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United States · US · US:0832-0465_3984f88f-d61f-1fa9-e063-6394a90acb11
Nyamyc
Orange BookUNIISPLATC D01AA01
Last synced from FDA National Drug Code directory (United States) on
Identification
ManufacturerUpsher-Smith Laboratories, LLC
CountryUS (United States)
ATC codeD01AA01
Dispensing—
ReimbursedNo
SourceFDA National Drug Code directory (United States)
Last synced6/3/2026
Packs · 3
- ndc1108320465151 BOTTLE, PLASTIC in 1 CARTON (0832-0465-15) / 15 g in 1 BOTTLE, PLASTIC
- ndc1108320465301 BOTTLE, PLASTIC in 1 CARTON (0832-0465-30) / 30 g in 1 BOTTLE, PLASTIC
- ndc1108320465601 BOTTLE, PLASTIC in 1 CARTON (0832-0465-60) / 60 g in 1 BOTTLE, PLASTIC
Annotations
UNII (FDA Substance ID)
BDF1O1C72E
NYSTATIN
RxCUI 7597
Orange Book
A065183
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": {
"01b44f91-9b68-464a-9693-b5d3e793bf3c": {
"match": "brand_token",
"title": "NYAMYC (NYSTATIN) POWDER [UPSHER-SMITH LABORATORIES, LLC]",
"spl_version": "12",
"published_date": "2025-07-11"
}
},
"productid": "0832-0465_3984f88f-d61f-1fa9-e063-6394a90acb11",
"productndc": "0832-0465",
"dosage_form": "POWDER",
"orange_book": {
"appl_no": "065183",
"products": [
{
"rs": false,
"rld": false,
"te_code": "AT",
"strength": "100,000 UNITS/GM",
"product_no": "001",
"approval_date": "May 3, 2005"
}
],
"appl_type": "A"
},
"dea_schedule": null,
"product_type": "HUMAN PRESCRIPTION DRUG",
"substance_name": "NYSTATIN",
"proprietary_name": "Nyamyc",
"active_ingred_unit": "[USP'U]/g",
"application_number": "ANDA065183",
"marketing_category": "ANDA",
"nonproprietary_name": "Nystatin",
"start_marketing_date": "20050503",
"active_numerator_strength": "100000"
}Related drugs
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