FDA.reportPublic FDA data

Eszopiclone

Product NDC
68788-7169
11-digit product format
687887169
Labeler code
68788
Product ID
68788-7169_9dec8075-bac4-4953-b317-f88ae1005a0e
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Eszopiclone
Dosage form
TABLET, FILM COATED
Route
ORAL
Labeler
Preferred Pharmaceuticals Inc.
Application
ANDA202929
Marketing category
ANDA
Marketing start
2018-06-11
Substance
ESZOPICLONE
Active strength
3 mg/1
DEA schedule
CIV
NDC exclude flag
No
Listing certified through
2027-12-31
Current FDA listing
Yes

Additional Listing Data#

Finished product
Yes
Brand name base
Eszopiclone
Listing expiration
2027-12-31

Active Ingredients#

Ingredient, Strength table
IngredientStrength
ESZOPICLONE3 mg/1

Harmonized Identifiers#

Field, Values table
FieldValues
UniiUZX80K71OE
Rxcui485465

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
68788-7169-1Eszopiclone10 in 1 BOTTLETABLET, FILM COATED109
68788-7169-2Eszopiclone20 in 1 BOTTLETABLET, FILM COATED209
68788-7169-3Eszopiclone30 in 1 BOTTLETABLET, FILM COATED309
68788-7169-6Eszopiclone60 in 1 BOTTLETABLET, FILM COATED609
68788-7169-9Eszopiclone90 in 1 BOTTLETABLET, FILM COATED909

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
68788-7169-1EA - Each68788-71696547f5c7-555b-4575-9bed-8a9151174ad612018-09-05
68788-7169-2EA - Each68788-7169f4e6bc50-a0dd-4ab0-96a9-6c974e7c45d612018-09-05
68788-7169-3EA - Each68788-7169d83ffcf2-04e2-44fb-8540-9302e95f68eb12018-09-05
68788-7169-6EA - Each68788-7169fbf16058-3a80-4623-a9cd-b7eb1b9b19da12018-09-05
68788-7169-9EA - Each68788-71699e4247ee-da02-4b4c-85a3-ee1817ab954112018-09-05

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
68788-7169ESZOPICLONE TABLET, FILM COATED [PREFERRED PHARMACEUTICALS INC.]8Current NDC, Legacy NDC, 5 package rows20250507_2b5b4fbb-9b86-46c6-9508-37d3d9806dec.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
485465eszopiclone 3 MG Oral TabletPSN2b5b4fbb-9b86-46c6-9508-37d3d9806dec9
485465eszopiclone 3 MG Oral TabletSCD2b5b4fbb-9b86-46c6-9508-37d3d9806dec9

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionMarketing startMarketing endSampleExclude flagStatus
68788-7169-16878871690110 TABLET, FILM COATED in 1 BOTTLE (68788-7169-1) 2018-06-110000-00-00NoNoCurrent
68788-7169-26878871690220 TABLET, FILM COATED in 1 BOTTLE (68788-7169-2) 2018-06-110000-00-00NoNoCurrent
68788-7169-36878871690330 TABLET, FILM COATED in 1 BOTTLE (68788-7169-3) 2018-06-110000-00-00NoNoCurrent
68788-7169-66878871690660 TABLET, FILM COATED in 1 BOTTLE (68788-7169-6) 2018-06-110000-00-00NoNoCurrent
68788-7169-96878871690990 TABLET, FILM COATED in 1 BOTTLE (68788-7169-9) 2018-06-110000-00-00NoNoCurrent