Prescription drug · BLA
Xultophy 100/3.6 (Insulin degludec and liraglutide) NDC 0169-2911
Insulin degludec 100 [iU]/mL; Liraglutide 3.6 mg/mL · Injection, Solution · Subcutaneous · Novo Nordisk
NDC codes
FDA NDC Directory| Package NDC | 11-digit (billing) | Package | Copy |
|---|---|---|---|
| 0169-2911-15 | 0016929111500169291115 | 5 SYRINGE, PLASTIC in 1 CARTON (0169-2911-15) / 3 mL in 1 SYRINGE, PLASTICMarketed 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)
- Xultophy 100/3.6
- Generic name (nonproprietary)
- insulin degludec and liraglutide
- Active ingredients
- Insulin degludec — 100 [iU]/mLLiraglutide — 3.6 mg/mL
- Dosage form
- Injection, Solution
- Route
- Subcutaneous
- Labeler
- Novo NordiskNDC labeler code 0169
- Product type
- Prescription drug
- Marketing category
- BLA — Biologics License ApplicationApplication BLA 208583
- 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 0169-2911_7ade72ef-d354-430d-afad-3b63b95f5b39SPL ID 7ade72ef-d354-430d-afad-3b63b95f5b39SPL set ID 21335fe4-d395-4501-ac2a-2f20d7520da9RxCUI 1860167, 1860172UNII 54Q18076QB, 839I73S42A
- 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
N400169291115followed by a unit qualifier and the quantityPackage 00169-2911-15. 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 . This label includes a boxed warning.
Indications (excerpt from the label)
XULTOPHY 100/3.6 is a combination of insulin degludec and liraglutide and is indicated as an adjunct to diet and exercise to improve glycemic control in adults with type 2 diabetes mellitus. Limitations of Use: • XULTOPHY 100/3.6 contains liraglutide. Coadministration with any other product containing liraglutide or another glucagon-like peptide-1 (GLP-1) receptor agonist is not recommended [see Warnings and Precautions ( 5.5 )]. • XULTOPHY 100/3.6 is not recommended for the treatment of diabetic ketoacidosis. • XULTOPHY 100/3.6 has not been studied in combination with prandial insulin. XULTOPHY 100/3.6 is a combination of insulin degludec, a long-acting human insulin analog, and liraglutide…
Excerpt only. Read the full label for complete information.
About NDC 0169-2911
- What is NDC 0169-2911?
- 0169-2911 is the product NDC for Xultophy 100/3.6, Insulin degludec 100 [iU]/mL; Liraglutide 3.6 mg/mL injection, solution, listed with the FDA by Novo Nordisk. It has 1 package NDC, shown above in 10- and 11-digit form.
- What drug is associated with this NDC?
- Xultophy 100/3.6 (Insulin degludec and liraglutide).
- What is the active ingredient?
- Insulin degludec, Liraglutide.
- Who is the labeler?
- Novo Nordisk, NDC labeler code 0169. The labeler is the company responsible for the label; it may be the manufacturer, a repackager or a distributor.
- What other NDCs exist for Xultophy 100/3.6?
- 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.