Paroxetine

Product NDC
60760-398
11-digit product format
607600398
Labeler code
60760
Product ID
60760-398_85020df0-53d9-0509-e053-2991aa0ad800
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Paroxetine
Dosage form
TABLET, FILM COATED
Route
ORAL
Labeler
St. Mary's Medical Park Pharmacy
Application
ANDA077584
Marketing category
ANDA
Marketing start
2019-03-20
Marketing end
0000-00-00
Substance
PAROXETINE HYDROCHLORIDE HEMIHYDRATE
Active strength
20 mg/1
Pharmacologic classes
Serotonin Reuptake Inhibitor [EPC],Serotonin Uptake Inhibitors [MoA]
NDC exclude flag
No
Listing certified through
2020-12-31
Current FDA listing
Historical FDA.report record

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
60760-398-90EA - Each60760-398ef9ce5e7-7013-49ee-b9f1-a079a53fca5012019-04-11

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
60760-398PAROXETINE TABLET, FILM COATED [ST. MARY'S MEDICAL PARK PHARMACY]1Legacy NDC20190329_85020965-cd8d-8325-e053-2a91aa0a7015.zip

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionMarketing startMarketing endSampleExclude flagStatus
60760-398-906076003989090 TABLET, FILM COATED in 1 BOTTLE, PLASTIC (60760-398-90) 2019-03-200000-00-00NoNoCurrent