FDA.reportPublic FDA data

Eszopiclone

Product NDC
60429-632
11-digit product format
604290632
Labeler code
60429
Product ID
60429-632_02e9fcb6-a4fc-ed47-e063-6394a90a7976
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
eszopiclone
Dosage form
TABLET, FILM COATED
Route
ORAL
Labeler
Golden State Medical Supply, Inc.
Application
ANDA091151
Marketing category
ANDA
Marketing start
2013-03-26
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, 485442, 485465

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
60429-632-01Eszopiclone100 in 1 BOTTLE, PLASTICTABLET, FILM COATED1008
60429-632-30Eszopiclone30 in 1 BOTTLE, PLASTICTABLET, FILM COATED308

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
60429-632-01EA - Each60429-6323f49894e-3983-4808-8a2d-d7579595a1b212016-05-16
60429-632-30EA - Each60429-632e27add8b-f0a1-4ec6-9354-7e6e21ac659c12021-06-02

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
60429-632ESZOPICLONE TABLET, FILM COATED [GOLDEN STATE MEDICAL SUPPLY, INC.]8Current NDC, Legacy NDC, 2 package rows20230819_fef87d8d-f375-4b00-8765-957ef076bf1a.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
485440eszopiclone 1 MG Oral TabletPSNfef87d8d-f375-4b00-8765-957ef076bf1a8
485442eszopiclone 2 MG Oral TabletPSNfef87d8d-f375-4b00-8765-957ef076bf1a8
485465eszopiclone 3 MG Oral TabletPSNfef87d8d-f375-4b00-8765-957ef076bf1a8
485440eszopiclone 1 MG Oral TabletSCDfef87d8d-f375-4b00-8765-957ef076bf1a8
485442eszopiclone 2 MG Oral TabletSCDfef87d8d-f375-4b00-8765-957ef076bf1a8
485465eszopiclone 3 MG Oral TabletSCDfef87d8d-f375-4b00-8765-957ef076bf1a8

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionMarketing startMarketing endSampleExclude flagStatus
60429-632-0160429063201100 TABLET, FILM COATED in 1 BOTTLE, PLASTIC (60429-632-01) 2016-04-040000-00-00NoNoCurrent
60429-632-306042906323030 TABLET, FILM COATED in 1 BOTTLE, PLASTIC (60429-632-30) 2021-02-220000-00-00NoNoCurrent