NDC 63629-6524

Jentadueto

Linagliptin And Metformin Hydrochloride

Jentadueto is a Oral Tablet, Film Coated in the Human Prescription Drug category. It is labeled and distributed by Bryant Ranch Prepack. The primary component is Linagliptin; Metformin Hydrochloride.

• Product ID: 63629-6524_0df22510-3c9c-498b-9a72-f7b053dc528c
• NDC: 63629-6524
• Product Type: Human Prescription Drug
• Proprietary Name: Jentadueto
• Generic Name: Linagliptin And Metformin Hydrochloride
• Dosage Form: Tablet, Film Coated
• Route of Administration: ORAL
• Marketing Start Date: 2012-02-13
• Marketing Category: NDA / NDA
• Application Number: NDA201281
• Labeler Name: Bryant Ranch Prepack
• Substance Name: LINAGLIPTIN; METFORMIN HYDROCHLORIDE
• Active Ingredient Strength: 3 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: 2019-12-31

Packaging

NDC 63629-6524-1

60 TABLET, FILM COATED in 1 BOTTLE (63629-6524-1)

• Marketing Start Date: 2015-07-27
• NDC Exclude Flag: N
• Sample Package?: N

NDC SPL Data Element Entries

NDC 63629-6524-1 [63629652401]

Jentadueto TABLET, FILM COATED

• Marketing Category: NDA
• Application Number: NDA201281
• Product Type: HUMAN PRESCRIPTION DRUG
• Marketing Start Date: 2015-07-27
• Inactivation Date: 2020-01-31

Drug Details

Active Ingredients

Ingredient	Strength
LINAGLIPTIN	2.5 mg/1

OpenFDA Data

• SPL SET ID: 3010d452-dab5-44c5-b8d0-bdc725679f07
• Manufacturer:
  • Bryant Ranch Prepack
• UNII:
  • 3X29ZEJ4R2
  • 786Z46389E
• RxNorm Concept Unique ID - RxCUI:
  • 1243020
  • 1243026

Pharmacological Class

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

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

NDC	Brand Name	Generic Name
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
0597-0270	Jentadueto XR	linagliptin and metformin hydrochloride
0597-0275	Jentadueto XR	linagliptin and metformin hydrochloride