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 5 of 5 · 90 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
ClonazepamCLONAZEPAMProficient Rx LP645fb912-479c-46de-b99c-4ea341bfd9ba2023-08-01Boxed warning, Warnings, Adverse reactionsExact identifier
rxcui: 197527
ClonazepamCLONAZEPAMAphena Pharma Solutions - Tennessee, LLC6be64dc3-3748-477c-8800-2c2175309c732023-07-17Boxed warning, Warnings, Adverse reactionsExact identifier
rxcui: 197527
ClonazepamCLONAZEPAMBryant Ranch Prepack6960e994-e9ea-4a4a-b674-7e6124d8b3812023-05-25Warnings, Adverse reactionsExact identifier
rxcui: 197527
ClonazepamCLONAZEPAMTeva Pharmaceuticals USA, Inc.8069b1a0-7c06-4252-b44e-e2eef065d9b82023-04-25Boxed warning, Warnings, Adverse reactionsExact identifier
rxcui: 197528
rxcui: 197529
rxcui: 197527
ClonazepamCLONAZEPAMAurobindo Pharma Limitedb1582eb7-af35-45d5-a52e-0e380d08527d2023-02-02Boxed warning, Warnings, Adverse reactionsExact identifier
rxcui: 197528
rxcui: 197529
rxcui: 197527
ClonazepamCLONAZEPAMProficient Rx LP4dcb6785-e16b-4692-89b3-f905979ca5ae2022-11-01Warnings, Adverse reactionsExact identifier
rxcui: 197527
ClonazepamCLONAZEPAMProficient Rx LP56175c25-3fde-43ea-89bf-22dcf3278b6b2022-11-01Warnings, Adverse reactionsExact identifier
rxcui: 197527
ClonazepamCLONAZEPAMProficient Rx LP63286201-4b79-45b8-8f48-7e21dadc14082021-02-01Warnings, Adverse reactionsExact identifier
rxcui: 197528
ClonazepamCLONAZEPAMAphena Pharma Solutions - Tennessee, LLCc68420a9-b646-4a4f-99f7-43d652312eb02018-02-14Warnings, Adverse reactionsExact identifier
rxcui: 197528
017D1C86-4A12-AE64-8A8F-FAF6C0005DA2ACBCE0E8-5098-4785-943B-8BDB5FF17FAB2008-03-18Warnings, Adverse reactionsExact identifier
spl id: 017D1C86-4A12-AE64-8A8F-FAF6C0005DA2
spl set id: ACBCE0E8-5098-4785-943B-8BDB5FF17FAB

Reported adverse events (FAERS/openFDA)#

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