Lunesta

Product NDC
68258-7049
11-digit product format
682587049
Labeler code
68258
Product ID
68258-7049_abf41383-30a2-43ec-b4d3-1c17836b8900
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
ESZOPICLONE
Dosage form
TABLET, COATED
Route
ORAL
Labeler
Dispensing Solutions, Inc.
Application
NDA021476
Marketing category
NDA
Marketing start
2005-04-04
Marketing end
0000-00-00
Substance
ESZOPICLONE
Active strength
3 mg/1
DEA schedule
CIV
NDC exclude flag
E
Listing certified through
2017-12-31
Current FDA listing
Historical FDA.report record

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
f65008ed-f925-2246-581a-e6a3201df7e4Product name520250107

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDCEffectiveActionDocumentIndexing SPLRelated label
68258-7049-32019-11-13C16284748780-197449f38-d391-f6ea-e053-dbdaa90aa703LUNESTA ® (eszopiclone) TABLETS 1 mg, 2 mg, 3 mg

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
68258-7049-3Lunesta30 in 1 BOTTLETABLET, COATED301

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
68258-7049-3EA - Each68258-70499104386c-f6e7-4e03-a207-03777dfc7c7612012-07-24

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIIDailyMed labelSPL versionUploaded
ESZOPICLONEACTIVE INGREDIENTUZX80K71OELUNESTA (ESZOPICLONE) TABLET, COATED [DISPENSING SOLUTIONS, INC.]1
ESZOPICLONEACTIVE MOIETYUZX80K71OELUNESTA (ESZOPICLONE) TABLET, COATED [DISPENSING SOLUTIONS, INC.]1
ANHYDROUS DIBASIC CALCIUM PHOSPHATEINACTIVE INGREDIENTL11K75P92JLUNESTA (ESZOPICLONE) TABLET, COATED [DISPENSING SOLUTIONS, INC.]1
CELLULOSE, MICROCRYSTALLINEINACTIVE INGREDIENTOP1R32D61ULUNESTA (ESZOPICLONE) TABLET, COATED [DISPENSING SOLUTIONS, INC.]1
CROSCARMELLOSE SODIUMINACTIVE INGREDIENTM28OL1HH48LUNESTA (ESZOPICLONE) TABLET, COATED [DISPENSING SOLUTIONS, INC.]1
FD&C BLUE NO. 2INACTIVE INGREDIENTL06K8R7DQKLUNESTA (ESZOPICLONE) TABLET, COATED [DISPENSING SOLUTIONS, INC.]1
HYPROMELLOSE 2910 (6 MPA.S)INACTIVE INGREDIENT0WZ8WG20P6LUNESTA (ESZOPICLONE) TABLET, COATED [DISPENSING SOLUTIONS, INC.]1
LACTOSE MONOHYDRATEINACTIVE INGREDIENTEWQ57Q8I5XLUNESTA (ESZOPICLONE) TABLET, COATED [DISPENSING SOLUTIONS, INC.]1
MAGNESIUM STEARATEINACTIVE INGREDIENT70097M6I30LUNESTA (ESZOPICLONE) TABLET, COATED [DISPENSING SOLUTIONS, INC.]1
POLYETHYLENE GLYCOLINACTIVE INGREDIENT3WJQ0SDW1ALUNESTA (ESZOPICLONE) TABLET, COATED [DISPENSING SOLUTIONS, INC.]1
SILICON DIOXIDEINACTIVE INGREDIENTETJ7Z6XBU4LUNESTA (ESZOPICLONE) TABLET, COATED [DISPENSING SOLUTIONS, INC.]1
TITANIUM DIOXIDEINACTIVE INGREDIENT15FIX9V2JPLUNESTA (ESZOPICLONE) TABLET, COATED [DISPENSING SOLUTIONS, INC.]1
TRIACETININACTIVE INGREDIENTXHX3C3X673LUNESTA (ESZOPICLONE) TABLET, COATED [DISPENSING SOLUTIONS, INC.]1

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
68258-7049LUNESTA (ESZOPICLONE) TABLET, COATED [DISPENSING SOLUTIONS, INC.]1Legacy NDC, 1 package rows20111013_20b122fb-42ec-4fa1-9a9e-e5930e5d2e7e.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
485442eszopiclone 2 MG Oral TabletPSN20b122fb-42ec-4fa1-9a9e-e5930e5d2e7e1
485465eszopiclone 3 MG Oral TabletPSN20b122fb-42ec-4fa1-9a9e-e5930e5d2e7e1
540409Lunesta 2 MG Oral TabletPSN20b122fb-42ec-4fa1-9a9e-e5930e5d2e7e1
540411Lunesta 3 MG Oral TabletPSN20b122fb-42ec-4fa1-9a9e-e5930e5d2e7e1
540409eszopiclone 2 MG Oral Tablet [Lunesta]SBD20b122fb-42ec-4fa1-9a9e-e5930e5d2e7e1
540411eszopiclone 3 MG Oral Tablet [Lunesta]SBD20b122fb-42ec-4fa1-9a9e-e5930e5d2e7e1
485442eszopiclone 2 MG Oral TabletSCD20b122fb-42ec-4fa1-9a9e-e5930e5d2e7e1
485465eszopiclone 3 MG Oral TabletSCD20b122fb-42ec-4fa1-9a9e-e5930e5d2e7e1
540409Lunesta 2 MG Oral TabletSY20b122fb-42ec-4fa1-9a9e-e5930e5d2e7e1
540411Lunesta 3 MG Oral TabletSY20b122fb-42ec-4fa1-9a9e-e5930e5d2e7e1

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionStatus
68258-7049-36825870490330 in 1 BOTTLEHistorical