Clonazepam

Product NDC
53002-7451
11-digit product format
530027451
Labeler code
53002
Product ID
53002-7451_9e27a2d4-69a0-4fcb-8b2e-846455684a7f
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Clonazepam
Dosage form
TABLET
Route
ORAL
Labeler
RPK Pharmaceuticals, Inc.
Application
ANDA074869
Marketing category
ANDA
Marketing start
1997-02-12
Marketing end
0000-00-00
Substance
CLONAZEPAM
Active strength
1 mg/1
Pharmacologic classes
Benzodiazepine [EPC],Benzodiazepines [CS]
DEA schedule
CIV
NDC exclude flag
No
Listing certified through
2021-12-31
Current FDA listing
Historical FDA.report record

DailyMed Product Concepts#

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

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDCEffectiveActionDocumentIndexing SPLRelated label
53002-7451-12023-01-30C16284748780-1f386c649-b6f1-0266-e053-dadaa90a7c1aCLONAZEPAM TABLETS, USP CIV
53002-7451-22023-01-30C16284748780-1f386c649-b6f1-0266-e053-dadaa90a7c1aCLONAZEPAM TABLETS, USP CIV
53002-7451-32023-01-30C16284748780-1f386c649-b6f1-0266-e053-dadaa90a7c1aCLONAZEPAM TABLETS, USP CIV

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
53002-7451-1Clonazepam10 in 1 BOTTLETABLET101
53002-7451-2Clonazepam20 in 1 BOTTLETABLET201
53002-7451-3Clonazepam30 in 1 BOTTLETABLET301

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
53002-7451CLONAZEPAM TABLET [RPK PHARMACEUTICALS, INC.]1Legacy NDC, 3 package rows20201224_34fd5bee-5fbe-418b-831b-0a338656a43e.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
197528clonazePAM 1 MG Oral TabletPSN34fd5bee-5fbe-418b-831b-0a338656a43e1
197528clonazepam 1 MG Oral TabletSCD34fd5bee-5fbe-418b-831b-0a338656a43e1

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
53002-7451-15300274510110 TABLET in 1 BOTTLE (53002-7451-1) 10 tablet2019-01-010000-00-00NoNoCurrent
53002-7451-25300274510220 TABLET in 1 BOTTLE (53002-7451-2) 20 tablet2019-01-010000-00-00NoNoCurrent
53002-7451-35300274510330 TABLET in 1 BOTTLE (53002-7451-3) 30 tablet2019-01-010000-00-00NoNoCurrent