🇺🇸
United States · US · US:0316-0221_48342e66-405b-57be-e063-6394a90a276c
Nystatin Cream
Orange BookUNIISPLATC D01AA01
Last synced from FDA National Drug Code directory (United States) on
Identification
ManufacturerCrown Laboratories
CountryUS (United States)
ATC codeD01AA01
Dispensing—
ReimbursedNo
SourceFDA National Drug Code directory (United States)
Last synced6/3/2026
Packs · 2
- ndc1103160221151 TUBE in 1 CARTON (0316-0221-15) / 15 g in 1 TUBE
- ndc1103160221301 TUBE in 1 CARTON (0316-0221-30) / 30 g in 1 TUBE
Annotations
UNII (FDA Substance ID)
BDF1O1C72E
NYSTATIN
RxCUI 7597
Orange Book
A207733
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": "0316-0221_48342e66-405b-57be-e063-6394a90a276c",
"productndc": "0316-0221",
"dosage_form": "CREAM",
"orange_book": {
"appl_no": "207733",
"products": [
{
"rs": false,
"rld": false,
"te_code": "AT",
"strength": "100,000 UNITS/GM",
"product_no": "001",
"approval_date": "Sep 26, 2017"
}
],
"appl_type": "A"
},
"dea_schedule": null,
"product_type": "HUMAN PRESCRIPTION DRUG",
"substance_name": "NYSTATIN",
"proprietary_name": "Nystatin Cream",
"active_ingred_unit": "[USP'U]/g",
"application_number": "ANDA207733",
"marketing_category": "ANDA",
"nonproprietary_name": "Nystatin Cream",
"start_marketing_date": "20171010",
"active_numerator_strength": "100000"
}Related drugs
Other records sharing ATC code D01AA01.
- CZFUNGICIDIN LÉČIVAZentiva, k.s., Praha
- 🇺🇸KLAYESTAEpic Pharma, LLC
- 🇺🇸MycostatinDirect_Rx
- 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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