FDA.reportPublic FDA data

Eszopiclone

Product NDC
55111-617
11-digit product format
551110617
Labeler code
55111
Product ID
55111-617_bf1433f5-bde8-8c67-9ff7-ec5d3ed26581
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Eszopiclone
Dosage form
TABLET, COATED
Route
ORAL
Labeler
Dr. Reddy's Laboratories Limited
Application
ANDA091024
Marketing category
ANDA
Marketing start
2014-04-15
Substance
ESZOPICLONE
Active strength
3 mg/1
DEA schedule
CIV
NDC exclude flag
No
Listing certified through
2026-12-31
Current FDA listing
Yes

Additional Listing Data#

Finished product
Yes
Brand name base
Eszopiclone
Listing expiration
2026-12-31

Active Ingredients#

Ingredient, Strength table
IngredientStrength
ESZOPICLONE3 mg/1

Harmonized Identifiers#

Field, Values table
FieldValues
UniiUZX80K71OE
Rxcui485440, 485442, 485465

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
55111-617-01Eszopiclone100 in 1 BOTTLETABLET, COATED10016
55111-617-05Eszopiclone500 in 1 BOTTLETABLET, COATED50016
55111-617-09Eszopiclone9 in 1 CARTONTABLET, COATED916
55111-617-30Eszopiclone30 in 1 BOTTLETABLET, COATED3016
55111-617-79Eszopiclone10 in 1 BLISTER PACKTABLET, COATED1016
55111-617-90Eszopiclone90 in 1 BOTTLETABLET, COATED9016

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
55111-617-01EA - Each55111-6176c5b8251-a9a9-4a4d-9456-28efc0a0e72512014-05-02

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIIDailyMed labelSPL versionUploaded
ESZOPICLONEACTIVE INGREDIENTUZX80K71OEESZOPICLONE TABLET, COATED [DR. REDDY'S LABORATORIES LIMITED]8
ESZOPICLONEACTIVE MOIETYUZX80K71OEESZOPICLONE TABLET, COATED [DR. REDDY'S LABORATORIES LIMITED]8
CELLULOSE, MICROCRYSTALLINEINACTIVE INGREDIENTOP1R32D61UESZOPICLONE TABLET, COATED [DR. REDDY'S LABORATORIES LIMITED]8
CROSCARMELLOSE SODIUMINACTIVE INGREDIENTM28OL1HH48ESZOPICLONE TABLET, COATED [DR. REDDY'S LABORATORIES LIMITED]8
FD&C BLUE NO. 2INACTIVE INGREDIENTL06K8R7DQKESZOPICLONE TABLET, COATED [DR. REDDY'S LABORATORIES LIMITED]8
HYPROMELLOSESINACTIVE INGREDIENT3NXW29V3WOESZOPICLONE TABLET, COATED [DR. REDDY'S LABORATORIES LIMITED]8
LACTOSE MONOHYDRATEINACTIVE INGREDIENTEWQ57Q8I5XESZOPICLONE TABLET, COATED [DR. REDDY'S LABORATORIES LIMITED]8
MAGNESIUM STEARATEINACTIVE INGREDIENT70097M6I30ESZOPICLONE TABLET, COATED [DR. REDDY'S LABORATORIES LIMITED]8
POLYETHYLENE GLYCOL 400INACTIVE INGREDIENTB697894SGQESZOPICLONE TABLET, COATED [DR. REDDY'S LABORATORIES LIMITED]8
TITANIUM DIOXIDEINACTIVE INGREDIENT15FIX9V2JPESZOPICLONE TABLET, COATED [DR. REDDY'S LABORATORIES LIMITED]8
TRIACETININACTIVE INGREDIENTXHX3C3X673ESZOPICLONE TABLET, COATED [DR. REDDY'S LABORATORIES LIMITED]8

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
55111-617ESZOPICLONE TABLET, COATED [DR. REDDY'S LABORATORIES LIMITED]16Current NDC, Legacy NDC, 6 package rows20241222_0b363b90-93dc-1fc1-0501-d140dfc762c7.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
485440eszopiclone 1 MG Oral TabletPSN0b363b90-93dc-1fc1-0501-d140dfc762c716
485442eszopiclone 2 MG Oral TabletPSN0b363b90-93dc-1fc1-0501-d140dfc762c716
485465eszopiclone 3 MG Oral TabletPSN0b363b90-93dc-1fc1-0501-d140dfc762c716
485440eszopiclone 1 MG Oral TabletSCD0b363b90-93dc-1fc1-0501-d140dfc762c716
485442eszopiclone 2 MG Oral TabletSCD0b363b90-93dc-1fc1-0501-d140dfc762c716
485465eszopiclone 3 MG Oral TabletSCD0b363b90-93dc-1fc1-0501-d140dfc762c716
485465eszopiclone 3 MG Oral TabletPSNaf86b753-d2ee-9b5f-e053-2a95a90ad23d7
485465eszopiclone 3 MG Oral TabletSCDaf86b753-d2ee-9b5f-e053-2a95a90ad23d7
485465eszopiclone 3 MG Oral TabletPSN44815d96-2157-454f-8dbb-d0b47f439d6b1
485465eszopiclone 3 MG Oral TabletSCD44815d96-2157-454f-8dbb-d0b47f439d6b1

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
55111-617-0155111061701100 TABLET, COATED in 1 BOTTLE (55111-617-01) 2014-04-150000-00-00NoNoCurrent
55111-617-0555111061705500 TABLET, COATED in 1 BOTTLE (55111-617-05) 2014-04-150000-00-00NoNoCurrent
55111-617-09551110617099 BLISTER PACK in 1 CARTON (55111-617-09) / 10 TABLET, COATED in 1 BLISTER PACK (55111-617-79) 9 blister pack2014-04-150000-00-00NoNoCurrent
55111-617-305511106173030 TABLET, COATED in 1 BOTTLE (55111-617-30) 2014-04-150000-00-00NoNoCurrent
55111-617-795511106177910 in 1 BLISTER PACKHistorical
55111-617-905511106179090 TABLET, COATED in 1 BOTTLE (55111-617-90) 2014-04-150000-00-00NoNoCurrent