FDA.reportPublic FDA data

Eszopiclone

Product NDC
55111-619
11-digit product format
551110619
Labeler code
55111
Product ID
55111-619_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
2 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
ESZOPICLONE2 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
55111-619-01Eszopiclone100 in 1 BOTTLETABLET, COATED10016
55111-619-05Eszopiclone500 in 1 BOTTLETABLET, COATED50016
55111-619-09Eszopiclone9 in 1 CARTONTABLET, COATED916
55111-619-30Eszopiclone30 in 1 BOTTLETABLET, COATED3016
55111-619-79Eszopiclone10 in 1 BLISTER PACKTABLET, COATED1016
55111-619-90Eszopiclone90 in 1 BOTTLETABLET, COATED9016

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
55111-619-01EA - Each55111-619cf025fc9-4c48-49a5-acf6-fa9a735ce27e12014-05-02

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
55111-619ESZOPICLONE 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
485442eszopiclone 2 MG Oral TabletPSNaf86ebdb-e47b-706a-e053-2995a90ad51c6
485442eszopiclone 2 MG Oral TabletSCDaf86ebdb-e47b-706a-e053-2995a90ad51c6
485442eszopiclone 2 MG Oral TabletPSN6ed9115e-4cf1-4a1d-aaeb-d62cb1e0303f4
485442eszopiclone 2 MG Oral TabletSCD6ed9115e-4cf1-4a1d-aaeb-d62cb1e0303f4
485442eszopiclone 2 MG Oral TabletPSN8edd5f22-cbdb-4286-8b35-9d09d84dafd71
485442eszopiclone 2 MG Oral TabletSCD8edd5f22-cbdb-4286-8b35-9d09d84dafd71

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
55111-619-0155111061901100 TABLET, COATED in 1 BOTTLE (55111-619-01) 2014-04-150000-00-00NoNoCurrent
55111-619-0555111061905500 TABLET, COATED in 1 BOTTLE (55111-619-05) 2014-04-150000-00-00NoNoCurrent
55111-619-09551110619099 BLISTER PACK in 1 CARTON (55111-619-09) / 10 TABLET, COATED in 1 BLISTER PACK (55111-619-79) 9 blister pack2014-04-150000-00-00NoNoCurrent
55111-619-305511106193030 TABLET, COATED in 1 BOTTLE (55111-619-30) 2014-04-150000-00-00NoNoCurrent
55111-619-795511106197910 in 1 BLISTER PACKHistorical
55111-619-905511106199090 TABLET, COATED in 1 BOTTLE (55111-619-90) 2014-04-150000-00-00NoNoCurrent