🇺🇸
United States · US · US:68788-8690_77d6819e-b284-42b7-af0b-ccf75793d70a
nystatin
Orange BookUNIISPLATC D01AA01
Last synced from FDA National Drug Code directory (United States) on
Identification
ManufacturerPreferred Pharmaceuticals Inc.
CountryUS (United States)
ATC codeD01AA01
Dispensing—
ReimbursedNo
SourceFDA National Drug Code directory (United States)
Last synced6/3/2026
Packs · 1
- ndc116878886901120 TABLET, COATED in 1 BOTTLE (68788-8690-1)
Annotations
UNII (FDA Substance ID)
BDF1O1C72E
NYSTATIN
RxCUI 7597
Orange Book
A062474
AA
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": "68788-8690_77d6819e-b284-42b7-af0b-ccf75793d70a",
"productndc": "68788-8690",
"dosage_form": "TABLET, COATED",
"orange_book": {
"appl_no": "062474",
"products": [
{
"rs": false,
"rld": false,
"te_code": "AA",
"strength": "500,000 UNITS",
"product_no": "001",
"approval_date": "Dec 22, 1983"
}
],
"appl_type": "A"
},
"dea_schedule": null,
"product_type": "HUMAN PRESCRIPTION DRUG",
"substance_name": "NYSTATIN",
"proprietary_name": "nystatin",
"active_ingred_unit": "[USP'U]/1",
"application_number": "ANDA062474",
"marketing_category": "ANDA",
"nonproprietary_name": "nystatin",
"start_marketing_date": "20240607",
"active_numerator_strength": "500000"
}Related drugs
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