Dabigatran Etexilate

Orange BookUNIISPLATC B01AE07

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

Identification

ManufacturerA-S Medication Solutions

CountryUS (United States)

ATC codeB01AE07

Dispensing—

ReimbursedNo

SourceFDA National Drug Code directory (United States)

Last synced6/3/2026

Packs · 1

ndc11
5009076570
60 CAPSULE, COATED PELLETS in 1 BOTTLE (50090-7657-0)

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": "50090-7657_18170616-bb47-48f0-b693-17de14a3c970",
  "productndc": "50090-7657",
  "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

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