NDC 72065-130

Gvoke PFS 0.5 mg Pre-filled Syringe

Glucagon Injection, Solution

Gvoke PFS 0.5 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 ID72065-130_92385737-dbae-98c5-e053-2995a90a2805
NDC72065-130
Product TypeHuman Prescription Drug
Proprietary NameGvoke PFS 0.5 mg Pre-filled Syringe
Generic NameGlucagon Injection, Solution
Dosage FormInjection, Solution
Route of AdministrationSUBCUTANEOUS
Marketing Start Date2019-09-10
Marketing CategoryNDA / NDA
Application NumberNDA212097
Labeler NameXeris Pharmaceuticals, Inc.
Substance NameGLUCAGON
Active Ingredient Strength1 mg/.1mL
Pharm ClassesAntihypoglycemic 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 FlagN
Listing Certified Through2020-12-31

Packaging

NDC 72065-130-11

1 POUCH in 1 CARTON (72065-130-11) > 1 SYRINGE, PLASTIC in 1 POUCH > .1 mL in 1 SYRINGE, PLASTIC
Marketing Start Date2019-09-10
NDC Exclude FlagN
Sample Package?N

NDC SPL Data Element Entries

NDC 72065-130-99 [72065013099]

Gvoke PFS 0.5 mg Pre-filled Syringe INJECTION, SOLUTION
Marketing CategoryNDA
Application NumberNDA212097
Product TypeHUMAN PRESCRIPTION DRUG
Marketing Start Date2019-10-28

NDC 72065-130-11 [72065013011]

Gvoke PFS 0.5 mg Pre-filled Syringe INJECTION, SOLUTION
Marketing CategoryNDA
Application NumberNDA212097
Product TypeHUMAN PRESCRIPTION DRUG
Billing UnitML
Marketing Start Date2019-09-10

NDC 72065-130-12 [72065013012]

Gvoke PFS 0.5 mg Pre-filled Syringe INJECTION, SOLUTION
Marketing CategoryNDA
Application NumberNDA212097
Product TypeHUMAN PRESCRIPTION DRUG
Billing UnitML
Marketing Start Date2019-09-10

Drug Details

Active Ingredients

IngredientStrength
GLUCAGON.5 mg/.1mL

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 0.5 mg Pre-filled Syringe" or generic name "Glucagon Injection, Solution"

NDCBrand NameGeneric Name
72065-120Gvoke HypoPenglucagon injection, solution
72065-121Gvoke HypoPenglucagon injection, solution
72065-140Gvoke Kitglucagon injection, solution
72065-141Gvoke Kitglucagon injection, solution
72065-130Gvoke PFSglucagon injection, solution
72065-131Gvoke PFSglucagon injection, solution

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