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
1a214cf1-b41e-46f6-8f24-e3637e6d2612
Product Type
HUMAN PRESCRIPTION DRUG LABEL
Effective Date
Jan 19, 2022
Manufacturers
FDA
Bryant Ranch Prepack
DUNS: 171714327
Products 1
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 Code63629-8242
Application NumberNDA022512
Product Classification
M
Marketing Category
C73594
G
Generic Name
dabigatran etexilate mesylate
Product Specifications
Route of AdministrationORAL
Effective DateJune 25, 2021
FDA Product Classification
INGREDIENTS (1)
DABIGATRAN ETEXILATE MESYLATEActive
Quantity: 150 mg in 1 1
Code: SC7NUW5IIT
Classification: ACTIR