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United States · US · US:62332-585_c98a4886-c5f9-425b-8770-7a753ba25fa8

Nystatin and Triamcinolone Acetonide

Orange BookUNIISPLATC A07AA

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

Identification

ManufacturerAlembic Pharmaceuticals Inc.
CountryUS (United States)
ATC codeA07AA
Dispensing
ReimbursedNo
SourceFDA National Drug Code directory (United States)
Last synced6/3/2026

Packs · 3

  • ndc11
    6233258515
    1 TUBE in 1 CARTON (62332-585-15) / 15 g in 1 TUBE
  • ndc11
    6233258530
    1 TUBE in 1 CARTON (62332-585-30) / 30 g in 1 TUBE
  • ndc11
    6233258560
    1 TUBE in 1 CARTON (62332-585-60) / 60 g in 1 TUBE

Annotations

UNII (FDA Substance ID)
BDF1O1C72E
NYSTATIN
RxCUI 7597
Orange Book
A214186
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": "62332-585_c98a4886-c5f9-425b-8770-7a753ba25fa8",
  "productndc": "62332-585",
  "dosage_form": "OINTMENT",
  "orange_book": {
    "appl_no": "214186",
    "products": [
      {
        "rs": false,
        "rld": false,
        "te_code": "AT",
        "strength": "100,000 UNITS/GM;0.1%",
        "product_no": "001",
        "approval_date": "Mar 4, 2022"
      }
    ],
    "appl_type": "A"
  },
  "dea_schedule": null,
  "product_type": "HUMAN PRESCRIPTION DRUG",
  "substance_name": "NYSTATIN; TRIAMCINOLONE ACETONIDE",
  "proprietary_name": "Nystatin and Triamcinolone Acetonide",
  "active_ingred_unit": "[USP'U]/g; mg/g",
  "application_number": "ANDA214186",
  "marketing_category": "ANDA",
  "nonproprietary_name": "Nystatin and Triamcinolone Acetonide",
  "start_marketing_date": "20220315",
  "active_numerator_strength": "100000; 1"
}

Related drugs

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