NDC 10631-103

Ultravate

Halobetasol Propionate

Ultravate is a Topical Cream in the Human Prescription Drug category. It is labeled and distributed by Ranbaxy Laboratories Inc.. The primary component is Halobetasol Propionate.

Product ID10631-103_cd9a3fc1-f9e4-4ab7-9c75-50ab9c65e270
NDC10631-103
Product TypeHuman Prescription Drug
Proprietary NameUltravate
Generic NameHalobetasol Propionate
Dosage FormCream
Route of AdministrationTOPICAL
Marketing Start Date2009-03-16
Marketing CategoryNDA / NDA
Application NumberNDA019967
Labeler NameRanbaxy Laboratories Inc.
Substance NameHALOBETASOL PROPIONATE
Active Ingredient Strength1 mg/g
Pharm ClassesCorticosteroid [EPC],Corticosteroid Hormone Receptor Agonists [MoA]
NDC Exclude FlagN
Listing Certified Through2019-12-31

Packaging

NDC 10631-103-50

1 TUBE in 1 CARTON (10631-103-50) > 50 g in 1 TUBE
Marketing Start Date2009-03-16
NDC Exclude FlagN
Sample Package?N

NDC SPL Data Element Entries

NDC 10631-103-15 [10631010315]

Ultravate CREAM
Marketing CategoryNDA
Application NumberNDA019967
Product TypeHUMAN PRESCRIPTION DRUG
Billing UnitGM
Marketing Start Date2009-03-16
Marketing End Date2020-01-18

NDC 10631-103-04 [10631010304]

Ultravate CREAM
Marketing CategoryNDA
Application NumberNDA019967
Product TypeHUMAN PRESCRIPTION DRUG
Marketing Start Date2009-03-16
Marketing End Date2017-06-30

NDC 10631-103-50 [10631010350]

Ultravate CREAM
Marketing CategoryNDA
Application NumberNDA019967
Product TypeHUMAN PRESCRIPTION DRUG
Billing UnitGM
Marketing Start Date2009-03-16
Marketing End Date2020-01-18

Drug Details

Active Ingredients

IngredientStrength
HALOBETASOL PROPIONATE.5 mg/g

OpenFDA Data

SPL SET ID:031f1120-7da1-4ea6-a0be-d368018e2c1f
Manufacturer
UNII
RxNorm Concept Unique ID - RxCUI
  • 977978
  • 977990
  • 977980
  • 977992

    • Pharmacological Class

    • 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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