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United States · US · US:68382-370_7f7aaf27-0265-40b9-a900-341232347fad
NYSTATIN
Orange BookUNIISPLATC D01AA01
Last synced from FDA National Drug Code directory (United States) on
Identification
ManufacturerZydus Pharmaceuticals USA Inc.
CountryUS (United States)
ATC codeD01AA01
Dispensing—
ReimbursedNo
SourceFDA National Drug Code directory (United States)
Last synced6/3/2026
Packs · 3
- ndc11683823700115 g in 1 BOTTLE, PLASTIC (68382-370-01)
- ndc11683823700230 g in 1 BOTTLE, PLASTIC (68382-370-02)
- ndc11683823700360 g in 1 BOTTLE, PLASTIC (68382-370-03)
Annotations
UNII (FDA Substance ID)
BDF1O1C72E
NYSTATIN
RxCUI 7597
Orange Book
A208581
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": "68382-370_7f7aaf27-0265-40b9-a900-341232347fad",
"productndc": "68382-370",
"dosage_form": "POWDER",
"orange_book": {
"appl_no": "208581",
"products": [
{
"rs": false,
"rld": false,
"te_code": "AT",
"strength": "100,000 UNITS/GM",
"product_no": "001",
"approval_date": "Jun 8, 2017"
}
],
"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": "ANDA208581",
"marketing_category": "ANDA",
"nonproprietary_name": "nystatin",
"start_marketing_date": "20211006",
"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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