FDA.reportPublic FDA data

Eszopiclone

Product NDC
76420-027
11-digit product format
764200027
Labeler code
76420
Product ID
76420-027_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
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
76420-027-01Eszopiclone100 in 1 BOTTLETABLET, FILM COATED1002
76420-027-10Eszopiclone10 in 1 BOTTLETABLET, FILM COATED102
76420-027-20Eszopiclone20 in 1 BOTTLETABLET, FILM COATED202
76420-027-30Eszopiclone30 in 1 BOTTLETABLET, FILM COATED302
76420-027-60Eszopiclone60 in 1 BOTTLETABLET, FILM COATED602
76420-027-90Eszopiclone90 in 1 BOTTLETABLET, FILM COATED902

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
76420-027-01EA - Each76420-027b45cb72c-e4f5-41e6-b122-455ff15ecc4d12022-08-04
76420-027-10EA - Each76420-02722f6cb78-9103-4328-99e8-9261ebd10daa12022-08-04
76420-027-20EA - Each76420-02777c91ee5-6555-4f91-b241-396952d1247c12022-08-04
76420-027-30EA - Each76420-027c371456e-f602-4aa1-ad2d-fe6041b31fd112022-08-04
76420-027-60EA - Each76420-02757c44bf4-dfea-4259-aaa7-92ccfd9a0ba112022-08-04
76420-027-90EA - Each76420-027c8eea544-e5ed-44e0-9213-b8492b8a457d12022-08-04

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
76420-027ESZOPICLONE 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
76420-027-0176420002701100 TABLET, FILM COATED in 1 BOTTLE (76420-027-01) 2020-06-170000-00-00NoNoCurrent
76420-027-107642000271010 TABLET, FILM COATED in 1 BOTTLE (76420-027-10) 2020-06-170000-00-00NoNoCurrent
76420-027-207642000272020 TABLET, FILM COATED in 1 BOTTLE (76420-027-20) 2020-06-170000-00-00NoNoCurrent
76420-027-307642000273030 TABLET, FILM COATED in 1 BOTTLE (76420-027-30) 2020-06-170000-00-00NoNoCurrent
76420-027-607642000276060 TABLET, FILM COATED in 1 BOTTLE (76420-027-60) 2020-06-170000-00-00NoNoCurrent
76420-027-907642000279090 TABLET, FILM COATED in 1 BOTTLE (76420-027-90) 2020-06-170000-00-00NoNoCurrent