FDA.reportPublic FDA data

NDC 80425-0357-01 - Clonazepam

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
80425-0357
Requested NDC
80425-0357-01
Package NDCs from labels
80425-0357-1, 80425-0357-2, 80425-0357-3, 80425-0357-01
Manufacturer
Advanced Rx Pharmacy of Tennessee, LLC
Effective date
2024-06-07
Current FDA listing
Not matched in FDA.report NDC product tables

DailyMed Labels#

Label, Manufacturer, Effective date table
LabelManufacturerEffective dateType
Clonazepam - Advanced Rx Pharmacy of Tennessee, LLCAdvanced Rx Pharmacy of Tennessee, LLC2024-06-07HUMAN PRESCRIPTION DRUG LABEL

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
80425-0357-1Clonazepam30 in 1 BOTTLETABLET302
80425-0357-2Clonazepam60 in 1 BOTTLETABLET602
80425-0357-3Clonazepam90 in 1 BOTTLETABLET902

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
80425-0357CLONAZEPAM TABLET [ADVANCED RX PHARMACY OF TENNESSEE, LLC]2Current NDC, 3 package rows20240612_04db0fbe-7fa3-28af-e063-6294a90abbe6.zip

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
80425-0357-1EA - Each80425-0357670ea3a6-d064-43c2-b52a-c3b4b0962d5b12023-10-16
80425-0357-2EA - Each80425-0357b8ffe809-61ff-496c-b326-07f342442b2012023-10-16
80425-0357-3EA - Each80425-0357138da6e5-1655-447f-9448-42b800a498e712023-10-16

