NDC 49884-902

Mafenide acetate

Mafenide Acetate

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

• Product ID: 49884-902_2ac267d5-35a9-4310-be5b-97b5dd6c46cb
• NDC: 49884-902
• Product Type: Human Prescription Drug
• Proprietary Name: Mafenide acetate
• Generic Name: Mafenide Acetate
• Dosage Form: Powder, For Solution
• Route of Administration: TOPICAL
• Marketing Start Date: 2013-02-12
• Marketing Category: ANDA / ANDA
• Application Number: ANDA201511
• Labeler Name: Par Pharmaceutical, Inc.
• Substance Name: MAFENIDE ACETATE
• Active Ingredient Strength: 50 g/1
• Pharm Classes: Methylated Sulfonamide Antibacterial [EPC],Methylated Sulfonamides [EXT]
• NDC Exclude Flag: N
• Listing Certified Through: 2020-12-31

Packaging

NDC 49884-902-52

1 CARTON in 1 PACKET (49884-902-52) > 5 POWDER, FOR SOLUTION in 1 CARTON (49884-902-78)

• Marketing Start Date: 2013-02-12
• NDC Exclude Flag: N
• Sample Package?: N

NDC SPL Data Element Entries

NDC 49884-902-52 [49884090252]

Mafenide acetate POWDER, FOR SOLUTION

• Marketing Category: ANDA
• Application Number: ANDA201511
• Product Type: HUMAN PRESCRIPTION DRUG
• Billing Unit: EA
• Marketing Start Date: 2013-02-12

NDC 49884-902-78 [49884090278]

Mafenide acetate POWDER, FOR SOLUTION

• Marketing Category: ANDA
• Application Number: ANDA201511
• Product Type: HUMAN PRESCRIPTION DRUG
• Billing Unit: EA
• Marketing Start Date: 2013-02-12

Drug Details

Active Ingredients

Ingredient	Strength
MAFENIDE ACETATE	50 g/1

OpenFDA Data

• SPL SET ID: e48cc935-2058-48c0-9281-b8b919629493
• Manufacturer:
  • Par Pharmaceutical, Inc.
• UNII:
  • RQ6LP6Z0WY
• RxNorm Concept Unique ID - RxCUI:
  • 251575
• UPC Code:
  • 0349884902520

Pharmacological Class

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

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

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