Clonazepam

Product NDC
43063-794
11-digit product format
430630794
Labeler code
43063
Product ID
43063-794_415b681a-3c14-e26d-e063-6394a90a2fcb
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
clonazepam
Dosage form
TABLET
Route
ORAL
Labeler
PD-Rx Pharmaceuticals, Inc.
Application
ANDA077147
Marketing category
ANDA
Marketing start
2011-06-03
Substance
CLONAZEPAM
Active strength
1 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
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
43063-794-30Clonazepam30 in 1 BOTTLE, PLASTICTABLET3016
43063-794-60Clonazepam60 in 1 BOTTLE, PLASTICTABLET6016

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
43063-794CLONAZEPAM TABLET [PD-RX PHARMACEUTICALS, INC.]15Current NDC, Legacy NDC, 2 package rows20240608_9ee4e019-6a99-4aac-84b0-9aae597815a7.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
197528clonazePAM 1 MG Oral TabletPSN9ee4e019-6a99-4aac-84b0-9aae597815a716
197528clonazepam 1 MG Oral TabletSCD9ee4e019-6a99-4aac-84b0-9aae597815a716

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
43063-794-304306307943030 TABLET in 1 BOTTLE, PLASTIC (43063-794-30) 30 tablet2017-10-100000-00-00NoNoCurrent
43063-794-604306307946060 TABLET in 1 BOTTLE, PLASTIC (43063-794-60) 60 tablet2017-10-100000-00-00NoNoCurrent