Prescription drug · NDA
Lunesta (Eszopiclone) NDC 80725-010
Eszopiclone 1 mg/1 · Tablet, Coated · Oral · Waylis Therapeutics LLC
NDC codes
FDA NDC Directory| Package NDC | 11-digit (billing) | Package | Copy |
|---|---|---|---|
| 80725-010-30 | 80725001030 | 30 TABLET, COATED in 1 BOTTLE (80725-010-30)Marketed from Aug 15, 2023 |
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)
- Lunesta
- Generic name (nonproprietary)
- eszopiclone
- Active ingredients
- Eszopiclone — 1 mg/1
- Dosage form
- Tablet, Coated
- Route
- Oral
- Labeler
- Waylis Therapeutics LLCNDC labeler code 80725
- Product type
- Prescription drug
- Marketing category
- NDA — New Drug ApplicationApplication NDA 021476
- Marketing start
- Listing expires
- DEA schedule
- CIV
- Identifiers
- Product ID 80725-010_4a1b20fc-a41d-41dd-a557-fa9333bb5c3bSPL ID 4a1b20fc-a41d-41dd-a557-fa9333bb5c3bSPL set ID 3821f4b7-a3c8-4920-ba80-18aa96532c09RxCUI 485440, 485442, 485465, 540407, 540409, 540411UNII UZX80K71OEUPC 0380725010301, 0380725012305, 0380725011308
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 HCPCS code in Med-Code's directory. Oral products like this are usually dispensed by a pharmacy and billed by NDC.
- NDC on a medical claim
N480725001030followed by a unit qualifier and the quantityPackage 80725-0010-30. 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)
LUNESTA ® (eszopiclone) is indicated for the treatment of insomnia. In controlled outpatient and sleep laboratory studies, LUNESTA administered at bedtime decreased sleep latency and improved sleep maintenance. The clinical trials performed in support of efficacy were up to 6 months in duration. The final formal assessments of sleep latency and maintenance were performed at 4 weeks in the 6-week study (adults only), at the end of both 2-week studies (elderly only) and at the end of the 6-month study (adults only). LUNESTA is indicated for the treatment of insomnia. LUNESTA has been shown to decrease sleep latency and improve sleep maintenance ( 1 )
Excerpt only. Read the full label for complete information.
About NDC 80725-010
- What is NDC 80725-010?
- 80725-010 is the product NDC for Lunesta (eszopiclone), Eszopiclone 1 mg/1 tablet, coated, listed with the FDA by Waylis Therapeutics LLC. It has 1 package NDC, shown above in 10- and 11-digit form.
- What drug is associated with this NDC?
- Lunesta (Eszopiclone).
- What is the active ingredient?
- Eszopiclone.
- Who is the labeler?
- Waylis Therapeutics LLC, NDC labeler code 80725. The labeler is the company responsible for the label; it may be the manufacturer, a repackager or a distributor.
- What other NDCs exist for Lunesta?
- 2 other product NDCs are listed under this name. See all Lunesta NDCs.
- Is there a related HCPCS / J-code?
- Not in Med-Code's curated HCPCS directory. See Billing references above.
Related NDCs: other Lunesta products
Other finished products listed under the same name: strengths, forms and labelers.
| Product | Strength | Form · route | Labeler | Product NDC | Package NDCs (11-digit) |
|---|---|---|---|---|---|
| Lunestaeszopiclone | Eszopiclone 2 mg/1 | Tablet, CoatedOral | Waylis Therapeutics LLC | 80725-011 | 80725-0011-30 |
| Lunestaeszopiclone | Eszopiclone 3 mg/1 | Tablet, CoatedOral | Waylis Therapeutics LLC | 80725-012 | 80725-0012-30 |
Other NDCs under NDA 021476
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 |
|---|---|---|---|---|
| Lunestaeszopiclone | Eszopiclone 2 mg/1 | Tablet, CoatedOral | Waylis Therapeutics LLC | 80725-011 |
| Lunestaeszopiclone | Eszopiclone 3 mg/1 | Tablet, CoatedOral | Waylis Therapeutics LLC | 80725-012 |