NDC 0054-0561

clobazam

Clobazam

clobazam is a Oral Solution in the Human Prescription Drug category. It is labeled and distributed by Hikma Pharmaceuticals Usa Inc.. The primary component is Clobazam.

Product ID0054-0561_1909ebf0-cc56-4c16-8238-a975b4ad2d56
NDC0054-0561
Product TypeHuman Prescription Drug
Proprietary Nameclobazam
Generic NameClobazam
Dosage FormSolution
Route of AdministrationORAL
Marketing Start Date2018-10-22
Marketing CategoryANDA / ANDA
Application NumberANDA209715
Labeler NameHikma Pharmaceuticals USA Inc.
Substance NameCLOBAZAM
Active Ingredient Strength3 mg/mL
Pharm ClassesBenzodiazepine [EPC],Benzodiazepines [CS],Cytochrome P450 2D6 Inhibitors [MoA],Cytochrome P450 3A4 Inducers [MoA]
DEA ScheduleCIV
NDC Exclude FlagN
Listing Certified Through2022-12-31

Packaging

NDC 0054-0561-50

1 BOTTLE in 1 CARTON (0054-0561-50) > 120 mL in 1 BOTTLE
Marketing Start Date2018-10-22
NDC Exclude FlagN
Sample Package?N

NDC SPL Data Element Entries

NDC 0054-0561-50 [00054056150]

clobazam SOLUTION
Marketing CategoryANDA
Application NumberANDA209715
Product TypeHUMAN PRESCRIPTION DRUG
Billing UnitML
Marketing Start Date2018-10-22

Drug Details

Active Ingredients

IngredientStrength
CLOBAZAM2.5 mg/mL

OpenFDA Data

SPL SET ID:cf35bff4-af9c-4a59-a5fa-cedacd3d4891
Manufacturer
UNII
RxNorm Concept Unique ID - RxCUI
  • 1366192
  • UPC Code
  • 0300540561505
  • Pharmacological Class

    • Benzodiazepine [EPC]
    • Benzodiazepines [CS]
    • Cytochrome P450 2D6 Inhibitors [MoA]
    • Cytochrome P450 3A4 Inducers [MoA]
    • Benzodiazepine [EPC]
    • Benzodiazepines [CS]
    • Cytochrome P450 2D6 Inhibitors [MoA]
    • Cytochrome P450 3A4 Inducers [MoA]

    NDC Crossover Matching brand name "clobazam" or generic name "Clobazam"

    NDCBrand NameGeneric Name
    0054-0526ClobazamClobazam
    0054-0527ClobazamClobazam
    0054-0561clobazamclobazam
    0378-8043ClobazamClobazam
    0527-1681Clobazamclobazam
    0527-1682Clobazamclobazam
    0527-5301Clobazamclobazam
    0781-8013ClobazamClobazam
    0781-8014ClobazamClobazam
    0832-0580ClobazamClobazam
    0832-0581ClobazamClobazam
    0832-0585Clobazamclobazam
    68180-156ClobazamClobazam
    68180-157ClobazamClobazam
    68180-158ClobazamClobazam
    69238-1305CLOBAZAMCLOBAZAM
    69238-1306CLOBAZAMCLOBAZAM
    69238-1535ClobazamClobazam
    69452-116ClobazamClobazam
    69452-115ClobazamClobazam
    69452-114ClobazamClobazam
    70710-1326CLOBAZAMCLOBAZAM
    70771-1440CLOBAZAMCLOBAZAM
    70771-1441CLOBAZAMCLOBAZAM
    70710-1325CLOBAZAMCLOBAZAM
    16714-888ClobazamClobazam
    16714-887ClobazamClobazam
    31722-639ClobazamClobazam
    31722-640ClobazamClobazam
    42571-315ClobazamClobazam
    42571-316ClobazamClobazam
    51672-4203ClobazamClobazam
    51672-4202ClobazamClobazam
    51991-900clobazamclobazam
    51991-901clobazamclobazam
    60687-423ClobazamClobazam
    51672-4210ClobazamClobazam
    66689-058ClobazamClobazam
    67877-666ClobazamClobazam
    67877-665ClobazamClobazam
    10094-205SYMPAZANclobazam
    10094-210SYMPAZANclobazam
    10094-220SYMPAZANclobazam

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