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United States · US · US:50090-2445_ea4a4cc3-d11c-46d6-aa97-d65eef8406dd

XIFAXAN

Orange BookUNIISPLATC D06AX11

Last synced from FDA National Drug Code directory (United States) on

Identification

ManufacturerA-S Medication Solutions
CountryUS (United States)
ATC codeD06AX11
Dispensing
ReimbursedNo
SourceFDA National Drug Code directory (United States)
Last synced6/3/2026

Packs · 1

  • ndc11
    5009024450
    9 TABLET in 1 BOTTLE (50090-2445-0)

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": "50090-2445_ea4a4cc3-d11c-46d6-aa97-d65eef8406dd",
  "productndc": "50090-2445",
  "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"
}

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