FDA labels

Search the openFDA drug-label export by label identifier, NDC, application, RxCUI, UNII, product name, or manufacturer.

OpenFDA label data provides additional search and identifier links. DailyMed’s Structured Product Label is the canonical label on FDA.report.

Label matches#

FDA label search results page 1 of 1 ยท 21 matching rows.

Label, Generic name, Manufacturer table
LabelGeneric nameManufacturerSPL set IDEffective dateSafety fieldsMatch
Dabigatran EtexilateDABIGATRAN ETEXILATEAscend Laboratories, LLC3a8ec82a-c367-40dc-9302-e1896fcb05ea2026-08-03Boxed warning, Warnings, Adverse reactionsName/manufacturer search
DABIGATRANDABIGATRAN ETEXILATEAmerican Health Packagingf7ea7e2c-ca54-4ecc-9fc7-bd3571b0ebc22026-07-15Boxed warning, Warnings, Adverse reactionsName/manufacturer search
dabigatran etexilateDABIGATRAN ETEXILATEApotex Corp.dd47a015-ff90-d7a7-8dcb-4e6e31a680712026-07-13Boxed warning, Warnings, Adverse reactionsName/manufacturer search
DABIGATRANDABIGATRAN ETEXILATENovadoz Pharmaceuticals LLC6f79088b-b353-485a-9df4-6f5088f5bd0f2026-02-06Boxed warning, Warnings, Adverse reactionsName/manufacturer search
DABIGATRANDABIGATRAN ETEXILATEAvKARE27e95caf-7938-ef8e-e063-6394a90a6a1a2026-01-13Boxed warning, Warnings, Adverse reactionsName/manufacturer search
Dabigatran EtexilateDABIGATRAN ETEXILATENorthStar RxLLCd5937f27-88c7-4c4a-801e-4c89450089822025-12-03Boxed warning, Warnings, Adverse reactionsName/manufacturer search
Dabigatran EtexilateDABIGATRAN ETEXILATEAlembic Pharmaceuticals Limited13649035-a498-4e31-a7ea-8b18cedceca72025-11-20Boxed warning, Warnings, Adverse reactionsName/manufacturer search
DABIGATRANDABIGATRAN ETEXILATEAvPAK39ac558a-b375-f3c1-e063-6394a90aa9012025-11-17Boxed warning, Warnings, Adverse reactionsName/manufacturer search
Dabigatran EtexilateDABIGATRAN ETEXILATEAlembic Pharmaceuticals Inc.834a3c5f-b723-4bcb-a560-dc305dd0d8292025-10-31Boxed warning, Warnings, Adverse reactionsName/manufacturer search
Dabigatran EtexilateDABIGATRAN ETEXILATEA-S Medication Solutionsb31d27e9-5502-43c5-83fa-89608c014b7a2025-09-22Boxed warning, Warnings, Adverse reactionsName/manufacturer search
Dabigatran EtexilateDABIGATRAN ETEXILATEA-S Medication Solutions369b945d-5bda-4773-910a-d0adef7f0f392025-09-19Boxed warning, Warnings, Adverse reactionsName/manufacturer search
DABIGATRAN ETEXILATEDABIGATRAN ETEXILATEAurobindo Pharma Limited5b196b1f-408e-4615-b980-9f822adff8352025-08-01Boxed warning, Warnings, Adverse reactionsName/manufacturer search
Dabigatran EtexilateDABIGATRAN ETEXILATECamber Pharmaceuticals, Inc.3c24e235-218b-438e-9456-42c18ff019132025-07-30Boxed warning, Warnings, Adverse reactionsName/manufacturer search
Dabigatran EtexilateDABIGATRAN ETEXILATEMylan Pharmaceuticals Inc.baafb5be-ffe6-4755-a7ab-817b3c9b222d2025-07-30Boxed warning, Warnings, Adverse reactionsName/manufacturer search
Dabigatran etexilateDABIGATRAN ETEXILATEDr.Reddys Laboratories Inca608e019-db9a-d6fb-cd0d-cecc1351a2b12025-07-24Boxed warning, Warnings, Adverse reactionsName/manufacturer search
Dabigatran EtexilateDABIGATRAN ETEXILATEMajor Pharmaceuticalsb76b79ce-b7dd-4390-b40e-71ae6c477d102025-06-12Boxed warning, Warnings, Adverse reactionsName/manufacturer search
DABIGATRANDABIGATRAN ETEXILATEA-S Medication Solutionsbee57f1b-ee5f-4f81-ae6f-ea65ddf9a1742025-04-09Boxed warning, Warnings, Adverse reactionsName/manufacturer search
DABIGATRANDABIGATRAN ETEXILATEA-S Medication Solutionse4e3b992-621a-43a5-be59-eeb5083fd2b42025-04-09Boxed warning, Warnings, Adverse reactionsName/manufacturer search
Dabigatran EtexilateDABIGATRAN ETEXILATEXLCare Pharmaceuticals, Inc.19b3bfc1-4fcb-4eb9-a611-02c27c05c56e2023-08-15Boxed warning, Warnings, Adverse reactionsName/manufacturer search
PradaxaDABIGATRAN ETEXILATEBoehringer Ingelheim Pharmaceuticals, Inc.9ac0a64a-8666-45f7-9d4f-40fd894f7e6d2025-06-27Boxed warning, Warnings, Adverse reactionsName/manufacturer search
PradaxaDABIGATRAN ETEXILATE MESYLATEBoehringer Ingelheim Pharmaceuticals Inc.ba74e3cd-b06f-4145-b284-5fd6b84ff3c92025-06-25Boxed warning, Warnings, Adverse reactionsName/manufacturer search