FDA.reportPublic FDA data

Escitalopram

Product NDC
50090-3360
11-digit product format
500903360
Labeler code
50090
Product ID
50090-3360_76f8127b-0646-4502-8edb-dd380b640614
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Escitalopram
Dosage form
TABLET, FILM COATED
Route
ORAL
Labeler
A-S Medication Solutions
Application
ANDA076765
Marketing category
ANDA
Marketing start
2012-03-14
Marketing end
0000-00-00
Substance
ESCITALOPRAM OXALATE
Active strength
10 mg/1
Pharmacologic classes
Serotonin Reuptake Inhibitor [EPC],Serotonin Uptake Inhibitors [MoA]
NDC exclude flag
No
Listing certified through
2019-12-31
Current FDA listing
Historical FDA.report record

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDCEffectiveActionDocumentIndexing SPLRelated label
50090-3360-02021-03-01C16284748780-19d75b9d0-905e-f424-e053-dadaa90a57ceThese highlights do not include all the information needed to use ESCITALOPRAM TABLETS safely and effectively. See full prescribing information for ESCITALOPRAM TABLETS. ESCITALOPRAM tablets, for oral use Initial U.S. Approval: 2002
50090-3360-12021-03-01C16284748780-19d75b9d0-905e-f424-e053-dadaa90a57ceThese highlights do not include all the information needed to use ESCITALOPRAM TABLETS safely and effectively. See full prescribing information for ESCITALOPRAM TABLETS. ESCITALOPRAM tablets, for oral use Initial U.S. Approval: 2002
50090-3360-02020-01-31C16284748780-19d75b9d0-905e-f424-e053-dadaa90a57ceThese highlights do not include all the information needed to use ESCITALOPRAM TABLETS safely and effectively. See full prescribing information for ESCITALOPRAM TABLETS. ESCITALOPRAM tablets, for oral use Initial U.S. Approval: 2002
50090-3360-12020-01-31C16284748780-19d75b9d0-905e-f424-e053-dadaa90a57ceThese highlights do not include all the information needed to use ESCITALOPRAM TABLETS safely and effectively. See full prescribing information for ESCITALOPRAM TABLETS. ESCITALOPRAM tablets, for oral use Initial U.S. Approval: 2002

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
50090-3360-0EA - Each50090-3360bc53379e-4fc1-4226-b455-a72f5e0d3c2212019-05-02
50090-3360-1EA - Each50090-336023175645-0048-432e-b9c8-d52b245a8f2412019-05-02