Clobazam

Product NDC
51672-4202
11-digit product format
516724202
Labeler code
51672
Product ID
51672-4202_9e675959-c479-406e-a6f7-dd330f166f6b
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
clobazam
Dosage form
TABLET
Route
ORAL
Labeler
Taro Pharmaceuticals U.S.A., Inc.
Application
ANDA209440
Marketing category
ANDA
Marketing start
2018-10-22
Substance
CLOBAZAM
Active strength
10 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
CLOBAZAM10 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
51672-4202-1Clobazam100 in 1 BOTTLETABLET1003

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
51672-4202CLOBAZAM TABLET [TARO PHARMACEUTICALS U.S.A., INC.]3Current NDC, Legacy NDC, 1 package rows20181024_c326d915-5cbb-4f96-ba5d-c2b298e10c5d.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
199450cloBAZam 10 MG Oral TabletPSNc326d915-5cbb-4f96-ba5d-c2b298e10c5d3
246172cloBAZam 20 MG Oral TabletPSNc326d915-5cbb-4f96-ba5d-c2b298e10c5d3
199450clobazam 10 MG Oral TabletSCDc326d915-5cbb-4f96-ba5d-c2b298e10c5d3
246172clobazam 20 MG Oral TabletSCDc326d915-5cbb-4f96-ba5d-c2b298e10c5d3

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
51672-4202-151672420201100 TABLET in 1 BOTTLE (51672-4202-1) 100 tablet2018-10-220000-00-00NoNoCurrent