NDC 55154-6931

ONGLYZA

Saxagliptin

ONGLYZA is a Oral Tablet, Film Coated in the Human Prescription Drug category. It is labeled and distributed by Cardinal Health 107, Llc. The primary component is Saxagliptin Hydrochloride.

• Product ID: 55154-6931_048ab1ca-6e74-49ad-9a9e-c866a2b9ce01
• NDC: 55154-6931
• Product Type: Human Prescription Drug
• Proprietary Name: ONGLYZA
• Generic Name: Saxagliptin
• Dosage Form: Tablet, Film Coated
• Route of Administration: ORAL
• Marketing Start Date: 2014-11-20
• Marketing Category: NDA / NDA
• Application Number: NDA022350
• Labeler Name: Cardinal Health 107, LLC
• Substance Name: SAXAGLIPTIN HYDROCHLORIDE
• Active Ingredient Strength: 5 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 55154-6931-2

1080 TABLET, FILM COATED in 1 BOTTLE, PLASTIC (55154-6931-2)

• Marketing Start Date: 2014-11-20
• NDC Exclude Flag: N
• Sample Package?: N

NDC SPL Data Element Entries

NDC 55154-6931-2 [55154693102]

ONGLYZA TABLET, FILM COATED

• Marketing Category: NDA
• Application Number: NDA022350
• Product Type: HUMAN PRESCRIPTION DRUG
• Marketing Start Date: 2014-11-20

NDC 55154-6931-8 [55154693108]

ONGLYZA TABLET, FILM COATED

• Marketing Category: NDA
• Application Number: NDA022350
• Product Type: HUMAN PRESCRIPTION DRUG
• Marketing Start Date: 2014-11-20
• Marketing End Date: 2018-02-28

Drug Details

Active Ingredients

Ingredient	Strength
SAXAGLIPTIN HYDROCHLORIDE	5 mg/1

OpenFDA Data

• SPL SET ID: e4f2a84f-5117-4738-b769-aba8debbddb0
• Manufacturer:
  • Cardinal Health
• UNII:
  • Z8J84YIX6L
• RxNorm Concept Unique ID - RxCUI:
  • 858036
  • 858040
• UPC Code:
  • 0355154693128

Pharmacological Class

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

NDC Crossover Matching brand name "ONGLYZA" or generic name "Saxagliptin"

NDC	Brand Name	Generic Name
0310-6100	ONGLYZA	SAXAGLIPTIN
0310-6105	ONGLYZA	SAXAGLIPTIN
55154-6931	ONGLYZA	SAXAGLIPTIN