Prescription drug · ANDA
Eszopiclone NDC 68180-322
Eszopiclone 1 mg/1 · Tablet, Film coated · Oral · Lupin Pharmaceuticals, Inc.
NDC codes
FDA NDC Directory| Package NDC | 11-digit (billing) | Package | Copy |
|---|---|---|---|
| 68180-322-01 | 68180032201 | 100 TABLET, FILM COATED in 1 BOTTLE (68180-322-01)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, Film coated
- Route
- Oral
- Labeler
- Lupin Pharmaceuticals, Inc.
- Product type
- Prescription drug
- Marketing category
- ANDA — Abbreviated New Drug Application (generic)Application ANDA 091124
- Marketing start
- Listing expires
- DEA schedule
- CIV
- Identifiers
- Product ID 68180-322_a3530781-6fea-425f-9958-eeb2d0b3c696SPL ID a3530781-6fea-425f-9958-eeb2d0b3c696SPL set ID 7068c455-691e-4c56-9857-b7b4e13f4784RxCUI 485440, 485442, 485465UNII UZX80K71OEUPC 0368180324010, 0368180323013, 0368180322016
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
N468180032201followed by a unit qualifier and the quantityPackage 68180-0322-01. 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. Eszopiclone tablet has been shown to decrease sleep latency and improve sleep maintenance ( 1 ) Eszopiclone tablet is 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 091124
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 1 mg/1 | Tablet, Film coatedOral | DIRECT RX | 72189-099 |
| Eszopiclone | Eszopiclone 2 mg/1 | Tablet, Film coatedOral | Lupin Pharmaceuticals, Inc. | 68180-323 |
| Eszopiclone | Eszopiclone 3 mg/1 | Tablet, Film coatedOral | Lupin Pharmaceuticals, Inc. | 68180-324 |
| Eszopiclone | Eszopiclone 1 mg/1 | Tablet, Film coatedOral | Advanced Rx of Tennessee, LLC | 80425-0098 |
| Eszopiclone | Eszopiclone 3 mg/1 | Tablet, Film coatedOral | Advanced Rx Pharmacy of Tennessee, LLC | 80425-0115 |
| Eszopiclone | Eszopiclone 3 mg/1 | Tablet, Film coatedOral | PD-Rx Pharmaceuticals, Inc. | 43063-795 |