🇺🇸
United States · US · US:68071-4293_275d40f9-dd81-6741-e063-6294a90aece1
Nystatin
Orange BookUNIISPLATC D01AA01
Last synced from FDA National Drug Code directory (United States) on
Identification
ManufacturerNuCare Pharmaceuticals,Inc.
CountryUS (United States)
ATC codeD01AA01
Dispensing—
ReimbursedNo
SourceFDA National Drug Code directory (United States)
Last synced6/3/2026
Packs · 1
- ndc11680714293330 g in 1 BOX (68071-4293-3)
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": "68071-4293_275d40f9-dd81-6741-e063-6294a90aece1",
"productndc": "68071-4293",
"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
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