Nystatin

Orange BookUNIISPLATC D01AA01

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

Identification

ManufacturerPAI Holdings, LLC dba PAI Pharma

CountryUS (United States)

ATC codeD01AA01

Dispensing—

ReimbursedNo

SourceFDA National Drug Code directory (United States)

Last synced6/3/2026

Packs · 4

ndc11
0121086800
10 TRAY in 1 CASE (0121-0868-00) / 10 CUP, UNIT-DOSE in 1 TRAY / 5 mL in 1 CUP, UNIT-DOSE (0121-0868-05)
ndc11
0121086802
60 mL in 1 BOTTLE, DROPPER (0121-0868-02)
ndc11
0121086816
473 mL in 1 BOTTLE (0121-0868-16)
ndc11
0121086850
5 TRAY in 1 CASE (0121-0868-50) / 10 CUP, UNIT-DOSE in 1 TRAY / 5 mL in 1 CUP, UNIT-DOSE (0121-0868-05)

Annotations

UNII (FDA Substance ID)

BDF1O1C72E

NYSTATIN

RxCUI 7597

Orange Book

A203621

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": "0121-0868_15a142a2-4bb9-444e-8b22-73acf9f91f3b",
  "productndc": "0121-0868",
  "dosage_form": "SUSPENSION",
  "orange_book": {
    "appl_no": "203621",
    "products": [
      {
        "rs": false,
        "rld": false,
        "te_code": "AA",
        "strength": "100,000 UNITS/ML",
        "product_no": "001",
        "approval_date": "Jan 7, 2016"
      }
    ],
    "appl_type": "A"
  },
  "dea_schedule": null,
  "product_type": "HUMAN PRESCRIPTION DRUG",
  "substance_name": "NYSTATIN",
  "proprietary_name": "Nystatin",
  "active_ingred_unit": "[USP'U]/mL",
  "application_number": "ANDA203621",
  "marketing_category": "ANDA",
  "nonproprietary_name": "NYSTATIN",
  "start_marketing_date": "20200717",
  "active_numerator_strength": "100000"
}

Related drugs

Other records sharing ATC code D01AA01.

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