FDA.reportPublic FDA data

Eszopiclone

Product NDC
80425-0407
11-digit product format
804250407
Labeler code
80425
Product ID
80425-0407_1baa56ec-7eaf-dda0-e063-6394a90af453
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Eszopiclone
Dosage form
TABLET, FILM COATED
Route
ORAL
Labeler
Advanced Rx of Tennessee, LLC
Application
ANDA091166
Marketing category
ANDA
Marketing start
2024-06-24
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

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
80425-0407-1Eszopiclone30 in 1 BOTTLETABLET, FILM COATED301
80425-0407-2Eszopiclone60 in 1 BOTTLETABLET, FILM COATED601
80425-0407-3Eszopiclone90 in 1 BOTTLETABLET, FILM COATED901

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
80425-0407-1EA - Each80425-040772225b78-f0d6-4320-8530-4253e7f1a7e712024-08-12
80425-0407-2EA - Each80425-0407d1d689f1-e427-49eb-bd1a-77b439909b4312024-08-12
80425-0407-3EA - Each80425-04071c920437-2757-43f6-ab1c-8e0e484ce85412024-08-12

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
80425-0407ESZOPICLONE TABLET, FILM COATED [ADVANCED RX OF TENNESSEE, LLC]1Current NDC, 3 package rows20240626_1baa56e5-34d5-c8a1-e063-6394a90ae6c7.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
485440eszopiclone 1 MG Oral TabletPSN1baa56e5-34d5-c8a1-e063-6394a90ae6c71
485440eszopiclone 1 MG Oral TabletSCD1baa56e5-34d5-c8a1-e063-6394a90ae6c71

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionMarketing startSampleExclude flagStatus
80425-0407-18042504070130 TABLET, FILM COATED in 1 BOTTLE (80425-0407-1) 2024-06-24NoNoHistorical
80425-0407-28042504070260 TABLET, FILM COATED in 1 BOTTLE (80425-0407-2) 2024-06-24NoNoHistorical
80425-0407-38042504070390 TABLET, FILM COATED in 1 BOTTLE (80425-0407-3) 2024-06-24NoNoHistorical