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 |
Marketing Start Date | 2019-09-10 |
NDC Exclude Flag | N |
Sample Package? | N |
Marketing Category | NDA |
Application Number | NDA212097 |
Product Type | HUMAN PRESCRIPTION DRUG |
Billing Unit | ML |
Marketing Start Date | 2019-09-10 |
Marketing Category | NDA |
Application Number | NDA212097 |
Product Type | HUMAN PRESCRIPTION DRUG |
Marketing Start Date | 2019-10-28 |
Marketing Category | NDA |
Application Number | NDA212097 |
Product Type | HUMAN PRESCRIPTION DRUG |
Billing Unit | ML |
Marketing Start Date | 2019-09-10 |
Ingredient | Strength |
---|---|
GLUCAGON | 1 mg/.2mL |
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 |