Prescription drug · ANDA
Eszopiclone NDC 82804-159
Eszopiclone 1 mg/1 · Tablet, Film coated · Oral · Proficient Rx LP
NDC codes
FDA NDC Directory| Package NDC | 11-digit (billing) | Package | Copy |
|---|---|---|---|
| 82804-159-30 | 82804015930 | 30 TABLET, FILM COATED in 1 BOTTLE (82804-159-30)Marketed from Feb 6, 2026 | |
| 82804-159-60 | 82804015960 | 60 TABLET, FILM COATED in 1 BOTTLE (82804-159-60)Marketed from Mar 12, 2025 | |
| 82804-159-90 | 82804015990 | 90 TABLET, FILM COATED in 1 BOTTLE (82804-159-90)Marketed from Oct 11, 2024 |
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)
- Eszopiclone
- Generic name (nonproprietary)
- eszopiclone
- Active ingredients
- Eszopiclone — 1 mg/1
- Dosage form
- Tablet, Film coated
- Route
- Oral
- Labeler
- Proficient Rx LPNDC labeler code 82804
- Product type
- Prescription drug
- Marketing category
- ANDA — Abbreviated New Drug Application (generic)Application ANDA 205504
- Marketing start
- Listing expires
- DEA schedule
- CIV
- Identifiers
- Product ID 82804-159_b36c020d-b30c-45b8-b5af-1c07a29ac3d0SPL ID b36c020d-b30c-45b8-b5af-1c07a29ac3d0SPL set ID dd7e4bab-8e25-4788-89e4-6b391f9596feRxCUI 485440UNII UZX80K71OEUPC 0382804159901
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
N482804015930followed by a unit qualifier and the quantityPackage 82804-0159-30. 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 .
Indications (excerpt from the label)
Eszopiclone tablets are indicated for the treatment of insomnia. In controlled outpatient and sleep laboratory studies, eszopiclone tablets 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). Eszopiclone tablets are indicated for the treatment of insomnia. Eszopiclone tablets has been shown to decrease sleep latency and improve sleep maintenance ( Error! Hyperl…
Excerpt only. Read the full label for complete information.
About NDC 82804-159
- What is NDC 82804-159?
- 82804-159 is the product NDC for Eszopiclone, Eszopiclone 1 mg/1 tablet, film coated, listed with the FDA by Proficient Rx LP. It has 3 package NDCs, shown above in 10- and 11-digit form.
- What drug is associated with this NDC?
- Eszopiclone.
- What is the active ingredient?
- Eszopiclone.
- Who is the labeler?
- Proficient Rx LP, NDC labeler code 82804. The labeler is the company responsible for the label; it may be the manufacturer, a repackager or a distributor.
- What other NDCs exist for Eszopiclone?
- 89 other product NDCs are listed under this name. See all Eszopiclone NDCs.
- Is there a related HCPCS / J-code?
- Not in Med-Code's curated HCPCS directory. See Billing references above.
Related NDCs: other Eszopiclone products
Other finished products listed under the same name: strengths, forms and labelers.
| Product | Strength | Form · route | Labeler | Product NDC | Package NDCs (11-digit) |
|---|---|---|---|---|---|
| Eszopiclone | Eszopiclone 2 mg/1 | Tablet, Film coatedOral | REMEDYREPACK INC. | 70518-4398 | 70518-4398-00 |
| Eszopiclone | Eszopiclone 2 mg/1 | Tablet, Film coatedOral | REMEDYREPACK INC. | 70518-4361 | 70518-4361-0070518-4361-01 |
| Eszopiclone | Eszopiclone 1 mg/1 | Tablet, Film coatedOral | Preferred Pharmaceuticals Inc. | 68788-8826 | 68788-8826-0368788-8826-06 |
| Eszopiclone | Eszopiclone 1 mg/1 | Tablet, Film coatedOral | Advanced Rx of Tennessee, LLC | 80425-0407 | 80425-0407-0180425-0407-0280425-0407-03 |
| Eszopiclone | Eszopiclone 1 mg/1 | Tablet, Film coatedOral | Camber Pharmaceuticals, Inc. | 31722-855 | 31722-0855-0131722-0855-30 |
| Eszopiclone | Eszopiclone 2 mg/1 | Tablet, Film coatedOral | Camber Pharmaceuticals, Inc. | 31722-856 | 31722-0856-0131722-0856-30 |
| Eszopiclone | Eszopiclone 3 mg/1 | Tablet, Film coatedOral | Camber Pharmaceuticals, Inc. | 31722-857 | 31722-0857-0131722-0857-30 |
| Eszopiclone | Eszopiclone 1 mg/1 | Tablet, Film coatedOral | Preferred Pharmaceuticals Inc. | 68788-8387 | 68788-8387-0368788-8387-06 |
| Eszopiclone | Eszopiclone 3 mg/1 | Tablet, Film coatedOral | REMEDYREPACK INC. | 70518-3576 | 70518-3576-0070518-3576-0170518-3576-02 |
| Eszopiclone | Eszopiclone 1 mg/1 | Tablet, Film coatedOral | Bionpharma Inc. | 69452-347 | 69452-0347-1369452-0347-20 |
Other NDCs under ANDA 205504
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 2 mg/1 | Tablet, Film coatedOral | REMEDYREPACK INC. | 70518-4361 |
| Eszopiclone | Eszopiclone 1 mg/1 | Tablet, Film coatedOral | Camber Pharmaceuticals, Inc. | 31722-855 |
| Eszopiclone | Eszopiclone 2 mg/1 | Tablet, Film coatedOral | Camber Pharmaceuticals, Inc. | 31722-856 |
| Eszopiclone | Eszopiclone 3 mg/1 | Tablet, Film coatedOral | Camber Pharmaceuticals, Inc. | 31722-857 |