FDA.reportPublic FDA data

Eszopiclone

Product NDC
33342-300
11-digit product format
333420300
Labeler code
33342
Product ID
33342-300_66cfec66-191e-4af9-a623-8464417fab6d
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Eszopiclone
Dosage form
TABLET, FILM COATED
Route
ORAL
Labeler
Macleods Pharmaceuticals Limited
Application
ANDA202929
Marketing category
ANDA
Marketing start
2015-01-31
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
33342-300-11Eszopiclone100 in 1 BOTTLETABLET, FILM COATED1009
33342-300-12Eszopiclone10 in 1 CARTONTABLET, FILM COATED109
33342-300-12Eszopiclone10 in 1 BLISTER PACKTABLET, FILM COATED109
33342-300-44Eszopiclone1000 in 1 BOTTLETABLET, FILM COATED10009

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
33342-300-11EA - Each33342-300eb9341dc-ce0b-4f01-8342-8a76e8072c0612015-10-02

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIIDailyMed labelSPL versionUploaded
ESZOPICLONEACTIVE INGREDIENTUZX80K71OEESZOPICLONE TABLET, FILM COATED [MACLEODS PHARMACEUTICALS LIMITED]3
ESZOPICLONEACTIVE MOIETYUZX80K71OEESZOPICLONE TABLET, FILM COATED [MACLEODS PHARMACEUTICALS LIMITED]3
CALCIUM PHOSPHATE, DIBASIC, DIHYDRATEINACTIVE INGREDIENTO7TSZ97GEPESZOPICLONE TABLET, FILM COATED [MACLEODS PHARMACEUTICALS LIMITED]3
CELLULOSE, MICROCRYSTALLINEINACTIVE INGREDIENTOP1R32D61UESZOPICLONE TABLET, FILM COATED [MACLEODS PHARMACEUTICALS LIMITED]3
COLLOIDAL SILICON DIOXIDEINACTIVE INGREDIENTETJ7Z6XBU4ESZOPICLONE TABLET, FILM COATED [MACLEODS PHARMACEUTICALS LIMITED]3
CROSCARMELLOSE SODIUMINACTIVE INGREDIENTM28OL1HH48ESZOPICLONE TABLET, FILM COATED [MACLEODS PHARMACEUTICALS LIMITED]3
FD&C BLUE NO. 2INACTIVE INGREDIENTL06K8R7DQKESZOPICLONE TABLET, FILM COATED [MACLEODS PHARMACEUTICALS LIMITED]3
HYPROMELLOSESINACTIVE INGREDIENT3NXW29V3WOESZOPICLONE TABLET, FILM COATED [MACLEODS PHARMACEUTICALS LIMITED]3
LACTOSE MONOHYDRATEINACTIVE INGREDIENTEWQ57Q8I5XESZOPICLONE TABLET, FILM COATED [MACLEODS PHARMACEUTICALS LIMITED]3
MAGNESIUM STEARATEINACTIVE INGREDIENT70097M6I30ESZOPICLONE TABLET, FILM COATED [MACLEODS PHARMACEUTICALS LIMITED]3
POLYETHYLENE GLYCOLSINACTIVE INGREDIENT3WJQ0SDW1AESZOPICLONE TABLET, FILM COATED [MACLEODS PHARMACEUTICALS LIMITED]3
TITANIUM DIOXIDEINACTIVE INGREDIENT15FIX9V2JPESZOPICLONE TABLET, FILM COATED [MACLEODS PHARMACEUTICALS LIMITED]3
TRIACETININACTIVE INGREDIENTXHX3C3X673ESZOPICLONE TABLET, FILM COATED [MACLEODS PHARMACEUTICALS LIMITED]3

