NDC 0597-0275

Jentadueto XR

Linagliptin And Metformin Hydrochloride

Jentadueto XR is a Oral Tablet, Film Coated, Extended Release in the Human Prescription Drug category. It is labeled and distributed by Boehringer Ingelheim Pharmaceuticals, Inc.. The primary component is Linagliptin; Metformin Hydrochloride.

• Product ID: 0597-0275_5a9c76e9-b479-4ea9-a29b-8eae9d5cfe47
• NDC: 0597-0275
• Product Type: Human Prescription Drug
• Proprietary Name: Jentadueto XR
• Generic Name: Linagliptin And Metformin Hydrochloride
• Dosage Form: Tablet, Film Coated, Extended Release
• Route of Administration: ORAL
• Marketing Start Date: 2016-05-27
• Marketing Category: NDA / NDA
• Application Number: NDA208026
• Labeler Name: Boehringer Ingelheim Pharmaceuticals, Inc.
• Substance Name: LINAGLIPTIN; METFORMIN HYDROCHLORIDE
• Active Ingredient Strength: 5 mg/1; mg/1
• Pharm Classes: Dipeptidyl Peptidase 4 Inhibitors [MoA],Dipeptidyl Peptidase 4 Inhibitor [EPC],Biguanide [EPC],Biguanides [CS]
• NDC Exclude Flag: N
• Listing Certified Through: 2022-12-31

Packaging

NDC 0597-0275-33

30 TABLET, FILM COATED, EXTENDED RELEASE in 1 BOTTLE (0597-0275-33)

• Marketing Start Date: 2016-05-27
• NDC Exclude Flag: N
• Sample Package?: N

NDC SPL Data Element Entries

NDC 0597-0275-88 [00597027588]

Jentadueto XR TABLET, FILM COATED, EXTENDED RELEASE

• Marketing Category: NDA
• Application Number: NDA208026
• Product Type: HUMAN PRESCRIPTION DRUG
• Marketing Start Date: 2016-05-27

NDC 0597-0275-81 [00597027581]

Jentadueto XR TABLET, FILM COATED, EXTENDED RELEASE

• Marketing Category: NDA
• Application Number: NDA208026
• Product Type: HUMAN PRESCRIPTION DRUG
• Billing Unit: EA
• Marketing Start Date: 2016-05-27

NDC 0597-0275-33 [00597027533]

Jentadueto XR TABLET, FILM COATED, EXTENDED RELEASE

• Marketing Category: NDA
• Application Number: NDA208026
• Product Type: HUMAN PRESCRIPTION DRUG
• Billing Unit: EA
• Marketing Start Date: 2016-05-27

Drug Details

Active Ingredients

Ingredient	Strength
LINAGLIPTIN	5 mg/1

OpenFDA Data

• SPL SET ID: 3d02a4d4-d312-80b4-05c4-691b8f0aa7aa
• Manufacturer:
  • Boehringer Ingelheim Pharmaceuticals, Inc.
• UNII:
  • 3X29ZEJ4R2
  • 786Z46389E
• RxNorm Concept Unique ID - RxCUI:
  • 1796096
  • 1796094
  • 1796089
  • 1796091

Pharmacological Class

• Dipeptidyl Peptidase 4 Inhibitors [MoA]
• Dipeptidyl Peptidase 4 Inhibitor [EPC]
• Biguanide [EPC]
• Biguanides [CS]

NDC Crossover Matching brand name "Jentadueto XR" or generic name "Linagliptin And Metformin Hydrochloride"

NDC	Brand Name	Generic Name
0597-0270	Jentadueto XR	linagliptin and metformin hydrochloride
0597-0275	Jentadueto XR	linagliptin and metformin hydrochloride
0597-0146	Jentadueto	linagliptin and metformin hydrochloride
0597-0147	Jentadueto	linagliptin and metformin hydrochloride
0597-0148	Jentadueto	linagliptin and metformin hydrochloride
63629-6524	Jentadueto	linagliptin and metformin hydrochloride