FDA.reportPublic FDA data

Eszopiclone

Product NDC
71335-0116
11-digit product format
713350116
Labeler code
71335
Product ID
71335-0116_1cede81a-b1b6-4a31-bba8-9f7d483d2292
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Eszopiclone
Dosage form
TABLET, FILM COATED
Route
ORAL
Labeler
Bryant Ranch Prepack
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
71335-0116-1Eszopiclone30 in 1 BOTTLETABLET, FILM COATED3021
71335-0116-2Eszopiclone60 in 1 BOTTLETABLET, FILM COATED6021
71335-0116-3Eszopiclone90 in 1 BOTTLETABLET, FILM COATED9021
71335-0116-4Eszopiclone120 in 1 BOTTLETABLET, FILM COATED12021
71335-0116-5Eszopiclone20 in 1 BOTTLETABLET, FILM COATED2021
71335-0116-6Eszopiclone28 in 1 BOTTLETABLET, FILM COATED2821
71335-0116-7Eszopiclone15 in 1 BOTTLETABLET, FILM COATED1521
71335-0116-8Eszopiclone100 in 1 BOTTLETABLET, FILM COATED10021

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
71335-0116-1EA - Each71335-011653a77a19-c169-43ae-bba0-59da2e1d514212018-04-19

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
71335-0116ESZOPICLONE TABLET, FILM COATED [BRYANT RANCH PREPACK]21Current NDC, Legacy NDC, 8 package rows20240809_9a891ab1-675f-498e-a21e-05964307d2dd.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
485440eszopiclone 1 MG Oral TabletPSN9a891ab1-675f-498e-a21e-05964307d2dd21
485442eszopiclone 2 MG Oral TabletPSN9a891ab1-675f-498e-a21e-05964307d2dd21
485465eszopiclone 3 MG Oral TabletPSN9a891ab1-675f-498e-a21e-05964307d2dd21
485440eszopiclone 1 MG Oral TabletSCD9a891ab1-675f-498e-a21e-05964307d2dd21
485442eszopiclone 2 MG Oral TabletSCD9a891ab1-675f-498e-a21e-05964307d2dd21
485465eszopiclone 3 MG Oral TabletSCD9a891ab1-675f-498e-a21e-05964307d2dd21

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionMarketing startMarketing endSampleExclude flagStatus
71335-0116-17133501160130 TABLET, FILM COATED in 1 BOTTLE (71335-0116-1) 2017-01-240000-00-00NoNoCurrent
71335-0116-27133501160260 TABLET, FILM COATED in 1 BOTTLE (71335-0116-2) 2017-01-240000-00-00NoNoCurrent
71335-0116-37133501160390 TABLET, FILM COATED in 1 BOTTLE (71335-0116-3) 2017-01-240000-00-00NoNoCurrent
71335-0116-471335011604120 TABLET, FILM COATED in 1 BOTTLE (71335-0116-4) 2017-01-240000-00-00NoNoCurrent
71335-0116-57133501160520 TABLET, FILM COATED in 1 BOTTLE (71335-0116-5) 2017-01-240000-00-00NoNoCurrent
71335-0116-67133501160628 TABLET, FILM COATED in 1 BOTTLE (71335-0116-6) 2017-01-240000-00-00NoNoCurrent
71335-0116-77133501160715 TABLET, FILM COATED in 1 BOTTLE (71335-0116-7) 2017-01-240000-00-00NoNoCurrent
71335-0116-871335011608100 TABLET, FILM COATED in 1 BOTTLE (71335-0116-8) 2017-01-240000-00-00NoNoCurrent