FDA.reportPublic FDA data

NDC 0591-0748 - 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
0591-0748
Package NDCs from labels
0591-0748-01, 0591-0748-05, 0591-0748-10
Manufacturer
Watson Laboratories, Inc.
Effective date
2008-03-18
Current FDA listing
Not matched in FDA.report NDC product tables

DailyMed Labels#

Label, Manufacturer, Effective date table
LabelManufacturerEffective dateType
Clonazepam Tablets USP Rx only C-IVWatson Laboratories, Inc.2008-03-18HUMAN PRESCRIPTION DRUG LABELING

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
0591-0748-01Clonazepam100 in 1 BOTTLETABLET1001
0591-0748-05Clonazepam500 in 1 BOTTLETABLET5001
0591-0748-10Clonazepam1000 in 1 BOTTLETABLET10001

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
0591-0748CLONAZEPAM (CLONAZEPAM) TABLET [WATSON LABORATORIES, INC.]13 package rows20080521_ACBCE0E8-5098-4785-943B-8BDB5FF17FAB.zip

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIIDailyMed labelSPL versionUploaded
ClonazepamACTIVE INGREDIENT5PE9FDE8GBCLONAZEPAM (CLONAZEPAM) TABLET [WATSON LABORATORIES, INC.]1
ClonazepamACTIVE MOIETY5PE9FDE8GBCLONAZEPAM (CLONAZEPAM) TABLET [WATSON LABORATORIES, INC.]1
D & C yellow #10 aluminum lakeINACTIVE INGREDIENTCLONAZEPAM (CLONAZEPAM) TABLET [WATSON LABORATORIES, INC.]1
docusate sodiumINACTIVE INGREDIENTF05Q2T2JA0CLONAZEPAM (CLONAZEPAM) TABLET [WATSON LABORATORIES, INC.]1
FD & C blue #1 aluminum lakeINACTIVE INGREDIENTCLONAZEPAM (CLONAZEPAM) TABLET [WATSON LABORATORIES, INC.]1
lactose monohydrateINACTIVE INGREDIENTEWQ57Q8I5XCLONAZEPAM (CLONAZEPAM) TABLET [WATSON LABORATORIES, INC.]1
magnesium stearateINACTIVE INGREDIENT70097M6I30CLONAZEPAM (CLONAZEPAM) TABLET [WATSON LABORATORIES, INC.]1
microcrystalline celluloseINACTIVE INGREDIENTCLONAZEPAM (CLONAZEPAM) TABLET [WATSON LABORATORIES, INC.]1
sodium benzoateINACTIVE INGREDIENTOJ245FE5EUCLONAZEPAM (CLONAZEPAM) TABLET [WATSON LABORATORIES, INC.]1
sodium starch glycolateINACTIVE INGREDIENTCLONAZEPAM (CLONAZEPAM) TABLET [WATSON LABORATORIES, INC.]1

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 · 90 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
ClonazepamCLONAZEPAMCoupler LLC2cdb55a7-54e4-17b6-e063-6294a90ac8272025-01-29Boxed warning, Warnings, Adverse reactionsExact identifier
rxcui: 197529
ClonazepamCLONAZEPAMDirect_Rxfc75869c-cd6b-44a3-e053-6294a90a699e2025-01-22Boxed warning, Warnings, Adverse reactionsExact identifier
rxcui: 197528
CLONAZEPAMCLONAZEPAMDIRECT RXa821f647-be5f-274c-e053-2a95a90a23ce2025-01-17Warnings, Adverse reactionsExact identifier
rxcui: 197527
ClonazepamCLONAZEPAMAdvanced Rx of Tennessee, LLC04db8e8c-38f9-0c4a-e063-6394a90a93f02024-12-31Boxed warning, Warnings, Adverse reactionsExact identifier
rxcui: 197527
ClonazepamCLONAZEPAMAdvanced Rx Pharmacy of Tennessee, LLCb9309a1a-a794-2f62-e053-2a95a90a7c342024-12-31Boxed warning, Warnings, Adverse reactionsExact identifier
rxcui: 197527
ClonazepamCLONAZEPAMAdvanced Rx Pharmacy of Tennessee, LLCbe383e56-d71f-7699-e053-2995a90a50c12024-12-31Boxed warning, Warnings, Adverse reactionsExact identifier
rxcui: 197528
ClonazepamCLONAZEPAMAphena Pharma Solutions - Tennessee, LLC263f99eb-9744-5601-e063-6394a90a47b12024-11-14Warnings, Adverse reactionsExact identifier
rxcui: 197527
ClonazepamCLONAZEPAMAphena Pharma Solutions - Tennessee, LLC8891c5aa-f42a-4206-92b9-f0ed0631dfcb2024-10-23Boxed warning, Warnings, Adverse reactionsExact identifier
rxcui: 197527
ClonazepamCLONAZEPAMAphena Pharma Solutions - Tennessee, LLC214e760b-c909-bd93-e063-6294a90ae74a2024-10-22Boxed warning, Warnings, Adverse reactionsExact identifier
rxcui: 197527
ClonazepamCLONAZEPAMNuCare Pharmaceuticals,Inc.555061d4-276a-4716-e054-00144ff88e882024-10-16Warnings, Adverse reactionsExact identifier
rxcui: 197527
ClonazepamCLONAZEPAMAphena Pharma Solutions - Tennessee, LLC66bf60fa-61ac-47a7-a081-36077af9007e2024-10-14Warnings, Adverse reactionsExact identifier
rxcui: 197527
ClonazepamCLONAZEPAMAphena Pharma Solutions - Tennessee, LLC7b0d716c-8f51-47a7-8bf2-07c6f9732a052024-09-29Warnings, Adverse reactionsExact identifier
rxcui: 197527
ClonazepamCLONAZEPAMAphena Pharma Solutions - Tennessee, LLC20b3125e-4489-3c53-e063-6294a90a65392024-08-27Boxed warning, Warnings, Adverse reactionsExact identifier
rxcui: 197528
ClonazepamCLONAZEPAMBryant Ranch Prepackb12661a6-2141-42a9-bcb0-c0aef81395ce2024-08-23Warnings, Adverse reactionsExact identifier
rxcui: 197527
ClonazepamCLONAZEPAMBryant Ranch Prepackb83009c2-26ed-45fa-819e-164cdac264e62024-08-23Warnings, Adverse reactionsExact identifier
rxcui: 197528
ClonazepamCLONAZEPAMBryant Ranch Prepack96518266-8f75-4301-b8fd-d2995a7f486d2024-08-06Warnings, Adverse reactionsExact identifier
rxcui: 197527
ClonazepamCLONAZEPAMBryant Ranch Prepackf06dc5fc-94e0-496e-bdf0-11f2b6ffc7862024-08-06Warnings, Adverse reactionsExact identifier
rxcui: 197529
ClonazepamCLONAZEPAMBryant Ranch Prepack254a03c9-070c-40e6-83ac-524c1aec3b6b2024-08-05Warnings, Adverse reactionsExact identifier
rxcui: 197528
ClonazepamCLONAZEPAMClinical Solutions Wholesale, LLC401cb3c0-4a5b-4ff9-baea-53095e60263d2024-08-01Boxed warning, Warnings, Adverse reactionsExact identifier
rxcui: 197528
rxcui: 197529
rxcui: 197527
ClonazepamCLONAZEPAMNuCare Pharmaceuticals,Inc.a4882077-694d-d46c-e053-2a95a90a217d2024-07-17Boxed warning, Warnings, Adverse reactionsExact identifier
rxcui: 197528

Reported adverse events (FAERS/openFDA)#

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