Nystatin Topical Powder

Orange BookUNIISPLATC D01AA01

Last synced from FDA National Drug Code directory (United States) on June 3, 2026

Identification

ManufacturerEpic Pharma, LLC

CountryUS (United States)

ATC codeD01AA01

Dispensing—

ReimbursedNo

SourceFDA National Drug Code directory (United States)

Last synced6/3/2026

Packs · 3

ndc11
4280618515
15 g in 1 BOTTLE (42806-185-15)
ndc11
4280618530
30 g in 1 BOTTLE (42806-185-30)
ndc11
4280618560
60 g in 1 BOTTLE (42806-185-60)

Annotations

UNII (FDA Substance ID)

BDF1O1C72E

NYSTATIN

RxCUI 7597

Orange Book

A210532

DailyMed SPL labels

1 version tracked

Raw payload (JSON)

{
  "unii": {
    "unii": "BDF1O1C72E",
    "rxcui": "7597",
    "inchikey": null,
    "display_name": "NYSTATIN",
    "substance_type": "mixture",
    "ingredient_type": "INGREDIENT SUBSTANCE"
  },
  "route": "TOPICAL",
  "spl_meta": {
    "50737729-a4a4-e747-e063-6394a90adcc5": {
      "match": "brand_token",
      "title": "NYSTATIN SUSPENSION [KESIN PHARMA CORPORATION]",
      "spl_version": "1",
      "published_date": "2026-06-01"
    }
  },
  "productid": "42806-185_8723c280-f501-46c5-8be5-8a3e9cbd28b9",
  "productndc": "42806-185",
  "dosage_form": "POWDER",
  "orange_book": {
    "appl_no": "210532",
    "products": [
      {
        "rs": false,
        "rld": false,
        "te_code": "AT",
        "strength": "100,000 UNITS/GM",
        "product_no": "001",
        "approval_date": "Apr 30, 2018"
      }
    ],
    "appl_type": "A"
  },
  "dea_schedule": null,
  "product_type": "HUMAN PRESCRIPTION DRUG",
  "substance_name": "NYSTATIN",
  "proprietary_name": "Nystatin Topical Powder",
  "active_ingred_unit": "U/g",
  "application_number": "ANDA210532",
  "marketing_category": "ANDA",
  "nonproprietary_name": "Nystatin Topical Powder",
  "start_marketing_date": "20230414",
  "active_numerator_strength": "100000"
}

Related drugs

Other records sharing ATC code D01AA01.

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