Pradaxa
These highlights do not include all the information needed to use PRADAXA safely and effectively. See full prescribing information for PRADAXA. PRADAXA® (dabigatran etexilate) capsules, for oral use Initial U.S. Approval: 2010
Approved
Approval ID
80637981-d5a7-48cb-b7b2-f50807a8ab20
Product Type
HUMAN PRESCRIPTION DRUG LABEL
Effective Date
Jun 16, 2021
Manufacturers
FDA
A-S Medication Solutions
DUNS: 830016429
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 Code50090-3617
Application NumberNDA022512
Product Classification
M
Marketing Category
C73594
G
Generic Name
dabigatran etexilate mesylate
Product Specifications
Route of AdministrationORAL
Effective DateApril 23, 2021
FDA Product Classification
INGREDIENTS (1)
DABIGATRAN ETEXILATE MESYLATEActive
Quantity: 150 mg in 1 1
Code: SC7NUW5IIT
Classification: ACTIR