FDA.reportPublic FDA data

Clonazepam

Product NDC
80425-0402
11-digit product format
804250402
Labeler code
80425
Product ID
80425-0402_1a50d75c-4b78-d4d0-e063-6394a90a1298
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Clonazepam
Dosage form
TABLET
Route
ORAL
Labeler
Advanced Rx Pharmacy of Tennessee, LLC
Application
ANDA075150
Marketing category
ANDA
Marketing start
2023-09-08
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

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
80425-0402-1Clonazepam30 in 1 BOTTLETABLET302
80425-0402-2Clonazepam60 in 1 BOTTLETABLET602
80425-0402-3Clonazepam90 in 1 BOTTLETABLET902

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
80425-0402-1EA - Each80425-040201750a9a-2130-4c1e-a51f-0ed5f0d766e112024-07-12
80425-0402-2EA - Each80425-040249ca49f2-2179-4de5-9f06-d92e44e0f3e412024-07-12
80425-0402-3EA - Each80425-04024e17fe34-074d-499b-9d7e-f26dc0a8db0712024-07-12

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
80425-0402CLONAZEPAM TABLET [ADVANCED RX PHARMACY OF TENNESSEE, LLC]2Current NDC, 3 package rows20240612_04db0fbe-7fa3-28af-e063-6294a90abbe6.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
197527clonazePAM 0.5 MG Oral TabletPSN04db0fbe-7fa3-28af-e063-6294a90abbe62
197528clonazePAM 1 MG Oral TabletPSN04db0fbe-7fa3-28af-e063-6294a90abbe62
197527clonazepam 0.5 MG Oral TabletSCD04db0fbe-7fa3-28af-e063-6294a90abbe62
197528clonazepam 1 MG Oral TabletSCD04db0fbe-7fa3-28af-e063-6294a90abbe62

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startSampleExclude flagStatus
80425-0402-18042504020130 TABLET in 1 BOTTLE (80425-0402-1) 30 tablet2024-06-07NoNoHistorical
80425-0402-28042504020260 TABLET in 1 BOTTLE (80425-0402-2) 60 tablet2024-06-07NoNoHistorical
80425-0402-38042504020390 TABLET in 1 BOTTLE (80425-0402-3) 90 tablet2024-06-07NoNoHistorical