NDC 67386-315

Onfi

Clobazam

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

Product ID67386-315_058376fd-0ee9-4e10-92aa-02d3a1692675
NDC67386-315
Product TypeHuman Prescription Drug
Proprietary NameOnfi
Generic NameClobazam
Dosage FormTablet
Route of AdministrationORAL
Marketing Start Date2013-12-10
Marketing CategoryNDA / NDA
Application NumberNDA202067
Labeler NameLundbeck Pharmaceuticals 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 Through2023-12-31

Packaging

NDC 67386-315-01

1 BOTTLE in 1 CARTON (67386-315-01) > 100 TABLET in 1 BOTTLE
Marketing Start Date2013-12-10
NDC Exclude FlagN
Sample Package?N

NDC SPL Data Element Entries

NDC 67386-315-01 [67386031501]

Onfi TABLET
Marketing CategoryNDA
Application NumberNDA202067
Product TypeHUMAN PRESCRIPTION DRUG
Billing UnitEA
Marketing Start Date2013-12-10

Drug Details

Active Ingredients

IngredientStrength
CLOBAZAM20 mg/1

OpenFDA Data

SPL SET ID:de03bd69-2dca-459c-93b4-541fd3e9571c
Manufacturer
UNII
RxNorm Concept Unique ID - RxCUI
  • 1191058
  • 246172
  • 1191056
  • 1366196
  • 1366192
  • 199450
  • UPC Code
  • 0367386313217
  • Pharmacological Class

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

    Medicade Reported Pricing

    67386031501 ONFI 20 MG TABLET

    Pricing Unit: EA | Drug Type:

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

    NDCBrand NameGeneric Name
    67386-313OnfiOnfi
    67386-314OnfiOnfi
    67386-315OnfiOnfi
    0054-0526ClobazamClobazam
    0054-0527ClobazamClobazam
    0054-0561clobazamclobazam
    0378-8043ClobazamClobazam
    0527-1681Clobazamclobazam
    0527-1682Clobazamclobazam
    0527-5301Clobazamclobazam
    0781-8013ClobazamClobazam
    0781-8014ClobazamClobazam
    0832-0580ClobazamClobazam
    0832-0581ClobazamClobazam
    0832-0585Clobazamclobazam
    10094-205SYMPAZANclobazam
    10094-210SYMPAZANclobazam
    10094-220SYMPAZANclobazam

    Trademark Results [Onfi]

    Mark Image

    Registration | Serial
    Company
    Trademark
    Application Date
    ONFI
    ONFI
    85976587 4162511 Live/Registered
    Lundbeck Inc.
    2010-11-02
    ONFI
    ONFI
    85166832 not registered Dead/Abandoned
    LUNDBECK LLC
    2010-11-02

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