Eszopiclone

Product NDC
71610-409
11-digit product format
716100409
Labeler code
71610
Product ID
71610-409_fa699b0f-cb02-4a27-b97a-80221ebeabed
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Eszopiclone
Dosage form
TABLET, FILM COATED
Route
ORAL
Labeler
Aphena Pharma Solutions - Tennessee, LLC
Application
ANDA091169
Marketing category
ANDA
Marketing start
2014-04-14
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
IngredientStrength
ESZOPICLONE3 mg/1

Harmonized Identifiers#

Field, Values table
FieldValues
UniiUZX80K71OE
Rxcui485465

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
f65008ed-f925-2246-581a-e6a3201df7e4Product name520250107
351abe41-466c-4dd8-840a-0fdb68318bd5Product name120230316

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
71610-409-30Eszopiclone30 in 1 BOTTLETABLET, FILM COATED301

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
71610-409-30EA - Each71610-40987f646ca-79cb-41ea-b44f-c225ffe639c212020-05-08

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
71610-409ESZOPICLONE TABLET, FILM COATED [APHENA PHARMA SOLUTIONS - TENNESSEE, LLC]1Current NDC, Legacy NDC, 1 package rows20200424_9bbf260f-3090-46b5-b3ef-81174697f166.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
485465eszopiclone 3 MG Oral TabletPSN9bbf260f-3090-46b5-b3ef-81174697f1661
485465eszopiclone 3 MG Oral TabletSCD9bbf260f-3090-46b5-b3ef-81174697f1661

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionMarketing startMarketing endSampleExclude flagStatus
71610-409-307161004093030 TABLET, FILM COATED in 1 BOTTLE (71610-409-30) 2020-03-260000-00-00NoNoCurrent