NDC 51672-1389

Azelaic Acid

Azelaic Acid

Azelaic Acid is a Topical Gel in the Human Prescription Drug category. It is labeled and distributed by Taro Pharmaceuticals U.s.a., Inc.. The primary component is Azelaic Acid.

Product ID51672-1389_41976f62-5ce0-4b0d-91bc-b4b4ce095dc8
NDC51672-1389
Product TypeHuman Prescription Drug
Proprietary NameAzelaic Acid
Generic NameAzelaic Acid
Dosage FormGel
Route of AdministrationTOPICAL
Marketing Start Date2019-08-23
Marketing CategoryANDA / ANDA
Application NumberANDA210549
Labeler NameTaro Pharmaceuticals U.S.A., 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 51672-1389-3

1 TUBE in 1 CARTON (51672-1389-3) > 50 g in 1 TUBE
Marketing Start Date2019-08-23
NDC Exclude FlagN
Sample Package?N

NDC SPL Data Element Entries

NDC 51672-1389-3 [51672138903]

Azelaic Acid GEL
Marketing CategoryANDA
Application NumberANDA210549
Product TypeHUMAN PRESCRIPTION DRUG
Billing UnitGM
Marketing Start Date2019-08-23

Drug Details

Active Ingredients

IngredientStrength
AZELAIC ACID.15 g/g

OpenFDA Data

SPL SET ID:d4e9e95d-1ebd-44df-a91e-59819715659c
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]

    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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