Prescription drug · ANDA
Liraglutide NDC 14403-3400
Liraglutide 18 mg/3mL · Injection, Solution · Subcutaneous · Hybio Pharmaceutical Co., Ltd. (Pingshan Factory)
NDC codes
FDA NDC Directory| Package NDC | 11-digit (billing) | Package | Copy |
|---|---|---|---|
| 14403-3400-1 | 14403340001 | 3 mL in 1 SYRINGE, PLASTIC (14403-3400-1)Marketed from Jun 21, 2024 |
How the 11-digit form is made: The package segment has 1 digit, so one leading zero is added to it (5-4-1 → 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 — 18 mg/3mL
- Dosage form
- Injection, Solution
- Route
- Subcutaneous
- Product type
- Prescription drug
- Marketing category
- ANDA — Abbreviated New Drug Application (generic)Application ANDA 215503
- Marketing start
- Listing expires
- Other FDA classes
- Glucagon-Like Peptide 1 (Chemical structure)Glucagon-like Peptide-1 (GLP-1) Agonists (Mechanism)
- Identifiers
- Product ID 14403-3400_1a36a385-111a-f5a9-e063-6294a90a29a7SPL ID 1a36a385-111a-f5a9-e063-6294a90a29a7SPL set ID 1a36b801-41e2-2eed-e063-6294a90a6f27RxCUI 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
N414403340001followed by a unit qualifier and the quantityPackage 14403-3400-01. 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)
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 should not be used in patients with type 1 diabetes mellitus. Liraglutide injection contains liraglutide and should not be coadministered with other liraglutide-containing products.
Excerpt only. Read the full label for complete information.
Other NDCs under ANDA 215503
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 | Hikma Pharmaceuticals USA Inc. | 0143-9144 |