Eszopiclone NDC 55111-617

NDC codes

FDA NDC Directory

Product NDC (as listed)55111-617Labeler and product segments. Claims need a package NDC.

Product NDC at billing width55111-0617Add the package segment from the table below.

Package NDCs as listed with the FDA, and the 11-digit 5-4-2 form used on claims. The highlighted digit is the added leading zero.
Package NDC	11-digit (billing)	Package
55111-617-01	55111061701	100 TABLET, COATED in 1 BOTTLE (55111-617-01)Marketed from Apr 15, 2014
55111-617-05	55111061705	500 TABLET, COATED in 1 BOTTLE (55111-617-05)Marketed from Apr 15, 2014
55111-617-09	55111061709	9 BLISTER PACK in 1 CARTON (55111-617-09) / 10 TABLET, COATED in 1 BLISTER PACK (55111-617-79)Marketed from Apr 15, 2014
55111-617-30	55111061730	30 TABLET, COATED in 1 BOTTLE (55111-617-30)Marketed from Apr 15, 2014
55111-617-90	55111061790	90 TABLET, COATED in 1 BOTTLE (55111-617-90)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 — 3 mg/1
Dosage form: Tablet, Coated
Route: Oral
Labeler: Dr. Reddy's Laboratories Limited
Product type: Prescription drug
Marketing category: ANDA — Abbreviated New Drug Application (generic)Application ANDA 091024
Marketing start: Apr 15, 2014
Listing expires: Dec 31, 2026
DEA schedule: CIV
Identifiers: Product ID 55111-617_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

N455111061701 followed by a unit qualifier and the quantity

Package 55111-0617-01. 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 Dec 19, 2024. 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.

Full label on DailyMed (opens in a new tab)

Other NDCs under ANDA 091024

Products listed under the same FDA application: other strengths and forms, and repackagers who relabel the same product.

FDA NDC Directory listings under ANDA 091024
Product	Strength	Form · route	Labeler	Product NDC
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
Eszopiclone	Eszopiclone 2 mg/1	Tablet, CoatedOral	Dr. Reddy's Laboratories Limited	55111-619
Eszopiclone	Eszopiclone 1 mg/1	Tablet, CoatedOral	Dr. Reddy's Laboratories Limited	55111-629