NDC 50090-4383

Tradjenta

Linagliptin

Tradjenta is a Oral Tablet, Film Coated in the Human Prescription Drug category. It is labeled and distributed by A-s Medication Solutions. The primary component is Linagliptin.

• Product ID: 50090-4383_5e9e8353-ce09-4675-b171-300d9019fda8
• NDC: 50090-4383
• Product Type: Human Prescription Drug
• Proprietary Name: Tradjenta
• Generic Name: Linagliptin
• Dosage Form: Tablet, Film Coated
• Route of Administration: ORAL
• Marketing Start Date: 2011-05-09
• Marketing Category: NDA / NDA
• Application Number: NDA201280
• Labeler Name: A-S Medication Solutions
• Substance Name: LINAGLIPTIN
• Active Ingredient Strength: 5 mg/1
• Pharm Classes: Dipeptidyl Peptidase 4 Inhibitors [MoA],Dipeptidyl Peptidase 4 Inhibitor [EPC]
• NDC Exclude Flag: N
• Listing Certified Through: 2020-12-31

Packaging

NDC 50090-4383-0

90 TABLET, FILM COATED in 1 BOTTLE (50090-4383-0)

• Marketing Start Date: 2019-06-24
• NDC Exclude Flag: N
• Sample Package?: N

NDC SPL Data Element Entries

NDC 50090-4383-0 [50090438300]

Tradjenta TABLET, FILM COATED

• Marketing Category: NDA
• Application Number: NDA201280
• Product Type: HUMAN PRESCRIPTION DRUG
• Marketing Start Date: 2019-06-24

Drug Details

Active Ingredients

Ingredient	Strength
LINAGLIPTIN	5 mg/1

OpenFDA Data

• SPL SET ID: b1da67d4-51e0-41b7-9fe1-7f38c0d1baa1
• Manufacturer:
  • A-S Medication Solutions
• UNII:
  • 3X29ZEJ4R2
• RxNorm Concept Unique ID - RxCUI:
  • 1100706
  • 1100702

Pharmacological Class

• Dipeptidyl Peptidase 4 Inhibitors [MoA]
• Dipeptidyl Peptidase 4 Inhibitor [EPC]
• Dipeptidyl Peptidase 4 Inhibitors [MoA]
• Dipeptidyl Peptidase 4 Inhibitor [EPC]

NDC Crossover Matching brand name "Tradjenta" or generic name "Linagliptin"

NDC	Brand Name	Generic Name
0597-0140	Tradjenta	linagliptin
50090-4383	Tradjenta	linagliptin
55154-0410	Tradjenta	linagliptin