FDA.reportPublic FDA data

Eszopiclone

Product NDC
71205-581
11-digit product format
712050581
Labeler code
71205
Product ID
71205-581_dfa6f802-b9c1-4874-9556-0b88e48bcc58
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Eszopiclone
Dosage form
TABLET, FILM COATED
Route
ORAL
Labeler
Proficient Rx LP
Application
ANDA091166
Marketing category
ANDA
Marketing start
2014-04-15
Substance
ESZOPICLONE
Active strength
1 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
IngredientStrength
ESZOPICLONE1 mg/1

Harmonized Identifiers#

Field, Values table
FieldValues
UniiUZX80K71OE
Rxcui485440

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
f65008ed-f925-2246-581a-e6a3201df7e4Product name520250107

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
71205-581-30Eszopiclone30 in 1 BOTTLETABLET, FILM COATED302
71205-581-60Eszopiclone60 in 1 BOTTLETABLET, FILM COATED602
71205-581-90Eszopiclone90 in 1 BOTTLETABLET, FILM COATED902

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
71205-581-30EA - Each71205-58165fe04d3-b479-447c-ba99-bae5509b12fe12021-10-08
71205-581-60EA - Each71205-581c4fbd2eb-3578-4d01-a640-aaa6e02ba36612021-10-08
71205-581-90EA - Each71205-5818b52037f-f6db-425e-a774-fb88befe155a12021-10-08

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
71205-581ESZOPICLONE TABLET, FILM COATED [PROFICIENT RX LP]2Current NDC, Legacy NDC, 3 package rows20220602_edc03482-b013-448a-8cd9-2a17bd6d15e9.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
485440eszopiclone 1 MG Oral TabletPSNedc03482-b013-448a-8cd9-2a17bd6d15e92
485440eszopiclone 1 MG Oral TabletSCDedc03482-b013-448a-8cd9-2a17bd6d15e92

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionMarketing startMarketing endSampleExclude flagStatus
71205-581-307120505813030 TABLET, FILM COATED in 1 BOTTLE (71205-581-30) 2021-06-230000-00-00NoNoCurrent
71205-581-607120505816060 TABLET, FILM COATED in 1 BOTTLE (71205-581-60) 2021-06-230000-00-00NoNoCurrent
71205-581-907120505819090 TABLET, FILM COATED in 1 BOTTLE (71205-581-90) 2021-06-230000-00-00NoNoCurrent