a2cb2025-05-19WarningsExact identifier
unii: ETJ7Z6XBU4
VermexARTEMISIA VULGARIS, CINA, TEUCRIUM MARUM, SPIGELIA ANTHELMIA, FILIX MAS, CALCAREA CARBONICA, GRAPHITES, MERCURIUS CORROSIVUS, SABADILLA, SILICEA, TANACETUM VULGARE, ASCARIS LUMBRICOIDES, TAENIA SOLIUMBioActive Nutritional, Inc.06b61e15-ab8b-4b7e-8378-48f87a963e442025-05-16WarningsExact identifier
unii: ETJ7Z6XBU4
Lymph IIECHINACEA (ANGUSTIFOLIA), COLLINSONIA CANADENSIS, PHYTOLACCA DECANDRA, KALI IODATUM, PINUS SYLVESTRIS, PIX LIQUIDA, FERRUM PHOSPHORICUM, AESCULUS HIPPOCASTANUM, BARYTA CARBONICA, BERBERIS VULGARIS, CALCAREA CARBONICA, CALCAREA PHOSPHORICA, CAUSTICUM, HEPAR SULPHURIS CALCAREUM, KREOSOTUM, LYCOPODIUM CLAVATUM, MERCURIUS SOLUBILIS, NATRUM MURIATICUM, NITRICUM ACIDUM, PHOSPHORUS, PULSATILLA (PRATENSIS), SILICEA, STELLARIA MEDIA, SULPHUR, TEREBINTHINA, THUJA OCCIDENTALIS, BUFO RANABioActive Nutritional, Inc.678874d0-7600-4d03-ad1e-e4dc671575972025-05-16WarningsExact identifier
unii: ETJ7Z6XBU4
Vax SodeTHUJA OCCIDENTALIS, CALCAREA CARBONICA, SILICEA, SALMONELLA TYPHI NOSODE, SERUM ANGUILLAE, BACILLUS TETANI(CLOSTRIDIUM TETANI), MALANDRINUM, MORBILLINUM, PAROTIDINUM, RUBELLA NOSODE, YERSINIA ENTEROCOLITICA, SALMONELLA ENTERIDITISNutritional Specialties, Inc.6f8cfcad-4d23-44d3-9369-22b575b1e7e62025-05-15WarningsExact identifier
unii: ETJ7Z6XBU4
ApnetemPHOSPHORICUM ACIDUM, ALUMEN, PHOSPHORUS, SENEGA OFFICINALIS, ADENOSINUM CYCLOPHOSPHORICUM, ANTIMONIUM TARTARICUM, GRINDELIA, SABADILLA, ALUMINA, CUPRUM METALLICUM, SANGUINARINUM NITRICUM, SILICEA, LACHESIS MUTUS, RHEUM (PALMATUM), ZINCUM METALLICUM, LYCOPODIUM CLAVATUM, MANGANUM PHOSPHORICUM, ANTIPYRINUM, COENZYME ANucleic Products, LLCec5bc7e7-4be6-45a6-8cd9-62fdfa7fb4692025-05-14WarningsExact identifier
unii: ETJ7Z6XBU4
DOCTRUST ONE S ToothSODIUM FLUORIDE, DENTAL TYPE SILICA, POTASSIUM NIRATEDOCSMEDI Co., Ltd.3382776a-a10e-1823-e063-6394a90a6f912025-04-24WarningsExact identifier
unii: ETJ7Z6XBU4
Trazodone HydrochlorideTRAZODONE HYDROCHLORIDEBryant Ranch Prepack65ef34fb-8fe4-4e9d-9068-98702515ffeb2025-04-23Boxed warning, Warnings, Adverse reactionsExact identifier
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
Bestmade Natural Products BM133 PelletsSILICEA, CARBO VEG, AURUM MUR, THUJA OCC, ACID NIT, FERRUM IODBestmade Natural Products3242a579-23f3-0063-e063-6394a90a93342025-04-08WarningsExact identifier
unii: ETJ7Z6XBU4
Bestmade Natural Products Silicea 8xSILICEABestmade Natural Products31e15fbf-2439-8d96-e063-6294a90a46ed2025-04-03WarningsExact identifier
unii: ETJ7Z6XBU4
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
application number: ANDA204852
ndc (product): 13107-079
rxcui: 856377
rxcui: 856364
rxcui: 856369
rxcui: 856373
spl id: db4e6aff-149f-4f16-9512-e81e0c3e6900
spl set id: 295e92a9-bcb0-4d53-ba62-e30020e9834b
unii: 6E8ZO8LRNM
Bestmade Natural Products BM238SANTONINE, CINA, SILICEA, INDIGO, AMBROSIA, CUCCURBITA CIT, CUCCURBITA PEPBestmade Natural Products298fb9e2-3f98-01e6-e063-6294a90a7aaf2025-03-26WarningsExact identifier
unii: ETJ7Z6XBU4
Bestmade Natural Products Silicea 6x Lactose-freeSILICEA ORGANIC CANE SUGARBestmade Natural Products2991ecbf-925e-00f3-e063-6294a90a37bf2025-03-25WarningsExact identifier
unii: ETJ7Z6XBU4
Bestmade Natural Products BM60CIMICIFUGAD6, DROSERAD6, FORMICA RUFAD6, FULIGOD6, INULA HELD6, KALI MURD6, LAPIS ALBUSD6, SILICEAD6Bestmade Natural Products29912fb7-8712-18d9-e063-6394a90a82f72025-03-25WarningsExact identifier
unii: ETJ7Z6XBU4
Trazodone HydrochlorideTRAZODONE HYDROCHLORIDECoupler LLC31356804-951b-68c7-e063-6294a90a64102025-03-25Boxed warning, Warnings, Adverse reactionsExact identifier
rxcui: 856373
unii: 6E8ZO8LRNM
Bestmade Natural Products SiliceaSILICEABestmade Natural Productse9eadb4e-659b-dcae-e053-2995a90a0db72025-03-21WarningsExact identifier
unii: ETJ7Z6XBU4
TRAZODONE HYDROCHLORIDETRAZODONE HYDROCHLORIDEAdvanced Rx of Tennessee, LLC30ca6faa-316d-5754-e063-6394a90a7eff2025-03-20Boxed warning, Warnings, Adverse reactionsExact identifier
application number: ANDA204852
ndc (package): 80425-0502-1
ndc (package): 80425-0502-2
ndc (package): 80425-0502-3
ndc (product): 80425-0502
ndc11 (package): 80425050201
rxcui: 856377
spl id: 30ca7888-edc4-b659-e063-6294a90ab232
spl set id: 30ca6faa-316d-5754-e063-6394a90a7eff
unii: 6E8ZO8LRNM
Natural Eyes Stye Relief Fast Dissolving TablesAPIS MELLIFICA, CARBONEUM SULPHURATUM, PULSATILLA, SEPIA, SILICEATRP Company30a5435b-32b0-807d-e063-6294a90a84da2025-03-18WarningsExact identifier
unii: ETJ7Z6XBU4

Reported adverse events (FAERS/openFDA)#

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