Dabigatran Etexilate

Orange BookUNIISPLATC B01AE07

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

Identification

ManufacturerAscend Laboratories, LLC

CountryUS (United States)

ATC codeB01AE07

Dispensing—

ReimbursedNo

SourceFDA National Drug Code directory (United States)

Last synced6/3/2026

Packs · 1

ndc11
6787747560
60 CAPSULE, COATED PELLETS in 1 BOTTLE (67877-475-60)

Annotations

UNII (FDA Substance ID)

SC7NUW5IIT

DABIGATRAN ETEXILATE MESYLATE

RxCUI 1037041

Orange Book

A208040

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": "67877-475_dd84fc7b-8d68-4a2b-ab48-9458f6586160",
  "productndc": "67877-475",
  "dosage_form": "CAPSULE, COATED PELLETS",
  "orange_book": {
    "appl_no": "208040",
    "products": [
      {
        "rs": false,
        "rld": false,
        "te_code": "AB",
        "strength": "EQ 75MG BASE",
        "product_no": "001",
        "approval_date": "Mar 11, 2020"
      },
      {
        "rs": false,
        "rld": false,
        "te_code": "AB",
        "strength": "EQ 150MG BASE",
        "product_no": "002",
        "approval_date": "Mar 11, 2020"
      },
      {
        "rs": false,
        "rld": false,
        "te_code": "AB",
        "strength": "EQ 110MG BASE",
        "product_no": "003",
        "approval_date": "Sep 11, 2024"
      }
    ],
    "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": "ANDA208040",
  "marketing_category": "ANDA",
  "nonproprietary_name": "Dabigatran Etexilate",
  "start_marketing_date": "20220620",
  "active_numerator_strength": "150"
}

Related drugs

Other records sharing ATC code B01AE07.

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