Eszopiclone

Product NDC
63187-970
11-digit product format
631870970
Labeler code
63187
Product ID
63187-970_c07cfea0-a9fa-4ed5-928f-5aab69e12793
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
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
63187-970-306318709703030 TABLET, FILM COATED in 1 BOTTLE (63187-970-30) 2018-01-01NoNoHistorical
63187-970-606318709706060 TABLET, FILM COATED in 1 BOTTLE (63187-970-60) 2018-01-01NoNoHistorical
63187-970-906318709709090 TABLET, FILM COATED in 1 BOTTLE (63187-970-90) 2018-01-01NoNoHistorical

Related DailyMed Labels

TitleManufacturerEffective dateTypeVersion
EszopicloneProficient Rx LP2022-07-01HUMAN PRESCRIPTION DRUG LABEL5