FDA.reportPublic FDA data

ESZOPICLONE

Product NDC
71335-9659
11-digit product format
713359659
Labeler code
71335
Product ID
71335-9659_f2270de0-47e3-4465-b5f9-74de3815ddc8
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
ESZOPICLONE
Dosage form
TABLET, FILM COATED
Route
ORAL
Labeler
Bryant Ranch Prepack
Application
ANDA208451
Marketing category
ANDA
Marketing start
2016-09-15
Substance
ESZOPICLONE
Active strength
1 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
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
71335-9659-1ESZOPICLONE30 in 1 BOTTLETABLET, FILM COATED30101
71335-9659-2ESZOPICLONE60 in 1 BOTTLETABLET, FILM COATED60101
71335-9659-3ESZOPICLONE90 in 1 BOTTLETABLET, FILM COATED90101
71335-9659-4ESZOPICLONE10 in 1 BOTTLETABLET, FILM COATED10101
71335-9659-5ESZOPICLONE120 in 1 BOTTLETABLET, FILM COATED120101
71335-9659-6ESZOPICLONE100 in 1 BOTTLETABLET, FILM COATED100101

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
71335-9659-1EA - Each71335-9659d3ee54d6-ed7c-4d6f-a5fc-62157ea0b55b12025-07-08
71335-9659-2EA - Each71335-96592daae4ec-b8e7-4bc4-b852-f8c589b6c45412026-02-05

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
71335-9659ESZOPICLONE TABLET, FILM COATED [BRYANT RANCH PREPACK]101Current NDC, 6 package rows20231128_39b96725-2a01-4d9f-a56d-af7491b3b601.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
485440eszopiclone 1 MG Oral TabletPSN39b96725-2a01-4d9f-a56d-af7491b3b601101
485440eszopiclone 1 MG Oral TabletSCD39b96725-2a01-4d9f-a56d-af7491b3b601101

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionMarketing startSampleExclude flagStatus
71335-9659-17133596590130 TABLET, FILM COATED in 1 BOTTLE (71335-9659-1) 2023-02-27NoNoHistorical
71335-9659-27133596590260 TABLET, FILM COATED in 1 BOTTLE (71335-9659-2) 2023-02-27NoNoHistorical
71335-9659-37133596590390 TABLET, FILM COATED in 1 BOTTLE (71335-9659-3) 2023-02-27NoNoHistorical
71335-9659-47133596590410 TABLET, FILM COATED in 1 BOTTLE (71335-9659-4) 2023-02-27NoNoHistorical
71335-9659-571335965905120 TABLET, FILM COATED in 1 BOTTLE (71335-9659-5) 2023-02-27NoNoHistorical
71335-9659-671335965906100 TABLET, FILM COATED in 1 BOTTLE (71335-9659-6) 2023-02-27NoNoHistorical