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United States · US · US:63629-8694_9579a03c-ea5a-40fc-b908-bc876c88d6f6
Nystatin
Orange BookUNIISPLATC D01AA01
Last synced from FDA National Drug Code directory (United States) on
Identification
ManufacturerBryant Ranch Prepack
CountryUS (United States)
ATC codeD01AA01
Dispensing—
ReimbursedNo
SourceFDA National Drug Code directory (United States)
Last synced6/3/2026
Packs · 1
- ndc1163629869411 TUBE in 1 CARTON (63629-8694-1) / 15 g in 1 TUBE
Annotations
UNII (FDA Substance ID)
BDF1O1C72E
NYSTATIN
RxCUI 7597
Orange Book
A062225
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": "63629-8694_9579a03c-ea5a-40fc-b908-bc876c88d6f6",
"productndc": "63629-8694",
"dosage_form": "CREAM",
"orange_book": {
"appl_no": "062225",
"products": [
{
"rs": false,
"rld": false,
"te_code": "AT",
"strength": "100,000 UNITS/GM",
"product_no": "001",
"approval_date": "Approved Prior to Jan 1, 1982"
}
],
"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": "ANDA062225",
"marketing_category": "ANDA",
"nonproprietary_name": "Nystatin",
"start_marketing_date": "20060921",
"active_numerator_strength": "100000"
}Related drugs
Other records sharing ATC code D01AA01.
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