NDC 0597-0127

Twynsta

Telmisartan/amlodipine

Twynsta is a Oral Tablet, Multilayer in the Human Prescription Drug category. It is labeled and distributed by Boehringer Ingelheim Pharmaceuticals, Inc.. The primary component is Telmisartan; Amlodipine Besylate.

Product ID0597-0127_43f1c4c4-29a0-aece-a936-bec5252240c5
NDC0597-0127
Product TypeHuman Prescription Drug
Proprietary NameTwynsta
Generic NameTelmisartan/amlodipine
Dosage FormTablet, Multilayer
Route of AdministrationORAL
Marketing Start Date2009-11-02
Marketing CategoryNDA / NDA
Application NumberNDA022401
Labeler NameBoehringer Ingelheim Pharmaceuticals, Inc.
Substance NameTELMISARTAN; AMLODIPINE BESYLATE
Active Ingredient Strength80 mg/1; mg/1
Pharm ClassesAngiotensin 2 Receptor Antagonists [MoA],Angiotensin 2 Receptor Blocker [EPC],Calcium Channel Antagonists [MoA],Dihydropyridine Calcium Channel Blocker [EPC],Dihydropyridines [CS]
NDC Exclude FlagN
Listing Certified Through2019-12-31

Packaging

NDC 0597-0127-37

3 BLISTER PACK in 1 CARTON (0597-0127-37) > 10 TABLET, MULTILAYER in 1 BLISTER PACK
Marketing Start Date2009-11-02
NDC Exclude FlagN
Sample Package?N

NDC SPL Data Element Entries

NDC 0597-0127-29 [00597012729]

Twynsta TABLET, MULTILAYER
Marketing CategoryNDA
Application NumberNDA022401
Product TypeHUMAN PRESCRIPTION DRUG
Marketing Start Date2009-11-02
Marketing End Date2010-10-19

NDC 0597-0127-37 [00597012737]

Twynsta TABLET, MULTILAYER
Marketing CategoryNDA
Application NumberNDA022401
Product TypeHUMAN PRESCRIPTION DRUG
Billing UnitEA
Marketing Start Date2009-11-02

NDC 0597-0127-31 [00597012731]

Twynsta TABLET, MULTILAYER
Marketing CategoryNDA
Application NumberNDA022401
Product TypeHUMAN PRESCRIPTION DRUG
Marketing Start Date2009-11-02
Marketing End Date2012-04-27

Drug Details

Active Ingredients

IngredientStrength
TELMISARTAN80 mg/1

OpenFDA Data

SPL SET ID:627146d8-fa8e-4c8b-b703-29ee080a6d5b
Manufacturer
UNII
RxNorm Concept Unique ID - RxCUI
  • 876529
  • 876533
  • 876524
  • 876528
  • 876514
  • 876519
  • 876518
  • 876523
  • Pharmacological Class

    • Angiotensin 2 Receptor Antagonists [MoA]
    • Angiotensin 2 Receptor Blocker [EPC]
    • Calcium Channel Antagonists [MoA]
    • Dihydropyridine Calcium Channel Blocker [EPC]
    • Dihydropyridines [CS]

    NDC Crossover Matching brand name "Twynsta" or generic name "Telmisartan/amlodipine"

    NDCBrand NameGeneric Name
    0597-0124Twynstatelmisartan/amlodipine
    0597-0125Twynstatelmisartan/amlodipine
    0597-0126Twynstatelmisartan/amlodipine
    0597-0127Twynstatelmisartan/amlodipine

    Trademark Results [Twynsta]

    Mark Image

    Registration | Serial
    Company
    Trademark
    Application Date
    TWYNSTA
    TWYNSTA
    87451191 5296555 Live/Registered
    Boehringer Ingelheim International GmbH
    2017-05-16
    TWYNSTA
    TWYNSTA
    85975380 4032833 Dead/Cancelled
    Boehringer Ingelheim International GmbH
    2010-04-06
    TWYNSTA
    TWYNSTA
    85007212 4115534 Dead/Cancelled
    Boehringer Ingelheim International GmbH
    2010-04-06
    TWYNSTA
    TWYNSTA
    79043030 3468250 Dead/Cancelled
    Boehringer Ingelheim International GmbH
    2007-08-03

    © 2024 FDA.report
    This site is not affiliated with or endorsed by the FDA.