ELIQUIS

Orange BookUNIISPLATC B01AF02

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

Identification

ManufacturerProficient Rx LP

CountryUS (United States)

ATC codeB01AF02

Dispensing—

ReimbursedNo

SourceFDA National Drug Code directory (United States)

Last synced6/3/2026

Packs · 2

ndc11
8280408530
30 TABLET, FILM COATED in 1 BOTTLE, PLASTIC (82804-085-30)
ndc11
8280408531
3 BLISTER PACK in 1 BAG (82804-085-31) / 10 TABLET, FILM COATED in 1 BLISTER PACK

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": "82804-085_1d796c29-7ed2-407f-abdd-7d2cc4c80e83",
  "productndc": "82804-085",
  "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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