Rivaroxaban

Orange BookUNIISPLATC B01AF01

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

Identification

ManufacturerAurobindo Pharma Limited

CountryUS (United States)

ATC codeB01AF01

Dispensing—

ReimbursedNo

SourceFDA National Drug Code directory (United States)

Last synced6/3/2026

Packs · 2

ndc11
5965184918
180 TABLET, FILM COATED in 1 BOTTLE (59651-849-18)
ndc11
5965184960
60 TABLET, FILM COATED in 1 BOTTLE (59651-849-60)

Annotations

UNII (FDA Substance ID)

9NDF7JZ4M3

RIVAROXABAN

RxCUI 1114195

Orange Book

A208544

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": "59651-849_41ba542b-b8da-4a6e-a39e-284fd6314627",
  "productndc": "59651-849",
  "dosage_form": "TABLET, FILM COATED",
  "orange_book": {
    "appl_no": "208544",
    "products": [
      {
        "rs": false,
        "rld": false,
        "te_code": "AB",
        "strength": "2.5MG",
        "product_no": "001",
        "approval_date": "Apr 10, 2025"
      },
      {
        "rs": false,
        "rld": false,
        "te_code": "AB",
        "strength": "10MG",
        "product_no": "002",
        "approval_date": "May 15, 2025"
      },
      {
        "rs": false,
        "rld": false,
        "te_code": "AB",
        "strength": "15MG",
        "product_no": "003",
        "approval_date": "May 15, 2025"
      },
      {
        "rs": false,
        "rld": false,
        "te_code": "AB",
        "strength": "20MG",
        "product_no": "004",
        "approval_date": "May 15, 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": "ANDA208544",
  "marketing_category": "ANDA",
  "nonproprietary_name": "Rivaroxaban",
  "start_marketing_date": "20250410",
  "active_numerator_strength": "2.5"
}

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