Prescription drug · BLA
Soliqua 100/33 (Insulin glargine and lixisenatide) NDC 0024-5761
Insulin glargine 100 U/mL; Lixisenatide 33 ug/mL · Injection, Solution · Subcutaneous · Sanofi-Aventis U.S. LLC
NDC codes
FDA NDC Directory| Package NDC | 11-digit (billing) | Package | Copy |
|---|---|---|---|
| 0024-5761-01 | 0002457610100024576101 | 1 SYRINGE in 1 CARTON (0024-5761-01) / 3 mL in 1 SYRINGEMarketed from Nov 21, 2016 | |
| 0024-5761-05 | 0002457610500024576105 | 5 SYRINGE in 1 CARTON (0024-5761-05) / 3 mL in 1 SYRINGE (0024-5761-02)Marketed from Nov 21, 2016 |
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)
- Soliqua 100/33
- Generic name (nonproprietary)
- insulin glargine and lixisenatide
- Active ingredients
- Insulin glargine — 100 U/mLLixisenatide — 33 ug/mL
- Dosage form
- Injection, Solution
- Route
- Subcutaneous
- Labeler
- Sanofi-Aventis U.S. LLCNDC labeler code 0024
- Product type
- Prescription drug
- Marketing category
- BLA — Biologics License ApplicationApplication BLA 208673
- Marketing start
- Listing expires
- Other FDA classes
- Glucagon-Like Peptide 1 (Chemical structure)Glucagon-like Peptide-1 (GLP-1) Agonists (Mechanism)Insulin (Chemical structure)
- Identifiers
- Product ID 0024-5761_dd3cca75-32f2-4e6d-8121-20f47e101495SPL ID dd3cca75-32f2-4e6d-8121-20f47e101495SPL set ID 4bba538b-cf7c-4310-ae8f-cb711ed21bccRxCUI 1858995, 1859000UNII 2ZM8CX04RZ, 74O62BB01U
- Pharmacologic class
- GLP-1 Receptor Agonist; 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
N400024576101followed by a unit qualifier and the quantityPackage 00024-5761-01. 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)
SOLIQUA 100/33 is a combination of insulin glargine and lixisenatide and is indicated as an adjunct to diet and exercise to improve glycemic control in adults with type 2 diabetes mellitus. SOLIQUA 100/33 is a combination of insulin glargine, an insulin analog, and lixisenatide, a glucagon-like peptide-1 (GLP-1) receptor agonist, indicated as an adjunct to diet and exercise to improve glycemic control in adults with type 2 diabetes mellitus. ( 1 ) Limitations of Use ( 1 ) : Concomitant use in combination with any other product containing a GLP-1 receptor agonist is not recommended. Not recommended for the treatment of diabetic ketoacidosis. Has not been studied in combination with prandial i…
Excerpt only. Read the full label for complete information.
About NDC 0024-5761
- What is NDC 0024-5761?
- 0024-5761 is the product NDC for Soliqua 100/33, Insulin glargine 100 U/mL; Lixisenatide 33 ug/mL injection, solution, listed with the FDA by Sanofi-Aventis U.S. LLC. It has 2 package NDCs, shown above in 10- and 11-digit form.
- What drug is associated with this NDC?
- Soliqua 100/33 (Insulin glargine and lixisenatide).
- What is the active ingredient?
- Insulin glargine, Lixisenatide.
- Who is the labeler?
- Sanofi-Aventis U.S. LLC, NDC labeler code 0024. The labeler is the company responsible for the label; it may be the manufacturer, a repackager or a distributor.
- What other NDCs exist for Soliqua 100/33?
- 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.