FDA.reportPublic FDA data

ESZOPICLONE

Product NDC
45865-829
11-digit product format
458650829
Labeler code
45865
Product ID
45865-829_9ab48833-f4f1-89fc-e053-2995a90a7d67
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
ESZOPICLONE
Dosage form
TABLET, FILM COATED
Route
ORAL
Labeler
Medsource Pharmaceuticals
Application
ANDA091103
Marketing category
ANDA
Marketing start
2014-04-15
Marketing end
0000-00-00
Substance
ESZOPICLONE
Active strength
2 mg/1
DEA schedule
CIV
NDC exclude flag
No
Listing certified through
2020-12-31
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
45865-829-202025-01-30C16284748780-12cef2736-942a-d83d-e063-dadaa90ab31fThese highlights do not include all the information needed to use ESZOPICLONE safely and effectively. See full prescribing information for ESZOPICLONE tablets. ESZOPICLONE tablets, for oral use, CIV Initial U.S. Approval: 2004
45865-829-302025-01-30C16284748780-12cef2736-942a-d83d-e063-dadaa90ab31fThese highlights do not include all the information needed to use ESZOPICLONE safely and effectively. See full prescribing information for ESZOPICLONE tablets. ESZOPICLONE tablets, for oral use, CIV Initial U.S. Approval: 2004
45865-829-602025-01-30C16284748780-12cef2736-942a-d83d-e063-dadaa90ab31fThese highlights do not include all the information needed to use ESZOPICLONE safely and effectively. See full prescribing information for ESZOPICLONE tablets. ESZOPICLONE tablets, for oral use, CIV Initial U.S. Approval: 2004

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
45865-829-20ESZOPICLONE20 in 1 BOTTLETABLET, FILM COATED203
45865-829-30ESZOPICLONE30 in 1 BOTTLETABLET, FILM COATED303
45865-829-60ESZOPICLONE60 in 1 BOTTLETABLET, FILM COATED603

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIIDailyMed labelSPL versionUploaded
ESZOPICLONEACTIVE INGREDIENTUZX80K71OEESZOPICLONE TABLET, FILM COATED [MEDSOURCE PHARMACEUTICALS]2
ESZOPICLONEACTIVE MOIETYUZX80K71OEESZOPICLONE TABLET, FILM COATED [MEDSOURCE PHARMACEUTICALS]2
ANHYDROUS LACTOSEINACTIVE INGREDIENT3SY5LH9PMKESZOPICLONE TABLET, FILM COATED [MEDSOURCE PHARMACEUTICALS]2
CELLULOSE, MICROCRYSTALLINEINACTIVE INGREDIENTOP1R32D61UESZOPICLONE TABLET, FILM COATED [MEDSOURCE PHARMACEUTICALS]2
CROSCARMELLOSE SODIUMINACTIVE INGREDIENTM28OL1HH48ESZOPICLONE TABLET, FILM COATED [MEDSOURCE PHARMACEUTICALS]2
FD&C BLUE NO. 2INACTIVE INGREDIENTL06K8R7DQKESZOPICLONE TABLET, FILM COATED [MEDSOURCE PHARMACEUTICALS]2
FD&C RED NO. 40INACTIVE INGREDIENTWZB9127XOAESZOPICLONE TABLET, FILM COATED [MEDSOURCE PHARMACEUTICALS]2
FD&C YELLOW NO. 6INACTIVE INGREDIENTH77VEI93A8ESZOPICLONE TABLET, FILM COATED [MEDSOURCE PHARMACEUTICALS]2
HYPROMELLOSESINACTIVE INGREDIENT3NXW29V3WOESZOPICLONE TABLET, FILM COATED [MEDSOURCE PHARMACEUTICALS]2
MAGNESIUM STEARATEINACTIVE INGREDIENT70097M6I30ESZOPICLONE TABLET, FILM COATED [MEDSOURCE PHARMACEUTICALS]2
POLYETHYLENE GLYCOL 400INACTIVE INGREDIENTB697894SGQESZOPICLONE TABLET, FILM COATED [MEDSOURCE PHARMACEUTICALS]2
POLYSORBATE 80INACTIVE INGREDIENT6OZP39ZG8HESZOPICLONE TABLET, FILM COATED [MEDSOURCE PHARMACEUTICALS]2
SILICON DIOXIDEINACTIVE INGREDIENTETJ7Z6XBU4ESZOPICLONE TABLET, FILM COATED [MEDSOURCE PHARMACEUTICALS]2
STARCH, CORNINACTIVE INGREDIENTO8232NY3SJESZOPICLONE TABLET, FILM COATED [MEDSOURCE PHARMACEUTICALS]2
TITANIUM DIOXIDEINACTIVE INGREDIENT15FIX9V2JPESZOPICLONE TABLET, FILM COATED [MEDSOURCE PHARMACEUTICALS]2

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
45865-829ESZOPICLONE TABLET, FILM COATED [MEDSOURCE PHARMACEUTICALS]3Legacy NDC, 3 package rows20191228_1bbd525e-be06-310d-e054-00144ff88e88.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
485440eszopiclone 1 MG Oral TabletPSN1bbd525e-be06-310d-e054-00144ff88e883
485442eszopiclone 2 MG Oral TabletPSN1bbd525e-be06-310d-e054-00144ff88e883
485465eszopiclone 3 MG Oral TabletPSN1bbd525e-be06-310d-e054-00144ff88e883
485440eszopiclone 1 MG Oral TabletSCD1bbd525e-be06-310d-e054-00144ff88e883
485442eszopiclone 2 MG Oral TabletSCD1bbd525e-be06-310d-e054-00144ff88e883
485465eszopiclone 3 MG Oral TabletSCD1bbd525e-be06-310d-e054-00144ff88e883

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionMarketing startMarketing endSampleExclude flagStatus
45865-829-204586508292020 TABLET, FILM COATED in 1 BOTTLE (45865-829-20) 2015-07-270000-00-00NoNoCurrent
45865-829-304586508293030 TABLET, FILM COATED in 1 BOTTLE (45865-829-30) 2015-07-270000-00-00NoNoCurrent
45865-829-604586508296060 TABLET, FILM COATED in 1 BOTTLE (45865-829-60) 2015-07-270000-00-00NoNoCurrent