sulfamylon

Generic: mafenide acetate

Labeler: rising pharma holdings, inc.
NDC Directory HUMAN PRESCRIPTION DRUG NDA Inactive Finished

Drug Facts

Product Profile

Brand Name sulfamylon
Generic Name mafenide acetate
Labeler rising pharma holdings, inc.
Dosage Form CREAM
Routes
TOPICAL
Active Ingredients

mafenide acetate 85 mg/g

Manufacturer
Rising Pharma Holdings, Inc.

Identifiers & Regulatory

Product NDC 16571-723
Product ID 16571-723_58d3a059-d175-4740-bf57-f156588c99b5
Product Type HUMAN PRESCRIPTION DRUG
Marketing Category NDA
Application Number NDA016763
Listing Expiration 2026-12-31
Marketing Start 2020-05-18

Pharmacologic Class

Classes
methylated sulfonamide antibacterial [epc] methylated sulfonamides [ext]

Normalized Code Variants

Searchable formats for this product NDC code

Digits Only 16571723
Hyphenated Format 16571-723

Supplemental Identifiers

RxCUI
201185 311406
UNII
RQ6LP6Z0WY

Packaging Origin

Original Packager
true

Resolved Product View

Precedence rule: structured NDC data is preferred, falling back to linked label metadata when unavailable. Source tags show the origin of each value.

Resolved Identity

Brand Name sulfamylon (source: ndc)
Generic Name mafenide acetate (source: ndc)
Application Number NDA016763 (source: ndc)
Routes
TOPICAL
source: ndc

Resolved Composition

Strengths
  • 85 mg/g
source: ndc
Packaging
  • 1 TUBE in 1 CARTON (16571-723-12) / 113.4 g in 1 TUBE
  • 453.6 g in 1 JAR (16571-723-48)
  • 1 TUBE in 1 CARTON (16571-723-60) / 56.7 g in 1 TUBE
source: ndc

Packages (3)

16571-723-12 1 TUBE in 1 CARTON (16571-723-12) / 113.4 g in 1 TUBE 16571-723-48 453.6 g in 1 JAR (16571-723-48) 16571-723-60 1 TUBE in 1 CARTON (16571-723-60) / 56.7 g in 1 TUBE

Ingredients (1)

mafenide acetate (85 mg/g)

Linked Drug Pages (1)

SULFAMYLON ndc-match (0.9)

Raw FDA Data

View complete raw FDA NDC JSON payload 
{"route": ["TOPICAL"], "spl_id": "58d3a059-d175-4740-bf57-f156588c99b5", "openfda": {"unii": ["RQ6LP6Z0WY"], "rxcui": ["201185", "311406"], "spl_set_id": ["008eaa23-8f19-4e39-85ff-540c1c834a9e"], "manufacturer_name": ["Rising Pharma Holdings, Inc."], "is_original_packager": [true]}, "finished": true, "packaging": [{"sample": false, "description": "1 TUBE in 1 CARTON (16571-723-12)  / 113.4 g in 1 TUBE", "package_ndc": "16571-723-12", "marketing_start_date": "20200518"}, {"sample": false, "description": "453.6 g in 1 JAR (16571-723-48)", "package_ndc": "16571-723-48", "marketing_start_date": "20200518"}, {"sample": false, "description": "1 TUBE in 1 CARTON (16571-723-60)  / 56.7 g in 1 TUBE", "package_ndc": "16571-723-60", "marketing_start_date": "20200518"}], "brand_name": "SULFAMYLON", "product_id": "16571-723_58d3a059-d175-4740-bf57-f156588c99b5", "dosage_form": "CREAM", "pharm_class": ["Methylated Sulfonamide Antibacterial [EPC]", "Methylated Sulfonamides [EXT]"], "product_ndc": "16571-723", "generic_name": "mafenide acetate", "labeler_name": "Rising Pharma Holdings, Inc.", "product_type": "HUMAN PRESCRIPTION DRUG", "brand_name_base": "SULFAMYLON", "active_ingredients": [{"name": "MAFENIDE ACETATE", "strength": "85 mg/g"}], "application_number": "NDA016763", "marketing_category": "NDA", "marketing_start_date": "20200518", "listing_expiration_date": "20261231"}