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United States · US · US:55154-0613_35ab1342-e927-4bd0-9020-628b859dfb38

ELIQUIS

Orange BookUNIISPLATC B01AF02

Last synced from FDA National Drug Code directory (United States) on

Identification

ManufacturerCardinal Health 107, LLC
CountryUS (United States)
ATC codeB01AF02
Dispensing
ReimbursedNo
SourceFDA National Drug Code directory (United States)
Last synced6/3/2026

Packs · 2

  • ndc11
    5515406130
    10 BLISTER PACK in 1 BAG (55154-0613-0) / 1 TABLET, FILM COATED in 1 BLISTER PACK
  • ndc11
    5515406138
    2040 TABLET, FILM COATED in 1 BOTTLE, PLASTIC (55154-0613-8)

Annotations

UNII (FDA Substance ID)
3Z9Y7UWC1J
APIXABAN
RxCUI 1364430
Orange Book
N202155
ABAB
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": {
    "a454cd24-0c6d-46e8-b1e4-197388606175": {
      "match": "brand_token",
      "title": "ELIQUIS (APIXABAN) TABLET, FILM COATED [CARDINAL HEALTH 107, LLC]",
      "spl_version": "38",
      "published_date": "2026-05-04"
    }
  },
  "productid": "55154-0613_35ab1342-e927-4bd0-9020-628b859dfb38",
  "productndc": "55154-0613",
  "dosage_form": "TABLET, FILM COATED",
  "orange_book": {
    "appl_no": "202155",
    "products": [
      {
        "rs": false,
        "rld": true,
        "te_code": "AB",
        "strength": "2.5MG",
        "product_no": "001",
        "approval_date": "Dec 28, 2012"
      },
      {
        "rs": true,
        "rld": true,
        "te_code": "AB",
        "strength": "5MG",
        "product_no": "002",
        "approval_date": "Dec 28, 2012"
      },
      {
        "rs": true,
        "rld": true,
        "te_code": null,
        "strength": "0.5MG",
        "product_no": "003",
        "approval_date": "Apr 17, 2025"
      }
    ],
    "appl_type": "N"
  },
  "dea_schedule": null,
  "product_type": "HUMAN PRESCRIPTION DRUG",
  "substance_name": "APIXABAN",
  "proprietary_name": "ELIQUIS",
  "active_ingred_unit": "mg/1",
  "application_number": "NDA202155",
  "marketing_category": "NDA",
  "nonproprietary_name": "apixaban",
  "start_marketing_date": "20121228",
  "active_numerator_strength": "5"
}

Related drugs

Other records sharing ATC code B01AF02.

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