FDA.reportPublic FDA data

dabigatran etexilate 50 MG Oral Pellet

RxCUI
2590635
RxNorm name
dabigatran etexilate 50 MG Oral Pellet
Display name
dabigatran etexilate 50 MG Oral Pellet
Full name
dabigatran etexilate 50 MG Oral Pellet
Term type
SCD
Status
DailyMed mapping
Updated
2026-06-04 23:39:10

RxNav Current And Historical NDCs#

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No records found.

UNII Substances#

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

No records found.

openFDA label cross-check#

Cross-check layer: openFDA label JSON enriches search and identifies hydration gaps. The DailyMed Structured Product Label remains the canonical label presentation on FDA.report. Every label matching the complete exact-identifier union is deduplicated and paginated 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: 2590635

DailyMed RxNorm Mappings#

Set ID, RxNorm string, TTY table
Set IDRxNorm stringTTYSPL versionLabelEffective
9ac0a64a-8666-45f7-9d4f-40fd894f7e6ddabigatran etexilate 50 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 50 MG (as dabigatran etexilate mesylate 57.65 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 50 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