Xarelto

Orange BookUNIISPLATC B01AF01

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

Identification

ManufacturerJanssen Pharmaceuticals, Inc.

CountryUS (United States)

ATC codeB01AF01

Dispensing—

ReimbursedNo

SourceFDA National Drug Code directory (United States)

Last synced6/3/2026

Packs · 4

ndc11
5045857807
7 TABLET, FILM COATED in 1 BOTTLE (50458-578-07)
ndc11
5045857810
10 BLISTER PACK in 1 CARTON (50458-578-10) / 10 TABLET, FILM COATED in 1 BLISTER PACK (50458-578-01)
ndc11
5045857830
30 TABLET, FILM COATED in 1 BOTTLE (50458-578-30)
ndc11
5045857890
90 TABLET, FILM COATED in 1 BOTTLE (50458-578-90)

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": "50458-578_452610f0-5abb-448d-a1fc-9dd9be02bb66",
  "productndc": "50458-578",
  "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"
}

Related drugs

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