What is NDC 63187-817?

63187-817 is the product NDC for Eszopiclone, Eszopiclone 1 mg/1 tablet, film coated, listed with the FDA by Proficient Rx LP. It has 3 package NDCs, shown above in 10- and 11-digit form.

Proficient Rx LP, NDC labeler code 63187. 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?

87 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 63187-817 | National Drug Code

NDC codes

FDA NDC Directory

Product NDC (as listed)63187-817Labeler and product segments. Claims need a package NDC.

Product NDC at billing width63187-0817Add 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
63187-817-30	6318708173063187081730	30 TABLET, FILM COATED in 1 BOTTLE (63187-817-30)Marketed from Feb 1, 2017
63187-817-60	6318708176063187081760	60 TABLET, FILM COATED in 1 BOTTLE (63187-817-60)Marketed from Feb 1, 2017
63187-817-90	6318708179063187081790	90 TABLET, FILM COATED in 1 BOTTLE (63187-817-90)Marketed from Feb 1, 2017

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: Proficient Rx LPNDC labeler code 63187
Product type: Prescription drug
Marketing category: ANDA — Abbreviated New Drug Application (generic)Application ANDA 202929
Marketing start: Apr 25, 2014
Listing expires: Dec 31, 2027
DEA schedule: CIV
Identifiers: Product ID 63187-817_db1ef475-ac5d-4e80-aac1-d7fc42696157SPL ID db1ef475-ac5d-4e80-aac1-d7fc42696157SPL set ID 1582ba77-a4e3-464f-876b-28cc7e41e8f1RxCUI 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

N463187081730 followed by a unit qualifier and the quantity

Package 63187-0817-30. 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 Feb 1, 2020.

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 63187-817

What is NDC 63187-817?: 63187-817 is the product NDC for Eszopiclone, Eszopiclone 1 mg/1 tablet, film coated, listed with the FDA by Proficient Rx LP. 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?: Proficient Rx LP, NDC labeler code 63187. 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?: 87 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	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

All 88 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 1 mg/1	Tablet, Film coatedOral	Macleods Pharmaceuticals Limited	33342-299
Eszopiclone	Eszopiclone 2 mg/1	Tablet, Film coatedOral	Macleods Pharmaceuticals Limited	33342-300
Eszopiclone	Eszopiclone 3 mg/1	Tablet, Film coatedOral	Macleods Pharmaceuticals Limited	33342-301
Eszopiclone	Eszopiclone 2 mg/1	Tablet, Film coatedOral	Quality Care Products LLC	55700-581
Eszopiclone	Eszopiclone 3 mg/1	Tablet, Film coatedOral	Quality Care Products LLC	55700-610
Eszopiclone	Eszopiclone 2 mg/1	Tablet, Film coatedOral	DIRECT RX	61919-033
Eszopiclone	Eszopiclone 3 mg/1	Tablet, Film coatedOral	Proficient Rx LP	63187-843
Eszopiclone	Eszopiclone 2 mg/1	Tablet, Film coatedOral	Proficient Rx LP	63187-970
Eszopiclone	Eszopiclone 3 mg/1	Tablet, Film coatedOral	NuCarePharmaceuticals, Inc.	68071-3376
Eszopiclone	Eszopiclone 2 mg/1	Tablet, Film coatedOral	Preferred Pharmaceuticals Inc.	68788-7029
Eszopiclone	Eszopiclone 3 mg/1	Tablet, Film coatedOral	Preferred Pharmaceuticals Inc.	68788-7169
Eszopiclone	Eszopiclone 1 mg/1	Tablet, Film coatedOral	Preferred Pharmaceuticals Inc.	68788-8826
Eszopiclone	Eszopiclone 3 mg/1	Tablet, Film coatedOral	REMEDYREPACK INC.	70518-3576
Eszopiclone	Eszopiclone 2 mg/1	Tablet, Film coatedOral	REMEDYREPACK INC.	70518-4398
Eszopiclone	Eszopiclone 2 mg/1	Tablet, Film coatedOral	Bryant Ranch Prepack	71335-0089
Eszopiclone	Eszopiclone 3 mg/1	Tablet, Film coatedOral	Bryant Ranch Prepack	71335-0116
Eszopiclone	Eszopiclone 1 mg/1	Tablet, Film coatedOral	Bryant Ranch Prepack	71335-0598
Eszopiclone	Eszopiclone 2 mg/1	Tablet, Film coatedOral	Bryant Ranch Prepack	71335-2698
Eszopiclone	Eszopiclone 2 mg/1	Tablet, Film coatedOral	Asclemed USA, Inc.	76420-024
Eszopiclone	Eszopiclone 1 mg/1	Tablet, Film coatedOral	Asclemed USA, Inc.	76420-026

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