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
33342-300ESZOPICLONE TABLET, FILM COATED [MACLEODS PHARMACEUTICALS LIMITED]9Current NDC, Legacy NDC, 4 package rows20221102_12593790-e72f-45b1-8895-987cdd075134.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
485440eszopiclone 1 MG Oral TabletPSN9a891ab1-675f-498e-a21e-05964307d2dd21
485442eszopiclone 2 MG Oral TabletPSN9a891ab1-675f-498e-a21e-05964307d2dd21
485465eszopiclone 3 MG Oral TabletPSN9a891ab1-675f-498e-a21e-05964307d2dd21
485440eszopiclone 1 MG Oral TabletSCD9a891ab1-675f-498e-a21e-05964307d2dd21
485442eszopiclone 2 MG Oral TabletSCD9a891ab1-675f-498e-a21e-05964307d2dd21
485465eszopiclone 3 MG Oral TabletSCD9a891ab1-675f-498e-a21e-05964307d2dd21
485440eszopiclone 1 MG Oral TabletPSN12593790-e72f-45b1-8895-987cdd0751349
485442eszopiclone 2 MG Oral TabletPSN12593790-e72f-45b1-8895-987cdd0751349
485442eszopiclone 2 MG Oral TabletPSNabe3a610-a25d-4b52-8537-c87e8ba3104a9
485465eszopiclone 3 MG Oral TabletPSN12593790-e72f-45b1-8895-987cdd0751349
485440eszopiclone 1 MG Oral TabletSCD12593790-e72f-45b1-8895-987cdd0751349
485442eszopiclone 2 MG Oral TabletSCDabe3a610-a25d-4b52-8537-c87e8ba3104a9
485442eszopiclone 2 MG Oral TabletSCD12593790-e72f-45b1-8895-987cdd0751349
485465eszopiclone 3 MG Oral TabletSCD12593790-e72f-45b1-8895-987cdd0751349
485440eszopiclone 1 MG Oral TabletPSN08a9069d-c914-48c8-a2cc-353965398f2c7
485442eszopiclone 2 MG Oral TabletPSN08a9069d-c914-48c8-a2cc-353965398f2c7
485465eszopiclone 3 MG Oral TabletPSN08a9069d-c914-48c8-a2cc-353965398f2c7
485440eszopiclone 1 MG Oral TabletSCD08a9069d-c914-48c8-a2cc-353965398f2c7
485442eszopiclone 2 MG Oral TabletSCD08a9069d-c914-48c8-a2cc-353965398f2c7
485465eszopiclone 3 MG Oral TabletSCD08a9069d-c914-48c8-a2cc-353965398f2c7
485442eszopiclone 2 MG Oral TabletPSNaf86fca8-571a-0cac-e053-2a95a90ae4026
485442eszopiclone 2 MG Oral TabletPSN7832f554-2b82-4ef2-b1ef-266179f271d36
485442eszopiclone 2 MG Oral TabletSCDaf86fca8-571a-0cac-e053-2a95a90ae4026
485442eszopiclone 2 MG Oral TabletSCD7832f554-2b82-4ef2-b1ef-266179f271d36
485442eszopiclone 2 MG Oral TabletPSN486b760b-7fea-306b-e054-00144ff8d46c5
485442eszopiclone 2 MG Oral TabletPSN5451be60-1315-4152-ad13-412e86903c8a5
485442eszopiclone 2 MG Oral TabletSCD486b760b-7fea-306b-e054-00144ff8d46c5
485442eszopiclone 2 MG Oral TabletSCD5451be60-1315-4152-ad13-412e86903c8a5
485440eszopiclone 1 MG Oral TabletPSN10175591-c1b4-461a-830e-8df982d0d2bf2
485442eszopiclone 2 MG Oral TabletPSN10175591-c1b4-461a-830e-8df982d0d2bf2
485465eszopiclone 3 MG Oral TabletPSN10175591-c1b4-461a-830e-8df982d0d2bf2
485440eszopiclone 1 MG Oral TabletSCD10175591-c1b4-461a-830e-8df982d0d2bf2
485442eszopiclone 2 MG Oral TabletSCD10175591-c1b4-461a-830e-8df982d0d2bf2
485465eszopiclone 3 MG Oral TabletSCD10175591-c1b4-461a-830e-8df982d0d2bf2
485442eszopiclone 2 MG Oral TabletPSN9dfe774a-2c7a-4e10-bedd-cde64ad286761
485442eszopiclone 2 MG Oral TabletPSNf6022b2f-9b43-40cc-91c7-c224b209efab1
485442eszopiclone 2 MG Oral TabletSCD9dfe774a-2c7a-4e10-bedd-cde64ad286761
485442eszopiclone 2 MG Oral TabletSCDf6022b2f-9b43-40cc-91c7-c224b209efab1

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
33342-300-1133342030011100 TABLET, FILM COATED in 1 BOTTLE (33342-300-11) 2015-01-310000-00-00NoNoCurrent
33342-300-123334203001210 BLISTER PACK in 1 CARTON (33342-300-12) / 10 TABLET, FILM COATED in 1 BLISTER PACK10 blister pack2015-01-310000-00-00NoNoCurrent
33342-300-44333420300441000 TABLET, FILM COATED in 1 BOTTLE (33342-300-44) 2015-01-310000-00-00NoNoCurrent