NDC 68462-626

azelaic acid

Azelaic Acid

azelaic acid is a Topical Gel in the Human Prescription Drug category. It is labeled and distributed by Glenmark Pharmaceuticals Inc., Usa. The primary component is Azelaic Acid.

Product ID68462-626_15d60661-fe22-494a-9532-a983347fa37f
NDC68462-626
Product TypeHuman Prescription Drug
Proprietary Nameazelaic acid
Generic NameAzelaic Acid
Dosage FormGel
Route of AdministrationTOPICAL
Marketing Start Date2018-11-19
Marketing CategoryANDA / ANDA
Application NumberANDA204637
Labeler NameGlenmark Pharmaceuticals Inc., USA
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 68462-626-52

1 TUBE in 1 CARTON (68462-626-52) > 50 g in 1 TUBE
Marketing Start Date2018-11-19
NDC Exclude FlagN
Sample Package?N

NDC SPL Data Element Entries

NDC 68462-626-42 [68462062642]

azelaic acid GEL
Marketing CategoryANDA
Application NumberANDA204637
Product TypeHUMAN PRESCRIPTION DRUG
Marketing Start Date2018-11-19
Marketing End Date2019-02-19

NDC 68462-626-52 [68462062652]

azelaic acid GEL
Marketing CategoryANDA
Application NumberANDA204637
Product TypeHUMAN PRESCRIPTION DRUG
Billing UnitGM
Marketing Start Date2018-11-19

Drug Details

Active Ingredients

IngredientStrength
AZELAIC ACID.15 g/g

OpenFDA Data

SPL SET ID:0b5ab22e-c78a-4429-9a76-a4ba2d11fcde
Manufacturer
UNII
RxNorm Concept Unique ID - RxCUI
  • 1041518

    • Pharmacological Class

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

    Medicade Reported Pricing

    68462062652 AZELAIC ACID 15% GEL

    Pricing Unit: GM | Drug Type:

    NDC Crossover Matching brand name "azelaic acid" or generic name "Azelaic Acid"

    NDCBrand NameGeneric Name
    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
    50222-303FINACEA FOAMazelaic acid
    50419-829FINACEA FOAMazelaic acid
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