FDA.reportPublic FDA data

dabigatran etexilate 75 MG Oral Capsule [Pradaxa]

RxCUI
1037181
RxNorm name
dabigatran etexilate 75 MG Oral Capsule [Pradaxa]
Display name
dabigatran etexilate 75 MG Oral Capsule [Pradaxa]
Full name
dabigatran etexilate 75 MG Oral Capsule [Pradaxa]
Term type
SBD
Status
DailyMed mapping
Updated
2026-06-04 23:39:18

RxNav Current And Historical NDCs#

RxNav current and historical NDC rows page 1 of 1 · 0 matching rows.

No records found.

UNII Substances#

UNII substance links page 1 of 1 · 0 matching rows.

No records found.

openFDA label cross-check#

OpenFDA label data provides additional search and identifier links. DailyMed’s Structured Product Label is the canonical label on FDA.report. Matching records are deduplicated before they are shown below.

Matched openFDA labels page 1 of 1 · 1 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
PradaxaDABIGATRAN ETEXILATE MESYLATEBoehringer Ingelheim Pharmaceuticals Inc.ba74e3cd-b06f-4145-b284-5fd6b84ff3c92025-06-25Boxed warning, Warnings, Adverse reactionsExact identifier
rxcui: 1037181

DailyMed RxNorm Mappings#

unique DailyMed labels mapped to this RxNorm concept page 1 of 1 · 1 matching rows.

Set ID, RxNorm mappings, Terms table
Set IDRxNorm mappingsTermsSPL versionLabelEffective
ba74e3cd-b06f-4145-b284-5fd6b84ff3c9Pradaxa 75 MG Oral Capsule [PSN] · dabigatran etexilate 75 MG Oral Capsule [Pradaxa] [SBD] · Pradaxa 75 MG (as dabigatran etexilate mesylate 86.48 MG) Oral Capsule [SY] · Pradaxa 75 MG Oral Capsule [SY]448These highlights do not include all the information needed to use PRADAXA Capsules safely and effectively. See full prescribing information for PRADAXA Capsules. PRADAXA ® (dabigatran etexilate) capsules, for oral use Initial U.S. Approval: 201020250625