Apixaban

Orange BookUNIISPLATC B01AF02

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

Identification

ManufacturerAmneal Pharmaceuticals of New York LLC

CountryUS (United States)

ATC codeB01AF02

Dispensing—

ReimbursedNo

SourceFDA National Drug Code directory (United States)

Last synced6/3/2026

Packs · 3

ndc11
0115172201
10 BLISTER PACK in 1 CARTON (0115-1722-01) / 10 TABLET, FILM COATED in 1 BLISTER PACK (0115-1722-15)
ndc11
0115172203
1000 TABLET, FILM COATED in 1 BOTTLE, PLASTIC (0115-1722-03)
ndc11
0115172213
60 TABLET, FILM COATED in 1 BOTTLE, PLASTIC (0115-1722-13)

Annotations

UNII (FDA Substance ID)

3Z9Y7UWC1J

APIXABAN

RxCUI 1364430

Orange Book

A209810

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": "0115-1722_ac3db938-22a3-42a0-ac3a-8628d9e0a7cf",
  "productndc": "0115-1722",
  "dosage_form": "TABLET, FILM COATED",
  "orange_book": {
    "appl_no": "209810",
    "products": [
      {
        "rs": false,
        "rld": false,
        "te_code": null,
        "strength": "2.5MG",
        "product_no": "001",
        "approval_date": "Feb 14, 2025"
      },
      {
        "rs": false,
        "rld": false,
        "te_code": null,
        "strength": "5MG",
        "product_no": "002",
        "approval_date": "Feb 14, 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": "ANDA209810",
  "marketing_category": "ANDA",
  "nonproprietary_name": "Apixaban",
  "start_marketing_date": "20180831",
  "active_numerator_strength": "5"
}

Related drugs

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