Eszopiclone

Product NDC
70518-4398
11-digit product format
705184398
Labeler code
70518
Product ID
70518-4398_3aaedc44-7250-b21e-e063-6394a90a2a93
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Eszopiclone
Dosage form
TABLET, FILM COATED
Route
ORAL
Labeler
REMEDYREPACK INC.
Application
ANDA202929
Marketing category
ANDA
Marketing start
2025-07-24
Substance
ESZOPICLONE
Active strength
2 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
ESZOPICLONE2 mg/1

Harmonized Identifiers#

Field, Values table
FieldValues
UniiUZX80K71OE
Rxcui485442

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
70518-4398-0Eszopiclone30 in 1 BOTTLE, PLASTICTABLET, FILM COATED301

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
485442eszopiclone 2 MG Oral TabletPSN9dfe774a-2c7a-4e10-bedd-cde64ad286761
485442eszopiclone 2 MG Oral TabletSCD9dfe774a-2c7a-4e10-bedd-cde64ad286761

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionMarketing startSampleExclude flagStatus
70518-4398-07051843980030 TABLET, FILM COATED in 1 BOTTLE, PLASTIC (70518-4398-0) 2025-07-24NoNoCurrent