FDA.reportPublic FDA data

eszopiclone

Product NDC
0054-0292
11-digit product format
000540292
Labeler code
0054
Product ID
0054-0292_accae4df-75e1-4493-a2f8-58bf28a327d1
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
eszopiclone
Dosage form
TABLET
Route
ORAL
Labeler
West-Ward Pharmaceuticals Corp.
Application
ANDA091153
Marketing category
ANDA
Marketing start
2014-04-15
Marketing end
2020-08-23
Substance
ESZOPICLONE
Active strength
3 mg/1
DEA schedule
CIV
NDC exclude flag
No
Listing certified through
0000-00-00
Current FDA listing
Historical FDA.report record

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
f65008ed-f925-2246-581a-e6a3201df7e4Product name520250107

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
0054-0292-25EA - Each0054-02929adca3cf-f037-4fa6-bad6-76fb3416578312014-05-02

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
485465eszopiclone 3 MG Oral TabletPSN673b7e99-1cbb-e888-e053-2a91aa0addc12
485465eszopiclone 3 MG Oral TabletSCD673b7e99-1cbb-e888-e053-2a91aa0addc12