NDC 80425-0358-01 - 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
80425-0358
Requested NDC
80425-0358-01
Package NDCs from labels
80425-0358-1, 80425-0358-2, 80425-0358-3, 80425-0358-01
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 4 of 5 · 100 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
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
ClonazepamCLONAZEPAMBryant Ranch Prepack254a03c9-070c-40e6-83ac-524c1aec3b6b2024-08-05Warnings, Adverse reactionsExact identifier
rxcui: 197528
unii: 5PE9FDE8GB
ClonazepamCLONAZEPAMClinical Solutions Wholesale, LLC401cb3c0-4a5b-4ff9-baea-53095e60263d2024-08-01Boxed warning, Warnings, Adverse reactionsExact identifier
rxcui: 197528
rxcui: 197529
rxcui: 197527
unii: 5PE9FDE8GB
ClonazepamCLONAZEPAMNuCare Pharmaceuticals,Inc.a4882077-694d-d46c-e053-2a95a90a217d2024-07-17Boxed warning, Warnings, Adverse reactionsExact identifier
application number: ANDA077147
rxcui: 197528
unii: 5PE9FDE8GB
ClonazepamCLONAZEPAMAdvanced Rx Pharmacy of Tennessee, LLC04db0fbe-7fa3-28af-e063-6294a90abbe62024-06-07Boxed warning, Warnings, Adverse reactionsExact identifier
rxcui: 197528
rxcui: 197527
unii: 5PE9FDE8GB
ClonazepamCLONAZEPAMNuCare Pharmaceuticals,Inc.19b1fe7b-8f7b-03b7-e063-6394a90a9ba52024-05-30Boxed warning, Warnings, Adverse reactionsExact identifier
rxcui: 197529
unii: 5PE9FDE8GB
ClonazepamCLONAZEPAMA-S Medication Solutionsb3c9d04a-431f-4cec-a809-847dfb8de7362024-05-24Boxed warning, Warnings, Adverse reactionsExact identifier
rxcui: 197527
unii: 5PE9FDE8GB
ClonazepamCLONAZEPAMTeva Pharmaceuticals USA, Inc.cb2e209e-e69b-422b-8abb-34df2bc92caa2024-05-14Boxed warning, Warnings, Adverse reactionsExact identifier
unii: 5PE9FDE8GB
ClonazepamCLONAZEPAMBryant Ranch Prepack213c0120-507c-4c39-8aa4-3377f0b06d742024-04-05Boxed warning, Warnings, Adverse reactionsExact identifier
application number: ANDA077147
rxcui: 197527
unii: 5PE9FDE8GB
ClonazepamCLONAZEPAMBryant Ranch Prepack4b5240a8-9e87-4664-8698-596a144d6d282024-04-05Boxed warning, Warnings, Adverse reactionsExact identifier
application number: ANDA077147
rxcui: 197528
unii: 5PE9FDE8GB
ClonazepamCLONAZEPAMBryant Ranch Prepack9a4d3762-cfeb-4ffb-9c9e-40627cc4df712024-04-05Boxed warning, Warnings, Adverse reactionsExact identifier
application number: ANDA077147
rxcui: 197529
unii: 5PE9FDE8GB
ClonazepamCLONAZEPAMAphena Pharma Solutions - Tennessee, LLC154806ed-91af-fc7f-e063-6294a90ae0f42024-04-04Boxed warning, Warnings, Adverse reactionsExact identifier
rxcui: 197529
unii: 5PE9FDE8GB
ClonazepamCLONAZEPAMBryant Ranch Prepack5ec3df57-1137-4402-84e6-28dd762864272024-04-04Boxed warning, Warnings, Adverse reactionsExact identifier
rxcui: 197528
unii: 5PE9FDE8GB
Pure Cornstarch BabyCORN STARCHWalgreen Companyd0e9bd13-b568-4f7e-b036-8d23e71ad8bf2024-03-25WarningsExact identifier
unii: O8232NY3SJ
ClonazepamCLONAZEPAMAphena Pharma Solutions - Tennessee, LLC2cb46dc0-a03e-42d7-ba67-22319598389f2024-02-06Boxed warning, Warnings, Adverse reactionsExact identifier
rxcui: 197528
unii: 5PE9FDE8GB
ClonazepamCLONAZEPAMBryant Ranch Prepackbaa86bf1-75f3-44da-b67f-b6e4b5303f1e2024-01-31Boxed warning, Warnings, Adverse reactionsExact identifier
rxcui: 197529
unii: 5PE9FDE8GB

Reported adverse events (FAERS/openFDA)#

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