What is NDC 0955-2900?

0955-2900 is the product NDC for Insulin glargine U-300 Max (insulin glargine), Insulin glargine 300 [iU]/mL injection, solution, listed with the FDA by Sanofi-Aventis U.S. LLC. It has 1 package NDC, shown above in 10- and 11-digit form.

What drug is associated with this NDC?

Insulin glargine U-300 Max (Insulin glargine).

Sanofi-Aventis U.S. LLC, NDC labeler code 0955. 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 glargine U-300 Max?

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.

Insulin glargine U-300 Max NDC 0955-2900

NDC codes

FDA NDC Directory

Product NDC (as listed)0955-2900Labeler and product segments. Claims need a package NDC.

Product NDC at billing width00955-2900Add 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
0955-2900-02	0095529000200955290002	2 SYRINGE in 1 CARTON (0955-2900-02) / 3 mL in 1 SYRINGE (0955-2900-01)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 Max
Generic name (nonproprietary): insulin glargine
Active ingredients: Insulin glargine — 300 [iU]/mL
Dosage form: Injection, Solution
Route: Subcutaneous
Labeler: Sanofi-Aventis U.S. LLCNDC labeler code 0955
Product type: Prescription drug
Marketing category: BLA — Biologics License ApplicationApplication BLA 206538
Marketing start: Apr 1, 2023
Listing expires: Dec 31, 2026
Other FDA classes: Insulin (Chemical structure)
Identifiers: Product ID 0955-2900_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.

How CPT relates to drug billing

NDC on a medical claim

N400955290002 followed by a unit qualifier and the quantity

Package 00955-2900-02. 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 May 30, 2025.

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.

Full label on DailyMed (opens in a new tab)

About NDC 0955-2900

What is NDC 0955-2900?: 0955-2900 is the product NDC for Insulin glargine U-300 Max (insulin glargine), Insulin glargine 300 [iU]/mL injection, solution, listed with the FDA by Sanofi-Aventis U.S. LLC. It has 1 package NDC, shown above in 10- and 11-digit form.
What drug is associated with this NDC?: Insulin glargine U-300 Max (Insulin glargine).
What is the active ingredient?: Insulin glargine.
Who is the labeler?: Sanofi-Aventis U.S. LLC, NDC labeler code 0955. 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 glargine U-300 Max?: 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 206538

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

FDA NDC Directory listings under BLA 206538
Product	Strength	Form · route	Labeler	Product NDC
Insulin glargine U-300insulin glargine	Insulin glargine 300 [iU]/mL	Injection, SolutionSubcutaneous	Sanofi-Aventis U.S. LLC	0955-3900
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
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

Insulin glargine U-300 Max (Insulin glargine) NDC 0955-2900