NDC 50222-505

Finacea

Azelaic Acid

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

Product ID50222-505_3d1df15b-444f-45d8-9a28-986e1638645c
NDC50222-505
Product TypeHuman Prescription Drug
Proprietary NameFinacea
Generic NameAzelaic Acid
Dosage FormGel
Route of AdministrationTOPICAL
Marketing Start Date2002-12-24
Marketing CategoryNDA / NDA
Application NumberNDA021470
Labeler NameLEO Pharma Inc.
Substance NameAZELAIC ACID
Active Ingredient Strength0 g/g
Pharm ClassesDecreased Protein Synthesis [PE],Decreased Sebaceous Gland Activity [PE]
NDC Exclude FlagN
Listing Certified Through2020-12-31

Packaging

NDC 50222-505-50

1 TUBE in 1 CARTON (50222-505-50) > 50 g in 1 TUBE
Marketing Start Date2018-10-01
NDC Exclude FlagN
Sample Package?N

NDC SPL Data Element Entries

NDC 50222-505-50 [50222050550]

Finacea GEL
Marketing CategoryNDA
Application NumberNDA021470
Product TypeHUMAN PRESCRIPTION DRUG
Billing UnitGM
Marketing Start Date2018-10-01

NDC 50222-505-91 [50222050591]

Finacea GEL
Marketing CategoryNDA
Application NumberNDA021470
Product TypeHUMAN PRESCRIPTION DRUG
Marketing Start Date2018-10-01

Drug Details

Active Ingredients

IngredientStrength
AZELAIC ACID.15 g/g

OpenFDA Data

SPL SET ID:bea1957c-55ca-48cd-8cbc-ed44d546a857
Manufacturer
UNII
RxNorm Concept Unique ID - RxCUI
  • 1043748
  • 1041518

    • Pharmacological Class

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

    Medicade Reported Pricing

    50222050550 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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