Eszopiclone

Product NDC
55700-610
11-digit product format
557000610
Labeler code
55700
Product ID
55700-610_5d65f795-1082-42f3-a054-7a9a205b7625
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Eszopiclone
Dosage form
TABLET, FILM COATED
Route
ORAL
Labeler
Quality Care Products LLC
Application
ANDA202929
Marketing category
ANDA
Marketing start
2018-05-04
Marketing end
2028-06-30
Substance
ESZOPICLONE
Active strength
3 mg/1
DEA schedule
CIV
NDC exclude flag
No
Current FDA listing
Yes

Additional Listing Data#

Finished product
Yes
Brand name base
Eszopiclone

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
55700-610-30Eszopiclone30 in 1 BOTTLETABLET, FILM COATED306
55700-610-60Eszopiclone60 in 1 BOTTLETABLET, FILM COATED606

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
55700-610-30EA - Each55700-610a38f9942-08a5-4e0d-ac68-f69160c42a9612018-06-11
55700-610-60EA - Each55700-610998bf1c1-f9cd-4b09-8691-a3649095dbfc12018-06-11

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
55700-610ESZOPICLONE TABLET, FILM COATED [QUALITY CARE PRODUCTS LLC]6Current NDC, Legacy NDC, 2 package rows20241219_3b8a09c6-0702-43a7-b47f-a36cd00b7584.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
485465eszopiclone 3 MG Oral TabletPSN3b8a09c6-0702-43a7-b47f-a36cd00b75846
485465eszopiclone 3 MG Oral TabletSCD3b8a09c6-0702-43a7-b47f-a36cd00b75846

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionMarketing startMarketing endSampleExclude flagStatus
55700-610-305570006103030 TABLET, FILM COATED in 1 BOTTLE (55700-610-30) 2018-05-042028-06-30NoNoCurrent
55700-610-605570006106060 TABLET, FILM COATED in 1 BOTTLE (55700-610-60) 2018-05-042028-06-30NoNoCurrent