NDC 0378-0040

Clorazepate Dipotassium

Clorazepate Dipotassium

Clorazepate Dipotassium is a Oral Tablet in the Human Prescription Drug category. It is labeled and distributed by Mylan Pharmaceuticals Inc.. The primary component is Clorazepate Dipotassium.

Product ID0378-0040_21627ba9-f1e6-4251-b3fc-8836c1f7266f
NDC0378-0040
Product TypeHuman Prescription Drug
Proprietary NameClorazepate Dipotassium
Generic NameClorazepate Dipotassium
Dosage FormTablet
Route of AdministrationORAL
Marketing Start Date1987-07-17
Marketing CategoryANDA / ANDA
Application NumberANDA071858
Labeler NameMylan Pharmaceuticals Inc.
Substance NameCLORAZEPATE DIPOTASSIUM
Active Ingredient Strength8 mg/1
Pharm ClassesBenzodiazepine [EPC],Benzodiazepines [CS]
DEA ScheduleCIV
NDC Exclude FlagN
Listing Certified Through2022-12-31

Packaging

NDC 0378-0040-01

100 TABLET in 1 BOTTLE, PLASTIC (0378-0040-01)
Marketing Start Date1987-07-17
NDC Exclude FlagN
Sample Package?N

NDC SPL Data Element Entries

NDC 0378-0040-01 [00378004001]

Clorazepate Dipotassium TABLET
Marketing CategoryANDA
Application NumberANDA071858
Product TypeHUMAN PRESCRIPTION DRUG
Billing UnitEA
Marketing Start Date1987-07-17

NDC 0378-0040-05 [00378004005]

Clorazepate Dipotassium TABLET
Marketing CategoryANDA
Application NumberANDA071858
Product TypeHUMAN PRESCRIPTION DRUG
Billing UnitEA
Marketing Start Date1987-07-17

Drug Details

Active Ingredients

IngredientStrength
CLORAZEPATE DIPOTASSIUM7.5 mg/1

OpenFDA Data

SPL SET ID:9acbb3f4-4bf6-40ae-89e3-303ec167912c
Manufacturer
UNII
RxNorm Concept Unique ID - RxCUI
  • 197466
  • 197465
  • 197464

    • Pharmacological Class

    • Benzodiazepine [EPC]
    • Benzodiazepines [CS]

    NDC Crossover Matching brand name "Clorazepate Dipotassium" or generic name "Clorazepate Dipotassium"

    NDCBrand NameGeneric Name
    0378-0030Clorazepate Dipotassiumclorazepate dipotassium
    0378-0040Clorazepate Dipotassiumclorazepate dipotassium
    0378-0070Clorazepate Dipotassiumclorazepate dipotassium
    13107-319CLORAZEPATE DIPOTASSIUMCLORAZEPATE DIPOTASSIUM
    13107-320CLORAZEPATE DIPOTASSIUMCLORAZEPATE DIPOTASSIUM
    13107-321CLORAZEPATE DIPOTASSIUMCLORAZEPATE DIPOTASSIUM
    21695-433Clorazepate DipotassiumClorazepate Dipotassium
    21695-434Clorazepate DipotassiumClorazepate Dipotassium
    43063-030Clorazepate Dipotassiumclorazepate dipotassium
    43063-164Clorazepate Dipotassiumclorazepate dipotassium
    43063-350Clorazepate Dipotassiumclorazepate dipotassium
    43063-893Clorazepate DipotassiumClorazepate Dipotassium
    51672-4042Clorazepate DipotassiumClorazepate Dipotassium
    51672-4043Clorazepate DipotassiumClorazepate Dipotassium
    51672-4044Clorazepate DipotassiumClorazepate Dipotassium
    60505-4754Clorazepate DipotassiumClorazepate Dipotassium
    63304-552Clorazepate dipotassiumClorazepate dipotassium
    63304-553Clorazepate dipotassiumClorazepate dipotassium
    63304-554Clorazepate dipotassiumClorazepate dipotassium
    63629-3646Clorazepate DipotassiumClorazepate Dipotassium
    63629-3858Clorazepate dipotassiumClorazepate dipotassium
    63629-3859Clorazepate DipotassiumClorazepate Dipotassium
    67046-906Clorazepate DipotassiumClorazepate Dipotassium
    67046-907Clorazepate dipotassiumClorazepate dipotassium
    67046-904Clorazepate dipotassiumClorazepate dipotassium
    55292-304Tranxeneclorazepate dipotassium
    © 2025 FDA.report
    This site is not affiliated with or endorsed by the FDA.