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United States · US · US:52015-080_21c95e9f-0a3d-4fb8-90b5-934bad817d00
Dificid
Orange BookUNIISPLATC A07AA12
Last synced from FDA National Drug Code directory (United States) on
Identification
ManufacturerMerck Sharp & Dohme LLC
CountryUS (United States)
ATC codeA07AA12
Dispensing—
ReimbursedNo
SourceFDA National Drug Code directory (United States)
Last synced6/3/2026
Packs · 1
- ndc1152015080011 BOTTLE in 1 CARTON (52015-080-01) / 20 TABLET, FILM COATED in 1 BOTTLE
Annotations
UNII (FDA Substance ID)
Z5N076G8YQ
FIDAXOMICIN
RxCUI 1111103
Orange Book
N201699
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": {
"dd966338-c820-4270-b704-09ef75fa3ceb": {
"match": "brand_token",
"title": "DIFICID (FIDAXOMICIN) TABLET, FILM COATED DIFICID (FIDAXOMICIN) GRANULE, FOR SUSPENSION [MERCK SHARP & DOHME LLC]",
"spl_version": "21",
"published_date": "2025-11-17"
}
},
"productid": "52015-080_21c95e9f-0a3d-4fb8-90b5-934bad817d00",
"productndc": "52015-080",
"dosage_form": "TABLET, FILM COATED",
"orange_book": {
"appl_no": "201699",
"products": [
{
"rs": true,
"rld": true,
"te_code": "AB",
"strength": "200MG",
"product_no": "001",
"approval_date": "May 27, 2011"
}
],
"appl_type": "N"
},
"dea_schedule": null,
"product_type": "HUMAN PRESCRIPTION DRUG",
"substance_name": "FIDAXOMICIN",
"proprietary_name": "Dificid",
"active_ingred_unit": "mg/1",
"application_number": "NDA201699",
"marketing_category": "NDA",
"nonproprietary_name": "fidaxomicin",
"start_marketing_date": "20110527",
"active_numerator_strength": "200"
}Related drugs
Other records sharing ATC code A07AA12.
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