FDA.reportPublic FDA data

Eszopiclone

Product NDC
82804-159
11-digit product format
828040159
Labeler code
82804
Product ID
82804-159_b36c020d-b30c-45b8-b5af-1c07a29ac3d0
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Eszopiclone
Dosage form
TABLET, FILM COATED
Route
ORAL
Labeler
Proficient Rx LP
Application
ANDA205504
Marketing category
ANDA
Marketing start
2024-01-04
Substance
ESZOPICLONE
Active strength
1 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
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
362d7abb-94e6-4c60-9a58-266894157713Product name120231023
816b97af-edc5-4060-aff1-b814bdbcad50Product name120190415
419aab54-5d5a-4146-9453-026d4a9991beProduct name220170525
89dac932-b90a-4410-9ab1-84c53e57de25Product name120150316
d723478e-ad4a-ec23-6bd7-cfe33e1e3840Product name120140508

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
82804-159-30Eszopiclone30 in 1 BOTTLETABLET, FILM COATED303
82804-159-60Eszopiclone60 in 1 BOTTLETABLET, FILM COATED603
82804-159-90Eszopiclone90 in 1 BOTTLETABLET, FILM COATED903

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
82804-159ESZOPICLONE TABLET, FILM COATED [PROFICIENT RX LP]2Current NDC, 3 package rows20250321_dd7e4bab-8e25-4788-89e4-6b391f9596fe.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
485440eszopiclone 1 MG Oral TabletPSNdd7e4bab-8e25-4788-89e4-6b391f9596fe3
485440eszopiclone 1 MG Oral TabletSCDdd7e4bab-8e25-4788-89e4-6b391f9596fe3

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionMarketing startSampleExclude flagStatus
82804-159-308280401593030 TABLET, FILM COATED in 1 BOTTLE (82804-159-30) 2026-02-06NoNoCurrent
82804-159-608280401596060 TABLET, FILM COATED in 1 BOTTLE (82804-159-60) 2025-03-12NoNoCurrent
82804-159-908280401599090 TABLET, FILM COATED in 1 BOTTLE (82804-159-90) 2024-10-11NoNoCurrent