CLOBAZAM

Product NDC
69238-1306
11-digit product format
692381306
Labeler code
69238
Product ID
69238-1306_a15a2ac8-fb25-4094-af85-fa11ab7e0c08
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
CLOBAZAM
Dosage form
TABLET
Route
ORAL
Labeler
Amneal Pharmaceuticals NY LLC
Application
ANDA209718
Marketing category
ANDA
Marketing start
2018-10-22
Substance
CLOBAZAM
Active strength
20 mg/1
Pharmacologic classes
Benzodiazepine [EPC], Benzodiazepines [CS], Cytochrome P450 2D6 Inhibitors [MoA], Cytochrome P450 3A4 Inducers [MoA]
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
CLOBAZAM
Listing expiration
2027-12-31

Active Ingredients#

Ingredient, Strength table
IngredientStrength
CLOBAZAM20 mg/1

Harmonized Identifiers#

Field, Values table
FieldValues
Unii2MRO291B4U
Rxcui199450, 246172

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
713032fb-f461-4501-be8a-ca575cddec45Product name720211028
f324c243-b420-476a-968a-bb1445dcc148Product name120190211

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
69238-1306-1CLOBAZAM100 in 1 BOTTLETABLET1009

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
69238-1306CLOBAZAM TABLET [AMNEAL PHARMACEUTICALS NY LLC]8Current NDC, Legacy NDC, 1 package rows20240629_6783eaa8-e236-4957-aaa9-b42bf8e709a7.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
199450cloBAZam 10 MG Oral TabletPSN6783eaa8-e236-4957-aaa9-b42bf8e709a79
246172cloBAZam 20 MG Oral TabletPSN6783eaa8-e236-4957-aaa9-b42bf8e709a79
199450clobazam 10 MG Oral TabletSCD6783eaa8-e236-4957-aaa9-b42bf8e709a79
246172clobazam 20 MG Oral TabletSCD6783eaa8-e236-4957-aaa9-b42bf8e709a79

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
69238-1306-169238130601100 TABLET in 1 BOTTLE (69238-1306-1) 100 tablet2018-10-220000-00-00NoNoCurrent