Prescription drug · ANDA
Eszopiclone NDC 55700-581
Eszopiclone 2 mg/1 · Tablet, Film coated · Oral · Quality Care Products LLC
NDC codes
FDA NDC Directory| Package NDC | 11-digit (billing) | Package | Copy |
|---|---|---|---|
| 55700-581-30 | 55700058130 | 30 TABLET, FILM COATED in 1 BOTTLE (55700-581-30)Marketed from Jan 19, 2018 |
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 — 2 mg/1
- Dosage form
- Tablet, Film coated
- Route
- Oral
- Labeler
- Quality Care Products LLC
- Product type
- Prescription drug
- Marketing category
- ANDA — Abbreviated New Drug Application (generic)Application ANDA 202929
- Marketing start
- Marketing end
- DEA schedule
- CIV
- Identifiers
- Product ID 55700-581_7bdcb296-7e0f-499b-8479-ea922a9bd654SPL ID 7bdcb296-7e0f-499b-8479-ea922a9bd654SPL set ID 7832f554-2b82-4ef2-b1ef-266179f271d3RxCUI 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
N455700058130followed by a unit qualifier and the quantityPackage 55700-0581-30. 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 ( 1 )…
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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