FDA.reportPublic FDA data

Clobazam

Product NDC
67877-665
11-digit product format
678770665
Labeler code
67877
Product ID
67877-665_f9dc8ac4-86be-49ab-9c2c-c60658f49d8f
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Clobazam
Dosage form
TABLET
Route
ORAL
Labeler
Ascend Laboratories, LLC
Application
ANDA212714
Marketing category
ANDA
Marketing start
2019-09-07
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, 427538

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
67877-665-01Clobazam1 in 1 CARTONTABLET118
67877-665-01Clobazam100 in 1 CONTAINERTABLET10018
67877-665-05Clobazam500 in 1 CONTAINERTABLET50018
67877-665-33Clobazam1 in 1 CARTONTABLET118
67877-665-33Clobazam10 in 1 BLISTER PACKTABLET1018

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
67877-665-01EA - Each67877-66556ad6656-57b1-46a0-b014-3a5c5a8c8cd912020-04-20

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
67877-665CLOBAZAM TABLET [ASCEND LABORATORIES, LLC]17Current NDC, Legacy NDC, 5 package rows20241130_a77ffbdd-4e3e-4ec4-b0fa-b51ee610df0f.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
199450cloBAZam 10 MG Oral TabletPSNa77ffbdd-4e3e-4ec4-b0fa-b51ee610df0f18
246172cloBAZam 20 MG Oral TabletPSNa77ffbdd-4e3e-4ec4-b0fa-b51ee610df0f18
427538cloBAZam 5 MG Oral TabletPSNa77ffbdd-4e3e-4ec4-b0fa-b51ee610df0f18
199450clobazam 10 MG Oral TabletSCDa77ffbdd-4e3e-4ec4-b0fa-b51ee610df0f18
246172clobazam 20 MG Oral TabletSCDa77ffbdd-4e3e-4ec4-b0fa-b51ee610df0f18
427538clobazam 5 MG Oral TabletSCDa77ffbdd-4e3e-4ec4-b0fa-b51ee610df0f18

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
67877-665-0167877066501100 CARTON in 1 CONTAINER (67877-665-01) / 1 TABLET in 1 CARTON100 carton2019-09-070000-00-00NoNoCurrent
67877-665-0567877066505500 TABLET in 1 CONTAINER (67877-665-05) 500 tablet2019-09-070000-00-00NoNoCurrent
67877-665-336787706653310 CARTON in 1 BLISTER PACK (67877-665-33) / 1 TABLET in 1 CARTON10 carton2019-09-070000-00-00NoNoCurrent