clobazam

Product NDC
51991-958
11-digit product format
519910958
Labeler code
51991
Product ID
51991-958_b7fdaf63-fecd-4bcc-bd00-efffe7e9becd
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
CLOBAZAM
Dosage form
TABLET
Route
ORAL
Labeler
Breckenridge Pharmaceutical, Inc.
Application
ANDA209308
Marketing category
ANDA
Marketing start
2021-10-19
Marketing end
0000-00-00
Substance
CLOBAZAM
Active strength
5 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
2023-12-31
Current FDA listing
Historical FDA.report record

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
51991-958CLOBAZAM TABLET [BRECKENRIDGE PHARMACEUTICAL, INC.]14Legacy NDC20230306_dd6a7bde-62c5-43e2-81f8-1f7dd63757b3.zip

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
51991-958-335199109583330 TABLET in 1 BOTTLE (51991-958-33) 30 tablet2021-10-190000-00-00NoNoCurrent