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United States · US · US:72162-2645_e2765480-7416-41c4-a4f5-4b5f5325e07f

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
    7216226452
    473 mL in 1 BOTTLE (72162-2645-2)
  • ndc11
    7216226456
    1 BOTTLE in 1 CARTON (72162-2645-6) / 60 mL in 1 BOTTLE

Annotations

UNII (FDA Substance ID)
BDF1O1C72E
NYSTATIN
RxCUI 7597
Orange Book
A062832
AA
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": "ORAL",
  "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": "72162-2645_e2765480-7416-41c4-a4f5-4b5f5325e07f",
  "productndc": "72162-2645",
  "dosage_form": "SUSPENSION",
  "orange_book": {
    "appl_no": "062832",
    "products": [
      {
        "rs": false,
        "rld": false,
        "te_code": "AA",
        "strength": "100,000 UNITS/ML",
        "product_no": "001",
        "approval_date": "Dec 27, 1991"
      }
    ],
    "appl_type": "A"
  },
  "dea_schedule": null,
  "product_type": "HUMAN PRESCRIPTION DRUG",
  "substance_name": "NYSTATIN",
  "proprietary_name": "NYSTATIN",
  "active_ingred_unit": "U/mL",
  "application_number": "ANDA062832",
  "marketing_category": "ANDA",
  "nonproprietary_name": "NYSTATIN",
  "start_marketing_date": "20200814",
  "active_numerator_strength": "100000"
}

Related drugs

Other records sharing ATC code D01AA01.

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