FDA.reportPublic FDA data

Eszopiclone

Product NDC
68462-384
11-digit product format
684620384
Labeler code
68462
Product ID
68462-384_59fb9200-74d0-472d-a4c7-96c9a4ded89c
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Eszopiclone
Dosage form
TABLET, FILM COATED
Route
ORAL
Labeler
Glenmark Pharmaceuticals Inc. USA
Application
ANDA091166
Marketing category
ANDA
Marketing start
2014-04-15
Substance
ESZOPICLONE
Active strength
3 mg/1
DEA schedule
CIV
NDC exclude flag
No
Listing certified through
2027-12-31
Current FDA listing
Yes

Additional Listing Data#

Finished product
Yes
Brand name base
Eszopiclone
Listing expiration
2027-12-31

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
68462-384-01Eszopiclone100 in 1 BOTTLETABLET, FILM COATED10011
68462-384-10Eszopiclone1000 in 1 BOTTLETABLET, FILM COATED100011
68462-384-30Eszopiclone30 in 1 BOTTLETABLET, FILM COATED3011

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
68462-384-01EA - Each68462-3845dd3e46c-82bb-452c-bb6a-f25ce495156312014-05-02

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIIDailyMed labelSPL versionUploaded
ESZOPICLONEACTIVE INGREDIENTUZX80K71OEESZOPICLONE TABLET, FILM COATED [GLENMARK PHARMACEUTICALS INC., USA]3
ESZOPICLONEACTIVE MOIETYUZX80K71OEESZOPICLONE TABLET, FILM COATED [GLENMARK PHARMACEUTICALS INC., USA]3
ANHYDROUS LACTOSEINACTIVE INGREDIENT3SY5LH9PMKESZOPICLONE TABLET, FILM COATED [GLENMARK PHARMACEUTICALS INC., USA]3
CALCIUM PHOSPHATE, DIBASIC, ANHYDROUSINACTIVE INGREDIENTL11K75P92JESZOPICLONE TABLET, FILM COATED [GLENMARK PHARMACEUTICALS INC., USA]3
CELLULOSE, MICROCRYSTALLINEINACTIVE INGREDIENTOP1R32D61UESZOPICLONE TABLET, FILM COATED [GLENMARK PHARMACEUTICALS INC., USA]3
CROSCARMELLOSE SODIUMINACTIVE INGREDIENTM28OL1HH48ESZOPICLONE TABLET, FILM COATED [GLENMARK PHARMACEUTICALS INC., USA]3
FD&C BLUE NO. 2INACTIVE INGREDIENTL06K8R7DQKESZOPICLONE TABLET, FILM COATED [GLENMARK PHARMACEUTICALS INC., USA]3
HYPROMELLOSESINACTIVE INGREDIENT3NXW29V3WOESZOPICLONE TABLET, FILM COATED [GLENMARK PHARMACEUTICALS INC., USA]3
LACTOSE MONOHYDRATEINACTIVE INGREDIENTEWQ57Q8I5XESZOPICLONE TABLET, FILM COATED [GLENMARK PHARMACEUTICALS INC., USA]3
MAGNESIUM STEARATEINACTIVE INGREDIENT70097M6I30ESZOPICLONE TABLET, FILM COATED [GLENMARK PHARMACEUTICALS INC., USA]3
POLYETHYLENE GLYCOLSINACTIVE INGREDIENT3WJQ0SDW1AESZOPICLONE TABLET, FILM COATED [GLENMARK PHARMACEUTICALS INC., USA]3
SILICON DIOXIDEINACTIVE INGREDIENTETJ7Z6XBU4ESZOPICLONE TABLET, FILM COATED [GLENMARK PHARMACEUTICALS INC., USA]3
TITANIUM DIOXIDEINACTIVE INGREDIENT15FIX9V2JPESZOPICLONE TABLET, FILM COATED [GLENMARK PHARMACEUTICALS INC., USA]3
TRIACETININACTIVE INGREDIENTXHX3C3X673ESZOPICLONE TABLET, FILM COATED [GLENMARK PHARMACEUTICALS INC., USA]3

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
68462-384ESZOPICLONE TABLET, FILM COATED [GLENMARK PHARMACEUTICALS INC. USA]10Current NDC, Legacy NDC, 3 package rows20230116_584dc66c-063a-4552-a056-74b811e2bc80.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
485465eszopiclone 3 MG Oral TabletPSNe04d4f8b-c9a1-4dc9-aac4-2e6376cd9a0c102
485465eszopiclone 3 MG Oral TabletSCDe04d4f8b-c9a1-4dc9-aac4-2e6376cd9a0c102
485440eszopiclone 1 MG Oral TabletPSN584dc66c-063a-4552-a056-74b811e2bc8011
485442eszopiclone 2 MG Oral TabletPSN584dc66c-063a-4552-a056-74b811e2bc8011
485465eszopiclone 3 MG Oral TabletPSN584dc66c-063a-4552-a056-74b811e2bc8011
485440eszopiclone 1 MG Oral TabletSCD584dc66c-063a-4552-a056-74b811e2bc8011
485442eszopiclone 2 MG Oral TabletSCD584dc66c-063a-4552-a056-74b811e2bc8011
485465eszopiclone 3 MG Oral TabletSCD584dc66c-063a-4552-a056-74b811e2bc8011
485442eszopiclone 2 MG Oral TabletPSNdc8db885-e4ef-4d72-9808-c5b2af2586593
485465eszopiclone 3 MG Oral TabletPSNac996f97-fd92-44f8-8bb5-478a81ffb33d3
485465eszopiclone 3 MG Oral TabletPSNdc8db885-e4ef-4d72-9808-c5b2af2586593
485442eszopiclone 2 MG Oral TabletSCDdc8db885-e4ef-4d72-9808-c5b2af2586593
485465eszopiclone 3 MG Oral TabletSCDac996f97-fd92-44f8-8bb5-478a81ffb33d3
485465eszopiclone 3 MG Oral TabletSCDdc8db885-e4ef-4d72-9808-c5b2af2586593
485440eszopiclone 1 MG Oral TabletPSN838559f7-4b69-4831-bf50-ab37c6c24c2b2
485442eszopiclone 2 MG Oral TabletPSN838559f7-4b69-4831-bf50-ab37c6c24c2b2
485465eszopiclone 3 MG Oral TabletPSN838559f7-4b69-4831-bf50-ab37c6c24c2b2
485465eszopiclone 3 MG Oral TabletPSNc24ec179-f869-746f-e053-2995a90aa1ff2
485440eszopiclone 1 MG Oral TabletSCD838559f7-4b69-4831-bf50-ab37c6c24c2b2
485442eszopiclone 2 MG Oral TabletSCD838559f7-4b69-4831-bf50-ab37c6c24c2b2
485465eszopiclone 3 MG Oral TabletSCDc24ec179-f869-746f-e053-2995a90aa1ff2
485465eszopiclone 3 MG Oral TabletSCD838559f7-4b69-4831-bf50-ab37c6c24c2b2

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionMarketing startMarketing endSampleExclude flagStatus
68462-384-0168462038401100 TABLET, FILM COATED in 1 BOTTLE (68462-384-01) 2014-04-150000-00-00NoNoCurrent
68462-384-10684620384101000 TABLET, FILM COATED in 1 BOTTLE (68462-384-10) 2014-04-150000-00-00NoNoCurrent
68462-384-306846203843030 TABLET, FILM COATED in 1 BOTTLE (68462-384-30) 2014-04-150000-00-00NoNoCurrent