Clobazam

Product NDC
0781-8014
11-digit product format
007818014
Labeler code
0781
Product ID
0781-8014_a538029f-6387-4ea1-aa62-ecd14f31e0b6
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Clobazam
Dosage form
TABLET
Route
ORAL
Labeler
Sandoz Inc.
Application
ANDA209808
Marketing category
ANDA
Marketing start
2018-10-23
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
0781-8014-01EA - Each0781-8014e8829aff-666b-4723-a985-663cfefda56c12018-12-13

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
0781-8014CLOBAZAM TABLET [SANDOZ INC.]7Legacy NDC20210227_df304c15-5c5a-43e5-8f3c-9520b0d50e46.zip

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
0781-8014-0100781801401100 TABLET in 1 BOTTLE, PLASTIC (0781-8014-01) 100 tablet2018-10-230000-00-00NoNoCurrent