FDA.reportPublic FDA data

Eszopiclone

Product NDC
71335-0512
11-digit product format
713350512
Labeler code
71335
Product ID
71335-0512_ceabe551-fe4c-4bbf-9f1f-349b51891a87
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Eszopiclone
Dosage form
TABLET, FILM COATED
Route
ORAL
Labeler
Bryant Ranch Prepack
Application
ANDA091166
Marketing category
ANDA
Marketing start
2014-04-15
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
Rxcui485440, 485442

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
71335-0512-1Eszopiclone30 in 1 BOTTLETABLET, FILM COATED3012
71335-0512-2Eszopiclone60 in 1 BOTTLETABLET, FILM COATED6012
71335-0512-3Eszopiclone90 in 1 BOTTLETABLET, FILM COATED9012
71335-0512-4Eszopiclone120 in 1 BOTTLETABLET, FILM COATED12012
71335-0512-5Eszopiclone20 in 1 BOTTLETABLET, FILM COATED2012
71335-0512-6Eszopiclone100 in 1 BOTTLETABLET, FILM COATED10012
71335-0512-7Eszopiclone28 in 1 BOTTLETABLET, FILM COATED2812
71335-0512-8Eszopiclone10 in 1 BOTTLETABLET, FILM COATED1012

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
71335-0512-8EA - Each71335-0512db9c0674-7c77-49a3-9f34-1334377e898412022-04-06

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
71335-0512ESZOPICLONE TABLET, FILM COATED [BRYANT RANCH PREPACK]12Current NDC, Legacy NDC, 8 package rows20240824_d1baa5ba-73ac-462b-a728-217d5992674a.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
485440eszopiclone 1 MG Oral TabletPSNd1baa5ba-73ac-462b-a728-217d5992674a12
485442eszopiclone 2 MG Oral TabletPSNd1baa5ba-73ac-462b-a728-217d5992674a12
485440eszopiclone 1 MG Oral TabletSCDd1baa5ba-73ac-462b-a728-217d5992674a12
485442eszopiclone 2 MG Oral TabletSCDd1baa5ba-73ac-462b-a728-217d5992674a12

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionMarketing startMarketing endSampleExclude flagStatus
71335-0512-17133505120130 TABLET, FILM COATED in 1 BOTTLE (71335-0512-1) 2015-11-160000-00-00NoNoCurrent
71335-0512-27133505120260 TABLET, FILM COATED in 1 BOTTLE (71335-0512-2) 2015-11-160000-00-00NoNoCurrent
71335-0512-37133505120390 TABLET, FILM COATED in 1 BOTTLE (71335-0512-3) 2015-11-160000-00-00NoNoCurrent
71335-0512-471335051204120 TABLET, FILM COATED in 1 BOTTLE (71335-0512-4) 2015-11-160000-00-00NoNoCurrent
71335-0512-57133505120520 TABLET, FILM COATED in 1 BOTTLE (71335-0512-5) 2015-11-160000-00-00NoNoCurrent
71335-0512-671335051206100 TABLET, FILM COATED in 1 BOTTLE (71335-0512-6) 2015-11-160000-00-00NoNoCurrent
71335-0512-77133505120728 TABLET, FILM COATED in 1 BOTTLE (71335-0512-7) 2015-11-160000-00-00NoNoCurrent
71335-0512-87133505120810 TABLET, FILM COATED in 1 BOTTLE (71335-0512-8) 2015-11-160000-00-00NoNoCurrent