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United States · US · US:17856-1045_35ceeae7-4f25-4d5a-e063-6394a90a8ff7
Nystatin
Orange BookUNIISPLATC D01AA01
Last synced from FDA National Drug Code directory (United States) on
Identification
ManufacturerATLANTIC BIOLOGICALS CORP.
CountryUS (United States)
ATC codeD01AA01
Dispensing—
ReimbursedNo
SourceFDA National Drug Code directory (United States)
Last synced6/3/2026
Packs · 5
- ndc11178561045172 CUP, UNIT-DOSE in 1 BOX, UNIT-DOSE (17856-1045-1) / 5 mL in 1 CUP, UNIT-DOSE (17856-1045-2)
- ndc11178561045348 SYRINGE in 1 BOX, UNIT-DOSE (17856-1045-3) / 5 mL in 1 SYRINGE (17856-1045-4)
- ndc11178561045548 SYRINGE in 1 BOX, UNIT-DOSE (17856-1045-5) / 5 mL in 1 SYRINGE (17856-1045-6)
- ndc111785610457120 SYRINGE in 1 BOX, UNIT-DOSE (17856-1045-7) / 1 mL in 1 SYRINGE (17856-1045-8)
- ndc1117856104591 SYRINGE in 1 BAG (17856-1045-9) / 5 mL in 1 SYRINGE
Annotations
UNII (FDA Substance ID)
BDF1O1C72E
NYSTATIN
RxCUI 7597
Orange Book
A203621
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": "17856-1045_35ceeae7-4f25-4d5a-e063-6394a90a8ff7",
"productndc": "17856-1045",
"dosage_form": "SUSPENSION",
"orange_book": {
"appl_no": "203621",
"products": [
{
"rs": false,
"rld": false,
"te_code": "AA",
"strength": "100,000 UNITS/ML",
"product_no": "001",
"approval_date": "Jan 7, 2016"
}
],
"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": "ANDA203621",
"marketing_category": "ANDA",
"nonproprietary_name": "NYSTATIN",
"start_marketing_date": "20240621",
"active_numerator_strength": "100000"
}Related drugs
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