Eszopiclone

Product NDC
55700-581
11-digit product format
557000581
Labeler code
55700
Product ID
55700-581_7bdcb296-7e0f-499b-8479-ea922a9bd654
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
2018-01-19
Marketing end
2028-08-31
Substance
ESZOPICLONE
Active strength
2 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
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
55700-581-30Eszopiclone30 in 1 BOTTLETABLET, FILM COATED306

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
55700-581-30EA - Each55700-5814fec5792-e8a4-4ae5-8b02-0aa961b0af0e12018-02-20

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
55700-581ESZOPICLONE TABLET, FILM COATED [QUALITY CARE PRODUCTS LLC]6Current NDC, Legacy NDC, 1 package rows20241219_7832f554-2b82-4ef2-b1ef-266179f271d3.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
485442eszopiclone 2 MG Oral TabletPSN7832f554-2b82-4ef2-b1ef-266179f271d36
485442eszopiclone 2 MG Oral TabletSCD7832f554-2b82-4ef2-b1ef-266179f271d36

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionMarketing startMarketing endSampleExclude flagStatus
55700-581-305570005813030 TABLET, FILM COATED in 1 BOTTLE (55700-581-30) 2018-01-192028-08-31NoNoCurrent