Prescription drug · ANDA
Eszopiclone NDC 80425-0168
Eszopiclone 1 mg/1 · Tablet, Film coated · Oral · Advanced Rx Pharmacy of Tennessee, LLC
NDC codes
FDA NDC Directory| Package NDC | 11-digit (billing) | Package | Copy |
|---|---|---|---|
| 80425-0168-1 | 80425016801 | 30 TABLET, FILM COATED in 1 BOTTLE (80425-0168-1)Marketed from Apr 5, 2023 | |
| 80425-0168-2 | 80425016802 | 60 TABLET, FILM COATED in 1 BOTTLE (80425-0168-2)Marketed from Jan 31, 2015 | |
| 80425-0168-3 | 80425016803 | 90 TABLET, FILM COATED in 1 BOTTLE (80425-0168-3)Marketed from Jan 31, 2015 |
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 — 1 mg/1
- Dosage form
- Tablet, Film coated
- Route
- Oral
- Product type
- Prescription drug
- Marketing category
- ANDA — Abbreviated New Drug Application (generic)Application ANDA 202929
- Marketing start
- Listing expires
- DEA schedule
- CIV
- Identifiers
- Product ID 80425-0168_2a99e9e8-3d16-ee0b-e063-6294a90ae4efSPL ID 2a99e9e8-3d16-ee0b-e063-6294a90ae4efSPL set ID c8ae09eb-4c9b-4560-e053-2995a90a02b1RxCUI 485440UNII 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
N480425016801followed by a unit qualifier and the quantityPackage 80425-0168-01. 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 INDICATIONS & USAGE 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).
Excerpt only. Read the full label for complete information.
Other NDCs under ANDA 202929
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 | Preferred Pharmaceuticals Inc. | 68788-7029 |
| Eszopiclone | Eszopiclone 1 mg/1 | Tablet, Film coatedOral | Preferred Pharmaceuticals Inc. | 68788-8826 |
| Eszopiclone | Eszopiclone 2 mg/1 | Tablet, Film coatedOral | DIRECT RX | 61919-033 |
| Eszopiclone | Eszopiclone 2 mg/1 | Tablet, Film coatedOral | Bryant Ranch Prepack | 71335-2698 |
| Eszopiclone | Eszopiclone 3 mg/1 | Tablet, Film coatedOral | NuCarePharmaceuticals, Inc. | 68071-3376 |
| Eszopiclone | Eszopiclone 3 mg/1 | Tablet, Film coatedOral | Asclemed USA, Inc. | 76420-027 |
| Eszopiclone | Eszopiclone 2 mg/1 | Tablet, Film coatedOral | Asclemed USA, Inc. | 76420-024 |
| Eszopiclone | Eszopiclone 1 mg/1 | Tablet, Film coatedOral | Asclemed USA, Inc. | 76420-026 |
| Eszopiclone | Eszopiclone 1 mg/1 | Tablet, Film coatedOral | Bryant Ranch Prepack | 71335-0598 |
| Eszopiclone | Eszopiclone 1 mg/1 | Tablet, Film coatedOral | Proficient Rx LP | 63187-817 |
| Eszopiclone | Eszopiclone 3 mg/1 | Tablet, Film coatedOral | Preferred Pharmaceuticals Inc. | 68788-7169 |
| Eszopiclone | Eszopiclone 3 mg/1 | Tablet, Film coatedOral | Advanced Rx of Tennessee, LLC | 80425-0065 |
| Eszopiclone | Eszopiclone 2 mg/1 | Tablet, Film coatedOral | Advanced Rx of Tennessee, LLC | 80425-0062 |
| Eszopiclone | Eszopiclone 2 mg/1 | Tablet, Film coatedOral | Bryant Ranch Prepack | 71335-0089 |
| Eszopiclone | Eszopiclone 3 mg/1 | Tablet, Film coatedOral | Proficient Rx LP | 63187-843 |
| Eszopiclone | Eszopiclone 3 mg/1 | Tablet, Film coatedOral | Bryant Ranch Prepack | 71335-0116 |
| Eszopiclone | Eszopiclone 3 mg/1 | Tablet, Film coatedOral | Macleods Pharmaceuticals Limited | 33342-301 |
| Eszopiclone | Eszopiclone 1 mg/1 | Tablet, Film coatedOral | Macleods Pharmaceuticals Limited | 33342-299 |
| Eszopiclone | Eszopiclone 2 mg/1 | Tablet, Film coatedOral | Macleods Pharmaceuticals Limited | 33342-300 |
| Eszopiclone | Eszopiclone 3 mg/1 | Tablet, Film coatedOral | Quality Care Products LLC | 55700-610 |
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