Prescription drug · NDA
Saxenda (liraglutide) NDC 0169-2800
Liraglutide 6 mg/mL · Injection, Solution · Subcutaneous · Novo Nordisk Pharmaceutical Industries, LP
NDC codes
FDA NDC Directory| Package NDC | 11-digit (billing) | Package | Copy |
|---|---|---|---|
| 0169-2800-15 | 00169280015 | 5 SYRINGE, PLASTIC in 1 CARTON (0169-2800-15) / 3 mL in 1 SYRINGE, PLASTICMarketed from Jan 19, 2015 | |
| 0169-2800-90 | 00169280090 | 1 SYRINGE, PLASTIC in 1 CARTON (0169-2800-90) / 3 mL in 1 SYRINGE, PLASTICMarketed from Jan 19, 2015 | |
| 0169-2800-97 | 00169280097 | 1 SYRINGE, PLASTIC in 1 CARTON (0169-2800-97) / 3 mL in 1 SYRINGE, PLASTICMarketed from Jan 19, 2015 |
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)
- Saxenda
- Generic name (nonproprietary)
- liraglutide
- Active ingredients
- Liraglutide — 6 mg/mL
- Dosage form
- Injection, Solution
- Route
- Subcutaneous
- Product type
- Prescription drug
- Marketing category
- NDA — New Drug ApplicationApplication NDA 206321
- Marketing start
- Listing expires
- Other FDA classes
- Glucagon-Like Peptide 1 (Chemical structure)Glucagon-like Peptide-1 (GLP-1) Agonists (Mechanism)
- Identifiers
- Product ID 0169-2800_7e183945-550d-4b6a-bf4e-300193517cacSPL ID 7e183945-550d-4b6a-bf4e-300193517cacSPL set ID 3946d389-0926-4f77-a708-0acb8153b143RxCUI 1598268, 2735350UNII 839I73S42A
- Pharmacologic class
- GLP-1 Receptor Agonist
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
N400169280015followed by a unit qualifier and the quantityPackage 00169-2800-15. 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)
SAXENDA is indicated in combination with a reduced calorie diet and increased physical activity to reduce excess body weight and maintain weight reduction long term in: • Adults and pediatric patients aged 12 years and older with body weight greater than 60 kg and obesity. • Adults with overweight in the presence of at least one weight-related comorbid condition. Limitations of Use • SAXENDA contains liraglutide. Coadministration with other liraglutide-containing products or with any other glucagon-like peptide-1 (GLP-1) receptor agonist is not recommended. • The safety and effectiveness of SAXENDA in pediatric patients with type 2 diabetes have not been established. SAXENDA is a glucagon li…
Excerpt only. Read the full label for complete information.
Other NDCs under NDA 206321
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 |
|---|---|---|---|---|
| Saxendaliraglutide | Liraglutide 6 mg/mL | Injection, SolutionSubcutaneous | A-S Medication Solutions | 50090-4257 |