NDC 63629-8242

Pradaxa

Dabigatran Etexilate Mesylate

Pradaxa is a Oral Capsule in the Human Prescription Drug category. It is labeled and distributed by Bryant Ranch Prepack. The primary component is Dabigatran Etexilate Mesylate.

Product ID63629-8242_1a214cf1-b41e-46f6-8f24-e3637e6d2612
NDC63629-8242
Product TypeHuman Prescription Drug
Proprietary NamePradaxa
Generic NameDabigatran Etexilate Mesylate
Dosage FormCapsule
Route of AdministrationORAL
Marketing Start Date2017-07-28
Marketing CategoryNDA / NDA
Application NumberNDA022512
Labeler NameBryant Ranch Prepack
Substance NameDABIGATRAN ETEXILATE MESYLATE
Active Ingredient Strength150 mg/1
Pharm ClassesDirect Thrombin Inhibitor [EPC], Thrombin Inhibitors [MoA]
NDC Exclude FlagN
Listing Certified Through2023-12-31

Packaging

NDC 63629-8242-1

30 CAPSULE in 1 BOTTLE (63629-8242-1)
Marketing Start Date2019-09-10
NDC Exclude FlagN
Sample Package?N

NDC SPL Data Element Entries

NDC 63629-8242-1 [63629824201]

Pradaxa CAPSULE
Marketing CategoryNDA
Application NumberNDA022512
Product TypeHUMAN PRESCRIPTION DRUG
Marketing Start Date2019-09-18

Drug Details

Active Ingredients

IngredientStrength
DABIGATRAN ETEXILATE MESYLATE150 mg/1

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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