Eszopiclone

Product NDC
71205-633
11-digit product format
712050633
Labeler code
71205
Product ID
71205-633_5381d4b2-e743-4ece-9fe3-e2be6eb85711
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Eszopiclone
Dosage form
TABLET, FILM COATED
Route
OROPHARYNGEAL
Labeler
Proficient Rx LP
Application
ANDA091166
Marketing category
ANDA
Marketing start
2014-04-15
Substance
ESZOPICLONE
Active strength
3 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
71205-633-307120506333030 TABLET, FILM COATED in 1 BOTTLE (71205-633-30) 2022-01-20NoNoHistorical
71205-633-607120506336060 TABLET, FILM COATED in 1 BOTTLE (71205-633-60) 2022-01-20NoNoHistorical
71205-633-907120506339090 TABLET, FILM COATED in 1 BOTTLE (71205-633-90) 2022-01-20NoNoHistorical

Related DailyMed Labels

TitleManufacturerEffective dateTypeVersion
EszopicloneProficient Rx LP2022-07-01HUMAN PRESCRIPTION DRUG LABEL3