Eszopiclone

Product NDC: 71205-633
11-digit product format: 712050633
Labeler code: 71205
Product ID: 71205-633_5381d4b2-e743-4ece-9fe3-e2be6eb85711
Type: HUMAN PRESCRIPTION DRUG
Nonproprietary name: Eszopiclone
Dosage form: TABLET, FILM COATED
Route: OROPHARYNGEAL
Labeler: Proficient Rx LP
Application: ANDA091166
Marketing category: ANDA
Marketing start: 2014-04-15
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
71205-633-30	Eszopiclone	30 in 1 BOTTLE	TABLET, FILM COATED	30		3
71205-633-60	Eszopiclone	60 in 1 BOTTLE	TABLET, FILM COATED	60		3
71205-633-90	Eszopiclone	90 in 1 BOTTLE	TABLET, FILM COATED	90		3

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDC	Billing unit	Product NDC	DailyMed indexing SPL	SPL version	Effective
71205-633-30	EA - Each	71205-633	d1f4f848-d901-4552-ae9b-50eea33ce185	1	2022-04-06

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDC	Dashboard title	SPL version	Validation	Dashboard ZIP
71205-633	ESZOPICLONE TABLET, FILM COATED [PROFICIENT RX LP]	3	Current NDC, Legacy NDC, 3 package rows	20220709_ac996f97-fd92-44f8-8bb5-478a81ffb33d.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUI	RxNorm string	TTY	DailyMed	SPL version
485465	eszopiclone 3 MG Oral Tablet	PSN	ac996f97-fd92-44f8-8bb5-478a81ffb33d	3
485465	eszopiclone 3 MG Oral Tablet	SCD	ac996f97-fd92-44f8-8bb5-478a81ffb33d	3

Packages#

Package NDC, 11-digit format, Description table
Package NDC	11-digit format	Description	Marketing start	Marketing end	Sample	Exclude flag	Status
71205-633-30	71205063330	30 TABLET, FILM COATED in 1 BOTTLE (71205-633-30)	2022-01-20	0000-00-00	No	No	Current
71205-633-60	71205063360	60 TABLET, FILM COATED in 1 BOTTLE (71205-633-60)	2022-01-20	0000-00-00	No	No	Current
71205-633-90	71205063390	90 TABLET, FILM COATED in 1 BOTTLE (71205-633-90)	2022-01-20	0000-00-00	No	No	Current