NDC 80425-0064-01 - Eszopiclone

This NDC is not currently matched to an FDA NDC product listing in FDA.report, but it is a valid NDC-form code. FDA.report is showing the available DailyMed label context for the product root.

Product NDC: 80425-0064
Requested NDC: 80425-0064-01
Package NDCs from labels: 80425-0064-1, 80425-0064-01
Manufacturer: Advanced Rx of Tennessee, LLC
Effective date: 2024-12-31
Current FDA listing: Not matched in FDA.report NDC product tables

DailyMed Labels#

Label, Manufacturer, Effective date table
Label	Manufacturer	Effective date	Type
Eszopiclone - Advanced Rx of Tennessee, LLC	Advanced Rx of Tennessee, LLC	2024-12-31	HUMAN PRESCRIPTION DRUG LABEL

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDC	Product	Description	Form	Quantity	Strength	SPL version
80425-0064-1	Eszopiclone	60 in 1 BOTTLE	TABLET, COATED	60		6

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDC	Dashboard title	SPL version	Validation	Dashboard ZIP
80425-0064	ESZOPICLONE TABLET, COATED [ADVANCED RX OF TENNESSEE, LLC]	6	Current NDC, Legacy NDC, 1 package rows	20250101_af86ebdb-e47b-706a-e053-2995a90ad51c.zip

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDC	Billing unit	Product NDC	DailyMed indexing SPL	SPL version	Effective
80425-0064-1	EA - Each	80425-0064	5518d65a-64cc-44d2-b977-33a59bc40158	1	2023-04-07

openFDA label cross-check#

OpenFDA label data provides additional search and identifier links. DailyMed’s Structured Product Label is the canonical label on FDA.report. Matching records are deduplicated before they are shown below.

Matched openFDA labels page 4 of 4 · 62 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
Eszopiclone	ESZOPICLONE	Proficient Rx LP	1582ba77-a4e3-464f-876b-28cc7e41e8f1	2020-02-01	Warnings, Adverse reactions	Exact identifier rxcui: 485440 unii: UZX80K71OE
ESZOPICLONE	ESZOPICLONE	Sun Pharmaceutical Industries, Inc.	8bb1965e-7845-4c5b-b021-38e251303d68	2018-10-25	Warnings, Adverse reactions	Exact identifier rxcui: 485465 rxcui: 485442 rxcui: 485440 unii: UZX80K71OE

Reported adverse events (FAERS/openFDA)#

Adverse event summaries are temporarily unavailable. Other product information remains available.