🇺🇸
United States · US · US:64950-372_319a98e0-8009-47c9-9f40-9cd288c26e48
NYSTATIN
Orange BookUNIISPLATC D01AA01
Last synced from FDA National Drug Code directory (United States) on
Identification
ManufacturerGenus Lifesciences Inc.
CountryUS (United States)
ATC codeD01AA01
Dispensing—
ReimbursedNo
SourceFDA National Drug Code directory (United States)
Last synced6/3/2026
Packs · 2
- ndc11649503720660 mL in 1 BOTTLE, DROPPER (64950-372-06)
- ndc116495037247473 mL in 1 BOTTLE (64950-372-47)
Annotations
UNII (FDA Substance ID)
BDF1O1C72E
NYSTATIN
RxCUI 7597
Orange Book
A065148
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": "64950-372_319a98e0-8009-47c9-9f40-9cd288c26e48",
"productndc": "64950-372",
"dosage_form": "SUSPENSION",
"orange_book": {
"appl_no": "065148",
"products": [
{
"rs": false,
"rld": false,
"te_code": "AA",
"strength": "100,000 UNITS/ML",
"product_no": "001",
"approval_date": "Jun 28, 2005"
}
],
"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": "ANDA065148",
"marketing_category": "ANDA",
"nonproprietary_name": "NYSTATIN",
"start_marketing_date": "20260324",
"active_numerator_strength": "100000"
}Related drugs
Other records sharing ATC code D01AA01.
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- FIMycostatinE.R. Squibb & Sons Limited
- 🇪🇸MYCOSTATIN 100.000 UI/ml SUSPENSION ORALSubstipharm
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- CANYADERMTARO PHARMACEUTICALS INC
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