NDC 51079-624

Sulfamylon

Mafenide Acetate

Sulfamylon is a Topical Powder, For Solution in the Human Prescription Drug category. It is labeled and distributed by Mylan Institutional Inc.. The primary component is Mafenide Acetate.

Product ID51079-624_a305122e-cec7-476d-8127-d2dd9de7430b
NDC51079-624
Product TypeHuman Prescription Drug
Proprietary NameSulfamylon
Generic NameMafenide Acetate
Dosage FormPowder, For Solution
Route of AdministrationTOPICAL
Marketing Start Date1998-06-05
Marketing End Date2023-12-31
Marketing CategoryNDA / NDA
Application NumberNDA019832
Labeler NameMylan Institutional Inc.
Substance NameMAFENIDE ACETATE
Active Ingredient Strength50 g/1
Pharm ClassesMethylated Sulfonamide Antibacterial [EPC],Methylated Sulfonamides [EXT]
NDC Exclude FlagN

Packaging

NDC 51079-624-85

5 PACKET in 1 CARTON (51079-624-85) > 1 POWDER, FOR SOLUTION in 1 PACKET (51079-624-84)
Marketing Start Date1998-06-05
Marketing End Date2023-12-31
NDC Exclude FlagN
Sample Package?N

NDC SPL Data Element Entries

NDC 51079-624-85 [51079062485]

Sulfamylon POWDER, FOR SOLUTION
Marketing CategoryNDA
Application NumberNDA019832
Product TypeHUMAN PRESCRIPTION DRUG
Billing UnitEA
Marketing Start Date1998-06-05

NDC 51079-624-84 [51079062484]

Sulfamylon POWDER, FOR SOLUTION
Marketing CategoryNDA
Application NumberNDA019832
Product TypeHUMAN PRESCRIPTION DRUG
Billing UnitEA
Marketing Start Date1998-06-05

Drug Details

Active Ingredients

IngredientStrength
MAFENIDE ACETATE50 g/1

OpenFDA Data

SPL SET ID:570ce479-d902-4394-bbae-41dfe16c5485
Manufacturer
UNII
RxNorm Concept Unique ID - RxCUI
  • 251575
  • 285024
  • Pharmacological Class

    • Methylated Sulfonamide Antibacterial [EPC]
    • Methylated Sulfonamides [EXT]
    • Methylated Sulfonamide Antibacterial [EPC]
    • Methylated Sulfonamides [EXT]

    NDC Crossover Matching brand name "Sulfamylon" or generic name "Mafenide Acetate"

    NDCBrand NameGeneric Name
    16571-723SULFAMYLONmafenide acetate
    51079-623SulfamylonMafenide Acetate
    51079-624Sulfamylonmafenide acetate
    49884-902Mafenide acetateMafenide acetate
    50742-310Mafenide AcetateMafenide Acetate

    Trademark Results [Sulfamylon]

    Mark Image

    Registration | Serial
    Company
    Trademark
    Application Date
    SULFAMYLON
    SULFAMYLON
    73641985 1456073 Live/Registered
    STERLING DRUG INC.
    1987-01-29
    SULFAMYLON
    SULFAMYLON
    71499184 0431858 Dead/Expired
    WINTHROP CHEMICAL COMPANY, INC.
    1946-03-28

    © 2022 FDA.report
    This site is not affiliated with or endorsed by the FDA.