XARELTO

Orange BookSPL

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

Identification

ManufacturerJanssen Pharmaceuticals, Inc.

CountryUS (United States)

ATC code—

Dispensing—

ReimbursedNo

SourceFDA National Drug Code directory (United States)

Last synced6/3/2026

Packs · 2

ndc11
5045858451
1 KIT in 1 CARTON (50458-584-51) * 42 TABLET, FILM COATED in 1 BLISTER PACK * 9 TABLET, FILM COATED in 1 BLISTER PACK
ndc11
5045858452
1 KIT in 1 CARTON (50458-584-52) * 42 TABLET, FILM COATED in 1 BLISTER PACK * 9 TABLET, FILM COATED in 1 BLISTER PACK

Annotations

Orange Book

N022406

ABABABAB

DailyMed SPL labels

1 version tracked

Raw payload (JSON)

{
  "route": null,
  "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": "50458-584_452610f0-5abb-448d-a1fc-9dd9be02bb66",
  "productndc": "50458-584",
  "dosage_form": "KIT",
  "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": null,
  "proprietary_name": "XARELTO",
  "active_ingred_unit": null,
  "application_number": "NDA022406",
  "marketing_category": "NDA",
  "nonproprietary_name": "Rivaroxaban",
  "start_marketing_date": "20140916",
  "active_numerator_strength": null
}

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