Back to search
🇺🇸

United States · US · US:72162-1385_ea5d13f8-38cd-4010-a78f-ccafe2002c4a

Nystatin

Orange BookUNIISPLATC D01AA01

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

Identification

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

Packs · 2

  • ndc11
    7216213852
    1 TUBE in 1 CARTON (72162-1385-2) / 15 g in 1 TUBE
  • ndc11
    7216213853
    1 TUBE in 1 CARTON (72162-1385-3) / 30 g in 1 TUBE

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": {
    "50737729-a4a4-e747-e063-6394a90adcc5": {
      "match": "brand_token",
      "title": "NYSTATIN SUSPENSION [KESIN PHARMA CORPORATION]",
      "spl_version": "1",
      "published_date": "2026-06-01"
    }
  },
  "productid": "72162-1385_ea5d13f8-38cd-4010-a78f-ccafe2002c4a",
  "productndc": "72162-1385",
  "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": "Nystatin",
  "active_ingred_unit": "[USP'U]/g",
  "application_number": "ANDA062225",
  "marketing_category": "ANDA",
  "nonproprietary_name": "Nystatin",
  "start_marketing_date": "20060921",
  "active_numerator_strength": "100000"
}

Related drugs

Other records sharing ATC code D01AA01.

Access this data programmatically

Query Nystatin and 610,000+ other drug records through a single REST API — with a last_synced_at provenance stamp on every response. Free tier includes 100 requests/day.