🇺🇸
United States · US · US:59651-907_1a24e1d4-b691-4849-822a-9a9a4aed4b27
NYSTATIN
Orange BookUNIISPLATC D01AA01
Last synced from FDA National Drug Code directory (United States) on
Identification
ManufacturerAurobindo Pharma Limited
CountryUS (United States)
ATC codeD01AA01
Dispensing—
ReimbursedNo
SourceFDA National Drug Code directory (United States)
Last synced6/3/2026
Packs · 2
- ndc1159651907141 TUBE in 1 CARTON (59651-907-14) / 15 g in 1 TUBE
- ndc1159651907301 TUBE in 1 CARTON (59651-907-30) / 30 g in 1 TUBE
Annotations
UNII (FDA Substance ID)
BDF1O1C72E
NYSTATIN
RxCUI 7597
Orange Book
A219527
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": "59651-907_1a24e1d4-b691-4849-822a-9a9a4aed4b27",
"productndc": "59651-907",
"dosage_form": "CREAM",
"orange_book": {
"appl_no": "219527",
"products": [
{
"rs": false,
"rld": false,
"te_code": "AT",
"strength": "100,000 UNITS/GM",
"product_no": "001",
"approval_date": "Mar 21, 2025"
}
],
"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": "ANDA219527",
"marketing_category": "ANDA",
"nonproprietary_name": "NYSTATIN",
"start_marketing_date": "20250321",
"active_numerator_strength": "100000"
}Related drugs
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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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