FDA.reportPublic FDA data

dabigatran etexilate 110 MG Oral Capsule

RxCUI
1723476
RxNorm name
dabigatran etexilate 110 MG Oral Capsule
Display name
dabigatran etexilate 110 MG Oral Capsule
Full name
dabigatran etexilate 110 MG Oral Capsule
Term type
SCD
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 · 10 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
Dabigatran EtexilateDABIGATRAN ETEXILATEAscend Laboratories, LLC3a8ec82a-c367-40dc-9302-e1896fcb05ea2026-08-03Boxed warning, Warnings, Adverse reactionsExact identifier
rxcui: 1723476
dabigatran etexilateDABIGATRAN ETEXILATEApotex Corp.dd47a015-ff90-d7a7-8dcb-4e6e31a680712026-07-13Boxed warning, Warnings, Adverse reactionsExact identifier
rxcui: 1723476
DABIGATRANDABIGATRAN ETEXILATENovadoz Pharmaceuticals LLC6f79088b-b353-485a-9df4-6f5088f5bd0f2026-02-06Boxed warning, Warnings, Adverse reactionsExact identifier
rxcui: 1723476
Dabigatran EtexilateDABIGATRAN ETEXILATEAlembic Pharmaceuticals Limited13649035-a498-4e31-a7ea-8b18cedceca72025-11-20Boxed warning, Warnings, Adverse reactionsExact identifier
rxcui: 1723476
Dabigatran EtexilateDABIGATRAN ETEXILATEAlembic Pharmaceuticals Inc.834a3c5f-b723-4bcb-a560-dc305dd0d8292025-10-31Boxed warning, Warnings, Adverse reactionsExact identifier
rxcui: 1723476
DABIGATRAN ETEXILATEDABIGATRAN ETEXILATEAurobindo Pharma Limited5b196b1f-408e-4615-b980-9f822adff8352025-08-01Boxed warning, Warnings, Adverse reactionsExact identifier
rxcui: 1723476
Dabigatran EtexilateDABIGATRAN ETEXILATECamber Pharmaceuticals, Inc.3c24e235-218b-438e-9456-42c18ff019132025-07-30Boxed warning, Warnings, Adverse reactionsExact identifier
rxcui: 1723476
Dabigatran etexilateDABIGATRAN ETEXILATEDr.Reddys Laboratories Inca608e019-db9a-d6fb-cd0d-cecc1351a2b12025-07-24Boxed warning, Warnings, Adverse reactionsExact identifier
rxcui: 1723476
PradaxaDABIGATRAN ETEXILATE MESYLATEBoehringer Ingelheim Pharmaceuticals Inc.ba74e3cd-b06f-4145-b284-5fd6b84ff3c92025-06-25Boxed warning, Warnings, Adverse reactionsExact identifier
rxcui: 1723476
Dabigatran EtexilateDABIGATRAN ETEXILATEMajor Pharmaceuticalsb76b79ce-b7dd-4390-b40e-71ae6c477d102025-06-12Boxed warning, Warnings, Adverse reactionsExact identifier
rxcui: 1723476

DailyMed RxNorm Mappings#

unique DailyMed labels mapped to this RxNorm concept page 1 of 1 · 10 matching rows.

