FDA.reportPublic FDA data

Clonazepam

Product NDC
68788-8499
11-digit product format
687888499
Labeler code
68788
Product ID
68788-8499_4ea55195-09c2-4c1b-862c-027e178c1e78
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
clonazepam
Dosage form
TABLET
Route
ORAL
Labeler
Preferred Pharmaceuticals Inc.
Application
ANDA077856
Marketing category
ANDA
Marketing start
2023-08-01
Substance
CLONAZEPAM
Active strength
2 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
CLONAZEPAM2 mg/1

Harmonized Identifiers#

Field, Values table
FieldValues
Unii5PE9FDE8GB
Rxcui197529

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
68788-8499-2Clonazepam20 in 1 BOTTLE, PLASTICTABLET204
68788-8499-3Clonazepam30 in 1 BOTTLE, PLASTICTABLET304
68788-8499-6Clonazepam60 in 1 BOTTLE, PLASTICTABLET604
68788-8499-9Clonazepam90 in 1 BOTTLE, PLASTICTABLET904

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
68788-8499-2EA - Each68788-8499bb4db383-5cb1-412e-b147-c526f748e9c512023-09-05
68788-8499-3EA - Each68788-8499e22c3b5f-b45e-4537-9b93-8fc8a9b9766712023-09-05
68788-8499-6EA - Each68788-8499115a3046-a307-41aa-ac17-abc880266c8612023-09-05
68788-8499-9EA - Each68788-84995b943a1d-99ee-4752-aa11-ac86abc9cd0b12023-09-05

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
68788-8499CLONAZEPAM TABLET [PREFERRED PHARMACEUTICALS INC.]3Current NDC, 4 package rows20250308_2fe0d214-9c4d-4a0c-9024-c2076c092c1a.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
197529clonazePAM 2 MG Oral TabletPSN2fe0d214-9c4d-4a0c-9024-c2076c092c1a4
197529clonazepam 2 MG Oral TabletSCD2fe0d214-9c4d-4a0c-9024-c2076c092c1a4

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startSampleExclude flagStatus
68788-8499-26878884990220 TABLET in 1 BOTTLE, PLASTIC (68788-8499-2) 20 tablet2023-08-01NoNoHistorical
68788-8499-36878884990330 TABLET in 1 BOTTLE, PLASTIC (68788-8499-3) 30 tablet2023-08-01NoNoHistorical
68788-8499-66878884990660 TABLET in 1 BOTTLE, PLASTIC (68788-8499-6) 60 tablet2023-08-01NoNoHistorical
68788-8499-96878884990990 TABLET in 1 BOTTLE, PLASTIC (68788-8499-9) 90 tablet2023-08-01NoNoHistorical