RIVAROXABAN

Orange BookUNIISPLATC B01AF01

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

Identification

ManufacturerXLCare Pharmaceuticals, Inc.

CountryUS (United States)

ATC codeB01AF01

Dispensing—

ReimbursedNo

SourceFDA National Drug Code directory (United States)

Last synced6/3/2026

Packs · 2

ndc11
7286532118
180 TABLET, FILM COATED in 1 BOTTLE (72865-321-18)
ndc11
7286532160
60 TABLET, FILM COATED in 1 BOTTLE (72865-321-60)

Annotations

UNII (FDA Substance ID)

9NDF7JZ4M3

RIVAROXABAN

RxCUI 1114195

Orange Book

A219332

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": {
    "925a9a11-ae5b-405c-96d2-b1be4b85bf71": {
      "match": "brand_token",
      "title": "RIVAROXABAN TABLET, COATED [SUN PHARMACEUTICAL INDUSTRIES, INC.]",
      "spl_version": "15",
      "published_date": "2026-05-28"
    }
  },
  "productid": "72865-321_a24524f3-072e-4484-b6c8-77c70e4e3005",
  "productndc": "72865-321",
  "dosage_form": "TABLET, FILM COATED",
  "orange_book": {
    "appl_no": "219332",
    "products": [
      {
        "rs": false,
        "rld": false,
        "te_code": "AB",
        "strength": "2.5MG",
        "product_no": "001",
        "approval_date": "May 14, 2025"
      },
      {
        "rs": false,
        "rld": false,
        "te_code": "AB",
        "strength": "10MG",
        "product_no": "002",
        "approval_date": "May 14, 2025"
      },
      {
        "rs": false,
        "rld": false,
        "te_code": "AB",
        "strength": "15MG",
        "product_no": "003",
        "approval_date": "May 14, 2025"
      },
      {
        "rs": false,
        "rld": false,
        "te_code": "AB",
        "strength": "20MG",
        "product_no": "004",
        "approval_date": "May 14, 2025"
      }
    ],
    "appl_type": "A"
  },
  "dea_schedule": null,
  "product_type": "HUMAN PRESCRIPTION DRUG",
  "substance_name": "RIVAROXABAN",
  "proprietary_name": "RIVAROXABAN",
  "active_ingred_unit": "mg/1",
  "application_number": "ANDA219332",
  "marketing_category": "ANDA",
  "nonproprietary_name": "RIVAROXABAN",
  "start_marketing_date": "20251217",
  "active_numerator_strength": "2.5"
}

Related drugs

Other records sharing ATC code B01AF01.

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