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United States · US · US:50090-6454_d32cc824-92b9-4b7e-969f-181b7f5d815d

ELIQUIS

Orange BookUNIISPLATC B01AF02

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

Identification

ManufacturerA-S Medication Solutions
CountryUS (United States)
ATC codeB01AF02
Dispensing
ReimbursedNo
SourceFDA National Drug Code directory (United States)
Last synced6/3/2026

Packs · 1

  • ndc11
    5009064540
    60 TABLET, FILM COATED in 1 BOTTLE, PLASTIC (50090-6454-0)

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": "50090-6454_d32cc824-92b9-4b7e-969f-181b7f5d815d",
  "productndc": "50090-6454",
  "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"
}

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