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 36 · 709 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
ClonazepamCLONAZEPAMREMEDYREPACK INC.874b0395-fecb-446a-966f-6ecbb23f1ff62026-07-07Boxed warning, Warnings, Adverse reactionsExact identifier
rxcui: 197528
unii: 5PE9FDE8GB
ClonazepamCLONAZEPAMREMEDYREPACK INC.3aa9c3eb-3a0a-4e8b-af68-4f87d87194dd2026-07-03Boxed warning, Warnings, Adverse reactionsExact identifier
rxcui: 197527
unii: 5PE9FDE8GB
The Cell Salt Co. Daily Blend 12 in 1CALC FLUOR, CALC PHOS, CALC SULPH, FERRUM PHOS, KALI MUR, KALI PHOS, KALI SULPH, MAG PHOS, NAT MUR, NAT PHOS, NAT SULPH, SILICEAThe Cell Salt Company LLC55826f59-acf4-7370-e063-6394a90afed72026-07-01WarningsExact identifier
unii: ETJ7Z6XBU4
Bambusa StannumBAMBUSA STANNUMUriel Pharmacy Inc.a0d4d0ac-e2d2-4381-8f93-e417195218592026-06-30WarningsExact identifier
unii: ETJ7Z6XBU4
ClonazepamCLONAZEPAMAdvagen Pharma Ltd30d674f9-f1b3-4c2d-a8e9-3bc8e476f1ec2026-06-25Boxed warning, Warnings, Adverse reactionsExact identifier
rxcui: 197528
rxcui: 197529
rxcui: 197527
unii: 5PE9FDE8GB
ClonazepamCLONAZEPAMCoupler LLC54d6e348-4c51-221e-e063-6294a90a9b7d2026-06-22Boxed warning, Warnings, Adverse reactionsExact identifier
rxcui: 197528
unii: 5PE9FDE8GB
ClonazepamCLONAZEPAMREMEDYREPACK INC.533a12a8-64fb-494f-a2a4-da1515ef19082026-06-19Boxed warning, Warnings, Adverse reactionsExact identifier
rxcui: 197528
unii: 5PE9FDE8GB
ClonazepamCLONAZEPAMUnit Dose Solutions, Inc.54789918-cc0c-7090-e063-6394a90aeba72026-06-17Boxed warning, Warnings, Adverse reactionsExact identifier
rxcui: 197528
rxcui: 197527
unii: 5PE9FDE8GB
H-Scars FormulaCALENDULA OFFICINALLIS, SILICEAHealing Natural Oils LLC8433ff00-d815-45e0-b0ec-1448668dd8f82026-06-16WarningsExact identifier
unii: ETJ7Z6XBU4
E-Z-GAS IIANTACID/ANTIFLATULENTE-Z-EM, INC.4e12e1cb-b033-076d-e054-00144ff8d46c2026-06-15WarningsExact identifier
unii: ETJ7Z6XBU4
BM BIO28 ALCOHOLCALC SULPH, CALC FLUOR, CALC PHOS, FERR PHOS, KALI MUR, KALI PHOS, KALI SULPH, MAG PHOS, NAT PHOS, NAT SULPH, NAT MUR, SILICEATotal Operations Management LLC DBA:Bestmade Natural Products Micro544b66c4-49df-556f-e063-6394a90af3ed2026-06-15WarningsExact identifier
unii: ETJ7Z6XBU4
BM Tooth RemineralizationCALC PHOS, CALC FLUOR, SILICEATotal Operations Management LLC DBA:Bestmade Natural Products Micro543bc298-ec32-38e9-e063-6394a90aac152026-06-14WarningsExact identifier
unii: ETJ7Z6XBU4
Nail Fungus Control Extra StrengthCALENDULA OFFICINALIS FLOWERING TOP, SILICON DIOXIDE, AND HYPERICUM PERFORATUMForces of Natured02b88a6-1999-4dcd-91b5-fad88a664fcb2026-06-14WarningsExact identifier
unii: ETJ7Z6XBU4
Nerve PainARABICA COFFEE BEAN, SILICON DIOXIDE, AND HYPERICUM PERFORATUMForces of Naturea9c3ba2e-9254-4ccd-9fe9-7a360fdf2bb72026-06-14WarningsExact identifier
unii: ETJ7Z6XBU4
Scar ControlCALENDULA OFFICINALIS FLOWERING TOP, ALLYLTHIOUREA, AND SILICON DIOXIDEForces of Nature595c3423-6b52-48fc-8a95-00b53c1ecc7b2026-06-14WarningsExact identifier
unii: ETJ7Z6XBU4
BM BM186 DROPSARNICA, FERR PHOS, HYPERICUM, IGNATIA, SILICATotal Operations Management LLC DBA:Bestmade Natural Products Micro54243745-bd67-19c1-e063-6394a90a4b722026-06-13WarningsExact identifier
unii: ETJ7Z6XBU4
BM BM186 DROPSARNICA, FERR PHOS, HYPERICUM, IGNATIA, SILICABM Private Limited540d8fbe-3bdb-1b54-e063-6394a90a114d2026-06-12WarningsExact identifier
unii: ETJ7Z6XBU4
BM BM5 DROPSAPIS MELL, BAPTISIA, CONIUM MAC, ECHINACEA, EUPATORIUM PERF, SILICEA, THUJA OCCTotal Operations Management LLC DBA:Bestmade Natural Products Micro540e4ee3-596f-4cea-e063-6294a90a6a602026-06-12WarningsExact identifier
unii: ETJ7Z6XBU4
ClonazepamCLONAZEPAMREMEDYREPACK INC.1fb0807c-dccd-47a5-ada4-91418c4f47f52026-06-11Boxed warning, Warnings, Adverse reactionsExact identifier
application number: ANDA075150
rxcui: 197527
unii: 5PE9FDE8GB
Jacksons Cell Salts SKIN BALANCECALC SULPH, KALI SULPH, SILICEAZettl Health Inc.54012f03-4c34-42f5-e063-6394a90aacc52026-06-11WarningsExact identifier
unii: ETJ7Z6XBU4

Reported adverse events (FAERS/openFDA)#

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