Eszopiclone NDC 60429-633

NDC codes

FDA NDC Directory

Product NDC (as listed)60429-633Labeler and product segments. Claims need a package NDC.

Product NDC at billing width60429-0633Add 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
60429-633-30	60429063330	30 TABLET, FILM COATED in 1 BOTTLE, PLASTIC (60429-633-30)Marketed from Feb 22, 2021

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: Golden State Medical Supply, Inc.
Product type: Prescription drug
Marketing category: ANDA — Abbreviated New Drug Application (generic)Application ANDA 091151
Marketing start: Mar 26, 2013
Listing expires: Dec 31, 2026
DEA schedule: CIV
Identifiers: Product ID 60429-633_02e9fcb6-a4fc-ed47-e063-6394a90a7976SPL ID 02e9fcb6-a4fc-ed47-e063-6394a90a7976SPL set ID fef87d8d-f375-4b00-8765-957ef076bf1aRxCUI 485440, 485442, 485465UNII 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

N460429063330 followed by a unit qualifier and the quantity

Package 60429-0633-30. 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 Aug 14, 2023. 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 have 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 091151

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

FDA NDC Directory listings under ANDA 091151
Product	Strength	Form · route	Labeler	Product NDC
Eszopiclone	Eszopiclone 1 mg/1	Tablet, Film coatedOral	Mylan Pharmaceuticals Inc.	0378-5270
Eszopiclone	Eszopiclone 2 mg/1	Tablet, Film coatedOral	Mylan Pharmaceuticals Inc.	0378-5271
Eszopiclone	Eszopiclone 3 mg/1	Tablet, Film coatedOral	Mylan Pharmaceuticals Inc.	0378-5272
Eszopiclone	Eszopiclone 1 mg/1	Tablet, Film coatedOral	Golden State Medical Supply, Inc.	60429-632
Eszopiclone	Eszopiclone 3 mg/1	Tablet, Film coatedOral	Golden State Medical Supply, Inc.	60429-634