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United States · US · US:0480-2596_62052410-0ab9-4ed6-aff5-36ef8eb81850
Fidaxomicin
Orange BookUNIISPLATC A07AA12
Last synced from FDA National Drug Code directory (United States) on
Identification
ManufacturerTeva Pharmaceuticals, Inc.
CountryUS (United States)
ATC codeA07AA12
Dispensing—
ReimbursedNo
SourceFDA National Drug Code directory (United States)
Last synced6/3/2026
Packs · 1
- ndc11048025963420 TABLET, FILM COATED in 1 BOTTLE (0480-2596-34)
Annotations
UNII (FDA Substance ID)
Z5N076G8YQ
FIDAXOMICIN
RxCUI 1111103
Orange Book
A208443
AB
DailyMed SPL labels
1 version tracked
Raw payload (JSON)
{
"unii": {
"unii": "Z5N076G8YQ",
"rxcui": "1111103",
"inchikey": "ZVGNESXIJDCBKN-UUEYKCAUSA-N",
"display_name": "FIDAXOMICIN",
"substance_type": "chemical",
"ingredient_type": "INGREDIENT SUBSTANCE"
},
"route": "ORAL",
"spl_meta": {
"6cc3e803-8935-f9b3-ab7f-fef8b1c02070": {
"match": "brand_token",
"title": "FIDAXOMICIN TABLET, FILM COATED [APOTEX CORP.]",
"spl_version": "2",
"published_date": "2026-02-16"
}
},
"productid": "0480-2596_62052410-0ab9-4ed6-aff5-36ef8eb81850",
"productndc": "0480-2596",
"dosage_form": "TABLET, FILM COATED",
"orange_book": {
"appl_no": "208443",
"products": [
{
"rs": false,
"rld": false,
"te_code": "AB",
"strength": "200MG",
"product_no": "001",
"approval_date": "Jan 16, 2024"
}
],
"appl_type": "A"
},
"dea_schedule": null,
"product_type": "HUMAN PRESCRIPTION DRUG",
"substance_name": "FIDAXOMICIN",
"proprietary_name": "Fidaxomicin",
"active_ingred_unit": "mg/1",
"application_number": "ANDA208443",
"marketing_category": "ANDA",
"nonproprietary_name": "fidaxomicin",
"start_marketing_date": "20250715",
"active_numerator_strength": "200"
}Related drugs
Other records sharing ATC code A07AA12.
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