FDA.reportPublic FDA data

Clonazepam

Product NDC
63187-603
11-digit product format
631870603
Labeler code
63187
Product ID
63187-603_0bfb873c-326d-4383-8a64-c6ffe16f0fbe
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
clonazepam
Dosage form
TABLET
Route
ORAL
Labeler
Proficient Rx LP
Application
ANDA077147
Marketing category
ANDA
Marketing start
2011-06-03
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
63187-603-30Clonazepam30 in 1 BOTTLE, PLASTICTABLET305
63187-603-60Clonazepam60 in 1 BOTTLE, PLASTICTABLET605
63187-603-90Clonazepam90 in 1 BOTTLE, PLASTICTABLET905

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
63187-603-30EA - Each63187-6032e178f99-89cf-4ae8-9a85-4cea74166c6912020-05-08

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
63187-603CLONAZEPAM TABLET [PROFICIENT RX LP]5Current NDC, Legacy NDC, 3 package rows20221104_4dcb6785-e16b-4692-89b3-f905979ca5ae.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
197527clonazePAM 0.5 MG Oral TabletPSN4dcb6785-e16b-4692-89b3-f905979ca5ae5
197527clonazepam 0.5 MG Oral TabletSCD4dcb6785-e16b-4692-89b3-f905979ca5ae5

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
63187-603-306318706033030 TABLET in 1 BOTTLE, PLASTIC (63187-603-30) 30 tablet2018-12-010000-00-00NoNoCurrent
63187-603-606318706036060 TABLET in 1 BOTTLE, PLASTIC (63187-603-60) 60 tablet2018-12-010000-00-00NoNoCurrent
63187-603-906318706039090 TABLET in 1 BOTTLE, PLASTIC (63187-603-90) 90 tablet2018-12-010000-00-00NoNoCurrent