FDA.reportPublic FDA data

Eszopiclone

Product NDC
33342-301
11-digit product format
333420301
Labeler code
33342
Product ID
33342-301_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
2014-04-25
Substance
ESZOPICLONE
Active strength
3 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
ESZOPICLONE3 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
33342-301-11Eszopiclone100 in 1 BOTTLETABLET, FILM COATED1009
33342-301-12Eszopiclone10 in 1 BLISTER PACKTABLET, FILM COATED109
33342-301-12Eszopiclone10 in 1 CARTONTABLET, FILM COATED109
33342-301-44Eszopiclone1000 in 1 BOTTLETABLET, FILM COATED10009

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
33342-301-11EA - Each33342-301ecc8270b-a04e-440b-a928-d41233fd060e12015-10-02

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
33342-301ESZOPICLONE 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
485465eszopiclone 3 MG Oral TabletPSN12593790-e72f-45b1-8895-987cdd0751349
485465eszopiclone 3 MG Oral TabletPSN2b5b4fbb-9b86-46c6-9508-37d3d9806dec9
485440eszopiclone 1 MG Oral TabletSCD12593790-e72f-45b1-8895-987cdd0751349
485442eszopiclone 2 MG Oral TabletSCD12593790-e72f-45b1-8895-987cdd0751349
485465eszopiclone 3 MG Oral TabletSCD12593790-e72f-45b1-8895-987cdd0751349
485465eszopiclone 3 MG Oral TabletSCD2b5b4fbb-9b86-46c6-9508-37d3d9806dec9
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
485465eszopiclone 3 MG Oral TabletPSNaf863d89-25db-2893-e053-2a95a90a704c6
485465eszopiclone 3 MG Oral TabletPSN3b8a09c6-0702-43a7-b47f-a36cd00b75846
485465eszopiclone 3 MG Oral TabletSCDaf863d89-25db-2893-e053-2a95a90a704c6
485465eszopiclone 3 MG Oral TabletSCD3b8a09c6-0702-43a7-b47f-a36cd00b75846
485465eszopiclone 3 MG Oral TabletPSN61fd4655-060f-4393-a610-019d8b1270585
485465eszopiclone 3 MG Oral TabletPSNd301b0cf-1492-4be9-83a0-1b64c8fa3b725
485465eszopiclone 3 MG Oral TabletSCD61fd4655-060f-4393-a610-019d8b1270585
485465eszopiclone 3 MG Oral TabletSCDd301b0cf-1492-4be9-83a0-1b64c8fa3b725
485465eszopiclone 3 MG Oral TabletPSN53fcee89-027a-13e5-e054-00144ff8d46c4
485465eszopiclone 3 MG Oral TabletSCD53fcee89-027a-13e5-e054-00144ff8d46c4
485465eszopiclone 3 MG Oral TabletPSN673c665b-488d-1d74-e053-2991aa0a543d3
485465eszopiclone 3 MG Oral TabletSCD673c665b-488d-1d74-e053-2991aa0a543d3
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
485465eszopiclone 3 MG Oral TabletPSN421c9fa7-107c-4265-9a7b-ac606b5c99231
485465eszopiclone 3 MG Oral TabletSCD421c9fa7-107c-4265-9a7b-ac606b5c99231

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
33342-301-1133342030111100 TABLET, FILM COATED in 1 BOTTLE (33342-301-11) 2015-01-310000-00-00NoNoCurrent
33342-301-123334203011210 BLISTER PACK in 1 CARTON (33342-301-12) / 10 TABLET, FILM COATED in 1 BLISTER PACK10 blister pack2015-01-310000-00-00NoNoCurrent
33342-301-44333420301441000 TABLET, FILM COATED in 1 BOTTLE (33342-301-44) 2015-01-310000-00-00NoNoCurrent