FDA.reportPublic FDA data

CLONAZEPAM

Product NDC
72189-081
11-digit product format
721890081
Labeler code
72189
Product ID
72189-081_2be81315-9d31-1301-e063-6394a90a6a84
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
CLONAZEPAM
Dosage form
TABLET
Route
ORAL
Labeler
DIRECT RX
Application
ANDA077856
Marketing category
ANDA
Marketing start
2020-06-15
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
72189-081-30CLONAZEPAM30 in 1 BOTTLETABLET304
72189-081-60CLONAZEPAM60 in 1 BOTTLETABLET604
72189-081-90CLONAZEPAM90 in 1 BOTTLETABLET904

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
72189-081-30EA - Each72189-081f1e9eb25-aba5-4ee9-b4f4-4491d52b55d112020-07-13
72189-081-60EA - Each72189-08102382695-c129-4a0a-918b-04fb00035e8e12020-07-13
72189-081-90EA - Each72189-0810bcf21aa-d618-40e9-a525-e8b75d9d549812022-10-06

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
72189-081CLONAZEPAM TABLET [DIRECT RX]4Current NDC, Legacy NDC, 3 package rows20250119_a821f647-be5f-274c-e053-2a95a90a23ce.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
197527clonazePAM 0.5 MG Oral TabletPSNa821f647-be5f-274c-e053-2a95a90a23ce4
197527clonazepam 0.5 MG Oral TabletSCDa821f647-be5f-274c-e053-2a95a90a23ce4

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
72189-081-307218900813030 TABLET in 1 BOTTLE (72189-081-30) 30 tablet2020-06-150000-00-00NoNoCurrent
72189-081-607218900816060 TABLET in 1 BOTTLE (72189-081-60) 60 tablet2020-06-150000-00-00NoNoCurrent
72189-081-907218900819090 TABLET in 1 BOTTLE (72189-081-90) 90 tablet2020-06-150000-00-00NoNoCurrent