Pradaxa
These 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: 2010
Approved
Approval ID
ba74e3cd-b06f-4145-b284-5fd6b84ff3c9
Product Type
HUMAN PRESCRIPTION DRUG LABEL
Effective Date
Nov 28, 2023
Manufacturers
FDA
Boehringer Ingelheim Pharmaceuticals Inc.
DUNS: 603175944
Products 3
Detailed information about drug products covered under this FDA approval, including NDC codes, dosage forms, ingredients, and administration routes.
dabigatran etexilate mesylate
Product Details
FDA regulatory identification and product classification information
FDA Identifiers
NDC Product Code0597-0355
Application NumberNDA022512
Product Classification
M
Marketing Category
C73594
G
Generic Name
dabigatran etexilate mesylate
Product Specifications
Route of AdministrationORAL
Effective DateNovember 28, 2023
FDA Product Classification
INGREDIENTS (1)
DABIGATRAN ETEXILATE MESYLATEActive
Quantity: 75 mg in 1 1
Code: SC7NUW5IIT
Classification: ACTIR
dabigatran etexilate mesylate
Product Details
FDA regulatory identification and product classification information
FDA Identifiers
NDC Product Code0597-0108
Application NumberNDA022512
Product Classification
M
Marketing Category
C73594
G
Generic Name
dabigatran etexilate mesylate
Product Specifications
Route of AdministrationORAL
Effective DateNovember 28, 2023
FDA Product Classification
INGREDIENTS (1)
DABIGATRAN ETEXILATE MESYLATEActive
Quantity: 110 mg in 1 1
Code: SC7NUW5IIT
Classification: ACTIR
dabigatran etexilate mesylate
Product Details
FDA regulatory identification and product classification information
FDA Identifiers
NDC Product Code0597-0360
Application NumberNDA022512
Product Classification
M
Marketing Category
C73594
G
Generic Name
dabigatran etexilate mesylate
Product Specifications
Route of AdministrationORAL
Effective DateNovember 28, 2023
FDA Product Classification
INGREDIENTS (1)
DABIGATRAN ETEXILATE MESYLATEActive
Quantity: 150 mg in 1 1
Code: SC7NUW5IIT
Classification: ACTIR