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 ID: 51079-624_a305122e-cec7-476d-8127-d2dd9de7430b
• NDC: 51079-624
• Product Type: Human Prescription Drug
• Proprietary Name: Sulfamylon
• Generic Name: Mafenide Acetate
• Dosage Form: Powder, For Solution
• Route of Administration: TOPICAL
• Marketing Start Date: 1998-06-05
• Marketing End Date: 2023-12-31
• Marketing Category: NDA / NDA
• Application Number: NDA019832
• Labeler Name: Mylan Institutional Inc.
• Substance Name: MAFENIDE ACETATE
• Active Ingredient Strength: 50 g/1
• Pharm Classes: Methylated Sulfonamide Antibacterial [EPC],Methylated Sulfonamides [EXT]
• NDC Exclude Flag: N

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 Date: 1998-06-05
• Marketing End Date: 2023-12-31
• NDC Exclude Flag: N
• Sample Package?: N

NDC SPL Data Element Entries

NDC 51079-624-85 [51079062485]

Sulfamylon POWDER, FOR SOLUTION

• Marketing Category: NDA
• Application Number: NDA019832
• Product Type: HUMAN PRESCRIPTION DRUG
• Billing Unit: EA
• Marketing Start Date: 1998-06-05

NDC 51079-624-84 [51079062484]

Sulfamylon POWDER, FOR SOLUTION

• Marketing Category: NDA
• Application Number: NDA019832
• Product Type: HUMAN PRESCRIPTION DRUG
• Billing Unit: EA
• Marketing Start Date: 1998-06-05

Drug Details

Active Ingredients

Ingredient	Strength
MAFENIDE ACETATE	50 g/1

OpenFDA Data

• SPL SET ID: 570ce479-d902-4394-bbae-41dfe16c5485
• Manufacturer:
  • Mylan Institutional Inc.
• UNII:
  • RQ6LP6Z0WY
• 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"

NDC	Brand Name	Generic Name
16571-723	SULFAMYLON	mafenide acetate
51079-623	Sulfamylon	Mafenide Acetate
51079-624	Sulfamylon	mafenide acetate
49884-902	Mafenide acetate	Mafenide acetate
50742-310	Mafenide Acetate	Mafenide Acetate