Eszopiclone

Product NDC
80425-0067
11-digit product format
804250067
Labeler code
80425
Product ID
80425-0067_2a98f01a-8da0-0770-e063-6294a90a7bab
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Eszopiclone
Dosage form
TABLET, COATED
Route
ORAL
Labeler
Advanced Rx of Tennessee, LLC
Application
ANDA091024
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
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

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
80425-0067-1Eszopiclone30 in 1 BOTTLETABLET, COATED307

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
80425-0067-1EA - Each80425-00672f6f9783-ba53-40c4-bd1b-70c4363fb15f12023-04-07

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
80425-0067ESZOPICLONE TABLET, COATED [ADVANCED RX OF TENNESSEE, LLC]7Current NDC, Legacy NDC, 1 package rows20250101_af86b753-d2ee-9b5f-e053-2a95a90ad23d.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
485465eszopiclone 3 MG Oral TabletPSNaf86b753-d2ee-9b5f-e053-2a95a90ad23d7
485465eszopiclone 3 MG Oral TabletSCDaf86b753-d2ee-9b5f-e053-2a95a90ad23d7

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionMarketing startMarketing endSampleExclude flagStatus
80425-0067-18042500670130 TABLET, COATED in 1 BOTTLE (80425-0067-1) 2014-04-150000-00-00NoNoCurrent