Clobazam

Product NDC
0832-0581
11-digit product format
008320581
Labeler code
0832
Product ID
0832-0581_1e02d082-c325-6bd1-e063-6294a90a14ac
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Clobazam
Dosage form
TABLET
Route
ORAL
Labeler
Upsher-Smith Laboratories, LLC
Application
ANDA209687
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
2026-12-31
Current FDA listing
Yes

Additional Listing Data#

Finished product
Yes
Brand name base
Clobazam
Listing expiration
2026-12-31

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
0832-0581-11Clobazam100 in 1 BOTTLETABLET1005

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
0832-0581-11EA - Each0832-0581ffeba6c3-444e-46a2-9e4d-62b11620116512018-11-06

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
0832-0581CLOBAZAM TABLET [UPSHER-SMITH LABORATORIES, LLC]5Current NDC, Legacy NDC, 1 package rows20240725_6da2c381-057b-456a-b57b-464f8b383371.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
199450cloBAZam 10 MG Oral TabletPSN6da2c381-057b-456a-b57b-464f8b3833715
246172cloBAZam 20 MG Oral TabletPSN6da2c381-057b-456a-b57b-464f8b3833715
199450clobazam 10 MG Oral TabletSCD6da2c381-057b-456a-b57b-464f8b3833715
246172clobazam 20 MG Oral TabletSCD6da2c381-057b-456a-b57b-464f8b3833715
199450cloBAZam 10 MG Oral TabletPSN2166ea46-28ff-f492-e063-6394a90a4a452
246172cloBAZam 20 MG Oral TabletPSN2166ea46-28ff-f492-e063-6394a90a4a452
199450clobazam 10 MG Oral TabletSCD2166ea46-28ff-f492-e063-6394a90a4a452
246172clobazam 20 MG Oral TabletSCD2166ea46-28ff-f492-e063-6394a90a4a452

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
0832-0581-1100832058111100 TABLET in 1 BOTTLE (0832-0581-11) 100 tablet2018-10-220000-00-00NoNoCurrent