XIFAXAN

Orange BookUNIISPLATC D06AX11

Last synced from FDA National Drug Code directory (United States) on June 3, 2026

Identification

ManufacturerSalix Pharmaceuticals, Inc.

CountryUS (United States)

ATC codeD06AX11

Dispensing—

ReimbursedNo

SourceFDA National Drug Code directory (United States)

Last synced6/3/2026

Packs · 4

ndc11
6564930301
3 CARTON in 1 TRAY (65649-303-01) / 1 BLISTER PACK in 1 CARTON / 2 TABLET in 1 BLISTER PACK
ndc11
6564930302
60 TABLET in 1 BOTTLE (65649-303-02)
ndc11
6564930303
6 BLISTER PACK in 1 CARTON (65649-303-03) / 10 TABLET in 1 BLISTER PACK
ndc11
6564930305
3 CARTON in 1 TRAY (65649-303-05) / 1 BLISTER PACK in 1 CARTON / 3 TABLET in 1 BLISTER PACK

Annotations

UNII (FDA Substance ID)

L36O5T016N

RIFAXIMIN

RxCUI 35619

Orange Book

N021361

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": "65649-303_b2e9bb84-e97e-4e7e-8a23-425418b4374d",
  "productndc": "65649-303",
  "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": "20100501",
  "active_numerator_strength": "550"
}

Related drugs

Other records sharing ATC code D06AX11.

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