Garzulys (insulin aspart-fsan) NDC 71288-904

NDC codes

FDA NDC Directory

Product NDC (as listed)71288-904Labeler and product segments. Claims need a package NDC.

Product NDC at billing width71288-0904Add 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 NDC	11-digit (billing)	Package	Copy
71288-904-10	71288090410	1 VIAL, GLASS in 1 CARTON (71288-904-10) / 10 mL in 1 VIAL, GLASSMarketed from Jul 24, 2026

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): Garzulys
Generic name (nonproprietary): insulin aspart-fsan
Active ingredients: Insulin aspart — 100 [iU]/mL
Dosage form: Injection, Solution
Route: Intravenous, Subcutaneous
Labeler: Meitheal Pharmaceuticals Inc.
Product type: Prescription drug
Marketing category: BLA — Biologics License ApplicationApplication BLA 761497
Marketing start: Jul 24, 2026
Listing expires: Dec 31, 2027
Other FDA classes: Insulin (Chemical structure)
Identifiers: Product ID 71288-904_dbc6ea33-ff54-44b2-9ac7-cd76b4cb9c43SPL ID dbc6ea33-ff54-44b2-9ac7-cd76b4cb9c43SPL set ID 30c64769-d2f7-4604-ac9e-2a6bc09506c9RxCUI 2748451, 2748457, 2748459, 2748463UNII 059QF0KO0R, D933668QVX
Pharmacologic class: Insulin Analog

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

N471288090410 followed by a unit qualifier and the quantity

Package 71288-0904-10. 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 Jul 31, 2026.

Indications (excerpt from the label)

Garzulys™ is indicated to improve glycemic control in adults and pediatric patients with diabetes mellitus. Garzulys is rapid acting human insulin analog indicated to improve glycemic control in adults and pediatric patients with diabetes mellitus ( 1 ).

Excerpt only. Read the full label for complete information.

Full label on DailyMed (opens in a new tab)

Other NDCs under BLA 761497

Products listed under the same FDA application: other strengths and forms, and repackagers who relabel the same product.

FDA NDC Directory listings under BLA 761497
Product	Strength	Form · route	Labeler	Product NDC
Garzulysinsulin aspart-fsan	Insulin aspart 100 [iU]/mL	Injection, SolutionSubcutaneous	Meitheal Pharmaceuticals Inc.	71288-903
Insulin Diluting Medium for Garzulyswater injection	Water 1 mL/mL	Injection, SolutionIntravenous, Subcutaneous	Meitheal Pharmaceuticals Inc.	71288-909