NDC 72065-131

Gvoke PFS 1 mg Pre-filled Syringe

Glucagon Injection, Solution

Gvoke PFS 1 mg Pre-filled Syringe is a Subcutaneous Injection, Solution in the Human Prescription Drug category. It is labeled and distributed by Xeris Pharmaceuticals, Inc.. The primary component is Glucagon.

• Product ID: 72065-131_92385737-dbae-98c5-e053-2995a90a2805
• NDC: 72065-131
• Product Type: Human Prescription Drug
• Proprietary Name: Gvoke PFS 1 mg Pre-filled Syringe
• Generic Name: Glucagon Injection, Solution
• Dosage Form: Injection, Solution
• Route of Administration: SUBCUTANEOUS
• Marketing Start Date: 2019-09-10
• Marketing Category: NDA / NDA
• Application Number: NDA212097
• Labeler Name: Xeris Pharmaceuticals, Inc.
• Substance Name: GLUCAGON
• Active Ingredient Strength: 1 mg/.2mL
• Pharm Classes: Antihypoglycemic Agent [EPC],Gastrointestinal Motility Inhibitor [EPC],Increased Gluconeogenesis [PE],Increased Glycogenolysis [PE],Decreased GI Smooth Muscle Tone [PE],Decreased GI Motility [PE],Decreased Glycolysis [PE]
• NDC Exclude Flag: N
• Listing Certified Through: 2020-12-31

Packaging

NDC 72065-131-11

1 POUCH in 1 CARTON (72065-131-11) > 1 SYRINGE, PLASTIC in 1 POUCH > .2 mL in 1 SYRINGE, PLASTIC

• Marketing Start Date: 2019-09-10
• NDC Exclude Flag: N
• Sample Package?: N

NDC SPL Data Element Entries

NDC 72065-131-12 [72065013112]

Gvoke PFS 1 mg Pre-filled Syringe INJECTION, SOLUTION

• Marketing Category: NDA
• Application Number: NDA212097
• Product Type: HUMAN PRESCRIPTION DRUG
• Billing Unit: ML
• Marketing Start Date: 2019-09-10

NDC 72065-131-99 [72065013199]

Gvoke PFS 1 mg Pre-filled Syringe INJECTION, SOLUTION

• Marketing Category: NDA
• Application Number: NDA212097
• Product Type: HUMAN PRESCRIPTION DRUG
• Marketing Start Date: 2019-10-28

NDC 72065-131-11 [72065013111]

Gvoke PFS 1 mg Pre-filled Syringe INJECTION, SOLUTION

• Marketing Category: NDA
• Application Number: NDA212097
• Product Type: HUMAN PRESCRIPTION DRUG
• Billing Unit: ML
• Marketing Start Date: 2019-09-10

Drug Details

Active Ingredients

Ingredient	Strength
GLUCAGON	1 mg/.2mL

Pharmacological Class

• Antihypoglycemic Agent [EPC]
• Gastrointestinal Motility Inhibitor [EPC]
• Increased Gluconeogenesis [PE]
• Increased Glycogenolysis [PE]
• Decreased GI Smooth Muscle Tone [PE]
• Decreased GI Motility [PE]
• Decreased Glycolysis [PE]

NDC Crossover Matching brand name "Gvoke PFS 1 mg Pre-filled Syringe" or generic name "Glucagon Injection, Solution"

NDC	Brand Name	Generic Name
72065-120	Gvoke HypoPen	glucagon injection, solution
72065-121	Gvoke HypoPen	glucagon injection, solution
72065-140	Gvoke Kit	glucagon injection, solution
72065-141	Gvoke Kit	glucagon injection, solution
72065-130	Gvoke PFS	glucagon injection, solution
72065-131	Gvoke PFS	glucagon injection, solution