NDC 70518-2046

Glyxambi

Empagliflozin And Linagliptin

Glyxambi is a Oral Tablet, Film Coated in the Human Prescription Drug category. It is labeled and distributed by Remedyrepack Inc.. The primary component is Empagliflozin; Linagliptin.

• Product ID: 70518-2046_87b3f850-6191-73e6-e053-2995a90a4d95
• NDC: 70518-2046
• Product Type: Human Prescription Drug
• Proprietary Name: Glyxambi
• Generic Name: Empagliflozin And Linagliptin
• Dosage Form: Tablet, Film Coated
• Route of Administration: ORAL
• Marketing Start Date: 2019-04-29
• Marketing Category: NDA / NDA
• Application Number: NDA206073
• Labeler Name: REMEDYREPACK INC.
• Substance Name: EMPAGLIFLOZIN; LINAGLIPTIN
• Active Ingredient Strength: 10 mg/1; mg/1
• Pharm Classes: Sodium-Glucose Cotransporter 2 Inhibitor [EPC],Sodium-Glucose Transporter 2 Inhibitors [MoA],Dipeptidyl Peptidase 4 Inhibitors [MoA],Dipeptidyl Peptidase 4 Inhibitor [EPC]
• NDC Exclude Flag: N
• Listing Certified Through: 2020-12-31

Packaging

NDC 70518-2046-0

90 TABLET, FILM COATED in 1 BOTTLE, PLASTIC (70518-2046-0)

• Marketing Start Date: 2019-04-29
• NDC Exclude Flag: N
• Sample Package?: N

NDC SPL Data Element Entries

NDC 70518-2046-0 [70518204600]

Glyxambi TABLET, FILM COATED

• Marketing Category: NDA
• Application Number: NDA206073
• Product Type: HUMAN PRESCRIPTION DRUG
• Marketing Start Date: 2019-04-29

Drug Details

Active Ingredients

Ingredient	Strength
EMPAGLIFLOZIN	10 mg/1

Pharmacological Class

• Sodium-Glucose Cotransporter 2 Inhibitor [EPC]
• Sodium-Glucose Transporter 2 Inhibitors [MoA]
• Dipeptidyl Peptidase 4 Inhibitors [MoA]
• Dipeptidyl Peptidase 4 Inhibitor [EPC]

NDC Crossover Matching brand name "Glyxambi" or generic name "Empagliflozin And Linagliptin"

NDC	Brand Name	Generic Name
0597-0164	Glyxambi	empagliflozin and linagliptin
0597-0182	Glyxambi	empagliflozin and linagliptin
70518-2046	Glyxambi	empagliflozin and linagliptin