ELIQUIS

Orange BookUNIISPLATC B01AF02

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

Identification

ManufacturerAphena Pharma Solutions - Tennessee, LLC

CountryUS (United States)

ATC codeB01AF02

Dispensing—

ReimbursedNo

SourceFDA National Drug Code directory (United States)

Last synced6/3/2026

Packs · 3

ndc11
7161081142
1800 TABLET, FILM COATED in 1 BOTTLE (71610-811-42)
ndc11
7161081180
180 TABLET, FILM COATED in 1 BOTTLE (71610-811-80)
ndc11
7161081183
3600 TABLET, FILM COATED in 1 BOTTLE (71610-811-83)

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": "71610-811_2d3e63c1-62ea-0c12-e063-6394a90aa931",
  "productndc": "71610-811",
  "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": "2.5"
}

Related drugs

Other records sharing ATC code B01AF02.

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