FDA.reportPublic FDA data

Eszopiclone

Product NDC
63187-817
11-digit product format
631870817
Labeler code
63187
Product ID
63187-817_db1ef475-ac5d-4e80-aac1-d7fc42696157
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
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
63187-817-30Eszopiclone30 in 1 BOTTLETABLET, FILM COATED304
63187-817-60Eszopiclone60 in 1 BOTTLETABLET, FILM COATED604
63187-817-90Eszopiclone90 in 1 BOTTLETABLET, FILM COATED904

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
63187-817-30EA - Each63187-8174f4c1d88-e598-4cc7-bf14-dc69c7b496cb12017-06-15
63187-817-60EA - Each63187-8178008b270-6da7-490f-b94e-ce58da0b8c6312017-06-15
63187-817-90EA - Each63187-817f3f47930-ac12-4e1b-97e9-f2fd71cc7e9a12017-03-06

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
63187-817ESZOPICLONE TABLET, FILM COATED [PROFICIENT RX LP]4Current NDC, Legacy NDC, 3 package rows20200222_1582ba77-a4e3-464f-876b-28cc7e41e8f1.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
485440eszopiclone 1 MG Oral TabletPSN1582ba77-a4e3-464f-876b-28cc7e41e8f14
485440eszopiclone 1 MG Oral TabletSCD1582ba77-a4e3-464f-876b-28cc7e41e8f14

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionMarketing startMarketing endSampleExclude flagStatus
63187-817-306318708173030 TABLET, FILM COATED in 1 BOTTLE (63187-817-30) 2017-02-010000-00-00NoNoCurrent
63187-817-606318708176060 TABLET, FILM COATED in 1 BOTTLE (63187-817-60) 2017-02-010000-00-00NoNoCurrent
63187-817-906318708179090 TABLET, FILM COATED in 1 BOTTLE (63187-817-90) 2017-02-010000-00-00NoNoCurrent