Clobazam

Product NDC
66689-058
11-digit product format
666890058
Labeler code
66689
Product ID
66689-058_efca6cd2-125e-4593-9d45-d2fd3e763d92
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Clobazam
Dosage form
SUSPENSION
Route
ORAL
Labeler
VistaPharm, Inc.
Application
ANDA210746
Marketing category
ANDA
Marketing start
2019-08-30
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
2023-12-31
Current FDA listing
Historical FDA.report record

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDCEffectiveActionDocumentIndexing SPLRelated label
66689-058-042024-01-30C16284748780-11030e365-27e1-111a-e063-dadaa90a10e2879e57c5-47ce-4942-acbb-6263951ba591

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
66689-058-04ML - Milliliter66689-05875d7d999-13d9-4b42-b56c-a5b04329b31412019-10-07

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
66689-058CLOBAZAM SUSPENSION [VISTAPHARM, LLC]18Legacy NDC20240712_879e57c5-47ce-4942-acbb-6263951ba591.zip

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionMarketing startMarketing endSampleExclude flagStatus
66689-058-04666890058041 BOTTLE, PLASTIC in 1 CARTON (66689-058-04) > 120 mL in 1 BOTTLE, PLASTIC2019-08-300000-00-00NoNoCurrent