NDC 80425-0135-01 - 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
80425-0135
Requested NDC
80425-0135-01
Package NDCs from labels
80425-0135-3, 80425-0135-1, 80425-0135-2, 80425-0135-01
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
Clonazepam - 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
80425-0135-1Clonazepam30 in 1 BOTTLETABLET308
80425-0135-2Clonazepam60 in 1 BOTTLETABLET608
80425-0135-3Clonazepam90 in 1 BOTTLETABLET908

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
80425-0135CLONAZEPAM TABLET [ADVANCED RX PHARMACY OF TENNESSEE, LLC]8Current NDC, Legacy NDC, 3 package rows20250101_be383e56-d71f-7699-e053-2995a90a50c1.zip

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
80425-0135-1EA - Each80425-013501a64af0-0642-427e-b87b-7a06c4e252b412023-03-13
80425-0135-2EA - Each80425-0135b5c23171-9c9f-42c3-a921-3fc06964724f12023-03-13
80425-0135-3EA - Each80425-0135fa89e882-87a4-4acb-842c-2eecbec4ec4b12023-03-13

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 5 · 94 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
ClonazepamCLONAZEPAMSt Marys Medical Park Pharmacy31a7ed52-48a6-1c87-e054-00144ff88e882025-05-22Warnings, Adverse reactionsExact identifier
application number: ANDA077147
rxcui: 197528
unii: 5PE9FDE8GB
ClonazepamCLONAZEPAMAmerican Health Packagingc13297e2-ae3e-4198-b7c8-55fd672436aa2025-03-21Boxed warning, Warnings, Adverse reactionsExact identifier
rxcui: 197528
rxcui: 197527
unii: 5PE9FDE8GB
ClonazepamCLONAZEPAMCoupler LLC2e970dc2-cd78-bcdf-e063-6294a90ad3e02025-02-20Boxed warning, Warnings, Adverse reactionsExact identifier
rxcui: 197527
unii: 5PE9FDE8GB
ClonazepamCLONAZEPAMCoupler LLC2cdb55a7-54e4-17b6-e063-6294a90ac8272025-01-29Boxed warning, Warnings, Adverse reactionsExact identifier
rxcui: 197529
unii: 5PE9FDE8GB
ClonazepamCLONAZEPAMDirect_Rxfc75869c-cd6b-44a3-e053-6294a90a699e2025-01-22Boxed warning, Warnings, Adverse reactionsExact identifier
rxcui: 197528
unii: 5PE9FDE8GB
CLONAZEPAMCLONAZEPAMDIRECT RXa821f647-be5f-274c-e053-2a95a90a23ce2025-01-17Warnings, Adverse reactionsExact identifier
rxcui: 197527
unii: 5PE9FDE8GB
ClonazepamCLONAZEPAMAdvanced Rx of Tennessee, LLC04db8e8c-38f9-0c4a-e063-6394a90a93f02024-12-31Boxed warning, Warnings, Adverse reactionsExact identifier
application number: ANDA077147
rxcui: 197527
unii: 5PE9FDE8GB
ClonazepamCLONAZEPAMAdvanced Rx Pharmacy of Tennessee, LLCb9309a1a-a794-2f62-e053-2a95a90a7c342024-12-31Boxed warning, Warnings, Adverse reactionsExact identifier
application number: ANDA077147
rxcui: 197527
unii: 5PE9FDE8GB
ClonazepamCLONAZEPAMAdvanced Rx Pharmacy of Tennessee, LLCbe383e56-d71f-7699-e053-2995a90a50c12024-12-31Boxed warning, Warnings, Adverse reactionsExact identifier
application number: ANDA077147
ndc (package): 80425-0135-1
ndc (package): 80425-0135-3
ndc (package): 80425-0135-2
ndc (product): 80425-0135
ndc11 (package): 80425013501
rxcui: 197528
spl id: 2a99b834-0c98-6f97-e063-6394a90a8407
spl set id: be383e56-d71f-7699-e053-2995a90a50c1
unii: 5PE9FDE8GB
ClonazepamCLONAZEPAMAphena Pharma Solutions - Tennessee, LLC263f99eb-9744-5601-e063-6394a90a47b12024-11-14Warnings, Adverse reactionsExact identifier
rxcui: 197527
unii: 5PE9FDE8GB
ClonazepamCLONAZEPAMAphena Pharma Solutions - Tennessee, LLC8891c5aa-f42a-4206-92b9-f0ed0631dfcb2024-10-23Boxed warning, Warnings, Adverse reactionsExact identifier
rxcui: 197527
unii: 5PE9FDE8GB
ClonazepamCLONAZEPAMAphena Pharma Solutions - Tennessee, LLC214e760b-c909-bd93-e063-6294a90ae74a2024-10-22Boxed warning, Warnings, Adverse reactionsExact identifier
rxcui: 197527
unii: 5PE9FDE8GB
ClonazepamCLONAZEPAMNuCare Pharmaceuticals,Inc.555061d4-276a-4716-e054-00144ff88e882024-10-16Warnings, Adverse reactionsExact identifier
application number: ANDA077147
rxcui: 197527
unii: 5PE9FDE8GB
ClonazepamCLONAZEPAMAphena Pharma Solutions - Tennessee, LLC66bf60fa-61ac-47a7-a081-36077af9007e2024-10-14Warnings, Adverse reactionsExact identifier
rxcui: 197527
unii: 5PE9FDE8GB
ClonazepamCLONAZEPAMAphena Pharma Solutions - Tennessee, LLC7b0d716c-8f51-47a7-8bf2-07c6f9732a052024-09-29Warnings, Adverse reactionsExact identifier
application number: ANDA077147
rxcui: 197527
unii: 5PE9FDE8GB
ClonazepamCLONAZEPAMAphena Pharma Solutions - Tennessee, LLC20b3125e-4489-3c53-e063-6294a90a65392024-08-27Boxed warning, Warnings, Adverse reactionsExact identifier
rxcui: 197528
unii: 5PE9FDE8GB
ClonazepamCLONAZEPAMBryant Ranch Prepackb12661a6-2141-42a9-bcb0-c0aef81395ce2024-08-23Warnings, Adverse reactionsExact identifier
rxcui: 197527
unii: 5PE9FDE8GB
ClonazepamCLONAZEPAMBryant Ranch Prepackb83009c2-26ed-45fa-819e-164cdac264e62024-08-23Warnings, Adverse reactionsExact identifier
rxcui: 197528
unii: 5PE9FDE8GB
ClonazepamCLONAZEPAMBryant Ranch Prepack96518266-8f75-4301-b8fd-d2995a7f486d2024-08-06Warnings, Adverse reactionsExact identifier
rxcui: 197527
unii: 5PE9FDE8GB
ClonazepamCLONAZEPAMBryant Ranch Prepackf06dc5fc-94e0-496e-bdf0-11f2b6ffc7862024-08-06Warnings, Adverse reactionsExact identifier
rxcui: 197529
unii: 5PE9FDE8GB

Reported adverse events (FAERS/openFDA)#

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