Clobazam

Product NDC
0527-5301
11-digit product format
005275301
Labeler code
0527
Product ID
0527-5301_0c6e540f-d675-4932-855c-b17a4a12197e
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
clobazam
Dosage form
SUSPENSION
Route
ORAL
Labeler
Lannett Company, Inc.
Application
ANDA213110
Marketing category
ANDA
Marketing start
2020-04-24
Marketing end
2023-06-30
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
0000-00-00
Current FDA listing
Historical FDA.report record

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
0527-5301-64ML - Milliliter0527-53010eb55ed6-39da-4759-a2f1-dc6d6320d51112020-06-05

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
0527-5301-64005275301641 BOTTLE in 1 CARTON (0527-5301-64) > 120 mL in 1 BOTTLE1 bottle2020-04-242023-06-30NoNoCurrent