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United States · US · US:14445-150_6a6e421b-6ed3-403c-b07d-09dbbd6a487c

apixaban

Orange BookUNIISPLATC B01AF02

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

Identification

ManufacturerIndoco Remedies Limited
CountryUS (United States)
ATC codeB01AF02
Dispensing
ReimbursedNo
SourceFDA National Drug Code directory (United States)
Last synced6/3/2026

Packs · 4

  • ndc11
    1444515005
    500 TABLET, FILM COATED in 1 BOTTLE (14445-150-05)
  • ndc11
    1444515010
    10 TABLET, FILM COATED in 1 BLISTER PACK (14445-150-10)
  • ndc11
    1444515018
    180 TABLET, FILM COATED in 1 BOTTLE (14445-150-18)
  • ndc11
    1444515060
    60 TABLET, FILM COATED in 1 BOTTLE (14445-150-60)

Annotations

UNII (FDA Substance ID)
3Z9Y7UWC1J
APIXABAN
RxCUI 1364430
Orange Book
A209898
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": {
    "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": "14445-150_6a6e421b-6ed3-403c-b07d-09dbbd6a487c",
  "productndc": "14445-150",
  "dosage_form": "TABLET, FILM COATED",
  "orange_book": {
    "appl_no": "209898",
    "products": [
      {
        "rs": false,
        "rld": false,
        "te_code": "AB",
        "strength": "2.5MG",
        "product_no": "001",
        "approval_date": "Sep 11, 2020"
      },
      {
        "rs": false,
        "rld": false,
        "te_code": "AB",
        "strength": "5MG",
        "product_no": "002",
        "approval_date": "Sep 11, 2020"
      }
    ],
    "appl_type": "A"
  },
  "dea_schedule": null,
  "product_type": "HUMAN PRESCRIPTION DRUG",
  "substance_name": "APIXABAN",
  "proprietary_name": "apixaban",
  "active_ingred_unit": "mg/1",
  "application_number": "ANDA209898",
  "marketing_category": "ANDA",
  "nonproprietary_name": "apixaban",
  "start_marketing_date": "20200916",
  "active_numerator_strength": "5"
}

Related drugs

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