NDC codes

FDA NDC Directory
Product NDC (as listed)72065-121Labeler and product segments. Claims need a package NDC.
Product NDC at billing width72065-0121Add the package segment from the table below.
Package NDCs as listed with the FDA, and the 11-digit 5-4-2 form used on claims. The highlighted digit is the added leading zero.
Package NDC11-digit (billing)PackageCopy
72065-121-1172065012111720650121111 POUCH in 1 CARTON (72065-121-11) / 1 SYRINGE, PLASTIC in 1 POUCH / .2 mL in 1 SYRINGE, PLASTICMarketed from Sep 10, 2019
72065-121-1272065012112720650121122 POUCH in 1 CARTON (72065-121-12) / 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 HypoPen 1 mg Auto-InjectorSuffix: 1 mg Auto-Injector
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 72065-121_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.

How CPT relates to drug billing

NDC on a medical claim

N472065012111 followed by a unit qualifier and the quantity

Package 72065-0121-11. 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 72065-121

What is NDC 72065-121?
72065-121 is the product NDC for Gvoke HypoPen 1 mg Auto-Injector, 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 HypoPen 1 mg Auto-Injector (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 HypoPen 1 mg Auto-Injector?
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.

FDA NDC Directory listings under NDA 212097
ProductStrengthForm · routeLabelerProduct NDC
Gvoke HypoPen 0.5 mg Auto-Injectorglucagon injection, solutionGlucagon .5 mg/.1mLInjection, SolutionSubcutaneousXeris Pharmaceuticals, Inc.72065-120
Gvoke Kitglucagon injection, solutionGlucagon 1 mg/.2mLInjection, SolutionSubcutaneousXeris Pharmaceuticals, Inc.72065-140
Gvoke PFS 1 mg Pre-filled Syringeglucagon injection, solutionGlucagon 1 mg/.2mLInjection, SolutionSubcutaneousXeris Pharmaceuticals, Inc.72065-131
Gvoke VialDxglucagon injectionGlucagon 1 mg/.2mLInjection, SolutionIntravenousAmerican Regent, Inc.0517-2901

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