ESZOPICLONE

Product NDC
71205-513
11-digit product format
712050513
Labeler code
71205
Product ID
71205-513_bad8fe65-73c1-4542-8050-720af889905a
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
ESZOPICLONE
Dosage form
TABLET, FILM COATED
Route
ORAL
Labeler
Proficient Rx LP
Application
ANDA208451
Marketing category
ANDA
Marketing start
2016-09-15
Substance
ESZOPICLONE
Active strength
2 mg/1
DEA schedule
CIV
NDC exclude flag
No
Listing certified through
2026-12-31
Current FDA listing
Yes

Related Records

Related UNII Ingredients

UNIIPreferred termRegistry numberMatched term
UZX80K71OEESZOPICLONE138729-47-2ESZOPICLONE

Packages

Package NDC11-digit formatDescriptionMarketing startSampleExclude flagStatus
71205-513-307120505133030 TABLET, FILM COATED in 1 BOTTLE (71205-513-30) 2020-12-08NoNoHistorical
71205-513-607120505136060 TABLET, FILM COATED in 1 BOTTLE (71205-513-60) 2020-12-08NoNoHistorical
71205-513-907120505139090 TABLET, FILM COATED in 1 BOTTLE (71205-513-90) 2020-12-08NoNoHistorical

Related DailyMed Labels

TitleManufacturerEffective dateTypeVersion
ESZOPICLONEProficient Rx LP2020-12-01HUMAN PRESCRIPTION DRUG LABEL1