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United States · US · US:0378-0265_6c6b985e-111f-4fe9-a1ca-785c450e444b
Dabigatran Etexilate
Orange BookUNIISPLATC B01AE07
Last synced from FDA National Drug Code directory (United States) on
Identification
ManufacturerMylan Pharmaceuticals Inc.
CountryUS (United States)
ATC codeB01AE07
Dispensing—
ReimbursedNo
SourceFDA National Drug Code directory (United States)
Last synced6/3/2026
Packs · 1
- ndc11037802659160 CAPSULE in 1 BOTTLE, PLASTIC (0378-0265-91)
Annotations
UNII (FDA Substance ID)
SC7NUW5IIT
DABIGATRAN ETEXILATE MESYLATE
RxCUI 1037041
Orange Book
A208067
ABAB
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": "0378-0265_6c6b985e-111f-4fe9-a1ca-785c450e444b",
"productndc": "0378-0265",
"dosage_form": "CAPSULE",
"orange_book": {
"appl_no": "208067",
"products": [
{
"rs": false,
"rld": false,
"te_code": "AB",
"strength": "EQ 75MG BASE",
"product_no": "001",
"approval_date": "Feb 3, 2025"
},
{
"rs": false,
"rld": false,
"te_code": "AB",
"strength": "EQ 150MG BASE",
"product_no": "002",
"approval_date": "Feb 3, 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": "ANDA208067",
"marketing_category": "ANDA",
"nonproprietary_name": "Dabigatran Etexilate",
"start_marketing_date": "20250225",
"active_numerator_strength": "75"
}Related drugs
Other records sharing ATC code B01AE07.
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