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 ID: 0597-0127_43f1c4c4-29a0-aece-a936-bec5252240c5
• NDC: 0597-0127
• Product Type: Human Prescription Drug
• Proprietary Name: Twynsta
• Generic Name: Telmisartan/amlodipine
• Dosage Form: Tablet, Multilayer
• Route of Administration: ORAL
• Marketing Start Date: 2009-11-02
• Marketing Category: NDA / NDA
• Application Number: NDA022401
• Labeler Name: Boehringer Ingelheim Pharmaceuticals, Inc.
• Substance Name: TELMISARTAN; AMLODIPINE BESYLATE
• Active Ingredient Strength: 80 mg/1; mg/1
• Pharm Classes: Angiotensin 2 Receptor Antagonists [MoA],Angiotensin 2 Receptor Blocker [EPC],Calcium Channel Antagonists [MoA],Dihydropyridine Calcium Channel Blocker [EPC],Dihydropyridines [CS]
• NDC Exclude Flag: N
• Listing Certified Through: 2019-12-31

Packaging

NDC 0597-0127-37

3 BLISTER PACK in 1 CARTON (0597-0127-37) > 10 TABLET, MULTILAYER in 1 BLISTER PACK

• Marketing Start Date: 2009-11-02
• NDC Exclude Flag: N
• Sample Package?: N

NDC SPL Data Element Entries

NDC 0597-0127-29 [00597012729]

Twynsta TABLET, MULTILAYER

• Marketing Category: NDA
• Application Number: NDA022401
• Product Type: HUMAN PRESCRIPTION DRUG
• Marketing Start Date: 2009-11-02
• Marketing End Date: 2010-10-19

NDC 0597-0127-37 [00597012737]

Twynsta TABLET, MULTILAYER

• Marketing Category: NDA
• Application Number: NDA022401
• Product Type: HUMAN PRESCRIPTION DRUG
• Billing Unit: EA
• Marketing Start Date: 2009-11-02

NDC 0597-0127-31 [00597012731]

Twynsta TABLET, MULTILAYER

• Marketing Category: NDA
• Application Number: NDA022401
• Product Type: HUMAN PRESCRIPTION DRUG
• Marketing Start Date: 2009-11-02
• Marketing End Date: 2012-04-27

Drug Details

Active Ingredients

Ingredient	Strength
TELMISARTAN	80 mg/1

OpenFDA Data

• SPL SET ID: 627146d8-fa8e-4c8b-b703-29ee080a6d5b
• Manufacturer:
  • Boehringer Ingelheim Pharmaceuticals, Inc.
• UNII:
  • U5SYW473RQ
  • 864V2Q084H
• 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"

NDC	Brand Name	Generic Name
0597-0124	Twynsta	telmisartan/amlodipine
0597-0125	Twynsta	telmisartan/amlodipine
0597-0126	Twynsta	telmisartan/amlodipine
0597-0127	Twynsta	telmisartan/amlodipine