Clobazam

Product NDC
0054-0527
11-digit product format
000540527
Labeler code
0054
Product ID
0054-0527_ae0f2e3a-718c-4c9e-8912-5939c323e325
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Clobazam
Dosage form
TABLET
Route
ORAL
Labeler
West-Ward Pharmaceuticals Corp.
Application
ANDA208785
Marketing category
ANDA
Marketing start
2018-10-22
Marketing end
0000-00-00
Substance
CLOBAZAM
Active strength
20 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
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
0054-0527-25EA - Each0054-052792228d51-e9ce-4b47-9316-f5b1208b912d12018-11-06

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
0054-0527-210005405272160 TABLET in 1 BOTTLE (0054-0527-21) 60 tablet2018-10-220000-00-00NoNoCurrent
0054-0527-2500054052725100 TABLET in 1 BOTTLE (0054-0527-25) 100 tablet2018-10-220000-00-00NoNoCurrent