Prescription drug · NDA
Byetta (Exenatide) NDC 0310-6524
Exenatide 250 ug/mL · Injection · Subcutaneous · AstraZeneca Pharmaceuticals LP
NDC codes
FDA NDC Directory| Package NDC | 11-digit (billing) | Package | Copy |
|---|---|---|---|
| 0310-6524-01 | 00310652401 | 1 CARTRIDGE in 1 CARTON (0310-6524-01) / 2.4 mL in 1 CARTRIDGEMarketed from Dec 12, 2014 |
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)
- Byetta
- Generic name (nonproprietary)
- exenatide
- Active ingredients
- Exenatide — 250 ug/mL
- Dosage form
- Injection
- Route
- Subcutaneous
- Labeler
- AstraZeneca Pharmaceuticals LPNDC labeler code 0310
- Product type
- Prescription drug
- Marketing category
- NDA — New Drug ApplicationApplication NDA 021773
- Marketing start
- Marketing end
- Other FDA classes
- Glucagon-Like Peptide 1 (Chemical structure)Glucagon-like Peptide-1 (GLP-1) Agonists (Mechanism)
- Identifiers
- Product ID 0310-6524_7333a7dd-9449-4c61-b36d-c5d8d7cc239bSPL ID 7333a7dd-9449-4c61-b36d-c5d8d7cc239bSPL set ID 53d03c03-ebf7-418d-88a8-533eabd2ee4fRxCUI 847910, 847913, 847915, 847917UNII 9P1872D4OL
- 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
N400310652401followed by a unit qualifier and the quantityPackage 00310-6524-01. 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)
BYETTA is indicated as an adjunct to diet and exercise to improve glycemic control in adults with type 2 diabetes mellitus. Limitations of Use • BYETTA contains exenatide. Coadministration with other exenatide-containing products is not recommended. BYETTA (exenatide) is 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 , 14 ) Limitations of Use • Coadministration with other exenatide-containing products is not recommended ( 1 ).
Excerpt only. Read the full label for complete information.
About NDC 0310-6524
- What is NDC 0310-6524?
- 0310-6524 is the product NDC for Byetta (exenatide), Exenatide 250 ug/mL injection, listed with the FDA by AstraZeneca Pharmaceuticals LP. It has 1 package NDC, shown above in 10- and 11-digit form.
- What drug is associated with this NDC?
- Byetta (Exenatide).
- What is the active ingredient?
- Exenatide.
- Who is the labeler?
- AstraZeneca Pharmaceuticals LP, NDC labeler code 0310. The labeler is the company responsible for the label; it may be the manufacturer, a repackager or a distributor.
- What other NDCs exist for Byetta?
- 1 other product NDC are listed under this name. See all Byetta NDCs.
- Is there a related HCPCS / J-code?
- Not in Med-Code's curated HCPCS directory. See Billing references above.
Related NDCs: other Byetta products
Other finished products listed under the same name: strengths, forms and labelers.
| Product | Strength | Form · route | Labeler | Product NDC | Package NDCs (11-digit) |
|---|---|---|---|---|---|
| Byettaexenatide | Exenatide 250 ug/mL | InjectionSubcutaneous | AstraZeneca Pharmaceuticals LP | 0310-6512 | 00310-6512-01 |
Other NDCs under NDA 021773
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 |
|---|---|---|---|---|
| Byettaexenatide | Exenatide 250 ug/mL | InjectionSubcutaneous | AstraZeneca Pharmaceuticals LP | 0310-6512 |