NDC 0115-1624

Azelaic Acid

Azelaic Acid

Azelaic Acid is a Topical Gel in the Human Prescription Drug category. It is labeled and distributed by Amneal Pharmaceuticals Of New York Llc. The primary component is Azelaic Acid.

Product ID0115-1624_8adcda98-4dc1-4379-84b8-c16b122c16d1
NDC0115-1624
Product TypeHuman Prescription Drug
Proprietary NameAzelaic Acid
Generic NameAzelaic Acid
Dosage FormGel
Route of AdministrationTOPICAL
Marketing Start Date2018-11-19
Marketing CategoryANDA / ANDA
Application NumberANDA208724
Labeler NameAmneal Pharmaceuticals of New York LLC
Substance NameAZELAIC ACID
Active Ingredient Strength0 g/g
Pharm ClassesDecreased Protein Synthesis [PE], Decreased Sebaceous Gland Activity [PE]
NDC Exclude FlagN
Listing Certified Through2023-12-31

Packaging

NDC 0115-1624-56

1 TUBE in 1 CARTON (0115-1624-56) > 50 g in 1 TUBE
Marketing Start Date2018-11-19
NDC Exclude FlagN
Sample Package?N

NDC SPL Data Element Entries

NDC 0115-1624-56 [00115162456]

Azelaic Acid GEL
Marketing CategoryANDA
Application NumberANDA208724
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:ed69bd06-9eae-4354-9250-dc92e16480ac
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" 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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