🇺🇸
United States · US · US:71205-437_711950c4-1889-4acd-ab76-9a16176ce1e4
Nystatin
Orange BookUNIISPLATC D01AA01
Last synced from FDA National Drug Code directory (United States) on
Identification
ManufacturerProficient Rx LP
CountryUS (United States)
ATC codeD01AA01
Dispensing—
ReimbursedNo
SourceFDA National Drug Code directory (United States)
Last synced6/3/2026
Packs · 1
- ndc1171205437151 TUBE in 1 CARTON (71205-437-15) / 15 g in 1 TUBE
Annotations
UNII (FDA Substance ID)
BDF1O1C72E
NYSTATIN
RxCUI 7597
Orange Book
A209114
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": "71205-437_711950c4-1889-4acd-ab76-9a16176ce1e4",
"productndc": "71205-437",
"dosage_form": "OINTMENT",
"orange_book": {
"appl_no": "209114",
"products": [
{
"rs": false,
"rld": false,
"te_code": "AT",
"strength": "100,000 UNITS/GM",
"product_no": "001",
"approval_date": "Oct 6, 2017"
}
],
"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": "ANDA209114",
"marketing_category": "ANDA",
"nonproprietary_name": "Nystatin Ointment",
"start_marketing_date": "20171006",
"active_numerator_strength": "100000"
}Related drugs
Other records sharing ATC code D01AA01.
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