What is NDC 65862-967?

65862-967 is the product NDC for Eszopiclone, Eszopiclone 1 mg/1 tablet, film coated, listed with the FDA by Aurobindo Pharma Limited. It has 2 package NDCs, shown above in 10- and 11-digit form.

Aurobindo Pharma Limited, NDC labeler code 65862. 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 65862-967 | National Drug Code

NDC codes

FDA NDC Directory

Product NDC (as listed)65862-967Labeler and product segments. Claims need a package NDC.

Product NDC at billing width65862-0967Add 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
65862-967-01	65862096701	100 TABLET, FILM COATED in 1 BOTTLE (65862-967-01)Marketed from Sep 15, 2016
65862-967-30	65862096730	30 TABLET, FILM COATED in 1 BOTTLE (65862-967-30)Marketed from Sep 15, 2016

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 — 1 mg/1
Dosage form: Tablet, Film coated
Route: Oral
Labeler: Aurobindo Pharma LimitedNDC labeler code 65862
Product type: Prescription drug
Marketing category: ANDA — Abbreviated New Drug Application (generic)Application ANDA 208451
Marketing start: Sep 15, 2016
Listing expires: Dec 31, 2026
DEA schedule: CIV
Identifiers: Product ID 65862-967_a39aa520-c8ad-4f39-ad71-04a839474b5bSPL ID a39aa520-c8ad-4f39-ad71-04a839474b5bSPL set ID f18cc76f-82aa-4ad7-b8ce-5737733ee104RxCUI 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

N465862096701 followed by a unit qualifier and the quantity

Package 65862-0967-01. 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 27, 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 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)

About NDC 65862-967

What is NDC 65862-967?: 65862-967 is the product NDC for Eszopiclone, Eszopiclone 1 mg/1 tablet, film coated, listed with the FDA by Aurobindo Pharma Limited. It has 2 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?: Aurobindo Pharma Limited, NDC labeler code 65862. 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 208451

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

FDA NDC Directory listings under ANDA 208451
Product	Strength	Form · route	Labeler	Product NDC
Eszopiclone	Eszopiclone 2 mg/1	Tablet, Film coatedOral	Proficient Rx LP	71205-513
Eszopiclone	Eszopiclone 2 mg/1	Tablet, Film coatedOral	Aurobindo Pharma Limited	65862-968
Eszopiclone	Eszopiclone 3 mg/1	Tablet, Film coatedOral	Aurobindo Pharma Limited	65862-969
Eszopiclone	Eszopiclone 3 mg/1	Tablet, Film coatedOral	Proficient Rx LP	71205-236
Eszopiclone	Eszopiclone 1 mg/1	Tablet, Film coatedOral	Proficient Rx LP	71205-384
Eszopiclone	Eszopiclone 2 mg/1	Tablet, Film coatedOral	Advanced Rx of Tennessee, LLC	80425-0063
Eszopiclone	Eszopiclone 3 mg/1	Tablet, Film coatedOral	Advanced Rx of Tennessee, LLC	80425-0066
Eszopiclone	Eszopiclone 3 mg/1	Tablet, Film coatedOral	PD-Rx Pharmaceuticals, Inc.	72789-067
Eszopiclone	Eszopiclone 2 mg/1	Tablet, Film coatedOral	REMEDYREPACK INC.	70518-1310
Eszopiclone	Eszopiclone 3 mg/1	Tablet, Film coatedOral	A-S Medication Solutions	50090-3514
Eszopiclone	Eszopiclone 1 mg/1	Tablet, Film coatedOral	A-S Medication Solutions	50090-7744
Eszopiclone	Eszopiclone 2 mg/1	Tablet, Film coatedOral	A-S Medication Solutions	50090-7745
Eszopiclone	Eszopiclone 3 mg/1	Tablet, Film coatedOral	A-S Medication Solutions	50090-7746
Eszopiclone	Eszopiclone 1 mg/1	Tablet, Film coatedOral	Bryant Ranch Prepack	71335-9659
Eszopiclone	Eszopiclone 1 mg/1	Tablet, Film coatedOral	Preferred Pharmaceuticals, Inc.	68788-7667