CLOBAZAM

Product NDC
72205-047
11-digit product format
722050047
Labeler code
72205
Product ID
72205-047_3c8a899d-7c67-43d5-9428-0c0d0f9583de
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
CLOBAZAM
Dosage form
TABLET
Route
ORAL
Labeler
Novadoz Pharmaceuticals LLC
Application
ANDA213404
Marketing category
ANDA
Marketing start
2022-06-10
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
72205-047-91CLOBAZAM1 in 1 CARTONTABLET12
72205-047-91CLOBAZAM100 in 1 BOTTLETABLET1002

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
72205-047-91EA - Each72205-047fa6d5a13-ca08-4321-8d74-0458c700c82912025-10-14

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
72205-047CLOBAZAM TABLET [NOVADOZ PHARMACEUTICALS LLC]2Current NDC, Legacy NDC, 2 package rows20241205_cf5bb37f-5386-47d3-8cec-d48253d359f6.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
199450cloBAZam 10 MG Oral TabletPSNcf5bb37f-5386-47d3-8cec-d48253d359f62
246172cloBAZam 20 MG Oral TabletPSNcf5bb37f-5386-47d3-8cec-d48253d359f62
199450clobazam 10 MG Oral TabletSCDcf5bb37f-5386-47d3-8cec-d48253d359f62
246172clobazam 20 MG Oral TabletSCDcf5bb37f-5386-47d3-8cec-d48253d359f62

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
72205-047-91722050047911 BOTTLE in 1 CARTON (72205-047-91) / 100 TABLET in 1 BOTTLE1 bottle2022-06-100000-00-00NoNoCurrent