Eszopiclone

Product NDC
60760-526
11-digit product format
607600526
Labeler code
60760
Product ID
60760-526_c4ff1df6-10a6-634a-e053-2a95a90ac4ce
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Eszopiclone
Dosage form
TABLET, FILM COATED
Route
ORAL
Labeler
St Mary's Medical Park Phcy
Application
ANDA091166
Marketing category
ANDA
Marketing start
2021-06-07
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
60760-526-30Eszopiclone30 in 1 BOTTLE, PLASTICTABLET, FILM COATED301

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
60760-526-30EA - Each60760-5262b1d6466-b911-4c54-a63d-dac42c27f44612021-08-05

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
60760-526ESZOPICLONE TABLET, FILM COATED [ST MARY'S MEDICAL PARK PHCY]1Current NDC, Legacy NDC, 1 package rows20210710_c4ff1d6a-918e-c046-e053-2a95a90a9c9b.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
485442eszopiclone 2 MG Oral TabletPSNc4ff1d6a-918e-c046-e053-2a95a90a9c9b1
485442eszopiclone 2 MG Oral TabletSCDc4ff1d6a-918e-c046-e053-2a95a90a9c9b1

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionMarketing startMarketing endSampleExclude flagStatus
60760-526-306076005263030 TABLET, FILM COATED in 1 BOTTLE, PLASTIC (60760-526-30) 2021-06-070000-00-00NoNoCurrent