DABIGATRAN

Orange BookUNIISPLATC B01AE07

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

Identification

ManufacturerAvPAK

CountryUS (United States)

ATC codeB01AE07

Dispensing—

ReimbursedNo

SourceFDA National Drug Code directory (United States)

Last synced6/3/2026

Packs · 1

ndc11
5026820016
60 BLISTER PACK in 1 BOX (50268-200-16) / 1 CAPSULE in 1 BLISTER PACK (50268-200-11)

Annotations

UNII (FDA Substance ID)

SC7NUW5IIT

DABIGATRAN ETEXILATE MESYLATE

RxCUI 1037041

Orange Book

A213879

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": "50268-200_43cbae6c-3c71-51aa-e063-6394a90a6d9a",
  "productndc": "50268-200",
  "dosage_form": "CAPSULE",
  "orange_book": {
    "appl_no": "213879",
    "products": [
      {
        "rs": false,
        "rld": false,
        "te_code": "AB",
        "strength": "EQ 75MG BASE",
        "product_no": "001",
        "approval_date": "May 22, 2024"
      },
      {
        "rs": false,
        "rld": false,
        "te_code": "AB",
        "strength": "EQ 150MG BASE",
        "product_no": "002",
        "approval_date": "May 22, 2024"
      },
      {
        "rs": false,
        "rld": false,
        "te_code": "AB",
        "strength": "EQ 110MG BASE",
        "product_no": "003",
        "approval_date": "Aug 12, 2024"
      }
    ],
    "appl_type": "A"
  },
  "dea_schedule": null,
  "product_type": "HUMAN PRESCRIPTION DRUG",
  "substance_name": "DABIGATRAN ETEXILATE MESYLATE",
  "proprietary_name": "DABIGATRAN",
  "active_ingred_unit": "mg/1",
  "application_number": "ANDA213879",
  "marketing_category": "ANDA",
  "nonproprietary_name": "DABIGATRAN ETEXILATE",
  "start_marketing_date": "20250712",
  "active_numerator_strength": "150"
}

Related drugs

Other records sharing ATC code B01AE07.

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