🇺🇸
United States · US · US:72189-408_4d3a9fbe-9f7f-e1a0-e063-6294a90a7857
Mycostatin
Orange BookUNIISPLATC D01AA01
Last synced from FDA National Drug Code directory (United States) on
Identification
ManufacturerDirect_Rx
CountryUS (United States)
ATC codeD01AA01
Dispensing—
ReimbursedNo
SourceFDA National Drug Code directory (United States)
Last synced6/3/2026
Packs · 1
- ndc11721894081515 g in 1 TUBE (72189-408-15)
Annotations
UNII (FDA Substance ID)
BDF1O1C72E
NYSTATIN
RxCUI 7597
Orange Book
A062225
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": {
"f1857ac0-806c-4a7e-e053-2995a90abbc0": {
"match": "brand_token",
"title": "MYCOSTATIN (NYSTATIN) CREAM [DIRECT_RX]",
"spl_version": "3",
"published_date": "2026-03-18"
}
},
"productid": "72189-408_4d3a9fbe-9f7f-e1a0-e063-6294a90a7857",
"productndc": "72189-408",
"dosage_form": "CREAM",
"orange_book": {
"appl_no": "062225",
"products": [
{
"rs": false,
"rld": false,
"te_code": "AT",
"strength": "100,000 UNITS/GM",
"product_no": "001",
"approval_date": "Approved Prior to Jan 1, 1982"
}
],
"appl_type": "A"
},
"dea_schedule": null,
"product_type": "HUMAN PRESCRIPTION DRUG",
"substance_name": "NYSTATIN",
"proprietary_name": "Mycostatin",
"active_ingred_unit": "[USP'U]/g",
"application_number": "ANDA062225",
"marketing_category": "ANDA",
"nonproprietary_name": "Nystatin",
"start_marketing_date": "20230105",
"active_numerator_strength": "100000"
}Related drugs
Other records sharing ATC code D01AA01.
- CZFUNGICIDIN LÉČIVAZentiva, k.s., Praha
- 🇺🇸KLAYESTAEpic Pharma, LLC
- 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
- 🇺🇸NyamycUpsher-Smith Laboratories, LLC
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