NDC 0310-6135

KOMBIGLYZE XR

Saxagliptin And Metformin Hydrochloride

KOMBIGLYZE XR is a Oral Tablet, Film Coated, Extended Release in the Human Prescription Drug category. It is labeled and distributed by Astrazeneca Pharmaceuticals Lp. The primary component is Saxagliptin Hydrochloride; Metformin Hydrochloride.

• Product ID: 0310-6135_1e7f37ed-134a-456b-a759-dffd0dbf1360
• NDC: 0310-6135
• Product Type: Human Prescription Drug
• Proprietary Name: KOMBIGLYZE XR
• Generic Name: Saxagliptin And Metformin Hydrochloride
• Dosage Form: Tablet, Film Coated, Extended Release
• Route of Administration: ORAL
• Marketing Start Date: 2014-12-04
• Marketing Category: NDA / NDA
• Application Number: NDA200678
• Labeler Name: AstraZeneca Pharmaceuticals LP
• Substance Name: SAXAGLIPTIN HYDROCHLORIDE; METFORMIN HYDROCHLORIDE
• Active Ingredient Strength: 5 mg/1; mg/1
• Pharm Classes: Dipeptidyl Peptidase 4 Inhibitor [EPC],Dipeptidyl Peptidase 4 Inhibitors [MoA],Biguanide [EPC],Biguanides [CS]
• NDC Exclude Flag: N
• Listing Certified Through: 2020-12-31

Packaging

NDC 0310-6135-30

30 TABLET, FILM COATED, EXTENDED RELEASE in 1 BOTTLE, PLASTIC (0310-6135-30)

• Marketing Start Date: 2015-01-01
• NDC Exclude Flag: N
• Sample Package?: N

NDC SPL Data Element Entries

NDC 0310-6135-95 [00310613595]

KOMBIGLYZE XR TABLET, FILM COATED, EXTENDED RELEASE

• Marketing Category: NDA
• Application Number: NDA200678
• Product Type: HUMAN PRESCRIPTION DRUG
• Marketing Start Date: 2015-01-01

NDC 0310-6135-30 [00310613530]

KOMBIGLYZE XR TABLET, FILM COATED, EXTENDED RELEASE

• Marketing Category: NDA
• Application Number: NDA200678
• Product Type: HUMAN PRESCRIPTION DRUG
• Billing Unit: EA
• Marketing Start Date: 2015-01-01

Drug Details

Active Ingredients

Ingredient	Strength
SAXAGLIPTIN HYDROCHLORIDE	5 mg/1

OpenFDA Data

• SPL SET ID: fbd25da4-ebe6-45c9-beb8-93523d11a0b4
• Manufacturer:
  • AstraZeneca Pharmaceuticals LP
• UNII:
  • Z8J84YIX6L
  • 786Z46389E
• RxNorm Concept Unique ID - RxCUI:
  • 1043563
  • 1043574
  • 1043578
  • 1043582
  • 1043570
  • 1043567

Pharmacological Class

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

NDC Crossover Matching brand name "KOMBIGLYZE XR" or generic name "Saxagliptin And Metformin Hydrochloride"

NDC	Brand Name	Generic Name
0310-6125	KOMBIGLYZE	SAXAGLIPTIN AND METFORMIN HYDROCHLORIDE
0310-6135	KOMBIGLYZE	SAXAGLIPTIN AND METFORMIN HYDROCHLORIDE
0310-6145	KOMBIGLYZE	SAXAGLIPTIN AND METFORMIN HYDROCHLORIDE