FDA.reportPublic FDA data

CLONAZEPAM

Product NDC
46708-366
11-digit product format
467080366
Labeler code
46708
Product ID
46708-366_e19dd42d-3043-4605-9adf-001741e03942
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
CLONAZEPAM
Dosage form
TABLET, ORALLY DISINTEGRATING
Route
ORAL
Labeler
Alembic Pharmaceuticals Limited
Application
ANDA211033
Marketing category
ANDA
Marketing start
2019-07-01
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
Rxcui349194, 349195, 349196, 349197, 349198

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
a62a50ac-1535-4461-9768-8ae703e2e9fbProduct name120210525
f8e2a02d-e7b1-29aa-eb39-98a679441d91Product name320190927
9514609b-a2a9-f8ec-6ba6-3f8e5ee89877Product name120140508
bc07ef78-e82d-0c19-31f4-31f263780582Product name120140508
dc4336d1-53d4-d410-38d3-71aa2ce4749bProduct name120140508

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
46708-366-06CLONAZEPAM60 in 1 CARTONTABLET, ORALLY DISINTEGRATING602
46708-366-06CLONAZEPAM6 in 1 BLISTER PACKTABLET, ORALLY DISINTEGRATING62

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
46708-366CLONAZEPAM TABLET, ORALLY DISINTEGRATING [ALEMBIC PHARMACEUTICALS LIMITED]2Current NDC, Legacy NDC, 2 package rows20230129_43ee20ce-0015-413c-b230-822e390b02f7.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
349194clonazePAM 0.125 MG Disintegrating Oral TabletPSN43ee20ce-0015-413c-b230-822e390b02f72
349195clonazePAM 0.25 MG Disintegrating Oral TabletPSN43ee20ce-0015-413c-b230-822e390b02f72
349198clonazePAM 0.5 MG Disintegrating Oral TabletPSN43ee20ce-0015-413c-b230-822e390b02f72
349196clonazePAM 1 MG Disintegrating Oral TabletPSN43ee20ce-0015-413c-b230-822e390b02f72
349197clonazePAM 2 MG Disintegrating Oral TabletPSN43ee20ce-0015-413c-b230-822e390b02f72
349194clonazepam 0.125 MG Disintegrating Oral TabletSCD43ee20ce-0015-413c-b230-822e390b02f72
349195clonazepam 0.25 MG Disintegrating Oral TabletSCD43ee20ce-0015-413c-b230-822e390b02f72
349198clonazepam 0.5 MG Disintegrating Oral TabletSCD43ee20ce-0015-413c-b230-822e390b02f72
349196clonazepam 1 MG Disintegrating Oral TabletSCD43ee20ce-0015-413c-b230-822e390b02f72
349197clonazepam 2 MG Disintegrating Oral TabletSCD43ee20ce-0015-413c-b230-822e390b02f72

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
46708-366-064670803660660 BLISTER PACK in 1 CARTON (46708-366-06) / 6 TABLET, ORALLY DISINTEGRATING in 1 BLISTER PACK60 blister pack2019-07-010000-00-00NoNoCurrent