ESZOPICLONE

Product NDC: 61919-587
11-digit product format: 619190587
Labeler code: 61919
Product ID: 61919-587_9c9402dc-ee0b-6c1f-e053-2995a90adabd
Type: HUMAN PRESCRIPTION DRUG
Nonproprietary name: ESZOPICLONE
Dosage form: TABLET, FILM COATED
Route: ORAL
Labeler: DIRECT RX
Application: ANDA091113
Marketing category: ANDA
Marketing start: 2017-02-15
Marketing end: 0000-00-00
Substance: ESZOPICLONE
Active strength: 2 mg/1
DEA schedule: CIV
NDC exclude flag: No
Listing certified through: 2021-12-31
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
61919-587-30	2023-01-30	C162847	48780-1	f386c64a-49a0-0266-e053-dadaa90a7c1a	ESZOPICLONE

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDC	Product	Description	Form	Quantity	Strength	SPL version
61919-587-30	ESZOPICLONE	30 in 1 BOTTLE	TABLET, FILM COATED	30		2

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUI	RxNorm string	TTY	DailyMed	SPL version
485442	eszopiclone 2 MG Oral Tablet	PSN	489833bd-1905-63b6-e054-00144ff8d46c	2
485442	eszopiclone 2 MG Oral Tablet	SCD	489833bd-1905-63b6-e054-00144ff8d46c	2

Packages#

Package NDC, 11-digit format, Description table
Package NDC	11-digit format	Description	Marketing start	Marketing end	Sample	Exclude flag	Status
61919-587-30	61919058730	30 TABLET, FILM COATED in 1 BOTTLE (61919-587-30)	2017-02-15	0000-00-00	No	No	Current