Apixaban

Orange BookUNIISPLATC B01AF02

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

Identification

ManufacturerMacleods Pharmaceuticals Limited

CountryUS (United States)

ATC codeB01AF02

Dispensing—

ReimbursedNo

SourceFDA National Drug Code directory (United States)

Last synced6/3/2026

Packs · 3

ndc11
3334233809
60 TABLET, FILM COATED in 1 BOTTLE (33342-338-09)
ndc11
3334233812
10 BLISTER PACK in 1 CARTON (33342-338-12) / 10 TABLET, FILM COATED in 1 BLISTER PACK
ndc11
3334233815
500 TABLET, FILM COATED in 1 BOTTLE (33342-338-15)

Annotations

UNII (FDA Substance ID)

3Z9Y7UWC1J

APIXABAN

RxCUI 1364430

Orange Book

A210067

DailyMed SPL labels

1 version tracked

Raw payload (JSON)

{
  "unii": {
    "unii": "3Z9Y7UWC1J",
    "rxcui": "1364430",
    "inchikey": "QNZCBYKSOIHPEH-UHFFFAOYSA-N",
    "display_name": "APIXABAN",
    "substance_type": "chemical",
    "ingredient_type": "INGREDIENT SUBSTANCE"
  },
  "route": "ORAL",
  "spl_meta": {
    "396912c0-9f68-47ed-ba3f-8d9ace755a48": {
      "match": "brand_token",
      "title": "APIXABAN TABLET, FILM COATED [MACLEODS PHARMACEUTICALS LIMITED]",
      "spl_version": "1",
      "published_date": "2025-04-28"
    }
  },
  "productid": "33342-338_396912c0-9f68-47ed-ba3f-8d9ace755a48",
  "productndc": "33342-338",
  "dosage_form": "TABLET, FILM COATED",
  "orange_book": {
    "appl_no": "210067",
    "products": [
      {
        "rs": false,
        "rld": false,
        "te_code": null,
        "strength": "2.5MG",
        "product_no": "001",
        "approval_date": "Feb 27, 2025"
      },
      {
        "rs": false,
        "rld": false,
        "te_code": null,
        "strength": "5MG",
        "product_no": "002",
        "approval_date": "Feb 27, 2025"
      }
    ],
    "appl_type": "A"
  },
  "dea_schedule": null,
  "product_type": "HUMAN PRESCRIPTION DRUG",
  "substance_name": "APIXABAN",
  "proprietary_name": "Apixaban",
  "active_ingred_unit": "mg/1",
  "application_number": "ANDA210067",
  "marketing_category": "ANDA",
  "nonproprietary_name": "Apixaban",
  "start_marketing_date": "20250227",
  "active_numerator_strength": "5"
}

Related drugs

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