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United States · US · US:0597-0355_ecf1aa06-c610-4fdb-a380-2e716d7e63c2
Pradaxa
Orange BookUNIISPLATC B01AE07
Last synced from FDA National Drug Code directory (United States) on
Identification
ManufacturerBoehringer Ingelheim Pharmaceuticals Inc.
CountryUS (United States)
ATC codeB01AE07
Dispensing—
ReimbursedNo
SourceFDA National Drug Code directory (United States)
Last synced6/3/2026
Packs · 2
- ndc1105970355091 BOTTLE in 1 CARTON (0597-0355-09) / 60 CAPSULE in 1 BOTTLE
- ndc11059703555660 BLISTER PACK in 1 CARTON (0597-0355-56) / 1 CAPSULE in 1 BLISTER PACK
Annotations
UNII (FDA Substance ID)
SC7NUW5IIT
DABIGATRAN ETEXILATE MESYLATE
RxCUI 1037041
Orange Book
N022512
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": {
"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": "0597-0355_ecf1aa06-c610-4fdb-a380-2e716d7e63c2",
"productndc": "0597-0355",
"dosage_form": "CAPSULE",
"orange_book": {
"appl_no": "022512",
"products": [
{
"rs": false,
"rld": true,
"te_code": "AB",
"strength": "EQ 75MG BASE",
"product_no": "001",
"approval_date": "Oct 19, 2010"
},
{
"rs": true,
"rld": true,
"te_code": "AB",
"strength": "EQ 150MG BASE",
"product_no": "002",
"approval_date": "Oct 19, 2010"
},
{
"rs": false,
"rld": true,
"te_code": "AB",
"strength": "EQ 110MG BASE",
"product_no": "003",
"approval_date": "Nov 20, 2015"
}
],
"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": "NDA022512",
"marketing_category": "NDA",
"nonproprietary_name": "dabigatran etexilate mesylate",
"start_marketing_date": "20110808",
"active_numerator_strength": "75"
}Related drugs
Other records sharing ATC code B01AE07.
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