FDA.reportPublic FDA data

ESZOPICLONE

Product NDC
71205-513
11-digit product format
712050513
Labeler code
71205
Product ID
71205-513_bad8fe65-73c1-4542-8050-720af889905a
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
ESZOPICLONE
Dosage form
TABLET, FILM COATED
Route
ORAL
Labeler
Proficient Rx LP
Application
ANDA208451
Marketing category
ANDA
Marketing start
2016-09-15
Substance
ESZOPICLONE
Active strength
2 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
ESZOPICLONE2 mg/1

Harmonized Identifiers#

Field, Values table
FieldValues
UniiUZX80K71OE
Rxcui485442

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
71205-513-30ESZOPICLONE30 in 1 BOTTLETABLET, FILM COATED301
71205-513-60ESZOPICLONE60 in 1 BOTTLETABLET, FILM COATED601
71205-513-90ESZOPICLONE90 in 1 BOTTLETABLET, FILM COATED901

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
71205-513-30EA - Each71205-5139b465fb7-c1af-4ddf-8078-43e896a2504912021-03-02

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
71205-513ESZOPICLONE TABLET, FILM COATED [PROFICIENT RX LP]1Current NDC, Legacy NDC, 3 package rows20201212_bad8fe65-73c1-4542-8050-720af889905a.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
485442eszopiclone 2 MG Oral TabletPSNbad8fe65-73c1-4542-8050-720af889905a1
485442eszopiclone 2 MG Oral TabletSCDbad8fe65-73c1-4542-8050-720af889905a1

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionMarketing startMarketing endSampleExclude flagStatus
71205-513-307120505133030 TABLET, FILM COATED in 1 BOTTLE (71205-513-30) 2020-12-080000-00-00NoNoCurrent
71205-513-607120505136060 TABLET, FILM COATED in 1 BOTTLE (71205-513-60) 2020-12-080000-00-00NoNoCurrent
71205-513-907120505139090 TABLET, FILM COATED in 1 BOTTLE (71205-513-90) 2020-12-080000-00-00NoNoCurrent