FDA.reportPublic FDA data

Clonazepam

Product NDC
67544-529
11-digit product format
675440529
Labeler code
67544
Product ID
67544-529_2458678c-6ce9-4fa4-976a-2c49b489a834
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Clonazepam
Dosage form
TABLET
Route
ORAL
Labeler
Aphena Pharma Solutions - Tennessee, LLC
Application
ANDA074569
Marketing category
ANDA
Marketing start
1996-09-18
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
67544-529-10Clonazepam10 in 1 BOTTLETABLET102
67544-529-15Clonazepam15 in 1 BOTTLETABLET152
67544-529-28Clonazepam28 in 1 BOTTLETABLET282
67544-529-30Clonazepam30 in 1 BOTTLETABLET302
67544-529-45Clonazepam45 in 1 BOTTLETABLET452
67544-529-53Clonazepam60 in 1 BOTTLETABLET602
67544-529-54Clonazepam84 in 1 BOTTLETABLET842
67544-529-55Clonazepam75 in 1 BOTTLETABLET752
67544-529-60Clonazepam90 in 1 BOTTLETABLET902
67544-529-70Clonazepam120 in 1 BOTTLETABLET1202
67544-529-75Clonazepam150 in 1 BOTTLETABLET1502
67544-529-80Clonazepam180 in 1 BOTTLETABLET1802

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
67544-529CLONAZEPAM TABLET [APHENA PHARMA SOLUTIONS - TENNESSEE, LLC]2Current NDC, Legacy NDC, 12 package rows20230718_6be64dc3-3748-477c-8800-2c2175309c73.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
197527clonazePAM 0.5 MG Oral TabletPSN6be64dc3-3748-477c-8800-2c2175309c732
197527clonazepam 0.5 MG Oral TabletSCD6be64dc3-3748-477c-8800-2c2175309c732

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
67544-529-106754405291010 TABLET in 1 BOTTLE (67544-529-10) 10 tablet2023-07-14NoNoCurrent
67544-529-156754405291515 TABLET in 1 BOTTLE (67544-529-15) 15 tablet2018-03-060000-00-00NoNoCurrent
67544-529-286754405292828 TABLET in 1 BOTTLE (67544-529-28) 28 tablet2023-07-14NoNoCurrent
67544-529-306754405293030 TABLET in 1 BOTTLE (67544-529-30) 30 tablet2018-03-060000-00-00NoNoCurrent
67544-529-456754405294545 TABLET in 1 BOTTLE (67544-529-45) 45 tablet2018-03-060000-00-00NoNoCurrent
67544-529-536754405295360 TABLET in 1 BOTTLE (67544-529-53) 60 tablet2018-03-060000-00-00NoNoCurrent
67544-529-546754405295484 TABLET in 1 BOTTLE (67544-529-54) 84 tablet2023-07-14NoNoCurrent
67544-529-556754405295575 TABLET in 1 BOTTLE (67544-529-55) 75 tablet2023-07-14NoNoCurrent
67544-529-606754405296090 TABLET in 1 BOTTLE (67544-529-60) 90 tablet2018-03-060000-00-00NoNoCurrent
67544-529-7067544052970120 TABLET in 1 BOTTLE (67544-529-70) 120 tablet2018-03-060000-00-00NoNoCurrent
67544-529-7567544052975150 TABLET in 1 BOTTLE (67544-529-75) 150 tablet2018-03-060000-00-00NoNoCurrent
67544-529-8067544052980180 TABLET in 1 BOTTLE (67544-529-80) 180 tablet2018-03-060000-00-00NoNoCurrent