FDA.reportPublic FDA data

Eszopiclone

Product NDC
68788-7029
11-digit product format
687887029
Labeler code
68788
Product ID
68788-7029_66106223-7a6c-406c-83e6-027e77882a71
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
2017-10-12
Substance
ESZOPICLONE
Active strength
2 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
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
68788-7029-1Eszopiclone10 in 1 BOTTLETABLET, FILM COATED109
68788-7029-2Eszopiclone20 in 1 BOTTLETABLET, FILM COATED209
68788-7029-3Eszopiclone30 in 1 BOTTLETABLET, FILM COATED309
68788-7029-6Eszopiclone60 in 1 BOTTLETABLET, FILM COATED609
68788-7029-9Eszopiclone90 in 1 BOTTLETABLET, FILM COATED909

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
68788-7029-1EA - Each68788-702967cc98c4-97e5-4751-b291-0f75a4d5bb0212020-01-03
68788-7029-2EA - Each68788-7029d7a99da4-3f41-4f18-8561-1bde9482fca212020-01-03
68788-7029-3EA - Each68788-70294f5b00ee-1fde-4f26-b424-f4b9d8bf430d12020-01-03
68788-7029-6EA - Each68788-70292a6be189-5152-4193-92df-3a30b732123312020-01-03
68788-7029-9EA - Each68788-70292f9eb018-2e47-459d-aa84-093c3628bf3612020-01-03

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
68788-7029ESZOPICLONE TABLET, FILM COATED [PREFERRED PHARMACEUTICALS INC.]8Current NDC, Legacy NDC, 5 package rows20250504_abe3a610-a25d-4b52-8537-c87e8ba3104a.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
485442eszopiclone 2 MG Oral TabletPSNabe3a610-a25d-4b52-8537-c87e8ba3104a9
485442eszopiclone 2 MG Oral TabletSCDabe3a610-a25d-4b52-8537-c87e8ba3104a9

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionMarketing startMarketing endSampleExclude flagStatus
68788-7029-16878870290110 TABLET, FILM COATED in 1 BOTTLE (68788-7029-1) 2017-10-120000-00-00NoNoCurrent
68788-7029-26878870290220 TABLET, FILM COATED in 1 BOTTLE (68788-7029-2) 2017-10-120000-00-00NoNoCurrent
68788-7029-36878870290330 TABLET, FILM COATED in 1 BOTTLE (68788-7029-3) 2017-10-120000-00-00NoNoCurrent
68788-7029-66878870290660 TABLET, FILM COATED in 1 BOTTLE (68788-7029-6) 2017-10-120000-00-00NoNoCurrent
68788-7029-96878870290990 TABLET, FILM COATED in 1 BOTTLE (68788-7029-9) 2017-10-120000-00-00NoNoCurrent