FDA.reportPublic FDA data

ESZOPICLONE

Product NDC
61919-502
11-digit product format
619190502
Labeler code
61919
Product ID
61919-502_6db26b35-5c99-412a-b880-37e5b713a9da
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
ESZOPICLONE
Dosage form
TABLET, FILM COATED
Route
ORAL
Labeler
DIRECT RX
Application
ANDA091103
Marketing category
ANDA
Marketing start
2015-01-01
Marketing end
0000-00-00
Substance
ESZOPICLONE
Active strength
1 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
61919-502-302020-01-31C16284748780-19d75b9d0-fe38-f424-e053-dadaa90a57ceESZOPICLONE
61919-502-602020-01-31C16284748780-19d75b9d0-fe38-f424-e053-dadaa90a57ceESZOPICLONE

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
61919-502-30ESZOPICLONE30 in 1 BOTTLETABLET, FILM COATED302
61919-502-60ESZOPICLONE60 in 1 BOTTLETABLET, FILM COATED602

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
61919-502-30EA - Each61919-5022d0c31d2-7853-40a4-941d-c670d6d8d4e912015-10-02
61919-502-60EA - Each61919-502d9ec86f3-f46f-497e-b655-2156edfee65012016-09-02

DailyMed Socrata Ingredients#

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

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
61919-502ESZOPICLONE TABLET, FILM COATED [DIRECT RX]2Legacy NDC, 2 package rows20150810_b8cd6577-17e7-4808-a9a8-3f65444c51cb.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
485440eszopiclone 1 MG Oral TabletPSNb8cd6577-17e7-4808-a9a8-3f65444c51cb2
485440eszopiclone 1 MG Oral TabletSCDb8cd6577-17e7-4808-a9a8-3f65444c51cb2

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionStatus
61919-502-306191905023030 in 1 BOTTLEHistorical
61919-502-606191905026060 in 1 BOTTLEHistorical