NDC 69452-116

Clobazam

Clobazam

Clobazam is a Oral Suspension in the Human Prescription Drug category. It is labeled and distributed by Bionpharma Inc.. The primary component is Clobazam.

Product ID69452-116_2b94cdca-53e4-4913-942f-7a482467b98d
NDC69452-116
Product TypeHuman Prescription Drug
Proprietary NameClobazam
Generic NameClobazam
Dosage FormSuspension
Route of AdministrationORAL
Marketing Start Date2018-10-22
Marketing CategoryANDA / ANDA
Application NumberANDA208819
Labeler NameBionpharma 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 Through2020-12-31

Packaging

NDC 69452-116-45

1 BOTTLE in 1 CARTON (69452-116-45) > 120 mL in 1 BOTTLE
Marketing Start Date2018-10-22
NDC Exclude FlagN
Sample Package?N

NDC SPL Data Element Entries

NDC 69452-116-45 [69452011645]

Clobazam SUSPENSION
Marketing CategoryANDA
Application NumberANDA208819
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:4b92ac57-25aa-4c00-b062-dee3944b271b
Manufacturer
UNII
RxNorm Concept Unique ID - RxCUI
  • 1366192
  • 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]

    Medicade Reported Pricing

    69452011645 CLOBAZAM 2.5 MG/ML SUSPENSION

    Pricing Unit: ML | Drug Type:

    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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