NDC 10922-825

Finacea

Azelaic Acid

Finacea is a Topical Gel in the Human Prescription Drug category. It is labeled and distributed by Intendis Inc.. The primary component is Azelaic Acid.

Product ID10922-825_a7594a20-f46e-4b33-91d5-410cc5e97b8d
NDC10922-825
Product TypeHuman Prescription Drug
Proprietary NameFinacea
Generic NameAzelaic Acid
Dosage FormGel
Route of AdministrationTOPICAL
Marketing Start Date2004-12-24
Marketing CategoryNDA / NDA
Application NumberNDA021470
Labeler NameIntendis Inc.
Substance NameAZELAIC ACID
Active Ingredient Strength0 g/g
Pharm ClassesDecreased Protein Synthesis [PE],Decreased Sebaceous Gland Activity [PE]
NDC Exclude FlagE
Listing Certified Through2017-12-31

Packaging

NDC 10922-825-02

1 TUBE in 1 CARTON (10922-825-02) > 50 g in 1 TUBE
Marketing Start Date2004-12-24
NDC Exclude FlagN
Sample Package?N

NDC SPL Data Element Entries

NDC 10922-825-02 [10922082502]

Finacea GEL
Marketing CategoryNDA
Application NumberNDA021470
Product TypeHUMAN PRESCRIPTION DRUG
Billing UnitGM
Marketing Start Date2004-12-24
Inactivation Date2019-11-27

Drug Details

Active Ingredients

IngredientStrength
AZELAIC ACID.15 g/g

OpenFDA Data

SPL SET ID:63773349-0295-4d56-a72e-0d7cade88ddb
Manufacturer
UNII
RxNorm Concept Unique ID - RxCUI
  • 1043748
  • 1041518
  • Pharmacological Class

    • Decreased Protein Synthesis [PE]
    • Decreased Sebaceous Gland Activity [PE]

    Medicade Reported Pricing

    10922082502 FINACEA 15% GEL

    Pricing Unit: GM | Drug Type:

    NDC Crossover Matching brand name "Finacea" or generic name "Azelaic Acid"

    NDCBrand NameGeneric Name
    10922-825Finaceaazelaic acid
    10922-826Finaceaazelaic acid
    50090-3032Finaceaazelaic acid
    50090-4473Finaceaazelaic acid
    50222-505Finaceaazelaic acid
    50419-825Finaceaazelaic acid
    0115-1624Azelaic AcidAzelaic Acid
    0591-2131azelaic acidazelaic acid
    51672-1389Azelaic AcidAzelaic Acid
    68462-626azelaic acidazelaic acid
    0781-7172Azelaic Acid Gelazelaic acid
    0023-8694AZELEXazelaic acid
    16110-869AZELEXazelaic acid
    50222-303FINACEA FOAMazelaic acid
    50419-829FINACEA FOAMazelaic acid

    Trademark Results [Finacea]

    Mark Image

    Registration | Serial
    Company
    Trademark
    Application Date
    FINACEA
    FINACEA
    76325515 2811242 Live/Registered
    LEO PHARMA A/S
    2001-10-12

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