Prescription drug · NDA
Gvoke PFS 1 mg Pre-filled Syringe (Glucagon injection, solution) NDC 72065-131
Glucagon 1 mg/.2mL · Injection, Solution · Subcutaneous · Xeris Pharmaceuticals, Inc.
NDC codes
FDA NDC Directory| Package NDC | 11-digit (billing) | Package | Copy |
|---|---|---|---|
| 72065-131-11 | 7206501311172065013111 | 1 POUCH in 1 CARTON (72065-131-11) / 1 SYRINGE, PLASTIC in 1 POUCH / .2 mL in 1 SYRINGE, PLASTICMarketed from Sep 10, 2019 | |
| 72065-131-12 | 7206501311272065013112 | 2 POUCH in 1 CARTON (72065-131-12) / 1 SYRINGE, PLASTIC in 1 POUCH / .2 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 PFS 1 mg Pre-filled SyringeSuffix: 1 mg Pre-filled Syringe
- Generic name (nonproprietary)
- glucagon injection, solution
- Active ingredients
- Glucagon — 1 mg/.2mL
- Dosage form
- Injection, Solution
- Route
- Subcutaneous
- Labeler
- Xeris Pharmaceuticals, Inc.NDC labeler code 72065
- 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 72065-131_050d2f58-d6e7-4cc6-8b27-f2f19158a36cSPL ID 050d2f58-d6e7-4cc6-8b27-f2f19158a36c
- 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
N472065013111followed by a unit qualifier and the quantityPackage 72065-0131-11. 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
The FDA listing for this product does not reference a label (SPL) set.
About NDC 72065-131
- What is NDC 72065-131?
- 72065-131 is the product NDC for Gvoke PFS 1 mg Pre-filled Syringe, Glucagon 1 mg/.2mL injection, solution, listed with the FDA by Xeris Pharmaceuticals, Inc.. It has 2 package NDCs, shown above in 10- and 11-digit form.
- What drug is associated with this NDC?
- Gvoke PFS 1 mg Pre-filled Syringe (Glucagon injection, solution).
- What is the active ingredient?
- Glucagon.
- Who is the labeler?
- Xeris Pharmaceuticals, Inc., NDC labeler code 72065. The labeler is the company responsible for the label; it may be the manufacturer, a repackager or a distributor.
- What other NDCs exist for Gvoke PFS 1 mg Pre-filled Syringe?
- None: this is the only finished product listed under this name.
- Is there a related HCPCS / J-code?
- Not in Med-Code's curated HCPCS directory. See Billing references above.
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 HypoPen 0.5 mg Auto-Injectorglucagon injection, solution | Glucagon .5 mg/.1mL | Injection, SolutionSubcutaneous | Xeris Pharmaceuticals, Inc. | 72065-120 |
| Gvoke HypoPen 1 mg Auto-Injectorglucagon injection, solution | Glucagon 1 mg/.2mL | Injection, SolutionSubcutaneous | Xeris Pharmaceuticals, Inc. | 72065-121 |
| Gvoke Kitglucagon injection, solution | Glucagon 1 mg/.2mL | Injection, SolutionSubcutaneous | Xeris Pharmaceuticals, Inc. | 72065-140 |
| Gvoke VialDxglucagon injection | Glucagon 1 mg/.2mL | Injection, SolutionIntravenous | American Regent, Inc. | 0517-2901 |