Pradaxa

Product NDC

0597-0149

11-digit product format

005970149

Labeler code

0597

Product ID

0597-0149_089eda8b-0f51-c567-37a7-6412754b1ff5

Type

HUMAN PRESCRIPTION DRUG

Nonproprietary name

dabigatran etexilate mesylate

Dosage form

CAPSULE

Route

ORAL

Labeler

Boehringer Ingelheim Pharmaceuticals Inc.

Application

NDA022512

Marketing category

NDA

Marketing start

2011-08-08

Marketing end

0000-00-00

Substance

DABIGATRAN ETEXILATE MESYLATE

Active strength

75 mg/1

NDC exclude flag

No

Listing certified through

2019-12-31

Current FDA listing

Historical FDA.report record