🇺🇸
United States · US · US:52015-700_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
- ndc1152015700221 POUCH in 1 CARTON (52015-700-22) / 1 BOTTLE, GLASS in 1 POUCH (52015-700-23) / 150 mL in 1 BOTTLE, GLASS (52015-700-21)
Annotations
UNII (FDA Substance ID)
Z5N076G8YQ
FIDAXOMICIN
RxCUI 1111103
Orange Book
N213138
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": "52015-700_21c95e9f-0a3d-4fb8-90b5-934bad817d00",
"productndc": "52015-700",
"dosage_form": "GRANULE, FOR SUSPENSION",
"orange_book": {
"appl_no": "213138",
"products": [
{
"rs": true,
"rld": true,
"te_code": null,
"strength": "40MG/ML",
"product_no": "001",
"approval_date": "Jan 24, 2020"
}
],
"appl_type": "N"
},
"dea_schedule": null,
"product_type": "HUMAN PRESCRIPTION DRUG",
"substance_name": "FIDAXOMICIN",
"proprietary_name": "DIFICID",
"active_ingred_unit": "mg/5mL",
"application_number": "NDA213138",
"marketing_category": "NDA",
"nonproprietary_name": "FIDAXOMICIN",
"start_marketing_date": "20200218",
"active_numerator_strength": "200"
}Related drugs
Other records sharing ATC code A07AA12.
Access this data programmatically
Query DIFICID and 610,000+ other drug records through a single REST API — with a last_synced_at provenance stamp on every response. Free tier includes 100 requests/day.