NDC 50222-303

FINACEA FOAM

Azelaic Acid

FINACEA FOAM is a Topical Aerosol, Foam in the Human Prescription Drug category. It is labeled and distributed by Leo Pharma Inc.. The primary component is Azelaic Acid.

Product ID50222-303_eb07175d-0d14-4381-ad77-5eea4db30929
NDC50222-303
Product TypeHuman Prescription Drug
Proprietary NameFINACEA FOAM
Generic NameAzelaic Acid
Dosage FormAerosol, Foam
Route of AdministrationTOPICAL
Marketing Start Date2018-10-01
Marketing CategoryNDA / NDA
Application NumberNDA207071
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 50222-303-50

1 CAN in 1 CARTON (50222-303-50) > 50 g in 1 CAN
Marketing Start Date2018-10-01
NDC Exclude FlagN
Sample Package?N

NDC SPL Data Element Entries

NDC 50222-303-50 [50222030350]

FINACEA FOAM AEROSOL, FOAM
Marketing CategoryNDA
Application NumberNDA207071
Product TypeHUMAN PRESCRIPTION DRUG
Billing UnitGM
Marketing Start Date2018-10-01

NDC 50222-303-91 [50222030391]

FINACEA FOAM AEROSOL, FOAM
Marketing CategoryNDA
Application NumberNDA207071
Product TypeHUMAN PRESCRIPTION DRUG
Marketing Start Date2018-10-01

Drug Details

Active Ingredients

IngredientStrength
AZELAIC ACID.15 g/g

OpenFDA Data

SPL SET ID:9fabd24e-4c3b-49a0-aa5f-c8d75ae67572
Manufacturer
UNII
RxNorm Concept Unique ID - RxCUI
  • 1659803
  • 1659800

    • Pharmacological Class

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

    NDC Crossover Matching brand name "FINACEA FOAM" or generic name "Azelaic Acid"

    NDCBrand NameGeneric Name
    50222-303FINACEA FOAMazelaic acid
    50419-829FINACEA FOAMazelaic 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
    10922-825Finaceaazelaic acid
    10922-826Finaceaazelaic acid
    50090-3032Finaceaazelaic acid
    50090-4473Finaceaazelaic acid
    50222-505Finaceaazelaic acid
    50419-825Finaceaazelaic acid
    © 2025 FDA.report
    This site is not affiliated with or endorsed by the FDA.