NDC 10631-122

Ultravate

Halobetasol Propionate

Ultravate is a Topical Lotion in the Human Prescription Drug category. It is labeled and distributed by Sun Pharmaceutical Industries, Inc.. The primary component is Halobetasol Propionate.

Product ID10631-122_33e85019-7fc9-49b2-8cfb-1bd5d10aed0a
NDC10631-122
Product TypeHuman Prescription Drug
Proprietary NameUltravate
Generic NameHalobetasol Propionate
Dosage FormLotion
Route of AdministrationTOPICAL
Marketing Start Date2016-03-01
Marketing CategoryNDA / NDA
Application NumberNDA208183
Labeler NameSun Pharmaceutical Industries, Inc.
Substance NameHALOBETASOL PROPIONATE
Active Ingredient Strength1 mg/g
Pharm ClassesCorticosteroid [EPC],Corticosteroid Hormone Receptor Agonists [MoA]
NDC Exclude FlagN
Listing Certified Through2020-12-31

Packaging

NDC 10631-122-04

59 g in 1 BOTTLE (10631-122-04)
Marketing Start Date2016-03-01
NDC Exclude FlagN
Sample Package?N

NDC SPL Data Element Entries

NDC 10631-122-70 [10631012270]

Ultravate LOTION
Marketing CategoryNDA
Application NumberNDA208183
Product TypeHUMAN PRESCRIPTION DRUG
Marketing Start Date2016-04-16

NDC 10631-122-04 [10631012204]

Ultravate LOTION
Marketing CategoryNDA
Application NumberNDA208183
Product TypeHUMAN PRESCRIPTION DRUG
Billing UnitML
Marketing Start Date2016-03-01

NDC 10631-122-19 [10631012219]

Ultravate LOTION
Marketing CategoryNDA
Application NumberNDA208183
Product TypeHUMAN PRESCRIPTION DRUG
Marketing Start Date2017-12-08

NDC 10631-122-51 [10631012251]

Ultravate LOTION
Marketing CategoryNDA
Application NumberNDA208183
Product TypeHUMAN PRESCRIPTION DRUG
Billing UnitML
Marketing Start Date2018-03-19

Drug Details

Active Ingredients

IngredientStrength
HALOBETASOL PROPIONATE.5 mg/g

OpenFDA Data

SPL SET ID:0d563d44-17fd-4976-9f2c-f1d509f29587
Manufacturer
UNII
RxNorm Concept Unique ID - RxCUI
  • 1789962
  • 1790329
    • UPC Code
  • 0310631122041

    • Pharmacological Class

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

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

    NDCBrand NameGeneric Name
    10631-102Ultravatehalobetasol propionate
    10631-103Ultravatehalobetasol propionate
    10631-122Ultravatehalobetasol propionate
    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
    10631-119Ultravate XHalobetasol Propionate
    10631-121Ultravate XHalobetasol Propionate

    Trademark Results [Ultravate]

    Mark Image

    Registration | Serial
    Company
    Trademark
    Application Date
    ULTRAVATE
    ULTRAVATE
    74024962 1647847 Live/Registered
    Westwood Pharmaceuticals Inc.
    1990-02-05
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