NDC 0597-0445

Pradaxa

Dabigatran Etexilate Mesylate

Pradaxa is a Oral Pellet in the Human Prescription Drug category. It is labeled and distributed by Boehringer Ingelheim Pharmaceuticals, Inc.. The primary component is Dabigatran Etexilate Mesylate.

Product ID0597-0445_435b5f18-05cd-4a0b-9627-5aec67b79974
NDC0597-0445
Product TypeHuman Prescription Drug
Proprietary NamePradaxa
Generic NameDabigatran Etexilate Mesylate
Dosage FormPellet
Route of AdministrationORAL
Marketing Start Date2022-02-01
Marketing CategoryNDA /
Application NumberNDA214358
Labeler NameBoehringer Ingelheim Pharmaceuticals, Inc.
Substance NameDABIGATRAN ETEXILATE MESYLATE
Active Ingredient Strength110 mg/1
NDC Exclude FlagN
Listing Certified Through2022-12-31

Packaging

NDC 0597-0445-87

1 BAG in 1 CARTON (0597-0445-87) > 60 PELLET in 1 BAG
Marketing Start Date2022-02-01
NDC Exclude FlagN
Sample Package?N

Drug Details

NDC Crossover Matching brand name "Pradaxa" or generic name "Dabigatran Etexilate Mesylate"

NDCBrand NameGeneric Name
0597-0108Pradaxadabigatran etexilate mesylate
0597-0135Pradaxadabigatran etexilate mesylate
0597-0149Pradaxadabigatran etexilate mesylate
0597-0355Pradaxadabigatran etexilate mesylate
0597-0360Pradaxadabigatran etexilate mesylate
0597-0425PradaxaDABIGATRAN ETEXILATE MESYLATE
0597-0430PradaxaDABIGATRAN ETEXILATE MESYLATE
0597-0435PradaxaDABIGATRAN ETEXILATE MESYLATE
0597-0440PradaxaDABIGATRAN ETEXILATE MESYLATE
0597-0445PradaxaDABIGATRAN ETEXILATE MESYLATE
0597-0450PradaxaDABIGATRAN ETEXILATE MESYLATE
21695-899PRADAXAdabigatran etexilate mesylate
50090-3617Pradaxadabigatran etexilate mesylate
50090-4480Pradaxadabigatran etexilate mesylate
63629-8242PradaxaPradaxa

Trademark Results [Pradaxa]

Mark Image

Registration | Serial
Company
Trademark
Application Date
PRADAXA
PRADAXA
85133694 3977066 Live/Registered
Boehringer Ingelheim Pharma GmbH & Co.,KG
2010-09-20
PRADAXA
PRADAXA
79193638 5173798 Live/Registered
Boehringer Ingelheim Pharma GmbH & Co KG
2016-04-06
PRADAXA
PRADAXA
79064548 3661185 Dead/Cancelled
Boehringer Ingelheim Pharma GmbH & Co. KG
2008-10-29
PRADAXA
PRADAXA
78282869 2874805 Live/Registered
Boehringer Ingelheim Pharma GmbH & Co. KG
2003-08-04

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