Eszopiclone

Product NDC: 53217-307
11-digit product format: 532170307
Labeler code: 53217
Product ID: 53217-307_4f0270d8-fdba-4379-893f-0dc9269273e4
Type: HUMAN PRESCRIPTION DRUG
Nonproprietary name: Eszopiclone
Dosage form: TABLET, COATED
Route: ORAL
Labeler: Aidarex Pharmaceuticals LLC
Application: ANDA091024
Marketing category: ANDA
Marketing start: 2014-04-15
Marketing end: 0000-00-00
Substance: ESZOPICLONE
Active strength: 2 mg/1
NDC exclude flag: E
Listing certified through: 2018-12-31
Current FDA listing: Historical FDA.report record

DailyMed Product Concepts#

Product concept, Relation, Version table
Product concept	Relation	Version	Effective
f65008ed-f925-2246-581a-e6a3201df7e4	Product name	5	20250107

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDC	Effective	Action	Document	Indexing SPL	Related label
53217-307-30	2020-01-31	C162847	48780-1	9d75b9d1-0f84-f424-e053-dadaa90a57ce	These highlights do not include all the information needed to use eszopiclone tablets safely and effectively. See full prescribing information for eszopiclone tablets. Eszopiclone Tablets, for oral use, CIV Initial U.S. Approval: 2004
53217-307-60	2020-01-31	C162847	48780-1	9d75b9d1-0f84-f424-e053-dadaa90a57ce	These highlights do not include all the information needed to use eszopiclone tablets safely and effectively. See full prescribing information for eszopiclone tablets. Eszopiclone Tablets, for oral use, CIV Initial U.S. Approval: 2004

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDC	Product	Description	Form	Quantity	Strength	SPL version
53217-307-30	Eszopiclone	30 in 1 BOTTLE	TABLET, COATED	30		1
53217-307-60	Eszopiclone	60 in 1 BOTTLE	TABLET, COATED	60		1

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDC	Billing unit	Product NDC	DailyMed indexing SPL	SPL version	Effective
53217-307-30	EA - Each	53217-307	9ab466ad-1916-4e6b-bf96-3a8bd1206d58	1	2017-07-07
53217-307-60	EA - Each	53217-307	bd7c44b0-647b-4a71-8e12-1bb5da326b63	1	2017-07-07

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDC	Dashboard title	SPL version	Validation	Dashboard ZIP
53217-307	ESZOPICLONE TABLET, COATED [AIDAREX PHARMACEUTICALS LLC]	1	Legacy NDC, 2 package rows	20170630_8edd5f22-cbdb-4286-8b35-9d09d84dafd7.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUI	RxNorm string	TTY	DailyMed	SPL version
485442	eszopiclone 2 MG Oral Tablet	PSN	8edd5f22-cbdb-4286-8b35-9d09d84dafd7	1
485442	eszopiclone 2 MG Oral Tablet	SCD	8edd5f22-cbdb-4286-8b35-9d09d84dafd7	1

Packages#

Package NDC, 11-digit format, Description table
Package NDC	11-digit format	Description	Status
53217-307-30	53217030730	30 in 1 BOTTLE	Historical
53217-307-60	53217030760	60 in 1 BOTTLE	Historical