Eszopiclone NDC 70518-4361

NDC codes

FDA NDC Directory

Product NDC (as listed)70518-4361Labeler and product segments. Claims need a package NDC.

Product NDC at billing width70518-4361Add 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	Copy
70518-4361-0	70518436100	30 TABLET, FILM COATED in 1 BOTTLE, PLASTIC (70518-4361-0)Marketed from Jun 17, 2025
70518-4361-1	70518436101	90 TABLET, FILM COATED in 1 BOTTLE, PLASTIC (70518-4361-1)Marketed from Sep 19, 2025

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 — 2 mg/1
Dosage form: Tablet, Film coated
Route: Oral
Labeler: REMEDYREPACK INC.
Product type: Prescription drug
Marketing category: ANDA — Abbreviated New Drug Application (generic)Application ANDA 205504
Marketing start: Jun 17, 2025
Listing expires: Dec 31, 2027
DEA schedule: CIV
Identifiers: Product ID 70518-4361_5afd4081-4593-bf41-e063-6294a90a6abbSPL ID 5afd4081-4593-bf41-e063-6294a90a6abbSPL set ID 52ab8ee9-a04d-4e27-b0f4-eb050f144715RxCUI 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

N470518436100 followed by a unit qualifier and the quantity

Package 70518-4361-00. 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 Sep 8, 2026. 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 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.

Full label on DailyMed (opens in a new tab)

Other NDCs under ANDA 205504

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

FDA NDC Directory listings under ANDA 205504
Product	Strength	Form · route	Labeler	Product NDC
Eszopiclone	Eszopiclone 3 mg/1	Tablet, Film coatedOral	Camber Pharmaceuticals, Inc.	31722-857
Eszopiclone	Eszopiclone 1 mg/1	Tablet, Film coatedOral	Proficient Rx LP	82804-159
Eszopiclone	Eszopiclone 1 mg/1	Tablet, Film coatedOral	Camber Pharmaceuticals, Inc.	31722-855
Eszopiclone	Eszopiclone 2 mg/1	Tablet, Film coatedOral	Camber Pharmaceuticals, Inc.	31722-856