Eszopiclone

Product NDC
63187-843
11-digit product format
631870843
Labeler code
63187
Product ID
63187-843_fe135c0b-c9e3-4078-958d-bd4ef956033b
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Eszopiclone
Dosage form
TABLET, FILM COATED
Route
ORAL
Labeler
Proficient Rx LP
Application
ANDA202929
Marketing category
ANDA
Marketing start
2014-04-25
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
63187-843-306318708433030 TABLET, FILM COATED in 1 BOTTLE (63187-843-30) 2017-05-01NoNoHistorical
63187-843-606318708436060 TABLET, FILM COATED in 1 BOTTLE (63187-843-60) 2017-05-01NoNoHistorical
63187-843-906318708439090 TABLET, FILM COATED in 1 BOTTLE (63187-843-90) 2017-05-01NoNoHistorical

Related DailyMed Labels

TitleManufacturerEffective dateTypeVersion
EszopicloneProficient Rx LP2023-07-01HUMAN PRESCRIPTION DRUG LABEL5