FDA.reportPublic FDA data

Eszopiclone

Product NDC
63187-970
11-digit product format
631870970
Labeler code
63187
Product ID
63187-970_c07cfea0-a9fa-4ed5-928f-5aab69e12793
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Eszopiclone
Dosage form
TABLET, FILM COATED
Route
ORAL
Labeler
Proficient Rx LP
Application
ANDA202929
Marketing category
ANDA
Marketing start
2014-04-25
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
63187-970-30Eszopiclone30 in 1 BOTTLETABLET, FILM COATED305
63187-970-60Eszopiclone60 in 1 BOTTLETABLET, FILM COATED605
63187-970-90Eszopiclone90 in 1 BOTTLETABLET, FILM COATED905

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
63187-970-30EA - Each63187-970b7b5a524-a4be-4029-b693-c7adc10abd7a12021-02-05

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
63187-970ESZOPICLONE TABLET, FILM COATED [PROFICIENT RX LP]5Current NDC, Legacy NDC, 3 package rows20220706_5451be60-1315-4152-ad13-412e86903c8a.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
485442eszopiclone 2 MG Oral TabletPSN5451be60-1315-4152-ad13-412e86903c8a5
485442eszopiclone 2 MG Oral TabletSCD5451be60-1315-4152-ad13-412e86903c8a5

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionMarketing startMarketing endSampleExclude flagStatus
63187-970-306318709703030 TABLET, FILM COATED in 1 BOTTLE (63187-970-30) 2018-01-010000-00-00NoNoCurrent
63187-970-606318709706060 TABLET, FILM COATED in 1 BOTTLE (63187-970-60) 2018-01-010000-00-00NoNoCurrent
63187-970-906318709709090 TABLET, FILM COATED in 1 BOTTLE (63187-970-90) 2018-01-010000-00-00NoNoCurrent