FDA.reportPublic FDA data

Eszopiclone

Product NDC
76420-026
11-digit product format
764200026
Labeler code
76420
Product ID
76420-026_2df4e9b7-6d0c-7409-e063-6294a90a46ce
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Eszopiclone
Dosage form
TABLET, FILM COATED
Route
ORAL
Labeler
Asclemed USA, Inc.
Application
ANDA202929
Marketing category
ANDA
Marketing start
2015-01-31
Substance
ESZOPICLONE
Active strength
1 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
ESZOPICLONE1 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
76420-026-01Eszopiclone100 in 1 BOTTLETABLET, FILM COATED1002
76420-026-10Eszopiclone10 in 1 BOTTLETABLET, FILM COATED102
76420-026-20Eszopiclone20 in 1 BOTTLETABLET, FILM COATED202
76420-026-30Eszopiclone30 in 1 BOTTLETABLET, FILM COATED302
76420-026-60Eszopiclone60 in 1 BOTTLETABLET, FILM COATED602
76420-026-90Eszopiclone90 in 1 BOTTLETABLET, FILM COATED902

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
76420-026-01EA - Each76420-026d8e74b26-0439-45f2-8a12-ad69dec4561212022-08-04
76420-026-10EA - Each76420-0261185154d-0764-4901-b34d-3dc47898ed3912022-08-04
76420-026-20EA - Each76420-0268930668f-13e7-4446-9241-f491faf7205c12022-08-04
76420-026-30EA - Each76420-026c8cae2cf-1f93-4dbc-b2f6-7c141721984412022-08-04
76420-026-60EA - Each76420-0266313d5d7-527f-4a74-8c32-e94c1b53011b12022-08-04
76420-026-90EA - Each76420-026b90df05a-d210-44be-9868-a7dfecddfc8912022-08-04

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
76420-026ESZOPICLONE TABLET, FILM COATED [ASCLEMED USA, INC.]2Current NDC, Legacy NDC, 6 package rows20250214_10175591-c1b4-461a-830e-8df982d0d2bf.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
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

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionMarketing startMarketing endSampleExclude flagStatus
76420-026-0176420002601100 TABLET, FILM COATED in 1 BOTTLE (76420-026-01) 2020-06-170000-00-00NoNoCurrent
76420-026-107642000261010 TABLET, FILM COATED in 1 BOTTLE (76420-026-10) 2020-06-170000-00-00NoNoCurrent
76420-026-207642000262020 TABLET, FILM COATED in 1 BOTTLE (76420-026-20) 2020-06-170000-00-00NoNoCurrent
76420-026-307642000263030 TABLET, FILM COATED in 1 BOTTLE (76420-026-30) 2020-06-170000-00-00NoNoCurrent
76420-026-607642000266060 TABLET, FILM COATED in 1 BOTTLE (76420-026-60) 2020-06-170000-00-00NoNoCurrent
76420-026-907642000269090 TABLET, FILM COATED in 1 BOTTLE (76420-026-90) 2020-06-170000-00-00NoNoCurrent