Dabigatran etexilate

Orange BookUNIISPLATC B01AE07

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

Identification

ManufacturerDr.Reddys Laboratories Inc

CountryUS (United States)

ATC codeB01AE07

Dispensing—

ReimbursedNo

SourceFDA National Drug Code directory (United States)

Last synced6/3/2026

Packs · 1

ndc11
4359864160
60 CAPSULE in 1 BOTTLE (43598-641-60)

Annotations

UNII (FDA Substance ID)

SC7NUW5IIT

DABIGATRAN ETEXILATE MESYLATE

RxCUI 1037041

Orange Book

A208048

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": "43598-641_e9e8ec3b-2d7e-31cc-6268-60e4da2236ba",
  "productndc": "43598-641",
  "dosage_form": "CAPSULE",
  "orange_book": {
    "appl_no": "208048",
    "products": [
      {
        "rs": false,
        "rld": false,
        "te_code": "AB",
        "strength": "EQ 75MG BASE",
        "product_no": "001",
        "approval_date": "Jan 28, 2025"
      },
      {
        "rs": false,
        "rld": false,
        "te_code": "AB",
        "strength": "EQ 110MG BASE",
        "product_no": "002",
        "approval_date": "Jan 28, 2025"
      },
      {
        "rs": false,
        "rld": false,
        "te_code": "AB",
        "strength": "EQ 150MG BASE",
        "product_no": "003",
        "approval_date": "Jan 28, 2025"
      }
    ],
    "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": "ANDA208048",
  "marketing_category": "ANDA",
  "nonproprietary_name": "Dabigatran etexilate",
  "start_marketing_date": "20250228",
  "active_numerator_strength": "150"
}

Related drugs

Other records sharing ATC code B01AE07.

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