🇺🇸
United States · US · US:63629-8350_3ac0334d-5698-4b3a-8ac8-7594526ec50c
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 · 4
- ndc11636298350128 TABLET, COATED in 1 BOTTLE (63629-8350-1)
- ndc11636298350256 TABLET, COATED in 1 BOTTLE (63629-8350-2)
- ndc11636298350330 TABLET, COATED in 1 BOTTLE (63629-8350-3)
- ndc116362983504120 TABLET, COATED in 1 BOTTLE (63629-8350-4)
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": "63629-8350_3ac0334d-5698-4b3a-8ac8-7594526ec50c",
"productndc": "63629-8350",
"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": "20111031",
"active_numerator_strength": "500000"
}Related drugs
Other records sharing ATC code D01AA01.
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- 🇺🇸KLAYESTAEpic Pharma, LLC
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- FIMycostatinE.R. Squibb & Sons Limited
- FIMycostatinE.R. Squibb & Sons Limited
- 🇪🇸MYCOSTATIN 100.000 UI/ml SUSPENSION ORALSubstipharm
- 🇮🇹MYCOSTATIN*orale sosp 100.000 UI/ml 100 mlSUBSTIPHARM
- CANYADERMTARO PHARMACEUTICALS INC
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