FDA.reportPublic FDA data

ESZOPICLONE

Product NDC
61919-500
11-digit product format
619190500
Labeler code
61919
Product ID
61919-500_9c93fcaa-4e2c-446d-e053-2995a90a0461
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
ESZOPICLONE
Dosage form
TABLET, FILM COATED
Route
ORAL
Labeler
Direct Rx
Application
ANDA091103
Marketing category
ANDA
Marketing start
2014-01-01
Marketing end
0000-00-00
Substance
ESZOPICLONE
Active strength
3 mg/1
DEA schedule
CIV
NDC exclude flag
No
Listing certified through
2021-12-31
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
61919-500-302023-01-30C16284748780-1f386c64a-1a4b-0266-e053-dadaa90a7c1aESZOPICLONE

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
61919-500-30ESZOPICLONE30 in 1 BOTTLETABLET, FILM COATED305

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIIDailyMed labelSPL versionUploaded
ESZOPICLONEACTIVE INGREDIENTUZX80K71OEESZOPICLONE TABLET, FILM COATED [DIRECT RX]1
ESZOPICLONEACTIVE MOIETYUZX80K71OEESZOPICLONE TABLET, FILM COATED [DIRECT RX]1
ANHYDROUS LACTOSEINACTIVE INGREDIENT3SY5LH9PMKESZOPICLONE TABLET, FILM COATED [DIRECT RX]1
CELLULOSE, MICROCRYSTALLINEINACTIVE INGREDIENTOP1R32D61UESZOPICLONE TABLET, FILM COATED [DIRECT RX]1
CROSCARMELLOSE SODIUMINACTIVE INGREDIENTM28OL1HH48ESZOPICLONE TABLET, FILM COATED [DIRECT RX]1
FD&C BLUE NO. 2INACTIVE INGREDIENTL06K8R7DQKESZOPICLONE TABLET, FILM COATED [DIRECT RX]1
HYPROMELLOSESINACTIVE INGREDIENT3NXW29V3WOESZOPICLONE TABLET, FILM COATED [DIRECT RX]1
MAGNESIUM STEARATEINACTIVE INGREDIENT70097M6I30ESZOPICLONE TABLET, FILM COATED [DIRECT RX]1
POLYETHYLENE GLYCOL 400INACTIVE INGREDIENTB697894SGQESZOPICLONE TABLET, FILM COATED [DIRECT RX]1
POLYSORBATE 80INACTIVE INGREDIENT6OZP39ZG8HESZOPICLONE TABLET, FILM COATED [DIRECT RX]1
SILICON DIOXIDEINACTIVE INGREDIENTETJ7Z6XBU4ESZOPICLONE TABLET, FILM COATED [DIRECT RX]1
STARCH, CORNINACTIVE INGREDIENTO8232NY3SJESZOPICLONE TABLET, FILM COATED [DIRECT RX]1
TITANIUM DIOXIDEINACTIVE INGREDIENT15FIX9V2JPESZOPICLONE TABLET, FILM COATED [DIRECT RX]1

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
61919-500ESZOPICLONE TABLET, FILM COATED [DIRECT RX]5Legacy NDC, 1 package rows20200121_211f00b0-c858-4afc-8424-e74edad9b180.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
485465eszopiclone 3 MG Oral TabletPSN211f00b0-c858-4afc-8424-e74edad9b1805
485465eszopiclone 3 MG Oral TabletSCD211f00b0-c858-4afc-8424-e74edad9b1805

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionMarketing startMarketing endSampleExclude flagStatus
61919-500-306191905003030 TABLET, FILM COATED in 1 BOTTLE (61919-500-30) 2014-01-010000-00-00NoNoCurrent