Prescription drug · ANDA
Eszopiclone NDC 80425-0064
Eszopiclone 2 mg/1 · Tablet, Coated · Oral · Advanced Rx of Tennessee, LLC
NDC codes
FDA NDC Directory| Package NDC | 11-digit (billing) | Package | Copy |
|---|---|---|---|
| 80425-0064-1 | 80425006401 | 60 TABLET, COATED in 1 BOTTLE (80425-0064-1)Marketed from Apr 15, 2014 |
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)
- Eszopiclone
- Generic name (nonproprietary)
- eszopiclone
- Active ingredients
- Eszopiclone — 2 mg/1
- Dosage form
- Tablet, Coated
- Route
- Oral
- Product type
- Prescription drug
- Marketing category
- ANDA — Abbreviated New Drug Application (generic)Application ANDA 091024
- Marketing start
- Listing expires
- DEA schedule
- CIV
- Identifiers
- Product ID 80425-0064_2a98e7e8-3af2-c7e0-e063-6294a90ad4f3SPL ID 2a98e7e8-3af2-c7e0-e063-6294a90ad4f3SPL set ID af86ebdb-e47b-706a-e053-2995a90ad51cRxCUI 485442UNII UZX80K71OE
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
N480425006401followed by a unit qualifier and the quantityPackage 80425-0064-01. 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 . This label includes a boxed warning.
Indications (excerpt from the label)
1. Indications and Usage Section 1 INDICATIONS AND USAGE Eszopiclone tablets are indicated for the treatment of insomnia. In controlled outpatient and sleep laboratory studies, eszopiclone tablets are 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).
Excerpt only. Read the full label for complete information.
Other NDCs under ANDA 091024
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 |
|---|---|---|---|---|
| Eszopiclone | Eszopiclone 3 mg/1 | Tablet, CoatedOral | Advanced Rx of Tennessee, LLC | 80425-0067 |
| Eszopiclone | Eszopiclone 2 mg/1 | Tablet, CoatedOral | Dr. Reddy's Laboratories Limited | 55111-619 |
| Eszopiclone | Eszopiclone 3 mg/1 | Tablet, CoatedOral | Dr. Reddy's Laboratories Limited | 55111-617 |
| Eszopiclone | Eszopiclone 1 mg/1 | Tablet, CoatedOral | Dr. Reddy's Laboratories Limited | 55111-629 |