NDC 0597-0108

Pradaxa

Dabigatran Etexilate Mesylate

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

Product ID0597-0108_089eda8b-0f51-c567-37a7-6412754b1ff5
NDC0597-0108
Product TypeHuman Prescription Drug
Proprietary NamePradaxa
Generic NameDabigatran Etexilate Mesylate
Dosage FormCapsule
Route of AdministrationORAL
Marketing Start Date2015-11-23
Marketing CategoryNDA / NDA
Application NumberNDA022512
Labeler NameBoehringer Ingelheim Pharmaceuticals Inc.
Substance NameDABIGATRAN ETEXILATE MESYLATE
Active Ingredient Strength110 mg/1
NDC Exclude FlagN
Listing Certified Through2019-12-31

Packaging

NDC 0597-0108-54

1 BOTTLE in 1 CARTON (0597-0108-54) > 60 CAPSULE in 1 BOTTLE
Marketing Start Date2017-07-07
NDC Exclude FlagN
Sample Package?N

NDC SPL Data Element Entries

NDC 0597-0108-54 [00597010854]

Pradaxa CAPSULE
Marketing CategoryNDA
Application NumberNDA022512
Product TypeHUMAN PRESCRIPTION DRUG
Billing UnitEA
Marketing Start Date2017-07-07

NDC 0597-0108-60 [00597010860]

Pradaxa CAPSULE
Marketing CategoryNDA
Application NumberNDA022512
Product TypeHUMAN PRESCRIPTION DRUG
Billing UnitEA
Marketing Start Date2015-11-23

Drug Details

Active Ingredients

IngredientStrength
DABIGATRAN ETEXILATE MESYLATE110 mg/1

OpenFDA Data

SPL SET ID:ba74e3cd-b06f-4145-b284-5fd6b84ff3c9
Manufacturer
UNII
RxNorm Concept Unique ID - RxCUI
  • 1723478
  • 1037049
  • 1037181
  • 1037179
  • 1037045
  • 1723476

    • 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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