Prescription drug · BLA
Insulin glargine U-300 (insulin glargine) NDC 0955-3900
Insulin glargine 300 [iU]/mL · Injection, Solution · Subcutaneous · Sanofi-Aventis U.S. LLC
NDC codes
FDA NDC Directory| Package NDC | 11-digit (billing) | Package | Copy |
|---|---|---|---|
| 0955-3900-03 | 00955390003 | 3 SYRINGE in 1 CARTON (0955-3900-03) / 1.5 mL in 1 SYRINGE (0955-3900-01)Marketed from Apr 1, 2023 |
How the 11-digit form is made: The labeler segment has 4 digits, so one leading zero is added to it (4-4-2 → 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 glargine U-300
- Generic name (nonproprietary)
- insulin glargine
- Active ingredients
- Insulin glargine — 300 [iU]/mL
- Dosage form
- Injection, Solution
- Route
- Subcutaneous
- Labeler
- Sanofi-Aventis U.S. LLC
- Product type
- Prescription drug
- Marketing category
- BLA — Biologics License ApplicationApplication BLA 206538
- Marketing start
- Listing expires
- Other FDA classes
- Insulin (Chemical structure)
- Identifiers
- Product ID 0955-3900_63c52b96-0bdf-42f0-9c6c-e439846e6926SPL ID 63c52b96-0bdf-42f0-9c6c-e439846e6926SPL set ID 99ea856d-9562-443a-9422-1006a3cff2f4RxCUI 1604539, 2002419UNII 2ZM8CX04RZ
- 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.
- NDC on a medical claim
N400955390003followed by a unit qualifier and the quantityPackage 00955-3900-03. 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)
Insulin Glargine, U-300 is indicated to improve glycemic control in adults and pediatric patients 6 years of age and older with diabetes mellitus. Insulin Glargine, U-300 is a long-acting human insulin analog indicated to improve glycemic control in adults and pediatric patients 6 years and older with diabetes mellitus. ( 1 ) Limitations of Use : Not recommended for the treatment of diabetic ketoacidosis. ( 1 ) Limitations of Use: Insulin Glargine, U-300 is not recommended for the treatment of diabetic ketoacidosis.
Excerpt only. Read the full label for complete information.
Other NDCs under BLA 206538
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 |
|---|---|---|---|---|
| Toujeoinsulin glargine | Insulin glargine 300 U/mL | Injection, SolutionSubcutaneous | Sanofi-Aventis U.S. LLC | 0024-5869 |
| Toujeoinsulin glargine | Insulin glargine 300 U/mL | Injection, SolutionSubcutaneous | A-S Medication Solutions | 50090-2193 |
| Insulin glargine U-300 Maxinsulin glargine | Insulin glargine 300 [iU]/mL | Injection, SolutionSubcutaneous | Sanofi-Aventis U.S. LLC | 0955-2900 |
| TOUJEO Maxinsulin glargine | Insulin glargine 300 U/mL | Injection, SolutionSubcutaneous | Sanofi-Aventis U.S. LLC | 0024-5871 |
| TOUJEO Maxinsulin glargine | Insulin glargine 300 U/mL | Injection, SolutionSubcutaneous | A-S Medication Solutions | 50090-4177 |