FDA.reportPublic FDA data

ESZOPICLONE

Product NDC
71205-236
11-digit product format
712050236
Labeler code
71205
Product ID
71205-236_257152f7-f81c-4be1-89ab-6ec7044555ff
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
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
Rxcui485465

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
71205-236-30ESZOPICLONE30 in 1 BOTTLETABLET, FILM COATED304
71205-236-60ESZOPICLONE60 in 1 BOTTLETABLET, FILM COATED604
71205-236-90ESZOPICLONE90 in 1 BOTTLETABLET, FILM COATED904

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
71205-236-30EA - Each71205-23612b71bbe-788c-4ba8-b572-c33fa18c7aa712019-06-19

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
71205-236ESZOPICLONE TABLET, FILM COATED [PROFICIENT RX LP]4Current NDC, Legacy NDC, 3 package rows20220816_2f4fa6e8-be82-4fb5-9a11-9ba8f557c027.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
485465eszopiclone 3 MG Oral TabletPSN2f4fa6e8-be82-4fb5-9a11-9ba8f557c0274
485465eszopiclone 3 MG Oral TabletSCD2f4fa6e8-be82-4fb5-9a11-9ba8f557c0274

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionMarketing startMarketing endSampleExclude flagStatus
71205-236-307120502363030 TABLET, FILM COATED in 1 BOTTLE (71205-236-30) 2019-03-010000-00-00NoNoCurrent
71205-236-607120502366060 TABLET, FILM COATED in 1 BOTTLE (71205-236-60) 2019-03-010000-00-00NoNoCurrent
71205-236-907120502369090 TABLET, FILM COATED in 1 BOTTLE (71205-236-90) 2019-03-010000-00-00NoNoCurrent