FDA.reportPublic FDA data

ESZOPICLONE

Product NDC
47335-587
11-digit product format
473350587
Labeler code
47335
Product ID
47335-587_95e952a3-5a7d-4b4c-9ac8-b5256a4371c3
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
ESZOPICLONE
Dosage form
TABLET, FILM COATED
Route
ORAL
Labeler
Sun Pharmaceutical Industries, Inc.
Application
ANDA091103
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
47335-587-08ESZOPICLONE100 in 1 BOTTLETABLET, FILM COATED1008
47335-587-18ESZOPICLONE1000 in 1 BOTTLETABLET, FILM COATED10008
47335-587-83ESZOPICLONE30 in 1 BOTTLETABLET, FILM COATED308
47335-587-88ESZOPICLONE100 in 1 BOTTLETABLET, FILM COATED1008

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
47335-587-88EA - Each47335-5875fa1f3cd-3176-4945-9947-fb5eedcee92112014-05-02

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIIDailyMed labelSPL versionUploaded
ESZOPICLONEACTIVE INGREDIENTUZX80K71OEESZOPICLONE TABLET, FILM COATED [BRYANT RANCH PREPACK]1000
ESZOPICLONEACTIVE MOIETYUZX80K71OEESZOPICLONE TABLET, FILM COATED [BRYANT RANCH PREPACK]1000
ANHYDROUS LACTOSEINACTIVE INGREDIENT3SY5LH9PMKESZOPICLONE TABLET, FILM COATED [BRYANT RANCH PREPACK]1000
CELLULOSE, MICROCRYSTALLINEINACTIVE INGREDIENTOP1R32D61UESZOPICLONE TABLET, FILM COATED [BRYANT RANCH PREPACK]1000
CROSCARMELLOSE SODIUMINACTIVE INGREDIENTM28OL1HH48ESZOPICLONE TABLET, FILM COATED [BRYANT RANCH PREPACK]1000
HYPROMELLOSESINACTIVE INGREDIENT3NXW29V3WOESZOPICLONE TABLET, FILM COATED [BRYANT RANCH PREPACK]1000
MAGNESIUM STEARATEINACTIVE INGREDIENT70097M6I30ESZOPICLONE TABLET, FILM COATED [BRYANT RANCH PREPACK]1000
POLYETHYLENE GLYCOL 400INACTIVE INGREDIENTB697894SGQESZOPICLONE TABLET, FILM COATED [BRYANT RANCH PREPACK]1000
POLYSORBATE 80INACTIVE INGREDIENT6OZP39ZG8HESZOPICLONE TABLET, FILM COATED [BRYANT RANCH PREPACK]1000
SILICON DIOXIDEINACTIVE INGREDIENTETJ7Z6XBU4ESZOPICLONE TABLET, FILM COATED [BRYANT RANCH PREPACK]1000
STARCH, CORNINACTIVE INGREDIENTO8232NY3SJESZOPICLONE TABLET, FILM COATED [BRYANT RANCH PREPACK]1000
TITANIUM DIOXIDEINACTIVE INGREDIENT15FIX9V2JPESZOPICLONE TABLET, FILM COATED [BRYANT RANCH PREPACK]1000
ESZOPICLONEACTIVE INGREDIENTUZX80K71OEESZOPICLONE TABLET, FILM COATED [SUN PHARMA GLOBAL FZE]5
ESZOPICLONEACTIVE MOIETYUZX80K71OEESZOPICLONE TABLET, FILM COATED [SUN PHARMA GLOBAL FZE]5
ANHYDROUS LACTOSEINACTIVE INGREDIENT3SY5LH9PMKESZOPICLONE TABLET, FILM COATED [SUN PHARMA GLOBAL FZE]5
CELLULOSE, MICROCRYSTALLINEINACTIVE INGREDIENTOP1R32D61UESZOPICLONE TABLET, FILM COATED [SUN PHARMA GLOBAL FZE]5
