Prescription drug · ANDA
Liraglutide NDC 71288-563
Liraglutide 6 mg/mL · Injection · Subcutaneous · Meitheal Pharmaceuticals Inc.
NDC codes
FDA NDC Directory| Package NDC | 11-digit (billing) | Package | Copy |
|---|---|---|---|
| 71288-563-84 | 71288056384 | 3 SYRINGE, PLASTIC in 1 CARTON (71288-563-84) / 3 mL in 1 SYRINGE, PLASTICMarketed from Apr 2, 2025 | |
| 71288-563-85 | 71288056385 | 2 SYRINGE, PLASTIC in 1 CARTON (71288-563-85) / 3 mL in 1 SYRINGE, PLASTICMarketed from Apr 2, 2025 |
How the 11-digit form is made: The product segment has 3 digits, so one leading zero is added to it (5-3-2 → 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)
- Liraglutide
- Generic name (nonproprietary)
- liraglutide
- Active ingredients
- Liraglutide — 6 mg/mL
- Dosage form
- Injection
- Route
- Subcutaneous
- Product type
- Prescription drug
- Marketing category
- ANDA — Abbreviated New Drug Application (generic)Application ANDA 218115
- Marketing start
- Listing expires
- Other FDA classes
- Glucagon-Like Peptide 1 (Chemical structure)Glucagon-like Peptide-1 (GLP-1) Agonists (Mechanism)
- Identifiers
- Product ID 71288-563_a0bb0116-f90a-490b-9ca9-5bcd6210c763SPL ID a0bb0116-f90a-490b-9ca9-5bcd6210c763SPL set ID 0efc3a89-211a-4496-baab-e8265e07de2bRxCUI 897122UNII 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
N471288056384followed by a unit qualifier and the quantityPackage 71288-0563-84. 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)
Liraglutide Injection is indicated: as an adjunct to diet and exercise to improve glycemic control in adults and pediatric patients aged 10 years and older with type 2 diabetes mellitus. Limitations of Use : Liraglutide Injection contains liraglutide. Coadministration with other liraglutide-containing products is not recommended. Liraglutide Injection is a glucagon-like peptide-1 (GLP-1) receptor agonist indicated: as an adjunct to diet and exercise to improve glycemic control in adults and pediatric patients aged 10 years and older with type 2 diabetes mellitus ( 1 ). Limitations of Use : Coadministration with other liraglutide-containing products is not recommended.
Excerpt only. Read the full label for complete information.
Other NDCs under ANDA 218115
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 |
|---|---|---|---|---|
| Liraglutide | Liraglutide 6 mg/mL | InjectionSubcutaneous | NorthStar Rx LLC | 72603-745 |