Prescription drug · BLA
Insulin Diluting Medium for Garzulys (Water injection) NDC 71288-909
Water 1 mL/mL · Injection, Solution · Intravenous, Subcutaneous · Meitheal Pharmaceuticals Inc.
NDC codes
FDA NDC Directory| Package NDC | 11-digit (billing) | Package | Copy |
|---|---|---|---|
| 71288-909-10 | 7128809091071288090910 | 1 VIAL, GLASS in 1 CARTON (71288-909-10) / 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)
- Insulin Diluting Medium for Garzulys
- Generic name (nonproprietary)
- water injection
- Active ingredients
- Water — 1 mL/mL
- Dosage form
- Injection, Solution
- Route
- Intravenous, Subcutaneous
- Labeler
- Meitheal Pharmaceuticals Inc.NDC labeler code 71288
- Product type
- Prescription drug
- Marketing category
- BLA — Biologics License ApplicationApplication BLA 761497
- Marketing start
- Listing expires
- Identifiers
- Product ID 71288-909_dbc6ea33-ff54-44b2-9ac7-cd76b4cb9c43SPL ID dbc6ea33-ff54-44b2-9ac7-cd76b4cb9c43SPL set ID 30c64769-d2f7-4604-ac9e-2a6bc09506c9RxCUI 2748451, 2748457, 2748459, 2748463UNII 059QF0KO0R, D933668QVX
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
N471288090910followed by a unit qualifier and the quantityPackage 71288-0909-10. 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 .
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.
About NDC 71288-909
- What is NDC 71288-909?
- 71288-909 is the product NDC for Insulin Diluting Medium for Garzulys, Water 1 mL/mL injection, solution, listed with the FDA by Meitheal Pharmaceuticals Inc.. It has 1 package NDC, shown above in 10- and 11-digit form.
- What drug is associated with this NDC?
- Insulin Diluting Medium for Garzulys (Water injection).
- What is the active ingredient?
- Water.
- Who is the labeler?
- Meitheal Pharmaceuticals Inc., NDC labeler code 71288. The labeler is the company responsible for the label; it may be the manufacturer, a repackager or a distributor.
- What other NDCs exist for Insulin Diluting Medium for Garzulys?
- 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 BLA 761497
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 |
|---|---|---|---|---|
| Garzulysinsulin aspart-fsan | Insulin aspart 100 [iU]/mL | Injection, SolutionSubcutaneous | Meitheal Pharmaceuticals Inc. | 71288-903 |
| Garzulysinsulin aspart-fsan | Insulin aspart 100 [iU]/mL | Injection, SolutionIntravenous, Subcutaneous | Meitheal Pharmaceuticals Inc. | 71288-904 |