Clobazam

Product NDC
51672-4227
11-digit product format
516724227
Labeler code
51672
Product ID
51672-4227_1fd3064f-ed73-9de1-e063-6294a90a0d97
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
clobazam
Dosage form
SUSPENSION
Route
ORAL
Labeler
Taro Pharmaceuticals U.S.A., Inc.
Application
ANDA210978
Marketing category
ANDA
Marketing start
2021-06-30
Substance
CLOBAZAM
Active strength
2.5 mg/mL
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
CLOBAZAM2.5 mg/mL

Harmonized Identifiers#

Field, Values table
FieldValues
Unii2MRO291B4U
Rxcui1366192

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
51672-4227-8Clobazam120 mL in 1 BOTTLESUSPENSION1206

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
51672-4227-8ML - Milliliter51672-4227a661112b-9bd4-4867-bb44-b0614a940b0612021-09-07

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
51672-4227CLOBAZAM SUSPENSION [TARO PHARMACEUTICALS U.S.A., INC.]6Current NDC, Legacy NDC, 1 package rows20240817_fd1e63bf-496c-427c-83b7-6acabc00a5e5.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
1366192cloBAZam 2.5 MG in 1 mL Oral SuspensionPSNfd1e63bf-496c-427c-83b7-6acabc00a5e56
1366192clobazam 2.5 MG/ML Oral SuspensionSCDfd1e63bf-496c-427c-83b7-6acabc00a5e56
1366192clobazam 2.5 MG per 1 ML Oral SuspensionSYfd1e63bf-496c-427c-83b7-6acabc00a5e56
1366192clobazam 4 MG per 10 ML Oral SuspensionSYfd1e63bf-496c-427c-83b7-6acabc00a5e56

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
51672-4227-851672422708120 mL in 1 BOTTLE (51672-4227-8) 120 ml2021-06-300000-00-00NoNoCurrent