FDA.reportPublic FDA data

Clobazam

Product NDC
42571-315
11-digit product format
425710315
Labeler code
42571
Product ID
42571-315_50d350cb-6640-b3c2-e063-6394a90a397b
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Clobazam
Dosage form
TABLET
Route
ORAL
Labeler
Micro Labs Limited
Application
ANDA211711
Marketing category
ANDA
Marketing start
2019-04-02
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
2027-12-31
Current FDA listing
Yes

Additional Listing Data#

Finished product
Yes
Brand name base
Clobazam
Listing expiration
2027-12-31

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
42571-315-01Clobazam100 in 1 BOTTLETABLET10010
42571-315-05Clobazam500 in 1 BOTTLETABLET50010
42571-315-11Clobazam100 in 1 CARTONTABLET10010
42571-315-20Clobazam10 in 1 BLISTER PACKTABLET1010
42571-315-30Clobazam30 in 1 BOTTLETABLET3010
42571-315-32Clobazam10 in 1 BLISTER PACKTABLET1010
42571-315-90Clobazam90 in 1 BOTTLETABLET9010
42571-315-91Clobazam100 in 1 CARTONTABLET10010

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
42571-315-01EA - Each42571-315a2fceb7b-42b1-4a45-b28a-d1fbe43e286e12019-07-02

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
42571-315CLOBAZAM (CLOBAZAM) TABLET [MICRO LABS LIMITED]8Current NDC, Legacy NDC, 8 package rows20240321_721dde68-db83-4dad-8649-8046cb455372.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
199450cloBAZam 10 MG Oral TabletPSN721dde68-db83-4dad-8649-8046cb45537210
246172cloBAZam 20 MG Oral TabletPSN721dde68-db83-4dad-8649-8046cb45537210
199450clobazam 10 MG Oral TabletSCD721dde68-db83-4dad-8649-8046cb45537210
246172clobazam 20 MG Oral TabletSCD721dde68-db83-4dad-8649-8046cb45537210

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
42571-315-0142571031501100 TABLET in 1 BOTTLE (42571-315-01) 100 tablet2019-04-020000-00-00NoNoCurrent
42571-315-0542571031505500 TABLET in 1 BOTTLE (42571-315-05) 500 tablet2019-04-020000-00-00NoNoCurrent
42571-315-1142571031511100 BLISTER PACK in 1 CARTON (42571-315-11) / 10 TABLET in 1 BLISTER PACK (42571-315-32) 100 blister pack2019-04-020000-00-00NoNoCurrent
42571-315-204257103152010 in 1 BLISTER PACKHistorical
42571-315-304257103153030 TABLET in 1 BOTTLE (42571-315-30) 30 tablet2019-04-020000-00-00NoNoCurrent
42571-315-324257103153210 in 1 BLISTER PACKHistorical
42571-315-904257103159090 TABLET in 1 BOTTLE (42571-315-90) 90 tablet2019-04-020000-00-00NoNoCurrent
42571-315-9142571031591100 BLISTER PACK in 1 CARTON (42571-315-91) / 10 TABLET in 1 BLISTER PACK (42571-315-20) 100 blister pack2019-04-020000-00-00NoNoCurrent