Eszopiclone

Product NDC: 63187-843
11-digit product format: 631870843
Labeler code: 63187
Product ID: 63187-843_fe135c0b-c9e3-4078-958d-bd4ef956033b
Type: HUMAN PRESCRIPTION DRUG
Nonproprietary name: Eszopiclone
Dosage form: TABLET, FILM COATED
Route: ORAL
Labeler: Proficient Rx LP
Application: ANDA202929
Marketing category: ANDA
Marketing start: 2014-04-25
Substance: ESZOPICLONE
Active strength: 3 mg/1
DEA schedule: CIV
NDC exclude flag: No
Listing certified through: 2026-12-31
Current FDA listing: Yes

Additional Listing Data#

Finished product: Yes
Brand name base: Eszopiclone
Listing expiration: 2026-12-31

Active Ingredients#

Ingredient, Strength table
Ingredient	Strength
ESZOPICLONE	3 mg/1

Harmonized Identifiers#

Field, Values table
Field	Values
Unii	UZX80K71OE
Rxcui	485465

DailyMed Product Concepts#

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

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDC	Product	Description	Form	Quantity	Strength	SPL version
63187-843-30	Eszopiclone	30 in 1 BOTTLE	TABLET, FILM COATED	30		5
63187-843-60	Eszopiclone	60 in 1 BOTTLE	TABLET, FILM COATED	60		5
63187-843-90	Eszopiclone	90 in 1 BOTTLE	TABLET, FILM COATED	90		5

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDC	Billing unit	Product NDC	DailyMed indexing SPL	SPL version	Effective
63187-843-30	EA - Each	63187-843	521d8f75-ebff-4796-83e0-60d70b894ccc	1	2017-06-15

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDC	Dashboard title	SPL version	Validation	Dashboard ZIP
63187-843	ESZOPICLONE TABLET, FILM COATED [PROFICIENT RX LP]	5	Current NDC, Legacy NDC, 3 package rows	20230712_d301b0cf-1492-4be9-83a0-1b64c8fa3b72.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUI	RxNorm string	TTY	DailyMed	SPL version
485465	eszopiclone 3 MG Oral Tablet	PSN	d301b0cf-1492-4be9-83a0-1b64c8fa3b72	5
485465	eszopiclone 3 MG Oral Tablet	SCD	d301b0cf-1492-4be9-83a0-1b64c8fa3b72	5

Packages#

Package NDC, 11-digit format, Description table
Package NDC	11-digit format	Description	Marketing start	Marketing end	Sample	Exclude flag	Status
63187-843-30	63187084330	30 TABLET, FILM COATED in 1 BOTTLE (63187-843-30)	2017-05-01	0000-00-00	No	No	Current
63187-843-60	63187084360	60 TABLET, FILM COATED in 1 BOTTLE (63187-843-60)	2017-05-01	0000-00-00	No	No	Current
63187-843-90	63187084390	90 TABLET, FILM COATED in 1 BOTTLE (63187-843-90)	2017-05-01	0000-00-00	No	No	Current