ESZOPICLONE

Product NDC
70518-1310
11-digit product format
705181310
Labeler code
70518
Product ID
70518-1310_48d52a4e-6e91-e9e5-e063-6394a90a2a94
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
ESZOPICLONE
Dosage form
TABLET, FILM COATED
Route
ORAL
Labeler
REMEDYREPACK INC.
Application
ANDA208451
Marketing category
ANDA
Marketing start
2018-07-18
Substance
ESZOPICLONE
Active strength
2 mg/1
DEA schedule
CIV
NDC exclude flag
No
Listing certified through
2027-12-31
Current FDA listing
Yes

Additional Listing Data#

Finished product
Yes
Brand name base
ESZOPICLONE
Listing expiration
2027-12-31

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
70518-1310-0ESZOPICLONE30 in 1 BOTTLE, PLASTICTABLET, FILM COATED3015

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
70518-1310-0EA - Each70518-1310cac392e9-7bc7-4e35-8ba1-f3cae3f9f8ca12026-01-08

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
70518-1310ESZOPICLONE TABLET, FILM COATED [REMEDYREPACK INC.]13Current NDC, Legacy NDC, 1 package rows20250510_7df922bc-5750-4259-906f-64f960c38d5f.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
485442eszopiclone 2 MG Oral TabletPSN7df922bc-5750-4259-906f-64f960c38d5f15
485442eszopiclone 2 MG Oral TabletSCD7df922bc-5750-4259-906f-64f960c38d5f15

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionMarketing startMarketing endSampleExclude flagStatus
70518-1310-07051813100030 TABLET, FILM COATED in 1 BOTTLE, PLASTIC (70518-1310-0) 2018-07-180000-00-00NoNoCurrent