Eszopiclone NDC 33342-301

NDC codes

FDA NDC Directory

Product NDC (as listed)33342-301Labeler and product segments. Claims need a package NDC.

Product NDC at billing width33342-0301Add 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
33342-301-11	33342030111	100 TABLET, FILM COATED in 1 BOTTLE (33342-301-11)Marketed from Jan 31, 2015
33342-301-12	33342030112	10 BLISTER PACK in 1 CARTON (33342-301-12) / 10 TABLET, FILM COATED in 1 BLISTER PACKMarketed from Jan 31, 2015
33342-301-44	33342030144	1000 TABLET, FILM COATED in 1 BOTTLE (33342-301-44)Marketed from Jan 31, 2015

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 — 3 mg/1
Dosage form: Tablet, Film coated
Route: Oral
Labeler: Macleods Pharmaceuticals Limited
Product type: Prescription drug
Marketing category: ANDA — Abbreviated New Drug Application (generic)Application ANDA 202929
Marketing start: Apr 25, 2014
Listing expires: Dec 31, 2026
DEA schedule: CIV
Identifiers: Product ID 33342-301_66cfec66-191e-4af9-a623-8464417fab6dSPL ID 66cfec66-191e-4af9-a623-8464417fab6dSPL set ID 12593790-e72f-45b1-8895-987cdd075134RxCUI 485440, 485442, 485465UNII UZX80K71OEUPC 0333342300119, 0333342299079, 0333342301116

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

N433342030111 followed by a unit qualifier and the quantity

Package 33342-0301-11. 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 Oct 29, 2022. 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)

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 2 mg/1	Tablet, Film coatedOral	Preferred Pharmaceuticals Inc.	68788-7029
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 2 mg/1	Tablet, Film coatedOral	Bryant Ranch Prepack	71335-2698
Eszopiclone	Eszopiclone 3 mg/1	Tablet, Film coatedOral	NuCarePharmaceuticals, Inc.	68071-3376
Eszopiclone	Eszopiclone 3 mg/1	Tablet, Film coatedOral	Asclemed USA, Inc.	76420-027
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
Eszopiclone	Eszopiclone 1 mg/1	Tablet, Film coatedOral	Bryant Ranch Prepack	71335-0598
Eszopiclone	Eszopiclone 1 mg/1	Tablet, Film coatedOral	Proficient Rx LP	63187-817
Eszopiclone	Eszopiclone 3 mg/1	Tablet, Film coatedOral	Preferred Pharmaceuticals Inc.	68788-7169
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
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 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	Quality Care Products LLC	55700-610
Eszopiclone	Eszopiclone 2 mg/1	Tablet, Film coatedOral	Quality Care Products LLC	55700-581

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