Set ID, RxNorm mappings, Terms table
Set IDRxNorm mappingsTermsSPL versionLabelEffective
ba74e3cd-b06f-4145-b284-5fd6b84ff3c9dabigatran etexilate 110 MG Oral Capsule [PSN] · dabigatran etexilate 110 MG Oral Capsule [SCD] · dabigatran etexilate 110 MG (as dabigatran etexilate mesylate 126.83 MG) Oral Capsule [SY]348These 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
3a8ec82a-c367-40dc-9302-e1896fcb05eadabigatran etexilate 110 MG Oral Capsule [PSN] · dabigatran etexilate 110 MG Oral Capsule [SCD] · dabigatran etexilate 110 MG (as dabigatran etexilate mesylate 126.83 MG) Oral Capsule [SY]326These highlights do not include all the information needed to use DABIGATRAN ETEXILATE CAPSULES safely and effectively. See full prescribing information for DABIGATRAN ETEXILATE CAPSULES. DABIGATRAN ETEXILATE capsules, for oral use Initial U.S. Approval: 201020250917
a608e019-db9a-d6fb-cd0d-cecc1351a2b1dabigatran etexilate 110 MG Oral Capsule [PSN] · dabigatran etexilate 110 MG Oral Capsule [SCD] · dabigatran etexilate 110 MG (as dabigatran etexilate mesylate 126.83 MG) Oral Capsule [SY]321These highlights do not include all the information needed to use DABIGATRAN ETEXILATE CAPSULES safely and effectively. See full prescribing information for DABIGATRAN ETEXILATE CAPSULES DABIGATRAN ETEXILATE capsules, for oral use Initial U.S. Approval: 201020250724
834a3c5f-b723-4bcb-a560-dc305dd0d829dabigatran etexilate 110 MG Oral Capsule [PSN] · dabigatran etexilate 110 MG Oral Capsule [SCD] · dabigatran etexilate 110 MG (as dabigatran etexilate mesylate 126.83 MG) Oral Capsule [SY]313These highlights do not include all the information needed to use DABIGATRAN ETEXILATE CAPSULES safely and effectively. See full prescribing information for DABIGATRAN ETEXILATE CAPSULES. DABIGATRAN ETEXILATE capsules, for oral use Initial U.S. Approval: 201020251031
3c24e235-218b-438e-9456-42c18ff01913dabigatran etexilate 110 MG Oral Capsule [PSN] · dabigatran etexilate 110 MG Oral Capsule [SCD] · dabigatran etexilate 110 MG (as dabigatran etexilate mesylate 126.83 MG) Oral Capsule [SY]38These highlights do not include all the information needed to use DABIGATRAN ETEXILATE CAPSULES safely and effectively. See full prescribing information for DABIGATRAN ETEXILATE CAPSULES. DABIGATRAN ETEXILATE capsules, for oral use Initial U.S. Approval: 201020250730
6f79088b-b353-485a-9df4-6f5088f5bd0fdabigatran etexilate 110 MG Oral Capsule [PSN] · dabigatran etexilate 110 MG Oral Capsule [SCD] · dabigatran etexilate 110 MG (as dabigatran etexilate mesylate 126.83 MG) Oral Capsule [SY]34These highlights do not include all the information needed to use DABIGATRAN ETEXILATE CAPSULES safely and effectively. See full prescribing information for DABIGATRAN ETEXILATE CAPSULES. DABIGATRAN ETEXILATE capsules, for oral use Initial U.S. Approval: 201020260206
dd47a015-ff90-d7a7-8dcb-4e6e31a68071dabigatran etexilate 110 MG Oral Capsule [PSN] · dabigatran etexilate 110 MG Oral Capsule [SCD] · dabigatran etexilate 110 MG (as dabigatran etexilate mesylate 126.83 MG) Oral Capsule [SY]34These highlights do not include all the information needed to use DABIGATRAN ETEXILATE CAPSULES safely and effectively. See full prescribing information for DABIGATRAN ETEXILATE CAPSULES. DABIGATRAN E TEXILATE capsules, for oral use Initial U.S. Approval: 201020250626
13649035-a498-4e31-a7ea-8b18cedceca7dabigatran etexilate 110 MG Oral Capsule [PSN] · dabigatran etexilate 110 MG Oral Capsule [SCD] · dabigatran etexilate 110 MG (as dabigatran etexilate mesylate 126.83 MG) Oral Capsule [SY]33These highlights do not include all the information needed to use DABIGATRAN ETEXILATE CAPSULES safely and effectively. See full prescribing information for DABIGATRAN ETEXILATE CAPSULES. DABIGATRAN ETEXILATE capsules, for oral use Initial U.S. Approval: 201020251120
5b196b1f-408e-4615-b980-9f822adff835dabigatran etexilate 110 MG Oral Capsule [PSN] · dabigatran etexilate 110 MG Oral Capsule [SCD] · dabigatran etexilate 110 MG (as dabigatran etexilate mesylate 126.83 MG) Oral Capsule [SY]33These highlights do not include all the information needed to use DABIGATRAN ETEXILATE CAPSULES safely and effectively. See full prescribing information for DABIGATRAN ETEXILATE CAPSULES. DABIGATRAN ETEXILATE capsules, for oral use Initial U.S. Approval: 201020250801
b76b79ce-b7dd-4390-b40e-71ae6c477d10dabigatran etexilate 110 MG Oral Capsule [PSN] · dabigatran etexilate 110 MG Oral Capsule [SCD] · dabigatran etexilate 110 MG (as dabigatran etexilate mesylate 126.83 MG) Oral Capsule [SY]32These highlights do not include all the information needed to use DABIGATRAN ETEXILATE CAPSULES safely and effectively. See full prescribing information for DABIGATRAN ETEXILATE CAPSULES. DABIGATRAN ETEXILATE capsules, for oral use Initial U.S. Approval: 201020250612