NDC 68180-158

Clobazam

Clobazam

Clobazam is a Oral Tablet in the Human Prescription Drug category. It is labeled and distributed by Lupin Pharmaceuticals, Inc.. The primary component is Clobazam.

Product ID68180-158_06ab994d-4d9d-41af-86fb-4bd05acbe4b4
NDC68180-158
Product TypeHuman Prescription Drug
Proprietary NameClobazam
Generic NameClobazam
Dosage FormTablet
Route of AdministrationORAL
Marketing Start Date2019-02-01
Marketing CategoryANDA / ANDA
Application NumberANDA210545
Labeler NameLupin Pharmaceuticals, Inc.
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 Through2019-12-31

Packaging

NDC 68180-158-01

1 BOTTLE in 1 CARTON (68180-158-01) > 100 TABLET in 1 BOTTLE
Marketing Start Date2019-05-08
NDC Exclude FlagN
Sample Package?N

NDC SPL Data Element Entries

NDC 68180-158-07 [68180015807]

Clobazam TABLET
Marketing CategoryANDA
Application NumberANDA210545
Product TypeHUMAN PRESCRIPTION DRUG
Marketing Start Date2019-05-08

NDC 68180-158-01 [68180015801]

Clobazam TABLET
Marketing CategoryANDA
Application NumberANDA210545
Product TypeHUMAN PRESCRIPTION DRUG
Billing UnitEA
Marketing Start Date2019-05-08

NDC 68180-158-09 [68180015809]

Clobazam TABLET
Marketing CategoryANDA
Application NumberANDA210545
Product TypeHUMAN PRESCRIPTION DRUG
Marketing Start Date2019-05-08

NDC 68180-158-06 [68180015806]

Clobazam TABLET
Marketing CategoryANDA
Application NumberANDA210545
Product TypeHUMAN PRESCRIPTION DRUG
Marketing Start Date2019-05-08

NDC 68180-158-02 [68180015802]

Clobazam TABLET
Marketing CategoryANDA
Application NumberANDA210545
Product TypeHUMAN PRESCRIPTION DRUG
Marketing Start Date2019-05-08

Drug Details

Active Ingredients

IngredientStrength
CLOBAZAM20 mg/1

OpenFDA Data

SPL SET ID:d9e03a2a-3fea-4c98-ab71-415e6ebda3e0
Manufacturer
UNII
RxNorm Concept Unique ID - RxCUI
  • 246172
  • 199450
    • UPC Code
  • 0368180157069
  • 0368180158066

    • Pharmacological Class

    • 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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