What is NDC 80425-0407?

80425-0407 is the product NDC for Eszopiclone, Eszopiclone 1 mg/1 tablet, film coated, listed with the FDA by Advanced Rx of Tennessee, LLC. It has 3 package NDCs, shown above in 10- and 11-digit form.

Advanced Rx of Tennessee, LLC, NDC labeler code 80425. The labeler is the company responsible for the label; it may be the manufacturer, a repackager or a distributor.

What other NDCs exist for Eszopiclone?

88 other product NDCs are listed under this name.

Is there a related HCPCS / J-code?

Not in Med-Code's curated HCPCS directory.

Eszopiclone NDC 80425-0407 | National Drug Code

NDC codes

FDA NDC Directory

Product NDC (as listed)80425-0407Labeler and product segments. Claims need a package NDC.

Product NDC at billing width80425-0407Add 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
80425-0407-1	80425040701	30 TABLET, FILM COATED in 1 BOTTLE (80425-0407-1)Marketed from Jun 24, 2024
80425-0407-2	80425040702	60 TABLET, FILM COATED in 1 BOTTLE (80425-0407-2)Marketed from Jun 24, 2024
80425-0407-3	80425040703	90 TABLET, FILM COATED in 1 BOTTLE (80425-0407-3)Marketed from Jun 24, 2024

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 — 1 mg/1
Dosage form: Tablet, Film coated
Route: Oral
Labeler: Advanced Rx of Tennessee, LLCNDC labeler code 80425
Product type: Prescription drug
Marketing category: ANDA — Abbreviated New Drug Application (generic)Application ANDA 091166
Marketing start: Jun 24, 2024
Listing expires: Dec 31, 2026
DEA schedule: CIV
Identifiers: Product ID 80425-0407_1baa56ec-7eaf-dda0-e063-6394a90af453SPL ID 1baa56ec-7eaf-dda0-e063-6394a90af453SPL set ID 1baa56e5-34d5-c8a1-e063-6394a90ae6c7RxCUI 485440UNII 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

N480425040701 followed by a unit qualifier and the quantity

Package 80425-0407-01. 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 Jun 24, 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 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)

About NDC 80425-0407

What is NDC 80425-0407?: 80425-0407 is the product NDC for Eszopiclone, Eszopiclone 1 mg/1 tablet, film coated, listed with the FDA by Advanced Rx of Tennessee, LLC. It has 3 package NDCs, shown above in 10- and 11-digit form.
What drug is associated with this NDC?: Eszopiclone.
What is the active ingredient?: Eszopiclone.
Who is the labeler?: Advanced Rx of Tennessee, LLC, NDC labeler code 80425. The labeler is the company responsible for the label; it may be the manufacturer, a repackager or a distributor.
What other NDCs exist for Eszopiclone?: 88 other product NDCs are listed under this name. See all Eszopiclone NDCs.
Is there a related HCPCS / J-code?: Not in Med-Code's curated HCPCS directory. See Billing references above.

Other finished products listed under the same name: strengths, forms and labelers.

Other Eszopiclone NDCs
Product	Strength	Form · route	Labeler	Product NDC	Package NDCs (11-digit)
Eszopiclone	Eszopiclone 2 mg/1	Tablet, Film coatedOral	REMEDYREPACK INC.	70518-4398	70518-4398-00
Eszopiclone	Eszopiclone 2 mg/1	Tablet, Film coatedOral	REMEDYREPACK INC.	70518-4361	70518-4361-0070518-4361-01
Eszopiclone	Eszopiclone 1 mg/1	Tablet, Film coatedOral	Preferred Pharmaceuticals Inc.	68788-8826	68788-8826-0368788-8826-06
Eszopiclone	Eszopiclone 1 mg/1	Tablet, Film coatedOral	Camber Pharmaceuticals, Inc.	31722-855	31722-0855-0131722-0855-30
Eszopiclone	Eszopiclone 2 mg/1	Tablet, Film coatedOral	Camber Pharmaceuticals, Inc.	31722-856	31722-0856-0131722-0856-30
Eszopiclone	Eszopiclone 3 mg/1	Tablet, Film coatedOral	Camber Pharmaceuticals, Inc.	31722-857	31722-0857-0131722-0857-30
Eszopiclone	Eszopiclone 1 mg/1	Tablet, Film coatedOral	Proficient Rx LP	82804-159	82804-0159-3082804-0159-6082804-0159-90
Eszopiclone	Eszopiclone 1 mg/1	Tablet, Film coatedOral	Preferred Pharmaceuticals Inc.	68788-8387	68788-8387-0368788-8387-06
Eszopiclone	Eszopiclone 3 mg/1	Tablet, Film coatedOral	REMEDYREPACK INC.	70518-3576	70518-3576-0070518-3576-0170518-3576-02
Eszopiclone	Eszopiclone 1 mg/1	Tablet, Film coatedOral	Bionpharma Inc.	69452-347	69452-0347-1369452-0347-20

All 89 Eszopiclone NDCs

Other NDCs under ANDA 091166

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

FDA NDC Directory listings under ANDA 091166
Product	Strength	Form · route	Labeler	Product NDC
Eszopiclone	Eszopiclone 2 mg/1	Tablet, Film coatedOral	St Mary's Medical Park Pharmacy	60760-526
Eszopiclone	Eszopiclone 3 mg/1	Tablet, Film coatedOropharyngeal	NuCare Pharmaceuticals,Inc.	68071-2403
Eszopiclone	Eszopiclone 1 mg/1	Tablet, Film coatedOral	Glenmark Pharmaceuticals Inc. USA	68462-382
Eszopiclone	Eszopiclone 2 mg/1	Tablet, Film coatedOral	Glenmark Pharmaceuticals Inc. USA	68462-383
Eszopiclone	Eszopiclone 3 mg/1	Tablet, Film coatedOral	Glenmark Pharmaceuticals Inc. USA	68462-384
Eszopiclone	Eszopiclone 1 mg/1	Tablet, Film coatedOral	Preferred Pharmaceuticals Inc.	68788-8387
Eszopiclone	Eszopiclone 1 mg/1	Tablet, Film coatedOral	Proficient Rx LP	71205-581
Eszopiclone	Eszopiclone 3 mg/1	Tablet, Film coatedOropharyngeal	Proficient Rx LP	71205-633
Eszopiclone	Eszopiclone 2 mg/1	Tablet, Film coatedOral	Bryant Ranch Prepack	71335-0512
Eszopiclone	Eszopiclone 1 mg/1	Tablet, Film coatedOral	Bryant Ranch Prepack	71335-0574
Eszopiclone	Eszopiclone 3 mg/1	Tablet, Film coatedOropharyngeal	Bryant Ranch Prepack	71335-2002
Eszopiclone	Eszopiclone 1 mg/1	Tablet, Film coatedOral	Asclemed USA, Inc.	76420-352
Eszopiclone	Eszopiclone 2 mg/1	Tablet, Film coatedOral	Asclemed USA, Inc.	76420-353
Eszopiclone	Eszopiclone 3 mg/1	Tablet, Film coatedOral	Asclemed USA, Inc.	76420-354
Eszopiclone	Eszopiclone 2 mg/1	Tablet, Film coatedOral	Proficient Rx LP	82804-076