Eszopiclone

Product NDC
55700-621
11-digit product format
557000621
Labeler code
55700
Product ID
55700-621_bfce1454-2e1e-49fd-b252-3530480d140f
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Eszopiclone
Dosage form
TABLET, FILM COATED
Route
ORAL
Labeler
Lake Erie Medical DBA Quality Care Products LLC
Application
ANDA202929
Marketing category
ANDA
Marketing start
2018-05-18
Marketing end
2026-08-31
Substance
ESZOPICLONE
Active strength
1 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
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

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
55700-621-30Eszopiclone30 in 1 BOTTLETABLET, FILM COATED306

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
55700-621-30EA - Each55700-621dc62a5a8-aadf-4fbb-969a-3e26596ff1b012018-06-11

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
55700-621ESZOPICLONE TABLET, FILM COATED [LAKE ERIE MEDICAL DBA QUALITY CARE PRODUCTS LLC]6Current NDC, Legacy NDC, 1 package rows20241220_9460be93-cd53-4429-a4d9-2f04e3835168.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
485440eszopiclone 1 MG Oral TabletPSN9460be93-cd53-4429-a4d9-2f04e38351686
485440eszopiclone 1 MG Oral TabletSCD9460be93-cd53-4429-a4d9-2f04e38351686

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionMarketing startMarketing endSampleExclude flagStatus
55700-621-305570006213030 TABLET, FILM COATED in 1 BOTTLE (55700-621-30) 2018-05-182026-08-31NoNoCurrent