Clobazam

Product NDC
0832-0585
11-digit product format
008320585
Labeler code
0832
Product ID
0832-0585_15f958c4-652f-4637-895b-4beb86a433db
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
clobazam
Dosage form
SUSPENSION
Route
ORAL
Labeler
Upsher-Smith Laboratories, LLC
Application
ANDA210569
Marketing category
ANDA
Marketing start
2018-10-22
Marketing end
0000-00-00
Substance
CLOBAZAM
Active strength
3 mg/mL
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
2022-12-31
Current FDA listing
Historical FDA.report record

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
0832-0585-25ML - Milliliter0832-05855fe3e49f-8401-406d-81b5-3199e5e0599212018-11-06

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
0832-0585-25008320585251 BOTTLE in 1 CARTON (0832-0585-25) > 120 mL in 1 BOTTLE1 bottle2018-10-220000-00-00NoNoCurrent