Clobazam

Product NDC
16714-887
11-digit product format
167140887
Labeler code
16714
Product ID
16714-887_223818f1-9350-07e9-e063-6294a90ab33a
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Clobazam
Dosage form
TABLET
Route
ORAL
Labeler
NorthStar RxLLC
Application
ANDA209795
Marketing category
ANDA
Marketing start
2018-11-12
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
16714-887-01Clobazam100 in 1 BOTTLETABLET1005

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
16714-887-01EA - Each16714-8871baa7a6c-d03b-4bf1-b909-85241e78e5fd12019-04-11

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
16714-887CLOBAZAM (CLOBAZAM) TABLET [NORTHSTAR RXLLC]5Current NDC, Legacy NDC, 1 package rows20240918_6f94e10e-ee4e-44e1-9c84-16c5d8c9b594.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
199450cloBAZam 10 MG Oral TabletPSN6f94e10e-ee4e-44e1-9c84-16c5d8c9b5945
246172cloBAZam 20 MG Oral TabletPSN6f94e10e-ee4e-44e1-9c84-16c5d8c9b5945
199450clobazam 10 MG Oral TabletSCD6f94e10e-ee4e-44e1-9c84-16c5d8c9b5945
246172clobazam 20 MG Oral TabletSCD6f94e10e-ee4e-44e1-9c84-16c5d8c9b5945

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
16714-887-0116714088701100 TABLET in 1 BOTTLE (16714-887-01) 100 tablet2018-11-120000-00-00NoNoCurrent