FDA.reportPublic FDA data

NDC 80425-0358-03 - 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
80425-0358
Requested NDC
80425-0358-03
Package NDCs from labels
80425-0358-1, 80425-0358-2, 80425-0358-3, 80425-0358-03
Manufacturer
Advanced Rx 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 of Tennessee, LLCAdvanced Rx of Tennessee, LLC2024-12-31HUMAN PRESCRIPTION DRUG LABEL

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
80425-0358-1Clonazepam30 in 1 BOTTLE, PLASTICTABLET302
80425-0358-2Clonazepam60 in 1 BOTTLE, PLASTICTABLET602
80425-0358-3Clonazepam90 in 1 BOTTLE, PLASTICTABLET902

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
80425-0358CLONAZEPAM TABLET [ADVANCED RX OF TENNESSEE, LLC]2Current NDC, 3 package rows20250101_04db8e8c-38f9-0c4a-e063-6394a90a93f0.zip

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
80425-0358-1EA - Each80425-035818c1b162-1578-45af-bca9-e2348a4f344c12023-10-16
80425-0358-2EA - Each80425-03580110193a-0a55-45ee-a8e0-df324fe46d3012023-10-16
80425-0358-3EA - Each80425-0358eb8cb3cc-4a39-4ce7-adea-7546438aaf6112023-10-16

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 1 of 6 · 101 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
ClonazepamCLONAZEPAMREMEDYREPACK INC.2606ecf9-3d71-4c1c-bfda-d7d98ffc60112026-08-27Boxed warning, Warnings, Adverse reactionsExact identifier
rxcui: 197528
unii: 5PE9FDE8GB
ClonazepamCLONAZEPAMREMEDYREPACK INC.9c3b1b37-8bc0-427a-8c7a-14da7bd49a7f2026-08-18Boxed warning, Warnings, Adverse reactionsExact identifier
rxcui: 197527
unii: 5PE9FDE8GB
ClonazepamCLONAZEPAMREMEDYREPACK INC.64bb2cdf-f57d-4a41-a5bf-ee77b6e64d062026-08-04Boxed warning, Warnings, Adverse reactionsExact identifier
rxcui: 197528
unii: 5PE9FDE8GB
ClonazepamCLONAZEPAMBryant Ranch Prepack19475112-60da-4d53-b330-70afe28ebaf32026-07-16Boxed warning, Warnings, Adverse reactionsExact identifier
rxcui: 197529
unii: 5PE9FDE8GB
ClonazepamCLONAZEPAMBryant Ranch Prepackc4b87c17-efcd-4b66-96e7-159a04c808b52026-07-15Boxed warning, Warnings, Adverse reactionsExact identifier
rxcui: 197527
unii: 5PE9FDE8GB
ClonazepamCLONAZEPAMBryant Ranch Prepack8bb69bbe-07e1-4123-9b70-fde78d1d0a342026-07-15Boxed warning, Warnings, Adverse reactionsExact identifier
rxcui: 197528
unii: 5PE9FDE8GB
ClonazepamCLONAZEPAMREMEDYREPACK INC.874b0395-fecb-446a-966f-6ecbb23f1ff62026-07-07Boxed warning, Warnings, Adverse reactionsExact identifier
application number: ANDA077147
rxcui: 197528
unii: 5PE9FDE8GB
ClonazepamCLONAZEPAMREMEDYREPACK INC.3aa9c3eb-3a0a-4e8b-af68-4f87d87194dd2026-07-03Boxed warning, Warnings, Adverse reactionsExact identifier
application number: ANDA077147
rxcui: 197527
unii: 5PE9FDE8GB
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
ClonazepamCLONAZEPAMREMEDYREPACK INC.1fb0807c-dccd-47a5-ada4-91418c4f47f52026-06-11Boxed warning, Warnings, Adverse reactionsExact identifier
rxcui: 197527
unii: 5PE9FDE8GB
ClonazepamCLONAZEPAMREMEDYREPACK INC.f613573a-3e8b-4abf-af69-0268f3d6f4812026-06-09Boxed warning, Warnings, Adverse reactionsExact identifier
rxcui: 197529
unii: 5PE9FDE8GB
ClonazepamCLONAZEPAMMajor Pharmaceuticals34366dd2-432c-4fa9-8fab-832cca781b842026-06-01Boxed warning, Warnings, Adverse reactionsExact identifier
rxcui: 197528
rxcui: 197527
unii: 5PE9FDE8GB
clonazepamCLONAZEPAMAdvagen Pharma Ltd19fc756c-72fe-4504-beaa-4fa2235af18c2026-05-27Boxed warning, Warnings, Adverse reactionsExact identifier
unii: 5PE9FDE8GB
ClonazepamCLONAZEPAMCoupler LLC511216c7-6878-f90a-e063-6394a90aaac82026-05-05Boxed warning, Warnings, Adverse reactionsExact identifier
rxcui: 197528
unii: 5PE9FDE8GB
Caldesene BabySTARCH, CORN AND ZINC OXIDEInsight Pharmaceuticals LLC9f12dee2-7afa-45e9-a729-0fd42bb777152026-04-22WarningsExact identifier
unii: O8232NY3SJ
Caldesene Medicated ProtectingCORNSTARCH AND ZINC OXIDEInsight Pharmaceuticals LLCffc92a0f-a7cf-4a46-b2f1-089df2bbb96b2026-04-22WarningsExact identifier
unii: O8232NY3SJ
ClonazepamCLONAZEPAMCardinal Health 107, LLC5ad315f2-fa09-4956-b931-f9966fb73e4e2026-04-21Boxed warning, Warnings, Adverse reactionsExact identifier
rxcui: 197528
rxcui: 197527
unii: 5PE9FDE8GB

Reported adverse events (FAERS/openFDA)#

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