NDC 0023-8694

AZELEX

Azelaic Acid

AZELEX is a Cutaneous Cream in the Human Prescription Drug category. It is labeled and distributed by Allergan, Inc.. The primary component is Azelaic Acid.

Product ID0023-8694_cafd9e33-4b13-48f0-bb02-c14886266b4f
NDC0023-8694
Product TypeHuman Prescription Drug
Proprietary NameAZELEX
Generic NameAzelaic Acid
Dosage FormCream
Route of AdministrationCUTANEOUS
Marketing Start Date1996-03-21
Marketing CategoryNDA / NDA
Application NumberNDA020428
Labeler NameAllergan, 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 0023-8694-30

1 TUBE in 1 CARTON (0023-8694-30) > 30 g in 1 TUBE
Marketing Start Date1996-03-21
NDC Exclude FlagN
Sample Package?N

NDC SPL Data Element Entries

NDC 0023-8694-50 [00023869450]

AZELEX CREAM
Marketing CategoryNDA
Application NumberNDA020428
Product TypeHUMAN PRESCRIPTION DRUG
Billing UnitGM
Marketing Start Date1996-03-21

NDC 0023-8694-30 [00023869430]

AZELEX CREAM
Marketing CategoryNDA
Application NumberNDA020428
Product TypeHUMAN PRESCRIPTION DRUG
Billing UnitGM
Marketing Start Date1996-03-21

Drug Details

Active Ingredients

IngredientStrength
AZELAIC ACID.2 g/g

OpenFDA Data

SPL SET ID:b086c825-401e-48e7-a6dd-2ad7423e86a0
Manufacturer
UNII
RxNorm Concept Unique ID - RxCUI
  • 1043753
  • 1041520

    • Pharmacological Class

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

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

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

    Trademark Results [AZELEX]

    Mark Image

    Registration | Serial
    Company
    Trademark
    Application Date
    AZELEX
    AZELEX
    74596777 1989254 Live/Registered
    ALMIRALL, LLC
    1994-11-08
    AZELEX
    AZELEX
    74299997 not registered Dead/Abandoned
    ALLERGAN, INC.
    1992-07-29
    © 2025 FDA.report
    This site is not affiliated with or endorsed by the FDA.