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United States · US · US:62332-635_7057c0da-54c3-4021-a4de-e948a7684dc2
Dabigatran Etexilate
Orange BookUNIISPLATC B01AE07
Last synced from FDA National Drug Code directory (United States) on
Identification
ManufacturerAlembic Pharmaceuticals Inc.
CountryUS (United States)
ATC codeB01AE07
Dispensing—
ReimbursedNo
SourceFDA National Drug Code directory (United States)
Last synced6/3/2026
Packs · 2
- ndc11623326350610 BLISTER PACK in 1 CARTON (62332-635-06) / 6 CAPSULE in 1 BLISTER PACK
- ndc11623326356060 CAPSULE in 1 BOTTLE (62332-635-60)
Annotations
UNII (FDA Substance ID)
SC7NUW5IIT
DABIGATRAN ETEXILATE MESYLATE
RxCUI 1037041
Orange Book
A215233
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": "62332-635_7057c0da-54c3-4021-a4de-e948a7684dc2",
"productndc": "62332-635",
"dosage_form": "CAPSULE",
"orange_book": {
"appl_no": "215233",
"products": [
{
"rs": false,
"rld": false,
"te_code": "AB",
"strength": "EQ 75MG BASE",
"product_no": "001",
"approval_date": "Jun 14, 2024"
},
{
"rs": false,
"rld": false,
"te_code": "AB",
"strength": "EQ 150MG BASE",
"product_no": "002",
"approval_date": "Jun 14, 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 Etexilate",
"active_ingred_unit": "mg/1",
"application_number": "ANDA215233",
"marketing_category": "ANDA",
"nonproprietary_name": "Dabigatran Etexilate",
"start_marketing_date": "20240813",
"active_numerator_strength": "110"
}Related drugs
Other records sharing ATC code B01AE07.
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