CROSCARMELLOSE SODIUMINACTIVE INGREDIENTM28OL1HH48ESZOPICLONE TABLET, FILM COATED [SUN PHARMA GLOBAL FZE]5
FD&C BLUE NO. 2INACTIVE INGREDIENTL06K8R7DQKESZOPICLONE TABLET, FILM COATED [SUN PHARMA GLOBAL FZE]5
FD&C RED NO. 40INACTIVE INGREDIENTWZB9127XOAESZOPICLONE TABLET, FILM COATED [SUN PHARMA GLOBAL FZE]5
FD&C YELLOW NO. 6INACTIVE INGREDIENTH77VEI93A8ESZOPICLONE TABLET, FILM COATED [SUN PHARMA GLOBAL FZE]5
HYPROMELLOSESINACTIVE INGREDIENT3NXW29V3WOESZOPICLONE TABLET, FILM COATED [SUN PHARMA GLOBAL FZE]5
MAGNESIUM STEARATEINACTIVE INGREDIENT70097M6I30ESZOPICLONE TABLET, FILM COATED [SUN PHARMA GLOBAL FZE]5
POLYETHYLENE GLYCOL 400INACTIVE INGREDIENTB697894SGQESZOPICLONE TABLET, FILM COATED [SUN PHARMA GLOBAL FZE]5
POLYSORBATE 80INACTIVE INGREDIENT6OZP39ZG8HESZOPICLONE TABLET, FILM COATED [SUN PHARMA GLOBAL FZE]5
SILICON DIOXIDEINACTIVE INGREDIENTETJ7Z6XBU4ESZOPICLONE TABLET, FILM COATED [SUN PHARMA GLOBAL FZE]5
STARCH, CORNINACTIVE INGREDIENTO8232NY3SJESZOPICLONE TABLET, FILM COATED [SUN PHARMA GLOBAL FZE]5
TITANIUM DIOXIDEINACTIVE INGREDIENT15FIX9V2JPESZOPICLONE TABLET, FILM COATED [SUN PHARMA GLOBAL FZE]5
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
47335-587ESZOPICLONE TABLET, FILM COATED [SUN PHARMACEUTICAL INDUSTRIES, INC.]8Current NDC, Legacy NDC, 4 package rows20181025_8bb1965e-7845-4c5b-b021-38e251303d68.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
485442eszopiclone 2 MG Oral TabletPSN29295c36-c640-48a5-8b6b-bae3b559f2c91007
485442eszopiclone 2 MG Oral TabletSCD29295c36-c640-48a5-8b6b-bae3b559f2c91007
485440eszopiclone 1 MG Oral TabletPSN8bb1965e-7845-4c5b-b021-38e251303d688
485442eszopiclone 2 MG Oral TabletPSN8bb1965e-7845-4c5b-b021-38e251303d688
485465eszopiclone 3 MG Oral TabletPSN8bb1965e-7845-4c5b-b021-38e251303d688
485440eszopiclone 1 MG Oral TabletSCD8bb1965e-7845-4c5b-b021-38e251303d688
485442eszopiclone 2 MG Oral TabletSCD8bb1965e-7845-4c5b-b021-38e251303d688
485465eszopiclone 3 MG Oral TabletSCD8bb1965e-7845-4c5b-b021-38e251303d688
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
47335-587-0847335058708100 TABLET, FILM COATED in 1 BOTTLE (47335-587-08) 2014-04-150000-00-00NoNoCurrent
47335-587-18473350587181000 TABLET, FILM COATED in 1 BOTTLE (47335-587-18) 2014-04-150000-00-00NoNoCurrent
47335-587-834733505878330 TABLET, FILM COATED in 1 BOTTLE (47335-587-83) 2014-04-150000-00-00NoNoCurrent
47335-587-8847335058788100 TABLET, FILM COATED in 1 BOTTLE (47335-587-88) 2014-04-150000-00-00NoNoCurrent