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United States · US · US:16571-723_58d3a059-d175-4740-bf57-f156588c99b5

SULFAMYLON

Orange BookUNIIATC D06BA03

Last synced from FDA National Drug Code directory (United States) on

Identification

ManufacturerRising Pharma Holdings, Inc.
CountryUS (United States)
ATC codeD06BA03
Dispensing
ReimbursedNo
SourceFDA National Drug Code directory (United States)
Last synced6/3/2026

Packs · 3

  • ndc11
    1657172312
    1 TUBE in 1 CARTON (16571-723-12) / 113.4 g in 1 TUBE
  • ndc11
    1657172348
    453.6 g in 1 JAR (16571-723-48)
  • ndc11
    1657172360
    1 TUBE in 1 CARTON (16571-723-60) / 56.7 g in 1 TUBE

Annotations

UNII (FDA Substance ID)
RQ6LP6Z0WY
MAFENIDE ACETATE
RxCUI 6573
Orange Book
N016763
Raw payload (JSON)
{
  "unii": {
    "unii": "RQ6LP6Z0WY",
    "rxcui": "6573",
    "inchikey": "UILOTUUZKGTYFQ-UHFFFAOYSA-N",
    "display_name": "MAFENIDE ACETATE",
    "substance_type": "chemical",
    "ingredient_type": "INGREDIENT SUBSTANCE"
  },
  "route": "TOPICAL",
  "productid": "16571-723_58d3a059-d175-4740-bf57-f156588c99b5",
  "productndc": "16571-723",
  "dosage_form": "CREAM",
  "orange_book": {
    "appl_no": "016763",
    "products": [
      {
        "rs": true,
        "rld": true,
        "te_code": null,
        "strength": "EQ 85MG BASE/GM",
        "product_no": "001",
        "approval_date": "Approved Prior to Jan 1, 1982"
      }
    ],
    "appl_type": "N"
  },
  "dea_schedule": null,
  "product_type": "HUMAN PRESCRIPTION DRUG",
  "substance_name": "MAFENIDE ACETATE",
  "proprietary_name": "SULFAMYLON",
  "active_ingred_unit": "mg/g",
  "application_number": "NDA016763",
  "marketing_category": "NDA",
  "nonproprietary_name": "mafenide acetate",
  "start_marketing_date": "20200518",
  "active_numerator_strength": "85"
}

Related drugs

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