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United States · US · US:65649-301_b2e9bb84-e97e-4e7e-8a23-425418b4374d
XIFAXAN
Orange BookUNIISPLATC D06AX11
Last synced from FDA National Drug Code directory (United States) on
Identification
ManufacturerSalix Pharmaceuticals, Inc.
CountryUS (United States)
ATC codeD06AX11
Dispensing—
ReimbursedNo
SourceFDA National Drug Code directory (United States)
Last synced6/3/2026
Packs · 1
- ndc11656493010330 TABLET in 1 BOTTLE (65649-301-03)
Annotations
UNII (FDA Substance ID)
L36O5T016N
RIFAXIMIN
RxCUI 35619
Orange Book
N021361
AB
DailyMed SPL labels
1 version tracked
Raw payload (JSON)
{
"unii": {
"unii": "L36O5T016N",
"rxcui": "35619",
"inchikey": "NZCRJKRKKOLAOJ-XRCRFVBUSA-N",
"display_name": "RIFAXIMIN",
"substance_type": "chemical",
"ingredient_type": "INGREDIENT SUBSTANCE"
},
"route": "ORAL",
"spl_meta": {
"c5e8e2fd-7087-4b78-9181-cc259c0be2f1": {
"match": "brand_token",
"title": "XIFAXAN (RIFAXIMIN) TABLET [SALIX PHARMACEUTICALS, INC.]",
"spl_version": "50",
"published_date": "2026-01-07"
}
},
"productid": "65649-301_b2e9bb84-e97e-4e7e-8a23-425418b4374d",
"productndc": "65649-301",
"dosage_form": "TABLET",
"orange_book": {
"appl_no": "021361",
"products": [
{
"rs": true,
"rld": true,
"te_code": null,
"strength": "200MG",
"product_no": "001",
"approval_date": "May 25, 2004"
},
{
"rs": true,
"rld": true,
"te_code": "AB",
"strength": "550MG",
"product_no": "002",
"approval_date": "Mar 24, 2010"
}
],
"appl_type": "N"
},
"dea_schedule": null,
"product_type": "HUMAN PRESCRIPTION DRUG",
"substance_name": "RIFAXIMIN",
"proprietary_name": "XIFAXAN",
"active_ingred_unit": "mg/1",
"application_number": "NDA021361",
"marketing_category": "NDA",
"nonproprietary_name": "rifaximin",
"start_marketing_date": "20040725",
"active_numerator_strength": "200"
}Related drugs
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