What is NDC 71335-0574?

71335-0574 is the product NDC for Eszopiclone, Eszopiclone 1 mg/1 tablet, film coated, listed with the FDA by Bryant Ranch Prepack. It has 5 package NDCs, shown above in 10- and 11-digit form.

Bryant Ranch Prepack, NDC labeler code 71335. 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 71335-0574 | National Drug Code

NDC codes

FDA NDC Directory

Product NDC (as listed)71335-0574Labeler and product segments. Claims need a package NDC.

Product NDC at billing width71335-0574Add 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
71335-0574-1	71335057401	30 TABLET, FILM COATED in 1 BOTTLE (71335-0574-1)Marketed from Jul 17, 2015
71335-0574-2	71335057402	60 TABLET, FILM COATED in 1 BOTTLE (71335-0574-2)Marketed from Jul 17, 2015
71335-0574-3	71335057403	90 TABLET, FILM COATED in 1 BOTTLE (71335-0574-3)Marketed from Jul 17, 2015
71335-0574-4	71335057404	10 TABLET, FILM COATED in 1 BOTTLE (71335-0574-4)Marketed from Jul 17, 2015
71335-0574-5	71335057405	120 TABLET, FILM COATED in 1 BOTTLE (71335-0574-5)Marketed from Jul 17, 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: Bryant Ranch PrepackNDC labeler code 71335
Product type: Prescription drug
Marketing category: ANDA — Abbreviated New Drug Application (generic)Application ANDA 091166
Marketing start: Apr 15, 2014
Listing expires: Dec 31, 2026
DEA schedule: CIV
Identifiers: Product ID 71335-0574_ceabe551-fe4c-4bbf-9f1f-349b51891a87SPL ID ceabe551-fe4c-4bbf-9f1f-349b51891a87SPL set ID d1baa5ba-73ac-462b-a728-217d5992674aRxCUI 485440, 485442UNII 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

N471335057401 followed by a unit qualifier and the quantity

Package 71335-0574-01. 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 Aug 23, 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 71335-0574

What is NDC 71335-0574?: 71335-0574 is the product NDC for Eszopiclone, Eszopiclone 1 mg/1 tablet, film coated, listed with the FDA by Bryant Ranch Prepack. It has 5 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?: Bryant Ranch Prepack, NDC labeler code 71335. 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	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 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 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 1 mg/1	Tablet, Film coatedOral	Advanced Rx of Tennessee, LLC	80425-0407
Eszopiclone	Eszopiclone 2 mg/1	Tablet, Film coatedOral	Proficient Rx LP	82804-076