NDC 0187-0002

Bryhali

Halobetasol Propionate

Bryhali is a Topical Lotion in the Human Prescription Drug category. It is labeled and distributed by Bausch Health Us, Llc. The primary component is Halobetasol Propionate.

Product ID0187-0002_9032be8c-875d-45a0-a51b-838b336f3514
NDC0187-0002
Product TypeHuman Prescription Drug
Proprietary NameBryhali
Generic NameHalobetasol Propionate
Dosage FormLotion
Route of AdministrationTOPICAL
Marketing Start Date2018-11-06
Marketing CategoryNDA / NDA
Application NumberNDA209355
Labeler NameBausch Health US, LLC
Substance NameHALOBETASOL PROPIONATE
Active Ingredient Strength0 mg/g
Pharm ClassesCorticosteroid [EPC],Corticosteroid Hormone Receptor Agonists [MoA]
NDC Exclude FlagN
Listing Certified Through2021-12-31

Packaging

NDC 0187-0002-01

1 TUBE in 1 CARTON (0187-0002-01) > 100 g in 1 TUBE
Marketing Start Date2018-11-06
NDC Exclude FlagN
Sample Package?N

NDC SPL Data Element Entries

NDC 0187-0002-60 [00187000260]

Bryhali LOTION
Marketing CategoryNDA
Application NumberNDA209355
Product TypeHUMAN PRESCRIPTION DRUG
Billing UnitGM
Marketing Start Date2018-11-06

NDC 0187-0002-03 [00187000203]

Bryhali LOTION
Marketing CategoryNDA
Application NumberNDA209355
Product TypeHUMAN PRESCRIPTION DRUG
Marketing Start Date2018-11-06

NDC 0187-0002-01 [00187000201]

Bryhali LOTION
Marketing CategoryNDA
Application NumberNDA209355
Product TypeHUMAN PRESCRIPTION DRUG
Billing UnitGM
Marketing Start Date2018-11-06

Drug Details

Active Ingredients

IngredientStrength
HALOBETASOL PROPIONATE.1 mg/g

OpenFDA Data

SPL SET ID:d4bbb66a-3f9d-4091-b1b0-1cbc908432d3
Manufacturer
UNII
RxNorm Concept Unique ID - RxCUI
  • 2101715
  • 2101710
  • Pharmacological Class

    • Corticosteroid [EPC]
    • Corticosteroid Hormone Receptor Agonists [MoA]

    NDC Crossover Matching brand name "Bryhali" or generic name "Halobetasol Propionate"

    NDCBrand NameGeneric Name
    0187-0002Bryhalihalobetasol propionate
    0168-0355Halobetasol Propionatehalobetasol propionate
    0168-0356Halobetasol Propionatehalobetasol propionate
    0713-0339Halobetasol PropionateHalobetasol Propionate
    0713-0639Halobetasol PropionateHalobetasol Propionate
    0713-0640Halobetasol PropionateHalobetasol Propionate
    0713-0758Halobetasol PropionateHalobetasol Propionate
    42254-250Halobetasol PropionateHalobetasol Propionate
    45802-129Halobetasol PropionateHalobetasol Propionate
    45802-131Halobetasol PropionateHalobetasol Propionate
    51672-1321Halobetasol PropionateHalobetasol Propionate
    51672-1322Halobetasol PropionateHalobetasol Propionate
    51862-606Halobetasol propionateHalobetasol propionate
    52565-073Halobetasol Propionatehalobetasol propionate
    52959-961Halobetasol PropionateHalobetasol Propionate
    55337-606Halobetasol propionateHalobetasol propionate
    63629-8664Halobetasol PropionateHalobetasol Propionate
    51862-604LEXETTEHalobetasol propionate
    10631-102Ultravatehalobetasol propionate
    10631-103Ultravatehalobetasol propionate
    10631-122Ultravatehalobetasol propionate
    10631-119Ultravate XHalobetasol Propionate
    10631-121Ultravate XHalobetasol Propionate

    Trademark Results [Bryhali]

    Mark Image

    Registration | Serial
    Company
    Trademark
    Application Date
    BRYHALI
    BRYHALI
    88098120 5933342 Live/Registered
    BAUSCH HEALTH IRELAND LIMITED
    2018-08-29
    BRYHALI
    BRYHALI
    87871415 5835667 Live/Registered
    BAUSCH HEALTH IRELAND LIMITED
    2018-04-10

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