dabigatran etexilate

Orange BookUNIISPLATC B01AE07

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

Identification

ManufacturerApotex Corp.

CountryUS (United States)

ATC codeB01AE07

Dispensing—

ReimbursedNo

SourceFDA National Drug Code directory (United States)

Last synced6/3/2026

Packs · 1

ndc11
6050543486
60 CAPSULE in 1 BOTTLE (60505-4348-6)

Annotations

UNII (FDA Substance ID)

SC7NUW5IIT

DABIGATRAN ETEXILATE MESYLATE

RxCUI 1037041

Orange Book

A208070

ABABAB

DailyMed SPL labels

1 version tracked

Raw payload (JSON)

{
  "unii": {
    "unii": "SC7NUW5IIT",
    "rxcui": "1037041",
    "inchikey": "XETBXHPXHHOLOE-UHFFFAOYSA-N",
    "display_name": "DABIGATRAN ETEXILATE MESYLATE",
    "substance_type": "chemical",
    "ingredient_type": "INGREDIENT SUBSTANCE"
  },
  "route": "ORAL",
  "spl_meta": {
    "6f79088b-b353-485a-9df4-6f5088f5bd0f": {
      "match": "brand_token",
      "title": "DABIGATRAN (DABIGATRAN ETEXILATE) CAPSULE [NOVADOZ PHARMACEUTICALS LLC]",
      "spl_version": "4",
      "published_date": "2026-02-09"
    }
  },
  "productid": "60505-4348_34169945-6c2a-c534-5f38-eeafa24cd108",
  "productndc": "60505-4348",
  "dosage_form": "CAPSULE",
  "orange_book": {
    "appl_no": "208070",
    "products": [
      {
        "rs": false,
        "rld": false,
        "te_code": "AB",
        "strength": "EQ 75MG BASE",
        "product_no": "001",
        "approval_date": "Dec 15, 2023"
      },
      {
        "rs": false,
        "rld": false,
        "te_code": "AB",
        "strength": "EQ 110MG BASE",
        "product_no": "002",
        "approval_date": "Dec 15, 2023"
      },
      {
        "rs": false,
        "rld": false,
        "te_code": "AB",
        "strength": "EQ 150MG BASE",
        "product_no": "003",
        "approval_date": "Dec 15, 2023"
      }
    ],
    "appl_type": "A"
  },
  "dea_schedule": null,
  "product_type": "HUMAN PRESCRIPTION DRUG",
  "substance_name": "DABIGATRAN ETEXILATE MESYLATE",
  "proprietary_name": "dabigatran etexilate",
  "active_ingred_unit": "mg/1",
  "application_number": "ANDA208070",
  "marketing_category": "ANDA",
  "nonproprietary_name": "dabigatran etexilate",
  "start_marketing_date": "20240213",
  "active_numerator_strength": "150"
}

Related drugs

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