🇺🇸
United States · US · US:0713-0686_0b479d47-d58c-1457-e063-6394a90a1256
Nystatin
Orange BookUNIISPLATC D01AA01
Last synced from FDA National Drug Code directory (United States) on
Identification
ManufacturerCosette Pharmaceuticals, Inc.
CountryUS (United States)
ATC codeD01AA01
Dispensing—
ReimbursedNo
SourceFDA National Drug Code directory (United States)
Last synced6/3/2026
Packs · 2
- ndc1107130686151 TUBE in 1 CARTON (0713-0686-15) / 15 g in 1 TUBE
- ndc1107130686311 TUBE in 1 CARTON (0713-0686-31) / 30 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": "0713-0686_0b479d47-d58c-1457-e063-6394a90a1256",
"productndc": "0713-0686",
"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.
Access this data programmatically
Query Nystatin and 610,000+ other drug records through a single REST API — with a last_synced_at provenance stamp on every response. Free tier includes 100 requests/day.