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United States · US · US:72205-203_50fb8204-a087-4f97-ab57-85773b8c0065
DABIGATRAN
Orange BookUNIISPLATC B01AE07
Last synced from FDA National Drug Code directory (United States) on
Identification
ManufacturerNovadoz Pharmaceuticals LLC
CountryUS (United States)
ATC codeB01AE07
Dispensing—
ReimbursedNo
SourceFDA National Drug Code directory (United States)
Last synced6/3/2026
Packs · 2
- ndc1172205203346 BLISTER PACK in 1 CARTON (72205-203-34) / 10 CAPSULE in 1 BLISTER PACK
- ndc11722052036060 CAPSULE in 1 BOTTLE (72205-203-60)
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": "72205-203_50fb8204-a087-4f97-ab57-85773b8c0065",
"productndc": "72205-203",
"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": "20240812",
"active_numerator_strength": "110"
}Related drugs
Other records sharing ATC code B01AE07.
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