FDA.reportPublic FDA data

Clonazepam

Product NDC
59651-722
11-digit product format
596510722
Labeler code
59651
Product ID
59651-722_b1582eb7-af35-45d5-a52e-0e380d08527d
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Clonazepam
Dosage form
TABLET
Route
ORAL
Labeler
Aurobindo Pharma Limited
Application
ANDA075150
Marketing category
ANDA
Marketing start
2023-01-17
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, 197528, 197529

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
59651-722-01Clonazepam100 in 1 BOTTLETABLET1001
59651-722-99Clonazepam1000 in 1 BOTTLETABLET10001

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
59651-722-01EA - Each59651-722033c0b03-c6e9-475f-adfa-a76f9285efd712023-06-06
59651-722-99EA - Each59651-722729b939e-ffe8-4c2e-bea6-b4e32bc3ec9912023-06-06

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
59651-722CLONAZEPAM TABLET [AUROBINDO PHARMA LIMITED]1Current NDC, 2 package rows20230329_b1582eb7-af35-45d5-a52e-0e380d08527d.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
197527clonazePAM 0.5 MG Oral TabletPSN1fb0807c-dccd-47a5-ada4-91418c4f47f57
197527clonazepam 0.5 MG Oral TabletSCD1fb0807c-dccd-47a5-ada4-91418c4f47f57
197527clonazePAM 0.5 MG Oral TabletPSN04db0fbe-7fa3-28af-e063-6294a90abbe62
197527clonazePAM 0.5 MG Oral TabletPSN214e760b-c909-bd93-e063-6294a90ae74a2
197528clonazePAM 1 MG Oral TabletPSN04db0fbe-7fa3-28af-e063-6294a90abbe62
197527clonazepam 0.5 MG Oral TabletSCD04db0fbe-7fa3-28af-e063-6294a90abbe62
197527clonazepam 0.5 MG Oral TabletSCD214e760b-c909-bd93-e063-6294a90ae74a2
197528clonazepam 1 MG Oral TabletSCD04db0fbe-7fa3-28af-e063-6294a90abbe62
197527clonazePAM 0.5 MG Oral TabletPSNb1582eb7-af35-45d5-a52e-0e380d08527d1
197528clonazePAM 1 MG Oral TabletPSNb1582eb7-af35-45d5-a52e-0e380d08527d1
197529clonazePAM 2 MG Oral TabletPSNb1582eb7-af35-45d5-a52e-0e380d08527d1
197527clonazepam 0.5 MG Oral TabletSCDb1582eb7-af35-45d5-a52e-0e380d08527d1
197528clonazepam 1 MG Oral TabletSCDb1582eb7-af35-45d5-a52e-0e380d08527d1
197529clonazepam 2 MG Oral TabletSCDb1582eb7-af35-45d5-a52e-0e380d08527d1

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startSampleExclude flagStatus
59651-722-0159651072201100 TABLET in 1 BOTTLE (59651-722-01) 100 tablet2023-01-17NoNoCurrent
59651-722-61596510722616000 TABLET in 1 BAG (59651-722-61)6000 tablet17-JAN-23Current
59651-722-99596510722991000 TABLET in 1 BOTTLE (59651-722-99) 1000 tablet2023-01-17NoNoCurrent