FDA.reportPublic FDA data

Clonazepam

Product NDC
68788-8473
11-digit product format
687888473
Labeler code
68788
Product ID
68788-8473_e5c4af7a-69eb-498e-99a9-fe539c76187d
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Clonazepam
Dosage form
TABLET
Route
ORAL
Labeler
Preferred Pharmaceuticals Inc.
Application
ANDA075468
Marketing category
ANDA
Marketing start
2023-06-30
Substance
CLONAZEPAM
Active strength
1 mg/1
Pharmacologic classes
Benzodiazepine [EPC], Benzodiazepines [CS]
DEA schedule
CIV
NDC exclude flag
No
Listing certified through
2027-12-31
Current FDA listing
Yes

Additional Listing Data#

Finished product
Yes
Brand name base
Clonazepam
Listing expiration
2027-12-31

Active Ingredients#

Ingredient, Strength table
IngredientStrength
CLONAZEPAM1 mg/1

Harmonized Identifiers#

Field, Values table
FieldValues
Unii5PE9FDE8GB
Rxcui197528

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
f8e2a02d-e7b1-29aa-eb39-98a679441d91Product name320190927
dc4336d1-53d4-d410-38d3-71aa2ce4749bProduct name120140508

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 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

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 RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
197528clonazePAM 1 MG Oral TabletPSNf803fefc-69ff-4963-950b-48c13998bc2c4
197528clonazepam 1 MG Oral TabletSCDf803fefc-69ff-4963-950b-48c13998bc2c4

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startSampleExclude flagStatus
68788-8473-26878884730220 TABLET in 1 BOTTLE (68788-8473-2) 20 tablet2023-06-30NoNoHistorical
68788-8473-36878884730330 TABLET in 1 BOTTLE (68788-8473-3) 30 tablet2023-06-30NoNoHistorical
68788-8473-66878884730660 TABLET in 1 BOTTLE (68788-8473-6) 60 tablet2023-06-30NoNoHistorical
68788-8473-86878884730828 TABLET in 1 BOTTLE (68788-8473-8) 28 tablet2023-06-30NoNoHistorical
68788-8473-96878884730990 TABLET in 1 BOTTLE (68788-8473-9) 90 tablet2023-06-30NoNoHistorical