NDC 0781-7172

Azelaic Acid Gel

Azelaic Acid

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

Product ID0781-7172_5e53de73-ad88-4f45-8fb1-47d5e18aaa55
NDC0781-7172
Product TypeHuman Prescription Drug
Proprietary NameAzelaic Acid Gel
Generic NameAzelaic Acid
Dosage FormGel
Route of AdministrationTOPICAL
Marketing Start Date2018-10-01
Marketing CategoryNDA AUTHORIZED GENERIC / NDA AUTHORIZED GENERIC
Application NumberNDA021470
Labeler NameSandoz Inc.
Substance NameAZELAIC ACID
Active Ingredient Strength0 g/g
Pharm ClassesDecreased Protein Synthesis [PE],Decreased Sebaceous Gland Activity [PE]
NDC Exclude FlagN
Listing Certified Through2022-12-31

Packaging

NDC 0781-7172-50

1 TUBE in 1 CARTON (0781-7172-50) > 50 g in 1 TUBE
Marketing Start Date2018-10-01
NDC Exclude FlagN
Sample Package?N

NDC SPL Data Element Entries

NDC 0781-7172-50 [00781717250]

Azelaic Acid Gel GEL
Marketing CategoryNDA authorized generic
Application NumberNDA021470
Product TypeHUMAN PRESCRIPTION DRUG
Billing UnitGM
Marketing Start Date2018-10-01

Drug Details

Active Ingredients

IngredientStrength
AZELAIC ACID.15 g/g

OpenFDA Data

SPL SET ID:66178511-5c1a-4ecd-bc98-2ceb54e710ac
Manufacturer
UNII
RxNorm Concept Unique ID - RxCUI
  • 1041518
  • Pharmacological Class

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

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

    NDCBrand NameGeneric Name
    0781-7172Azelaic Acid Gelazelaic acid
    0115-1624Azelaic AcidAzelaic Acid
    0591-2131azelaic acidazelaic acid
    51672-1389Azelaic AcidAzelaic Acid
    68462-626azelaic acidazelaic 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
    50222-303FINACEA FOAMazelaic acid
    50419-829FINACEA FOAMazelaic acid

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