Clonazepam

Product NDC
43063-797
11-digit product format
430630797
Labeler code
43063
Product ID
43063-797_415b8bf8-892a-0f23-e063-6394a90a8856
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
clonazepam
Dosage form
TABLET
Route
ORAL
Labeler
PD-Rx Pharmaceuticals, Inc.
Application
ANDA077147
Marketing category
ANDA
Marketing start
2018-01-19
Substance
CLONAZEPAM
Active strength
.5 mg/1
Pharmacologic classes
Benzodiazepine [EPC], Benzodiazepines [CS]
DEA schedule
CIV
NDC exclude flag
No
Listing certified through
2026-12-31
Current FDA listing
Yes

Additional Listing Data#

Finished product
Yes
Brand name base
Clonazepam
Listing expiration
2026-12-31

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
43063-797-30Clonazepam30 in 1 BOTTLE, PLASTICTABLET3017
43063-797-60Clonazepam60 in 1 BOTTLE, PLASTICTABLET6017

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
43063-797CLONAZEPAM TABLET [PD-RX PHARMACEUTICALS, INC.]16Current NDC, Legacy NDC, 2 package rows20240608_c707caa1-d6fd-4790-9a64-f749bf93ef18.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
197527clonazePAM 0.5 MG Oral TabletPSNc707caa1-d6fd-4790-9a64-f749bf93ef1817
197527clonazepam 0.5 MG Oral TabletSCDc707caa1-d6fd-4790-9a64-f749bf93ef1817

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
43063-797-304306307973030 TABLET in 1 BOTTLE, PLASTIC (43063-797-30) 30 tablet2018-01-190000-00-00NoNoCurrent
43063-797-604306307976060 TABLET in 1 BOTTLE, PLASTIC (43063-797-60) 60 tablet2018-01-190000-00-00NoNoCurrent