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 ID: 51079-623_a7c2f9d9-d661-4f52-9e27-e59fe4892c27
• NDC: 51079-623
• Product Type: Human Prescription Drug
• Proprietary Name: Sulfamylon
• Generic Name: Mafenide Acetate
• Dosage Form: Cream
• Route of Administration: TOPICAL
• Marketing Start Date: 2006-12-08
• Marketing Category: NDA / NDA
• Application Number: NDA016763
• Labeler Name: Mylan Institutional Inc.
• Substance Name: MAFENIDE ACETATE
• Active Ingredient Strength: 85 mg/g
• Pharm Classes: Methylated Sulfonamide Antibacterial [EPC],Methylated Sulfonamides [EXT]
• NDC Exclude Flag: N
• Listing Certified Through: 2020-12-31

Packaging

NDC 51079-623-81

1 TUBE in 1 CARTON (51079-623-81) > 56.7 g in 1 TUBE

• Marketing Start Date: 2006-12-08
• NDC Exclude Flag: N
• Sample Package?: N

NDC SPL Data Element Entries

NDC 51079-623-81 [51079062381]

Sulfamylon CREAM

• Marketing Category: NDA
• Application Number: NDA016763
• Product Type: HUMAN PRESCRIPTION DRUG
• Billing Unit: GM
• Marketing Start Date: 2006-12-08

NDC 51079-623-82 [51079062382]

Sulfamylon CREAM

• Marketing Category: NDA
• Application Number: NDA016763
• Product Type: HUMAN PRESCRIPTION DRUG
• Billing Unit: GM
• Marketing Start Date: 2006-12-08

NDC 51079-623-83 [51079062383]

Sulfamylon CREAM

• Marketing Category: NDA
• Application Number: NDA016763
• Product Type: HUMAN PRESCRIPTION DRUG
• Billing Unit: GM
• Marketing Start Date: 2006-12-08

Drug Details

Active Ingredients

Ingredient	Strength
MAFENIDE ACETATE	85 mg/g

OpenFDA Data

• SPL SET ID: 9972db4c-703f-4cbc-915c-ec993bff6fb9
• Manufacturer:
  • Mylan Institutional Inc.
• UNII:
  • RQ6LP6Z0WY
• 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"

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