NDC 69238-1306

CLOBAZAM

Clobazam

CLOBAZAM is a Oral Tablet in the Human Prescription Drug category. It is labeled and distributed by Amneal Pharmaceuticals Ny Llc. The primary component is Clobazam.

Product ID69238-1306_1b10850c-d732-4a5b-a328-471e42958649
NDC69238-1306
Product TypeHuman Prescription Drug
Proprietary NameCLOBAZAM
Generic NameClobazam
Dosage FormTablet
Route of AdministrationORAL
Marketing Start Date2018-10-22
Marketing CategoryANDA / ANDA
Application NumberANDA209718
Labeler NameAmneal Pharmaceuticals NY LLC
Substance NameCLOBAZAM
Active Ingredient Strength20 mg/1
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 69238-1306-1

100 TABLET in 1 BOTTLE (69238-1306-1)
Marketing Start Date2018-10-22
NDC Exclude FlagN
Sample Package?N

NDC SPL Data Element Entries

NDC 69238-1306-1 [69238130601]

CLOBAZAM TABLET
Marketing CategoryANDA
Application NumberANDA209718
Product TypeHUMAN PRESCRIPTION DRUG
Billing UnitEA
Marketing Start Date2018-10-22

Drug Details

Active Ingredients

IngredientStrength
CLOBAZAM20 mg/1

OpenFDA Data

SPL SET ID:6783eaa8-e236-4957-aaa9-b42bf8e709a7
Manufacturer
UNII
RxNorm Concept Unique ID - RxCUI
  • 246172
  • 199450
  • UPC Code
  • 0369238130515
  • Pharmacological Class

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

    Medicade Reported Pricing

    69238130601 CLOBAZAM 20 MG TABLET

    Pricing Unit: EA | 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

    © 2024 FDA.report
    This site is not affiliated with or endorsed by the FDA.