NDC 66215-102

Tracleer

Bosentan

Tracleer is a Oral Tablet, Film Coated in the Human Prescription Drug category. It is labeled and distributed by Actelion Pharmaceuticals Us, Inc.. The primary component is Bosentan.

Product ID66215-102_345b005a-6394-11ea-8c7b-1b34fc2ca371
NDC66215-102
Product TypeHuman Prescription Drug
Proprietary NameTracleer
Generic NameBosentan
Dosage FormTablet, Film Coated
Route of AdministrationORAL
Marketing Start Date2001-11-20
Marketing CategoryNDA / NDA
Application NumberNDA021290
Labeler NameActelion Pharmaceuticals US, Inc.
Substance NameBOSENTAN
Active Ingredient Strength125 mg/1
Pharm ClassesEndothelin Receptor Antagonist [EPC],Endothelin Receptor Antagonists [MoA],Cytochrome P450 3A Inducers [MoA],Cytochrome P450 2C9 Inducers [MoA]
NDC Exclude FlagN
Listing Certified Through2021-12-31

Packaging

NDC 66215-102-03

10 BLISTER PACK in 1 CARTON (66215-102-03) > 3 TABLET, FILM COATED in 1 BLISTER PACK
Marketing Start Date2012-10-02
NDC Exclude FlagN
Sample Package?N

NDC SPL Data Element Entries

NDC 66215-102-06 [66215010206]

Tracleer TABLET, FILM COATED
Marketing CategoryNDA
Application NumberNDA021290
Product TypeHUMAN PRESCRIPTION DRUG
Billing UnitEA
Marketing Start Date2001-11-20

NDC 66215-102-03 [66215010203]

Tracleer TABLET, FILM COATED
Marketing CategoryNDA
Application NumberNDA021290
Product TypeHUMAN PRESCRIPTION DRUG
Billing UnitEA
Marketing Start Date2012-10-02

Drug Details

Active Ingredients

IngredientStrength
BOSENTAN125 mg/1

OpenFDA Data

SPL SET ID:749e42fb-2fe0-45dd-9268-b43bb3f4081c
Manufacturer
UNII
RxNorm Concept Unique ID - RxCUI
  • 656660
  • 656659
  • 352066
  • 349253
  • 1989085
  • 1989081
  • Pharmacological Class

    • Endothelin Receptor Antagonist [EPC]
    • Endothelin Receptor Antagonists [MoA]
    • Cytochrome P450 3A Inducers [MoA]
    • Cytochrome P450 2C9 Inducers [MoA]

    NDC Crossover Matching brand name "Tracleer" or generic name "Bosentan"

    NDCBrand NameGeneric Name
    66215-101Tracleerbosentan
    66215-102TracleerTracleer
    66215-103TracleerTracleer
    0054-0520BosentanBosentan
    0054-0521BosentanBosentan
    0591-2511bosentanbosentan
    0591-2512bosentanbosentan
    10148-125bosentanbosentan
    10148-625bosentanbosentan
    46708-383BosentanBosentan
    46708-384BosentanBosentan
    47335-038BosentanBosentan
    47335-039BosentanBosentan
    47781-270BosentanBosentan
    47781-271BosentanBosentan
    49884-058BosentanBosentan
    49884-059BosentanBosentan
    62332-383BosentanBosentan
    62332-384BosentanBosentan
    65162-873BosentanBosentan
    65162-874BosentanBosentan

    Trademark Results [Tracleer]

    Mark Image

    Registration | Serial
    Company
    Trademark
    Application Date
    TRACLEER
    TRACLEER
    76177722 2648305 Live/Registered
    Actelion Pharmaceuticals Ltd.
    2000-12-07

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