NDC 55154-5040

JANUVIA

Sitagliptin

JANUVIA is a Oral Tablet, Film Coated in the Human Prescription Drug category. It is labeled and distributed by Cardinal Health. The primary component is Sitagliptin Phosphate.

• Product ID: 55154-5040_044fc35c-103c-4c88-83fd-936dbfa32a1c
• NDC: 55154-5040
• Product Type: Human Prescription Drug
• Proprietary Name: JANUVIA
• Generic Name: Sitagliptin
• Dosage Form: Tablet, Film Coated
• Route of Administration: ORAL
• Marketing Start Date: 2006-10-16
• Marketing Category: NDA / NDA
• Application Number: NDA021995
• Labeler Name: Cardinal Health
• Substance Name: SITAGLIPTIN PHOSPHATE
• Active Ingredient Strength: 50 mg/1
• Pharm Classes: Dipeptidyl Peptidase 4 Inhibitor [EPC], Dipeptidyl Peptidase 4 Inhibitors [MoA]
• NDC Exclude Flag: N
• Listing Certified Through: 2023-12-31

Packaging

NDC 55154-5040-8

2340 TABLET, FILM COATED in 1 BOTTLE, PLASTIC (55154-5040-8)

• Marketing Start Date: 2006-10-16
• NDC Exclude Flag: N
• Sample Package?: N

NDC SPL Data Element Entries

NDC 55154-5040-8 [55154504008]

JANUVIA TABLET, FILM COATED

• Marketing Category: NDA
• Application Number: NDA021995
• Product Type: HUMAN PRESCRIPTION DRUG
• Marketing Start Date: 2006-10-16

Drug Details

Active Ingredients

Ingredient	Strength
SITAGLIPTIN PHOSPHATE	50 mg/1

OpenFDA Data

• SPL SET ID: 39253ddd-0245-43b1-ad28-d5923983afb4
• Manufacturer:
  • Cardinal Health
• UNII:
  • TS63EW8X6F
• RxNorm Concept Unique ID - RxCUI:
  • 665033
  • 665044
  • 665036
  • 665042
• UPC Code:
  • 0355154504127
  • 0355154504189
  • 0355154504080

Pharmacological Class

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

NDC Crossover Matching brand name "JANUVIA" or generic name "Sitagliptin"

NDC	Brand Name	Generic Name
0006-0112	JANUVIA	sitagliptin
0006-0221	JANUVIA	sitagliptin
0006-0277	JANUVIA	sitagliptin
50090-3472	JANUVIA	sitagliptin
50090-3527	JANUVIA	sitagliptin
50090-4084	JANUVIA	sitagliptin
50090-4086	JANUVIA	sitagliptin
50090-4087	JANUVIA	sitagliptin
50090-5517	JANUVIA	sitagliptin
50090-5547	JANUVIA	sitagliptin
50090-5585	JANUVIA	sitagliptin
55154-5040	JANUVIA	sitagliptin
55154-5042	JANUVIA	sitagliptin
55154-5044	JANUVIA	JANUVIA