Pradaxa

Orange BookUNIISPLATC B01AE07

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

Identification

ManufacturerBoehringer Ingelheim Pharmaceuticals, Inc.

CountryUS (United States)

ATC codeB01AE07

Dispensing—

ReimbursedNo

SourceFDA National Drug Code directory (United States)

Last synced6/3/2026

Packs · 1

ndc11
0597042578
1 BAG in 1 CARTON (0597-0425-78) / 60 PELLET in 1 BAG

Annotations

UNII (FDA Substance ID)

SC7NUW5IIT

DABIGATRAN ETEXILATE MESYLATE

RxCUI 1037041

Orange Book

N214358

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": {
    "9ac0a64a-8666-45f7-9d4f-40fd894f7e6d": {
      "match": "brand_token",
      "title": "PRADAXA (DABIGATRAN ETEXILATE) PELLET [BOEHRINGER INGELHEIM PHARMACEUTICALS, INC.]",
      "spl_version": "7",
      "published_date": "2025-07-02"
    }
  },
  "productid": "0597-0425_56b1a7c2-0afd-40c6-bda5-563e234a9f28",
  "productndc": "0597-0425",
  "dosage_form": "PELLET",
  "orange_book": {
    "appl_no": "214358",
    "products": [
      {
        "rs": false,
        "rld": true,
        "te_code": null,
        "strength": "EQ 20MG BASE/PACKET",
        "product_no": "001",
        "approval_date": "Jun 21, 2021"
      },
      {
        "rs": false,
        "rld": true,
        "te_code": null,
        "strength": "EQ 30MG BASE/PACKET",
        "product_no": "002",
        "approval_date": "Jun 21, 2021"
      },
      {
        "rs": false,
        "rld": true,
        "te_code": null,
        "strength": "EQ 40MG BASE/PACKET",
        "product_no": "003",
        "approval_date": "Jun 21, 2021"
      },
      {
        "rs": false,
        "rld": true,
        "te_code": null,
        "strength": "EQ 50MG BASE/PACKET",
        "product_no": "004",
        "approval_date": "Jun 21, 2021"
      },
      {
        "rs": false,
        "rld": true,
        "te_code": null,
        "strength": "EQ 110MG BASE/PACKET",
        "product_no": "005",
        "approval_date": "Jun 21, 2021"
      },
      {
        "rs": true,
        "rld": true,
        "te_code": null,
        "strength": "EQ 150MG BASE/PACKET",
        "product_no": "006",
        "approval_date": "Jun 21, 2021"
      }
    ],
    "appl_type": "N"
  },
  "dea_schedule": null,
  "product_type": "HUMAN PRESCRIPTION DRUG",
  "substance_name": "DABIGATRAN ETEXILATE MESYLATE",
  "proprietary_name": "Pradaxa",
  "active_ingred_unit": "mg/1",
  "application_number": "NDA214358",
  "marketing_category": "NDA",
  "nonproprietary_name": "dabigatran etexilate",
  "start_marketing_date": "20220316",
  "active_numerator_strength": "20"
}

Related drugs

Other records sharing ATC code B01AE07.

Access this data programmatically

Query Pradaxa and 610,000+ other drug records through a single REST API — with a last_synced_at provenance stamp on every response. Free tier includes 100 requests/day.

Get a free API key Read the API docs