FDA.reportPublic FDA data

ESZOPICLONE

Product NDC
68788-7667
11-digit product format
687887667
Labeler code
68788
Product ID
68788-7667_1fb749c5-2de2-4875-8a41-2eaf6747db82
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
ESZOPICLONE
Dosage form
TABLET, FILM COATED
Route
ORAL
Labeler
Preferred Pharmaceuticals, Inc.
Application
ANDA208451
Marketing category
ANDA
Marketing start
2020-02-28
Substance
ESZOPICLONE
Active strength
1 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
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
362d7abb-94e6-4c60-9a58-266894157713Product name120231023
816b97af-edc5-4060-aff1-b814bdbcad50Product name120190415
419aab54-5d5a-4146-9453-026d4a9991beProduct name220170525
89dac932-b90a-4410-9ab1-84c53e57de25Product name120150316
d723478e-ad4a-ec23-6bd7-cfe33e1e3840Product name120140508

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
68788-7667-0ESZOPICLONE100 in 1 BOTTLETABLET, FILM COATED1007
68788-7667-1ESZOPICLONE10 in 1 BOTTLETABLET, FILM COATED107
68788-7667-2ESZOPICLONE20 in 1 BOTTLETABLET, FILM COATED207
68788-7667-3ESZOPICLONE30 in 1 BOTTLETABLET, FILM COATED307
68788-7667-5ESZOPICLONE15 in 1 BOTTLETABLET, FILM COATED157
68788-7667-6ESZOPICLONE60 in 1 BOTTLETABLET, FILM COATED607
68788-7667-7ESZOPICLONE7 in 1 BOTTLETABLET, FILM COATED77
68788-7667-9ESZOPICLONE90 in 1 BOTTLETABLET, FILM COATED907

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
68788-7667-0EA - Each68788-76677636ec67-9db7-4051-ad2d-908e0320dfb612020-05-08
68788-7667-1EA - Each68788-7667d3955f4d-dc78-4d1f-b74f-21e0a73ff56e12020-05-08
68788-7667-2EA - Each68788-7667404924a1-6ea9-48cb-a94e-52b1f33d0e6e12020-05-08
68788-7667-3EA - Each68788-76671f4a6642-4042-417b-a820-a01f7df741f312020-05-08
68788-7667-5EA - Each68788-7667675d597f-82fc-47b0-ba62-2ff559d6b99612020-05-08
68788-7667-6EA - Each68788-7667c42f48cd-7c7f-4352-933c-e9214917925112020-05-08
68788-7667-7EA - Each68788-76671560ef9b-4447-437d-902d-06e87a96a4c612020-05-08
68788-7667-9EA - Each68788-7667545de869-6f5b-4df0-a9af-bf4128511fb012020-05-08

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
68788-7667ESZOPICLONE TABLET, FILM COATED [PREFERRED PHARMACEUTICALS, INC.]6Current NDC, Legacy NDC, 8 package rows20250504_45558f0a-83f1-49b9-ab18-f436c0be9677.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
485440eszopiclone 1 MG Oral TabletPSN45558f0a-83f1-49b9-ab18-f436c0be96777
485440eszopiclone 1 MG Oral TabletSCD45558f0a-83f1-49b9-ab18-f436c0be96777

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionMarketing startMarketing endSampleExclude flagStatus
68788-7667-068788766700100 TABLET, FILM COATED in 1 BOTTLE (68788-7667-0) 2020-02-280000-00-00NoNoCurrent
68788-7667-16878876670110 TABLET, FILM COATED in 1 BOTTLE (68788-7667-1) 2020-02-280000-00-00NoNoCurrent
68788-7667-26878876670220 TABLET, FILM COATED in 1 BOTTLE (68788-7667-2) 2020-02-280000-00-00NoNoCurrent
68788-7667-36878876670330 TABLET, FILM COATED in 1 BOTTLE (68788-7667-3) 2020-02-280000-00-00NoNoCurrent
68788-7667-56878876670515 TABLET, FILM COATED in 1 BOTTLE (68788-7667-5) 2020-02-280000-00-00NoNoCurrent
68788-7667-66878876670660 TABLET, FILM COATED in 1 BOTTLE (68788-7667-6) 2020-02-280000-00-00NoNoCurrent
68788-7667-7687887667077 TABLET, FILM COATED in 1 BOTTLE (68788-7667-7) 2020-02-280000-00-00NoNoCurrent
68788-7667-96878876670990 TABLET, FILM COATED in 1 BOTTLE (68788-7667-9) 2020-02-280000-00-00NoNoCurrent