ESZOPICLONE

Product NDC
72189-099
11-digit product format
721890099
Labeler code
72189
Product ID
72189-099_2be80953-8e55-14bd-e063-6294a90a4fae
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
ESZOPICLONE
Dosage form
TABLET, FILM COATED
Route
ORAL
Labeler
DIRECT RX
Application
ANDA091124
Marketing category
ANDA
Marketing start
2020-06-10
Substance
ESZOPICLONE
Active strength
1 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
ESZOPICLONE1 mg/1

Harmonized Identifiers#

Field, Values table
FieldValues
UniiUZX80K71OE
Rxcui485440

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
72189-099-30ESZOPICLONE30 in 1 BOTTLETABLET, FILM COATED303
72189-099-90ESZOPICLONE90 in 1 BOTTLETABLET, FILM COATED903

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
72189-099-30EA - Each72189-09989e7faac-b8f1-4d87-a544-064e0c8f7db612020-07-13
72189-099-90EA - Each72189-0993062bee3-fe48-4bff-97cc-b0ea802a32df12020-07-13

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
72189-099ESZOPICLONE TABLET, FILM COATED [DIRECT RX]3Current NDC, Legacy NDC, 2 package rows20250119_a7bd3e3c-26e9-07e7-e053-2995a90a9ca5.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
485440eszopiclone 1 MG Oral TabletPSNa7bd3e3c-26e9-07e7-e053-2995a90a9ca53
485440eszopiclone 1 MG Oral TabletSCDa7bd3e3c-26e9-07e7-e053-2995a90a9ca53

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionMarketing startMarketing endSampleExclude flagStatus
72189-099-307218900993030 TABLET, FILM COATED in 1 BOTTLE (72189-099-30) 2020-06-100000-00-00NoNoCurrent
72189-099-907218900999090 TABLET, FILM COATED in 1 BOTTLE (72189-099-90) 2020-06-100000-00-00NoNoCurrent