NDC 72065-120
Gvoke HypoPen 0.5 mg Auto-Injector
Glucagon Injection, Solution
Gvoke HypoPen 0.5 mg Auto-Injector 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 | 72065-120_92385737-dbae-98c5-e053-2995a90a2805 |
| NDC | 72065-120 |
| Product Type | Human Prescription Drug |
| Proprietary Name | Gvoke HypoPen 0.5 mg Auto-Injector |
| 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/.1mL |
| 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 72065-120-11
1 POUCH in 1 CARTON (72065-120-11) > 1 SYRINGE, PLASTIC in 1 POUCH > .1 mL in 1 SYRINGE, PLASTIC
| Marketing Start Date | 2019-09-10 |
| NDC Exclude Flag | N |
| Sample Package? | N |
NDC SPL Data Element Entries
NDC 72065-120-12 [72065012012]
Gvoke HypoPen 0.5 mg Auto-Injector INJECTION, SOLUTION
| Marketing Category | NDA |
| Application Number | NDA212097 |
| Product Type | HUMAN PRESCRIPTION DRUG |
| Billing Unit | ML |
| Marketing Start Date | 2019-09-10 |
NDC 72065-120-11 [72065012011]
Gvoke HypoPen 0.5 mg Auto-Injector 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 | .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 HypoPen 0.5 mg Auto-Injector" 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 |
Trademark Results [Gvoke HypoPen]
Mark Image Registration | Serial | Company Trademark Application Date |
|---|---|
 GVOKE HYPOPEN 88011932 not registered Live/Pending |
Xeris Pharmaceuticals, Inc. 2018-06-22 |
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