Eszopiclone

Product NDC
53217-150
11-digit product format
532170150
Labeler code
53217
Product ID
53217-150_da945963-e887-4560-9951-93ec1552cb45
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Eszopiclone
Dosage form
TABLET, FILM COATED
Route
ORAL
Labeler
Aidarex Pharmaceuticals LLC
Application
ANDA091166
Marketing category
ANDA
Marketing start
2014-04-15
Marketing end
0000-00-00
Substance
ESZOPICLONE
Active strength
1 mg/1
DEA schedule
CIV
NDC exclude flag
No
Listing certified through
2019-12-31
Current FDA listing
Historical FDA.report record

Related Records

Related UNII Ingredients

UNIIPreferred termRegistry numberMatched term
UZX80K71OEESZOPICLONE138729-47-2ESZOPICLONE

Related DailyMed Labels

TitleManufacturerEffective dateTypeVersion
EszopicloneAidarex Pharmaceuticals LLC2017-03-02HUMAN PRESCRIPTION DRUG LABEL1