Prescription drug · ANDA
Eszopiclone NDC 76420-352
Eszopiclone 1 mg/1 · Tablet, Film coated · Oral · Asclemed USA, Inc.
NDC codes
FDA NDC Directory| Package NDC | 11-digit (billing) | Package | Copy |
|---|---|---|---|
| 76420-352-00 | 76420035200 | 1000 TABLET, FILM COATED in 1 BOTTLE (76420-352-00)Marketed from May 22, 2025 | |
| 76420-352-01 | 76420035201 | 100 TABLET, FILM COATED in 1 BOTTLE (76420-352-01)Marketed from May 22, 2025 | |
| 76420-352-30 | 76420035230 | 30 TABLET, FILM COATED in 1 BOTTLE (76420-352-30)Marketed from May 22, 2025 | |
| 76420-352-60 | 76420035260 | 60 TABLET, FILM COATED in 1 BOTTLE (76420-352-60)Marketed from May 22, 2025 | |
| 76420-352-90 | 76420035290 | 90 TABLET, FILM COATED in 1 BOTTLE (76420-352-90)Marketed from May 22, 2025 |
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
- Asclemed USA, Inc.
- Product type
- Prescription drug
- Marketing category
- ANDA — Abbreviated New Drug Application (generic)Application ANDA 091166
- Marketing start
- Listing expires
- DEA schedule
- CIV
- Identifiers
- Product ID 76420-352_4ca4de13-a880-98bf-e063-6294a90aa9f2SPL ID 4ca4de13-a880-98bf-e063-6294a90aa9f2SPL set ID 838559f7-4b69-4831-bf50-ab37c6c24c2bRxCUI 485440, 485442, 485465UNII 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
N476420035200followed by a unit qualifier and the quantityPackage 76420-0352-00. 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)
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 have been shown to decrease sleep latency and improve sleep maintenance ( 1 ).…
Excerpt only. Read the full label for complete information.
Other NDCs under ANDA 091166
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, Film coatedOropharyngeal | Proficient Rx LP | 71205-633 |
| Eszopiclone | Eszopiclone 2 mg/1 | Tablet, Film coatedOral | Bryant Ranch Prepack | 71335-0512 |
| Eszopiclone | Eszopiclone 2 mg/1 | Tablet, Film coatedOral | Asclemed USA, Inc. | 76420-353 |
| Eszopiclone | Eszopiclone 3 mg/1 | Tablet, Film coatedOral | Asclemed USA, Inc. | 76420-354 |
| Eszopiclone | Eszopiclone 1 mg/1 | Tablet, Film coatedOral | Bryant Ranch Prepack | 71335-0574 |
| Eszopiclone | Eszopiclone 3 mg/1 | Tablet, Film coatedOropharyngeal | NuCare Pharmaceuticals,Inc. | 68071-2403 |
| Eszopiclone | Eszopiclone 1 mg/1 | Tablet, Film coatedOral | Preferred Pharmaceuticals Inc. | 68788-8387 |
| Eszopiclone | Eszopiclone 1 mg/1 | Tablet, Film coatedOral | Glenmark Pharmaceuticals Inc. USA | 68462-382 |
| Eszopiclone | Eszopiclone 2 mg/1 | Tablet, Film coatedOral | Glenmark Pharmaceuticals Inc. USA | 68462-383 |
| Eszopiclone | Eszopiclone 3 mg/1 | Tablet, Film coatedOropharyngeal | Bryant Ranch Prepack | 71335-2002 |
| Eszopiclone | Eszopiclone 3 mg/1 | Tablet, Film coatedOral | Glenmark Pharmaceuticals Inc. USA | 68462-384 |
| Eszopiclone | Eszopiclone 2 mg/1 | Tablet, Film coatedOral | Proficient Rx LP | 82804-076 |
| Eszopiclone | Eszopiclone 2 mg/1 | Tablet, Film coatedOral | St Mary's Medical Park Pharmacy | 60760-526 |
| Eszopiclone | Eszopiclone 1 mg/1 | Tablet, Film coatedOral | Advanced Rx of Tennessee, LLC | 80425-0407 |
| Eszopiclone | Eszopiclone 1 mg/1 | Tablet, Film coatedOral | Proficient Rx LP | 71205-581 |