Eszopiclone NDC 0093-5539

NDC codes

FDA NDC Directory

Product NDC (as listed)0093-5539Labeler and product segments. Claims need a package NDC.

Product NDC at billing width00093-5539Add 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
0093-5539-01	00093553901	100 TABLET, FILM COATED in 1 BOTTLE (0093-5539-01)Marketed from Apr 14, 2014

How the 11-digit form is made: The labeler segment has 4 digits, so one leading zero is added to it (4-4-2 → 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, Film coated
Route: Oral
Labeler: Teva Pharmaceuticals USA, Inc.
Product type: Prescription drug
Marketing category: ANDA — Abbreviated New Drug Application (generic)Application ANDA 091169
Marketing start: Apr 14, 2014
Marketing end: Feb 28, 2027
DEA schedule: CIV
Identifiers: Product ID 0093-5539_efcf4106-ac0a-4f8b-bcd0-743e45e66924SPL ID efcf4106-ac0a-4f8b-bcd0-743e45e66924SPL set ID 2435e2f1-bc52-488f-80e9-f1758e354aaeRxCUI 485440, 485442, 485465UNII UZX80K71OEUPC 0300935538013, 0300935539010, 0300935537566

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

N400093553901 followed by a unit qualifier and the quantity

Package 00093-5539-01. 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 Aug 1, 2021. 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 091169

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

FDA NDC Directory listings under ANDA 091169
Product	Strength	Form · route	Labeler	Product NDC
Eszopiclone	Eszopiclone 2 mg/1	Tablet, Film coatedOral	Teva Pharmaceuticals USA, Inc.	0093-5538
Eszopiclone	Eszopiclone 1 mg/1	Tablet, Film coatedOral	Teva Pharmaceuticals USA, Inc.	0093-5537
Eszopiclone	Eszopiclone 3 mg/1	Tablet, Film coatedOral	Aphena Pharma Solutions - Tennessee, LLC	71610-409