FDA.reportPublic FDA data

NDC 0591-0747-01 - 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
0591-0747
Requested NDC
0591-0747-01
Package NDCs from labels
0591-0747-01, 0591-0747-05, 0591-0747-10
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
0591-0747-01Clonazepam100 in 1 BOTTLETABLET1001
0591-0747-05Clonazepam500 in 1 BOTTLETABLET5001
0591-0747-10Clonazepam1000 in 1 BOTTLETABLET10001

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
0591-0747CLONAZEPAM (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 4 of 5 · 90 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
ClonazepamCLONAZEPAMAdvanced Rx Pharmacy of Tennessee, LLC04db0fbe-7fa3-28af-e063-6294a90abbe62024-06-07Boxed warning, Warnings, Adverse reactionsExact identifier
rxcui: 197528
rxcui: 197527
ClonazepamCLONAZEPAMNuCare Pharmaceuticals,Inc.19b1fe7b-8f7b-03b7-e063-6394a90a9ba52024-05-30Boxed warning, Warnings, Adverse reactionsExact identifier
rxcui: 197529
ClonazepamCLONAZEPAMA-S Medication Solutionsb3c9d04a-431f-4cec-a809-847dfb8de7362024-05-24Boxed warning, Warnings, Adverse reactionsExact identifier
rxcui: 197527
ClonazepamCLONAZEPAMBryant Ranch Prepack213c0120-507c-4c39-8aa4-3377f0b06d742024-04-05Boxed warning, Warnings, Adverse reactionsExact identifier
rxcui: 197527
ClonazepamCLONAZEPAMBryant Ranch Prepack4b5240a8-9e87-4664-8698-596a144d6d282024-04-05Boxed warning, Warnings, Adverse reactionsExact identifier
rxcui: 197528
ClonazepamCLONAZEPAMBryant Ranch Prepack9a4d3762-cfeb-4ffb-9c9e-40627cc4df712024-04-05Boxed warning, Warnings, Adverse reactionsExact identifier
rxcui: 197529
ClonazepamCLONAZEPAMAphena Pharma Solutions - Tennessee, LLC154806ed-91af-fc7f-e063-6294a90ae0f42024-04-04Boxed warning, Warnings, Adverse reactionsExact identifier
rxcui: 197529
ClonazepamCLONAZEPAMBryant Ranch Prepack5ec3df57-1137-4402-84e6-28dd762864272024-04-04Boxed warning, Warnings, Adverse reactionsExact identifier
rxcui: 197528
ClonazepamCLONAZEPAMAphena Pharma Solutions - Tennessee, LLC2cb46dc0-a03e-42d7-ba67-22319598389f2024-02-06Boxed warning, Warnings, Adverse reactionsExact identifier
rxcui: 197528
ClonazepamCLONAZEPAMBryant Ranch Prepackbaa86bf1-75f3-44da-b67f-b6e4b5303f1e2024-01-31Boxed warning, Warnings, Adverse reactionsExact identifier
rxcui: 197529
ClonazepamCLONAZEPAMBryant Ranch Prepackcd364371-d2af-4cb4-a5df-3d3149580e162024-01-31Boxed warning, Warnings, Adverse reactionsExact identifier
rxcui: 197527
ClonazepamCLONAZEPAMClinical Solutions Wholesale, LLC429a15d1-1675-42cc-97f1-c49b037474162024-01-09Boxed warning, Warnings, Adverse reactionsExact identifier
rxcui: 197527
ClonazepamCLONAZEPAMBryant Ranch Prepackd732be07-6eb7-48f2-b6cd-28baad46aca52024-01-09Warnings, Adverse reactionsExact identifier
rxcui: 197527
ClonazepamCLONAZEPAMAccord Healthcare Inc.ebc11109-e7bf-452d-b675-4b3236d541642024-01-04Boxed warning, Warnings, Adverse reactionsExact identifier
rxcui: 197528
rxcui: 197529
rxcui: 197527
ClonazepamCLONAZEPAMAphena Pharma Solutions - Tennessee, LLC73125f86-ce24-44c0-a2b1-a5d12a607a942023-11-15Boxed warning, Warnings, Adverse reactionsExact identifier
rxcui: 197529
ClonazepamCLONAZEPAMChartwell RX, LLC7b543f77-4388-4227-942f-7933f200b3a52023-11-01Boxed warning, Warnings, Adverse reactionsExact identifier
rxcui: 197528
rxcui: 197529
rxcui: 197527
ClonazepamCLONAZEPAMBryant Ranch Prepack5f3a2f64-57ed-475c-9d8c-b2094bf1d79e2023-10-26Warnings, Adverse reactionsExact identifier
rxcui: 197529
ClonazepamCLONAZEPAMBryant Ranch Prepack5ae98718-9da5-4edc-8efb-67b2125775482023-10-18Warnings, Adverse reactionsExact identifier
rxcui: 197528
ClonazepamCLONAZEPAMBryant Ranch Prepackcc14bb7b-d0c8-4f41-bcd9-a0c860b45a432023-10-18Warnings, Adverse reactionsExact identifier
rxcui: 197529
ClonazepamCLONAZEPAMProficient Rx LPd65c9a1e-f2f4-46d2-9b28-ba0e5c67e5422023-10-01Warnings, Adverse reactionsExact identifier
rxcui: 197528

Reported adverse events (FAERS/openFDA)#

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