Rivaroxaban

Orange BookUNIISPLATC B01AF01

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

Identification

ManufacturerIndoco Remedies Limited

CountryUS (United States)

ATC codeB01AF01

Dispensing—

ReimbursedNo

SourceFDA National Drug Code directory (United States)

Last synced6/3/2026

Packs · 4

ndc11
1444518400
1000 TABLET, FILM COATED in 1 BOTTLE (14445-184-00)
ndc11
1444518410
10 BLISTER PACK in 1 CARTON (14445-184-10) / 10 TABLET, FILM COATED in 1 BLISTER PACK (14445-184-02)
ndc11
1444518430
30 TABLET, FILM COATED in 1 BOTTLE (14445-184-30)
ndc11
1444518490
90 TABLET, FILM COATED in 1 BOTTLE (14445-184-90)

Annotations

UNII (FDA Substance ID)

9NDF7JZ4M3

RIVAROXABAN

RxCUI 1114195

Orange Book

A218445

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": "14445-184_b57414a3-eca8-4cda-b7eb-7c060d52a6b6",
  "productndc": "14445-184",
  "dosage_form": "TABLET, FILM COATED",
  "orange_book": {
    "appl_no": "218445",
    "products": [
      {
        "rs": false,
        "rld": false,
        "te_code": "AB",
        "strength": "2.5MG",
        "product_no": "001",
        "approval_date": "Aug 11, 2025"
      },
      {
        "rs": false,
        "rld": false,
        "te_code": "AB",
        "strength": "10MG",
        "product_no": "002",
        "approval_date": "Aug 11, 2025"
      },
      {
        "rs": false,
        "rld": false,
        "te_code": "AB",
        "strength": "15MG",
        "product_no": "003",
        "approval_date": "Aug 11, 2025"
      },
      {
        "rs": false,
        "rld": false,
        "te_code": "AB",
        "strength": "20MG",
        "product_no": "004",
        "approval_date": "Aug 11, 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": "ANDA218445",
  "marketing_category": "ANDA",
  "nonproprietary_name": "Rivaroxaban",
  "start_marketing_date": "20250811",
  "active_numerator_strength": "20"
}

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