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United States · US · US:72189-408_4d3a9fbe-9f7f-e1a0-e063-6294a90a7857

Mycostatin

Orange BookUNIISPLATC D01AA01

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

Identification

ManufacturerDirect_Rx
CountryUS (United States)
ATC codeD01AA01
Dispensing
ReimbursedNo
SourceFDA National Drug Code directory (United States)
Last synced6/3/2026

Packs · 1

  • ndc11
    7218940815
    15 g in 1 TUBE (72189-408-15)

Annotations

UNII (FDA Substance ID)
BDF1O1C72E
NYSTATIN
RxCUI 7597
Orange Book
A062225
AT
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": {
    "f1857ac0-806c-4a7e-e053-2995a90abbc0": {
      "match": "brand_token",
      "title": "MYCOSTATIN (NYSTATIN) CREAM [DIRECT_RX]",
      "spl_version": "3",
      "published_date": "2026-03-18"
    }
  },
  "productid": "72189-408_4d3a9fbe-9f7f-e1a0-e063-6294a90a7857",
  "productndc": "72189-408",
  "dosage_form": "CREAM",
  "orange_book": {
    "appl_no": "062225",
    "products": [
      {
        "rs": false,
        "rld": false,
        "te_code": "AT",
        "strength": "100,000 UNITS/GM",
        "product_no": "001",
        "approval_date": "Approved Prior to Jan 1, 1982"
      }
    ],
    "appl_type": "A"
  },
  "dea_schedule": null,
  "product_type": "HUMAN PRESCRIPTION DRUG",
  "substance_name": "NYSTATIN",
  "proprietary_name": "Mycostatin",
  "active_ingred_unit": "[USP'U]/g",
  "application_number": "ANDA062225",
  "marketing_category": "ANDA",
  "nonproprietary_name": "Nystatin",
  "start_marketing_date": "20230105",
  "active_numerator_strength": "100000"
}

Related drugs

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