Prescription drug · ANDA
Eszopiclone NDC 55111-629
Eszopiclone 1 mg/1 · Tablet, Coated · Oral · Dr. Reddy's Laboratories Limited
NDC codes
FDA NDC Directory| Package NDC | 11-digit (billing) | Package | Copy |
|---|---|---|---|
| 55111-629-01 | 5511106290155111062901 | 100 TABLET, COATED in 1 BOTTLE (55111-629-01)Marketed from Apr 15, 2014 | |
| 55111-629-05 | 5511106290555111062905 | 500 TABLET, COATED in 1 BOTTLE (55111-629-05)Marketed from Apr 15, 2014 | |
| 55111-629-30 | 5511106293055111062930 | 30 TABLET, COATED in 1 BOTTLE (55111-629-30)Marketed from Apr 15, 2014 |
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, Coated
- Route
- Oral
- Labeler
- Dr. Reddy's Laboratories LimitedNDC labeler code 55111
- 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 55111-629_bf1433f5-bde8-8c67-9ff7-ec5d3ed26581SPL ID bf1433f5-bde8-8c67-9ff7-ec5d3ed26581SPL set ID 0b363b90-93dc-1fc1-0501-d140dfc762c7RxCUI 485440, 485442, 485465UNII UZX80K71OEUPC 0355111617013, 0355111629306, 0355111619017
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
N455111062901followed by a unit qualifier and the quantityPackage 55111-0629-01. 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)
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). Eszopiclone tablets are indicated for the treatment of insomnia. Eszopiclone has been shown to decrease sleep latency and improve sleep maintenance (1)…
Excerpt only. Read the full label for complete information.
About NDC 55111-629
- What is NDC 55111-629?
- 55111-629 is the product NDC for Eszopiclone, Eszopiclone 1 mg/1 tablet, coated, listed with the FDA by Dr. Reddy's Laboratories Limited. 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?
- Dr. Reddy's Laboratories Limited, NDC labeler code 55111. 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?
- 87 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 | Proficient Rx LP | 82804-159 | 82804-0159-3082804-0159-6082804-0159-90 |
| 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 |
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 | Dr. Reddy's Laboratories Limited | 55111-617 |
| Eszopiclone | Eszopiclone 2 mg/1 | Tablet, CoatedOral | Dr. Reddy's Laboratories Limited | 55111-619 |
| Eszopiclone | Eszopiclone 2 mg/1 | Tablet, CoatedOral | Advanced Rx of Tennessee, LLC | 80425-0064 |
| Eszopiclone | Eszopiclone 3 mg/1 | Tablet, CoatedOral | Advanced Rx of Tennessee, LLC | 80425-0067 |