FDA.reportPublic FDA data

ESZOPICLONE

Product NDC
50090-7746
11-digit product format
500907746
Labeler code
50090
Product ID
50090-7746_3f806e65-407d-400a-a538-76dd31ec1943
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
ESZOPICLONE
Dosage form
TABLET, FILM COATED
Route
ORAL
Labeler
A-S Medication Solutions
Application
ANDA208451
Marketing category
ANDA
Marketing start
2016-09-15
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
50090-7746-0ESZOPICLONE30 in 1 BOTTLETABLET, FILM COATED301

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
50090-7746-0EA - Each50090-774657121647-a2ca-4795-af86-1f0f1c07fb5312025-12-16

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
485465eszopiclone 3 MG Oral TabletPSNe261bf7f-1b89-4393-8c48-4e72fc29192f1
485465eszopiclone 3 MG Oral TabletSCDe261bf7f-1b89-4393-8c48-4e72fc29192f1

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionMarketing startSampleExclude flagStatus
50090-7746-05009077460030 TABLET, FILM COATED in 1 BOTTLE (50090-7746-0) 2025-10-31NoNoCurrent