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United States · US · US:50090-3625_555f1ee6-225c-4834-b936-cdad8f836f81

Xarelto

Orange BookUNIISPLATC B01AF01

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

Identification

ManufacturerA-S Medication Solutions
CountryUS (United States)
ATC codeB01AF01
Dispensing
ReimbursedNo
SourceFDA National Drug Code directory (United States)
Last synced6/3/2026

Packs · 2

  • ndc11
    5009036250
    90 TABLET, FILM COATED in 1 BOTTLE (50090-3625-0)
  • ndc11
    5009036251
    12 TABLET, FILM COATED in 1 BOTTLE (50090-3625-1)

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": "50090-3625_555f1ee6-225c-4834-b936-cdad8f836f81",
  "productndc": "50090-3625",
  "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": "20110701",
  "active_numerator_strength": "10"
}

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