FDA.reportPublic FDA data

NDC 68788-8473-09 - 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
68788-8473
Requested NDC
68788-8473-09
Package NDCs from labels
68788-8473-2, 68788-8473-8, 68788-8473-3, 68788-8473-6, 68788-8473-9, 68788-8473-09
Manufacturer
Preferred Pharmaceuticals Inc.
Effective date
2026-03-31
Current FDA listing
Not matched in FDA.report NDC product tables

DailyMed Labels#

Label, Manufacturer, Effective date table
LabelManufacturerEffective dateType
Clonazepam Tablets, USP Rx onlyPreferred Pharmaceuticals Inc.2026-03-31HUMAN PRESCRIPTION DRUG LABEL

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
68788-8473-2Clonazepam20 in 1 BOTTLETABLET204
68788-8473-3Clonazepam30 in 1 BOTTLETABLET304
68788-8473-6Clonazepam60 in 1 BOTTLETABLET604
68788-8473-8Clonazepam28 in 1 BOTTLETABLET284
68788-8473-9Clonazepam90 in 1 BOTTLETABLET904

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
68788-8473CLONAZEPAM TABLET [PREFERRED PHARMACEUTICALS INC.]3Current NDC, 5 package rows20250308_f803fefc-69ff-4963-950b-48c13998bc2c.zip

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
68788-8473-2EA - Each68788-8473b43ed606-02ea-44f1-a4fe-52e709923a8412023-08-08
68788-8473-3EA - Each68788-847327ebdf1f-4211-45b1-8803-35e6a04d8f6c12023-08-08
68788-8473-6EA - Each68788-84731e30b8ac-8cd1-42cb-b367-90b23fac062712023-08-08
68788-8473-8EA - Each68788-84738db4e44a-2d66-498f-903f-fe76cc21924d12023-08-08
68788-8473-9EA - Each68788-8473b851bf63-ee58-4293-9885-256ada84d9af12023-08-08

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 5 · 96 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
application number: ANDA075468
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
application number: ANDA075468
rxcui: 197529
unii: 5PE9FDE8GB
ClonazepamCLONAZEPAMBryant Ranch Prepackc4b87c17-efcd-4b66-96e7-159a04c808b52026-07-15Boxed warning, Warnings, Adverse reactionsExact identifier
application number: ANDA075468
rxcui: 197527
unii: 5PE9FDE8GB
ClonazepamCLONAZEPAMBryant Ranch Prepack8bb69bbe-07e1-4123-9b70-fde78d1d0a342026-07-15Boxed warning, Warnings, Adverse reactionsExact identifier
application number: ANDA075468
rxcui: 197528
unii: 5PE9FDE8GB
ClonazepamCLONAZEPAMREMEDYREPACK INC.874b0395-fecb-446a-966f-6ecbb23f1ff62026-07-07Boxed warning, Warnings, Adverse reactionsExact identifier
rxcui: 197528
unii: 5PE9FDE8GB
ClonazepamCLONAZEPAMREMEDYREPACK INC.3aa9c3eb-3a0a-4e8b-af68-4f87d87194dd2026-07-03Boxed warning, Warnings, Adverse reactionsExact identifier
rxcui: 197527
unii: 5PE9FDE8GB
ClonazepamCLONAZEPAMAdvagen Pharma Ltd30d674f9-f1b3-4c2d-a8e9-3bc8e476f1ec2026-06-25Boxed warning, Warnings, Adverse reactionsExact identifier
application number: ANDA075468
ndc (product): 72888-153
rxcui: 204892
rxcui: 197528
rxcui: 197529
rxcui: 197527
spl id: 5510f17b-a980-f412-e063-6394a90ae1c4
spl set id: 30d674f9-f1b3-4c2d-a8e9-3bc8e476f1ec
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
application number: ANDA075468
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
ClonazepamCLONAZEPAMCardinal Health 107, LLC5ad315f2-fa09-4956-b931-f9966fb73e4e2026-04-21Boxed warning, Warnings, Adverse reactionsExact identifier
rxcui: 197528
rxcui: 197527
unii: 5PE9FDE8GB
ClonazepamCLONAZEPAMPreferred Pharmaceuticals Inc.2fe0d214-9c4d-4a0c-9024-c2076c092c1a2026-03-31Boxed warning, Warnings, Adverse reactionsExact identifier
rxcui: 197529
unii: 5PE9FDE8GB
ClonazepamCLONAZEPAMPreferred Pharmaceuticals Inc.f803fefc-69ff-4963-950b-48c13998bc2c2026-03-31Boxed warning, Warnings, Adverse reactionsExact identifier
application number: ANDA075468
ndc (package): 68788-8473-2
ndc (package): 68788-8473-9
ndc (package): 68788-8473-8
ndc (package): 68788-8473-3
ndc (package): 68788-8473-6
ndc (product): 68788-8473
ndc11 (package): 68788847309
rxcui: 197528
spl id: e5c4af7a-69eb-498e-99a9-fe539c76187d
spl set id: f803fefc-69ff-4963-950b-48c13998bc2c
unii: 5PE9FDE8GB

Reported adverse events (FAERS/openFDA)#

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