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United States · US · US:68788-8561_22fc2dd7-78fc-497b-84e2-96ec602eec21
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
- ndc116878885614473 mL in 1 BOTTLE (68788-8561-4)
Annotations
UNII (FDA Substance ID)
BDF1O1C72E
NYSTATIN
RxCUI 7597
Orange Book
A214346
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": "68788-8561_22fc2dd7-78fc-497b-84e2-96ec602eec21",
"productndc": "68788-8561",
"dosage_form": "SUSPENSION",
"orange_book": {
"appl_no": "214346",
"products": [
{
"rs": true,
"rld": false,
"te_code": "AA",
"strength": "100,000 UNITS/ML",
"product_no": "001",
"approval_date": "Mar 10, 2022"
}
],
"appl_type": "A"
},
"dea_schedule": null,
"product_type": "HUMAN PRESCRIPTION DRUG",
"substance_name": "NYSTATIN",
"proprietary_name": "NYSTATIN",
"active_ingred_unit": "[USP'U]/mL",
"application_number": "ANDA214346",
"marketing_category": "ANDA",
"nonproprietary_name": "NYSTATIN",
"start_marketing_date": "20240108",
"active_numerator_strength": "100000"
}Related drugs
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