Clobazam

Product NDC
67877-664
11-digit product format
678770664
Labeler code
67877
Product ID
67877-664_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
2023-10-18
Substance
CLOBAZAM
Active strength
5 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
CLOBAZAM5 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
67877-664-01Clobazam100 in 1 BOTTLETABLET10018
67877-664-01Clobazam1 in 1 CARTONTABLET118
67877-664-05Clobazam500 in 1 BOTTLETABLET50018
67877-664-33Clobazam10 in 1 BLISTER PACKTABLET1018
67877-664-33Clobazam1 in 1 CARTONTABLET118

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
67877-664CLOBAZAM TABLET [ASCEND LABORATORIES, LLC]17Current 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 startSampleExclude flagStatus
67877-664-01678770664011 BOTTLE in 1 CARTON (67877-664-01) / 100 TABLET in 1 BOTTLE1 bottle2023-10-18NoNoCurrent
67877-664-0567877066405500 TABLET in 1 BOTTLE (67877-664-05) 500 tablet2023-10-18NoNoCurrent
67877-664-33678770664331 BLISTER PACK in 1 CARTON (67877-664-33) / 10 TABLET in 1 BLISTER PACK1 blister pack2023-10-18NoNoCurrent