FDA.reportPublic FDA data

dabigatran etexilate 40 MG Oral Pellet

RxCUI
2590631
RxNorm name
dabigatran etexilate 40 MG Oral Pellet
Display name
dabigatran etexilate 40 MG Oral Pellet
Full name
dabigatran etexilate 40 MG Oral Pellet
Term type
SCD
Status
DailyMed mapping
Updated
2026-06-04 23:39:10

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 ETEXILATEBoehringer Ingelheim Pharmaceuticals, Inc.9ac0a64a-8666-45f7-9d4f-40fd894f7e6d2025-06-27Boxed warning, Warnings, Adverse reactionsExact identifier
rxcui: 2590631

DailyMed RxNorm Mappings#

Set ID, RxNorm string, TTY table
Set IDRxNorm stringTTYSPL versionLabelEffective
9ac0a64a-8666-45f7-9d4f-40fd894f7e6ddabigatran etexilate 40 MG Oral PelletSCD7These highlights do not include all the information needed to use PRADAXA Oral Pellets safely and effectively. See full prescribing information for PRADAXA Oral Pellets. PRADAXA ® (dabigatran etexilate) oral pellets Initial U.S. Approval: 201020250627
9ac0a64a-8666-45f7-9d4f-40fd894f7e6ddabigatran etexilate 40 MG (as dabigatran etexilate mesylate 46.12 MG) Oral PelletSY7These highlights do not include all the information needed to use PRADAXA Oral Pellets safely and effectively. See full prescribing information for PRADAXA Oral Pellets. PRADAXA ® (dabigatran etexilate) oral pellets Initial U.S. Approval: 201020250627
9ac0a64a-8666-45f7-9d4f-40fd894f7e6ddabigatran etexilate 40 MG Oral PelletPSN7These highlights do not include all the information needed to use PRADAXA Oral Pellets safely and effectively. See full prescribing information for PRADAXA Oral Pellets. PRADAXA ® (dabigatran etexilate) oral pellets Initial U.S. Approval: 201020250627