NDC 16110-526

Aczone

Dapsone

Aczone is a Topical Gel in the Human Prescription Drug category. It is labeled and distributed by Almirall, Llc. The primary component is Dapsone.

Product ID16110-526_6655b5f4-f3b7-11eb-85b4-0800200c9a66
NDC16110-526
Product TypeHuman Prescription Drug
Proprietary NameAczone
Generic NameDapsone
Dosage FormGel
Route of AdministrationTOPICAL
Marketing Start Date2019-09-10
Marketing CategoryNDA / NDA
Application NumberNDA207154
Labeler NameAlmirall, LLC
Substance NameDAPSONE
Active Ingredient Strength75 mg/g
Pharm ClassesSulfone [EPC],Sulfones [CS]
NDC Exclude FlagN
Listing Certified Through2022-12-31

Packaging

NDC 16110-526-30

1 BOTTLE, PUMP in 1 CARTON (16110-526-30) > 30 g in 1 BOTTLE, PUMP
Marketing Start Date2019-09-10
NDC Exclude FlagN
Sample Package?N

NDC SPL Data Element Entries

NDC 16110-526-30 [16110052630]

Aczone GEL
Marketing CategoryNDA
Application NumberNDA207154
Product TypeHUMAN PRESCRIPTION DRUG
Marketing Start Date2019-09-10

NDC 16110-526-90 [16110052690]

Aczone GEL
Marketing CategoryNDA
Application NumberNDA207154
Product TypeHUMAN PRESCRIPTION DRUG
Marketing Start Date2019-09-10

NDC 16110-526-60 [16110052660]

Aczone GEL
Marketing CategoryNDA
Application NumberNDA207154
Product TypeHUMAN PRESCRIPTION DRUG
Billing UnitGM
Marketing Start Date2019-09-10

Drug Details

Active Ingredients

IngredientStrength
DAPSONE75 mg/g

OpenFDA Data

SPL SET ID:22058b7d-a578-4eaa-a476-ac982337f02a
Manufacturer
UNII
RxNorm Concept Unique ID - RxCUI
  • 1741905
  • 1741907
  • UPC Code
  • 0316110526904
  • 0316110526607
  • Pharmacological Class

    • Sulfone [EPC]
    • Sulfones [CS]
    • Sulfone [EPC]
    • Sulfones [CS]

    NDC Crossover Matching brand name "Aczone" or generic name "Dapsone"

    NDCBrand NameGeneric Name
    0023-3670ACZONEdapsone
    0023-5206ACZONEdapsone
    16110-367ACZONEdapsone
    16110-526Aczonedapsone
    0378-4830DapsoneDapsone
    0904-7018DAPSONEDapsone
    0904-7019DAPSONEDapsone
    10135-654DAPSONEDapsone
    10135-655DAPSONEDapsone
    13668-605dapsonedapsone
    13925-504DapsoneDapsone
    13925-505DapsoneDapsone
    16714-956DapsoneDapsone
    29033-036DapsoneDapsone
    29033-037DapsoneDapsone
    42291-298DapsoneDapsone
    42291-299DapsoneDapsone
    43353-222DapsoneDapsone
    43353-223DapsoneDapsone
    47781-333Dapsonedapsone
    47781-334Dapsonedapsone
    49938-101DapsoneDapsone
    49938-102DapsoneDapsone
    51672-1387DapsoneDapsone
    51672-1388DapsoneDapsone
    51672-4197DapsoneDapsone

    Trademark Results [Aczone]

    Mark Image

    Registration | Serial
    Company
    Trademark
    Application Date
    ACZONE
    ACZONE
    78360867 3419732 Live/Registered
    ALMIRALL, LLC
    2004-02-02

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