FDA.reportPublic FDA data

Clonazepam

Product NDC
68788-8420
11-digit product format
687888420
Labeler code
68788
Product ID
68788-8420_66b06aba-22c4-4762-8c21-8de43e1de185
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
clonazepam
Dosage form
TABLET
Route
ORAL
Labeler
Preferred Pharmaceuticals Inc.
Application
ANDA077856
Marketing category
ANDA
Marketing start
2023-04-13
Substance
CLONAZEPAM
Active strength
.5 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
CLONAZEPAM.5 mg/1

Harmonized Identifiers#

Field, Values table
FieldValues
Unii5PE9FDE8GB
Rxcui197527

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
68788-8420-2Clonazepam20 in 1 BOTTLE, PLASTICTABLET204
68788-8420-3Clonazepam30 in 1 BOTTLE, PLASTICTABLET304
68788-8420-6Clonazepam60 in 1 BOTTLE, PLASTICTABLET604
68788-8420-9Clonazepam90 in 1 BOTTLE, PLASTICTABLET904

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
68788-8420-2EA - Each68788-842089bf3ca0-8407-4cf7-897e-30736f33b1d712023-06-06
68788-8420-3EA - Each68788-842030353409-ba96-44eb-9452-dfce2986ea1c12023-06-06
68788-8420-6EA - Each68788-84200d8e3b36-e24d-4991-bbd2-9eb9ab64b6bc12023-06-06
68788-8420-9EA - Each68788-842026f43ab3-1065-49a2-8860-0bfdd19cdc0812023-06-06

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
68788-8420CLONAZEPAM TABLET [PREFERRED PHARMACEUTICALS INC.]3Current NDC, 4 package rows20250308_939dee35-3987-4ce2-9985-3751ceffa20e.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
197527clonazePAM 0.5 MG Oral TabletPSN939dee35-3987-4ce2-9985-3751ceffa20e4
197527clonazepam 0.5 MG Oral TabletSCD939dee35-3987-4ce2-9985-3751ceffa20e4

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startSampleExclude flagStatus
68788-8420-26878884200220 TABLET in 1 BOTTLE, PLASTIC (68788-8420-2) 20 tablet2023-04-13NoNoHistorical
68788-8420-36878884200330 TABLET in 1 BOTTLE, PLASTIC (68788-8420-3) 30 tablet2023-04-13NoNoHistorical
68788-8420-66878884200660 TABLET in 1 BOTTLE, PLASTIC (68788-8420-6) 60 tablet2023-04-13NoNoHistorical
68788-8420-96878884200990 TABLET in 1 BOTTLE, PLASTIC (68788-8420-9) 90 tablet2023-04-13NoNoHistorical