Prescription drug · NDA
Gvoke HypoPen 0.5 mg Auto-Injector NDC 72065-120
glucagon injection, solution · Glucagon .5 mg/.1mL · Injection, Solution · Subcutaneous · Xeris Pharmaceuticals, Inc.
NDC codes
FDA NDC Directory| Package NDC | 11-digit (billing) | Package | Copy |
|---|---|---|---|
| 72065-120-11 | 72065012011 | 1 POUCH in 1 CARTON (72065-120-11) / 1 SYRINGE, PLASTIC in 1 POUCH / .1 mL in 1 SYRINGE, PLASTICMarketed from Sep 10, 2019 | |
| 72065-120-12 | 72065012012 | 2 POUCH in 1 CARTON (72065-120-12) / 1 SYRINGE, PLASTIC in 1 POUCH / .1 mL in 1 SYRINGE, PLASTICMarketed from Sep 10, 2019 |
How the 11-digit form is made: The product segment has 3 digits, so one leading zero is added to it (5-3-2 → 5-4-2). Formatting the NDC does not by itself make it billable — the product, package and quantity must match what was dispensed or administered, and payer rules apply. Conversion rules
Product information
- Brand name (proprietary)
- Gvoke HypoPen 0.5 mg Auto-InjectorSuffix: 0.5 mg Auto-Injector
- Generic name (nonproprietary)
- glucagon injection, solution
- Active ingredients
- Glucagon — .5 mg/.1mL
- Dosage form
- Injection, Solution
- Route
- Subcutaneous
- Labeler
- Xeris Pharmaceuticals, Inc.
- Product type
- Prescription drug
- Marketing category
- NDA — New Drug ApplicationApplication NDA 212097
- Marketing start
- Listing expires
- Other FDA classes
- Decreased GI Motility (Physiologic effect)Decreased GI Smooth Muscle Tone (Physiologic effect)Decreased Glycolysis (Physiologic effect)Increased Gluconeogenesis (Physiologic effect)Increased Glycogenolysis (Physiologic effect)
- Identifiers
- Product ID 72065-120_8c693dd2-e196-41fe-bd0f-584c1254174cSPL ID 8c693dd2-e196-41fe-bd0f-584c1254174cSPL set ID 92385737-dbad-98c5-e053-2995a90a2805RxCUI 2199299, 2199304, 2199307, 2199308, 2199315, 2199316, 2587358, 2587361UNII 76LA80IG2G
- Pharmacologic class
- Antihypoglycemic Agent; Gastrointestinal Motility Inhibitor
Billing references
What Med-Code can say about coding this product, and where each statement comes from. Nothing here is inferred from the name alone.
- HCPCS codeNo match
No drug-specific HCPCS code in Med-Code's directory for this product. The directory is curated and not complete — check the current CMS HCPCS file before billing.
- Administration
Drug administration (CPT 96360–96549)
When a clinician administers the drug, the administration is reported separately. Codes in this range cover hydration, therapeutic injections and infusions, and chemotherapy or other complex drug administration. The right code depends on route, duration and drug type, and self-administered drugs are not billed this way.
- NDC on a medical claim
N472065012011followed by a unit qualifier and the quantityPackage 72065-0120-11. Unit qualifiers: F2 (international unit), GR (gram), ME (milligram), ML (milliliter), UN (unit (each)). The qualifier and quantity depend on what was given. About the N4 qualifier
Product label
Current FDA label (SPL), effective .
Indications (excerpt from the label)
GVOKE is an antihypoglycemic agent indicated for subcutaneous use for the treatment of severe hypoglycemia in adult and pediatric patients aged two years and older with diabetes ( 1.1 ) GVOKE VialDx is a gastrointestinal motility inhibitor indicated for intravenous use as a diagnostic aid during radiologic examinations to temporarily inhibit movement of the gastrointestinal tract in adult patients ( 1.2 ) 1.1 Severe Hypoglycemia in Adult and Pediatric Patients Aged 2 Years and Older with Diabetes GVOKE is indicated for subcutaneous use for the treatment of severe hypoglycemia in adult and pediatric patients aged two and older with diabetes. 1.2 Diagnostic Aid in Adults GVOKE VialDx is indica…
Excerpt only. Read the full label for complete information.
Other NDCs under NDA 212097
Products listed under the same FDA application: other strengths and forms, and repackagers who relabel the same product.
| Product | Strength | Form · route | Labeler | Product NDC |
|---|---|---|---|---|
| Gvoke Kitglucagon injection, solution | Glucagon 1 mg/.2mL | Injection, SolutionSubcutaneous | Xeris Pharmaceuticals, Inc. | 72065-140 |
| Gvoke HypoPen 1 mg Auto-Injectorglucagon injection, solution | Glucagon 1 mg/.2mL | Injection, SolutionSubcutaneous | Xeris Pharmaceuticals, Inc. | 72065-121 |
| Gvoke PFS 1 mg Pre-filled Syringeglucagon injection, solution | Glucagon 1 mg/.2mL | Injection, SolutionSubcutaneous | Xeris Pharmaceuticals, Inc. | 72065-131 |
| Gvoke VialDxglucagon injection | Glucagon 1 mg/.2mL | Injection, SolutionIntravenous | American Regent, Inc. | 0517-2901 |