FDA.reportPublic FDA data

Clonazepam

Product NDC
72603-308
11-digit product format
726030308
Labeler code
72603
Product ID
72603-308_4764ed40-0c42-835c-e063-6394a90a9b68
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Clonazepam
Dosage form
TABLET
Route
ORAL
Labeler
Northstar Rx LLC
Application
ANDA075468
Marketing category
ANDA
Marketing start
2000-10-06
Substance
CLONAZEPAM
Active strength
1 mg/1
Pharmacologic classes
Benzodiazepine [EPC], Benzodiazepines [CS]
DEA schedule
CIV
NDC exclude flag
No
Listing certified through
2027-12-31
Current FDA listing
Yes

Additional Listing Data#

Finished product
Yes
Brand name base
Clonazepam
Listing expiration
2027-12-31

Active Ingredients#

Ingredient, Strength table
IngredientStrength
CLONAZEPAM1 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
72603-308-01Clonazepam100 in 1 BOTTLETABLET1002
72603-308-02Clonazepam500 in 1 BOTTLETABLET5002
72603-308-03Clonazepam1000 in 1 BOTTLETABLET10002

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
72603-308-01EA - Each72603-30800b96333-71a5-4b88-9a6b-463e468f154e12025-01-14
72603-308-02EA - Each72603-308483003d4-2a29-4882-aba3-d833301fbbb912025-01-14
72603-308-03EA - Each72603-30813137fef-361a-4371-9a08-707c98176f3b12025-01-14

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
72603-308CLONAZEPAM TABLET [NORTHSTAR RX LLC]1Current NDC, 3 package rows20241031_017534e6-49ff-45f3-b88f-2f34cf0cf8fd.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
197527clonazePAM 0.5 MG Oral TabletPSN017534e6-49ff-45f3-b88f-2f34cf0cf8fd2
197528clonazePAM 1 MG Oral TabletPSN017534e6-49ff-45f3-b88f-2f34cf0cf8fd2
197529clonazePAM 2 MG Oral TabletPSN017534e6-49ff-45f3-b88f-2f34cf0cf8fd2
197527clonazepam 0.5 MG Oral TabletSCD017534e6-49ff-45f3-b88f-2f34cf0cf8fd2
197528clonazepam 1 MG Oral TabletSCD017534e6-49ff-45f3-b88f-2f34cf0cf8fd2
197529clonazepam 2 MG Oral TabletSCD017534e6-49ff-45f3-b88f-2f34cf0cf8fd2

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startSampleExclude flagStatus
72603-308-0172603030801100 TABLET in 1 BOTTLE (72603-308-01) 100 tablet2024-11-01NoNoHistorical
72603-308-0272603030802500 TABLET in 1 BOTTLE (72603-308-02) 500 tablet2024-11-01NoNoHistorical
72603-308-03726030308031000 TABLET in 1 BOTTLE (72603-308-03) 1000 tablet2024-11-01NoNoHistorical