What is NDC 80425-0168?

80425-0168 is the product NDC for Eszopiclone, Eszopiclone 1 mg/1 tablet, film coated, listed with the FDA by Advanced Rx Pharmacy of Tennessee, LLC. It has 3 package NDCs, shown above in 10- and 11-digit form.

Advanced Rx Pharmacy 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?

89 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 80425-0168 | National Drug Code

NDC codes

FDA NDC Directory

Product NDC (as listed)80425-0168Labeler and product segments. Claims need a package NDC.

Product NDC at billing width80425-0168Add 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
80425-0168-1	80425016801	30 TABLET, FILM COATED in 1 BOTTLE (80425-0168-1)Marketed from Apr 5, 2023
80425-0168-2	80425016802	60 TABLET, FILM COATED in 1 BOTTLE (80425-0168-2)Marketed from Jan 31, 2015
80425-0168-3	80425016803	90 TABLET, FILM COATED in 1 BOTTLE (80425-0168-3)Marketed from Jan 31, 2015

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 Pharmacy of Tennessee, LLCNDC labeler code 80425
Product type: Prescription drug
Marketing category: ANDA — Abbreviated New Drug Application (generic)Application ANDA 202929
Marketing start: Jan 31, 2015
Listing expires: Dec 31, 2026
DEA schedule: CIV
Identifiers: Product ID 80425-0168_2a99e9e8-3d16-ee0b-e063-6294a90ae4efSPL ID 2a99e9e8-3d16-ee0b-e063-6294a90ae4efSPL set ID c8ae09eb-4c9b-4560-e053-2995a90a02b1RxCUI 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

N480425016801 followed by a unit qualifier and the quantity

Package 80425-0168-01. 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 31, 2024. This label includes a boxed warning.

Indications (excerpt from the label)

1. Indications and Usage Section INDICATIONS & USAGE 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).

Excerpt only. Read the full label for complete information.

Full label on DailyMed (opens in a new tab)

About NDC 80425-0168

What is NDC 80425-0168?: 80425-0168 is the product NDC for Eszopiclone, Eszopiclone 1 mg/1 tablet, film coated, listed with the FDA by Advanced Rx Pharmacy 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 Pharmacy 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?: 89 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	Advanced Rx of Tennessee, LLC	80425-0407	80425-0407-0180425-0407-0280425-0407-03
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	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	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

All 90 Eszopiclone NDCs

Other NDCs under ANDA 202929

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

FDA NDC Directory listings under ANDA 202929
Product	Strength	Form · route	Labeler	Product NDC
Eszopiclone	Eszopiclone 3 mg/1	Tablet, Film coatedOral	REMEDYREPACK INC.	70518-3576
Eszopiclone	Eszopiclone 2 mg/1	Tablet, Film coatedOral	Bryant Ranch Prepack	71335-0089
Eszopiclone	Eszopiclone 3 mg/1	Tablet, Film coatedOral	Proficient Rx LP	63187-843
Eszopiclone	Eszopiclone 3 mg/1	Tablet, Film coatedOral	Bryant Ranch Prepack	71335-0116
Eszopiclone	Eszopiclone 2 mg/1	Tablet, Film coatedOral	Macleods Pharmaceuticals Limited	33342-300
Eszopiclone	Eszopiclone 1 mg/1	Tablet, Film coatedOral	Macleods Pharmaceuticals Limited	33342-299
Eszopiclone	Eszopiclone 3 mg/1	Tablet, Film coatedOral	Macleods Pharmaceuticals Limited	33342-301
Eszopiclone	Eszopiclone 2 mg/1	Tablet, Film coatedOral	Proficient Rx LP	63187-970
Eszopiclone	Eszopiclone 2 mg/1	Tablet, Film coatedOral	Preferred Pharmaceuticals Inc.	68788-7029
Eszopiclone	Eszopiclone 2 mg/1	Tablet, Film coatedOral	Quality Care Products LLC	55700-581
Eszopiclone	Eszopiclone 2 mg/1	Tablet, Film coatedOral	REMEDYREPACK INC.	70518-4398
Eszopiclone	Eszopiclone 3 mg/1	Tablet, Film coatedOral	Quality Care Products LLC	55700-610
Eszopiclone	Eszopiclone 2 mg/1	Tablet, Film coatedOral	Asclemed USA, Inc.	76420-024
Eszopiclone	Eszopiclone 3 mg/1	Tablet, Film coatedOral	Preferred Pharmaceuticals Inc.	68788-7169
Eszopiclone	Eszopiclone 1 mg/1	Tablet, Film coatedOral	Asclemed USA, Inc.	76420-026
Eszopiclone	Eszopiclone 3 mg/1	Tablet, Film coatedOral	Asclemed USA, Inc.	76420-027
Eszopiclone	Eszopiclone 1 mg/1	Tablet, Film coatedOral	Preferred Pharmaceuticals Inc.	68788-8826
Eszopiclone	Eszopiclone 2 mg/1	Tablet, Film coatedOral	DIRECT RX	61919-033
Eszopiclone	Eszopiclone 3 mg/1	Tablet, Film coatedOral	Advanced Rx of Tennessee, LLC	80425-0065
Eszopiclone	Eszopiclone 2 mg/1	Tablet, Film coatedOral	Advanced Rx of Tennessee, LLC	80425-0062

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