NDC 51079-623

Sulfamylon

Mafenide Acetate

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

Product ID51079-623_a7c2f9d9-d661-4f52-9e27-e59fe4892c27
NDC51079-623
Product TypeHuman Prescription Drug
Proprietary NameSulfamylon
Generic NameMafenide Acetate
Dosage FormCream
Route of AdministrationTOPICAL
Marketing Start Date2006-12-08
Marketing CategoryNDA / NDA
Application NumberNDA016763
Labeler NameMylan Institutional Inc.
Substance NameMAFENIDE ACETATE
Active Ingredient Strength85 mg/g
Pharm ClassesMethylated Sulfonamide Antibacterial [EPC],Methylated Sulfonamides [EXT]
NDC Exclude FlagN
Listing Certified Through2020-12-31

Packaging

NDC 51079-623-81

1 TUBE in 1 CARTON (51079-623-81) > 56.7 g in 1 TUBE
Marketing Start Date2006-12-08
NDC Exclude FlagN
Sample Package?N

NDC SPL Data Element Entries

NDC 51079-623-81 [51079062381]

Sulfamylon CREAM
Marketing CategoryNDA
Application NumberNDA016763
Product TypeHUMAN PRESCRIPTION DRUG
Billing UnitGM
Marketing Start Date2006-12-08

NDC 51079-623-82 [51079062382]

Sulfamylon CREAM
Marketing CategoryNDA
Application NumberNDA016763
Product TypeHUMAN PRESCRIPTION DRUG
Billing UnitGM
Marketing Start Date2006-12-08

NDC 51079-623-83 [51079062383]

Sulfamylon CREAM
Marketing CategoryNDA
Application NumberNDA016763
Product TypeHUMAN PRESCRIPTION DRUG
Billing UnitGM
Marketing Start Date2006-12-08

Drug Details

Active Ingredients

IngredientStrength
MAFENIDE ACETATE85 mg/g

OpenFDA Data

SPL SET ID:9972db4c-703f-4cbc-915c-ec993bff6fb9
Manufacturer
UNII
RxNorm Concept Unique ID - RxCUI
  • 201185
  • 311406
  • 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

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