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United States · US · US:55154-1424_fcb2aab9-1150-4d49-baf7-d03e0551d3c3

Xarelto

Orange BookUNIISPLATC B01AF01

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

Identification

ManufacturerCardinal Health 107, LLC
CountryUS (United States)
ATC codeB01AF01
Dispensing
ReimbursedNo
SourceFDA National Drug Code directory (United States)
Last synced6/3/2026

Packs · 1

  • ndc11
    5515414248
    2070 TABLET, FILM COATED in 1 BOTTLE, PLASTIC (55154-1424-8)

Annotations

UNII (FDA Substance ID)
9NDF7JZ4M3
RIVAROXABAN
RxCUI 1114195
Orange Book
N022406
ABABABAB
DailyMed SPL labels
1 version tracked
Raw payload (JSON)
{
  "unii": {
    "unii": "9NDF7JZ4M3",
    "rxcui": "1114195",
    "inchikey": "KGFYHTZWPPHNLQ-AWEZNQCLSA-N",
    "display_name": "RIVAROXABAN",
    "substance_type": "chemical",
    "ingredient_type": "INGREDIENT SUBSTANCE"
  },
  "route": "ORAL",
  "spl_meta": {
    "10db92f9-2300-4a80-836b-673e1ae91610": {
      "match": "brand_token",
      "title": "XARELTO (RIVAROXABAN) TABLET, FILM COATED XARELTO (RIVAROXABAN) TABLET, FILM COATED XARELTO (RIVAROXABAN) KIT XARELTO (RIVAROXABAN) GRANULE, FOR SUSPENSION [JANSSEN PHARMACEUTICALS, INC.]",
      "spl_version": "64",
      "published_date": "2026-04-06"
    }
  },
  "productid": "55154-1424_fcb2aab9-1150-4d49-baf7-d03e0551d3c3",
  "productndc": "55154-1424",
  "dosage_form": "TABLET, FILM COATED",
  "orange_book": {
    "appl_no": "022406",
    "products": [
      {
        "rs": false,
        "rld": true,
        "te_code": "AB",
        "strength": "10MG",
        "product_no": "001",
        "approval_date": "Jul 1, 2011"
      },
      {
        "rs": false,
        "rld": true,
        "te_code": "AB",
        "strength": "15MG",
        "product_no": "002",
        "approval_date": "Nov 4, 2011"
      },
      {
        "rs": true,
        "rld": true,
        "te_code": "AB",
        "strength": "20MG",
        "product_no": "003",
        "approval_date": "Nov 4, 2011"
      },
      {
        "rs": false,
        "rld": true,
        "te_code": "AB",
        "strength": "2.5MG",
        "product_no": "004",
        "approval_date": "Oct 11, 2018"
      }
    ],
    "appl_type": "N"
  },
  "dea_schedule": null,
  "product_type": "HUMAN PRESCRIPTION DRUG",
  "substance_name": "RIVAROXABAN",
  "proprietary_name": "Xarelto",
  "active_ingred_unit": "mg/1",
  "application_number": "NDA022406",
  "marketing_category": "NDA",
  "nonproprietary_name": "rivaroxaban",
  "start_marketing_date": "20111104",
  "active_numerator_strength": "15"
}

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