FDA.reportPublic FDA data

ESZOPICLONE

Product NDC
69452-347
11-digit product format
694520347
Labeler code
69452
Product ID
69452-347_903d952f-704a-4227-a829-5bddbd5793cb
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
ESZOPICLONE
Dosage form
TABLET, FILM COATED
Route
ORAL
Labeler
Bionpharma Inc.
Application
ANDA091113
Marketing category
ANDA
Marketing start
2022-06-01
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, 485442, 485465

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
69452-347-13ESZOPICLONE30 in 1 BOTTLE, PLASTICTABLET, FILM COATED304
69452-347-20ESZOPICLONE100 in 1 BOTTLE, PLASTICTABLET, FILM COATED1004

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
69452-347-13EA - Each69452-3475e23a2a0-a6d5-4a89-a5d0-0f8471e317ab12023-02-06

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
69452-347ESZOPICLONE TABLET, FILM COATED [BIONPHARMA INC.]4Current NDC, Legacy NDC, 2 package rows20231202_ec6ac172-509e-403a-aa0d-4c60010a0035.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
485440eszopiclone 1 MG Oral TabletPSNec6ac172-509e-403a-aa0d-4c60010a00354
485442eszopiclone 2 MG Oral TabletPSNec6ac172-509e-403a-aa0d-4c60010a00354
485465eszopiclone 3 MG Oral TabletPSNec6ac172-509e-403a-aa0d-4c60010a00354
485440eszopiclone 1 MG Oral TabletSCDec6ac172-509e-403a-aa0d-4c60010a00354
485442eszopiclone 2 MG Oral TabletSCDec6ac172-509e-403a-aa0d-4c60010a00354
485465eszopiclone 3 MG Oral TabletSCDec6ac172-509e-403a-aa0d-4c60010a00354

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionMarketing startMarketing endSampleExclude flagStatus
69452-347-136945203471330 TABLET, FILM COATED in 1 BOTTLE, PLASTIC (69452-347-13) 2022-06-010000-00-00NoNoCurrent
69452-347-2069452034720100 TABLET, FILM COATED in 1 BOTTLE, PLASTIC (69452-347-20) 2022-06-010000-00-00NoNoCurrent