Paroxetine

Product NDC
71335-0750
11-digit product format
713350750
Labeler code
71335
Product ID
71335-0750_45a41f01-91d9-43cc-baaa-e65e7d72bfff
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
paroxetine hydrochloride hemihydrate
Dosage form
TABLET, FILM COATED
Route
ORAL
Labeler
Bryant Ranch Prepack
Application
ANDA205528
Marketing category
ANDA
Marketing start
2015-11-20
Marketing end
0000-00-00
Substance
PAROXETINE HYDROCHLORIDE ANHYDROUS
Active strength
20 mg/1
Pharmacologic classes
Serotonin Reuptake Inhibitor [EPC],Serotonin Uptake Inhibitors [MoA]
NDC exclude flag
No
Listing certified through
2021-12-31
Current FDA listing
Historical FDA.report record

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionMarketing startMarketing endSampleExclude flagStatus
71335-0750-17133507500130 TABLET, FILM COATED in 1 BOTTLE (71335-0750-1) 2018-03-260000-00-00NoNoCurrent
71335-0750-27133507500260 TABLET, FILM COATED in 1 BOTTLE (71335-0750-2) 2018-03-260000-00-00NoNoCurrent
71335-0750-37133507500328 TABLET, FILM COATED in 1 BOTTLE (71335-0750-3) 2018-03-260000-00-00NoNoCurrent
71335-0750-47133507500490 TABLET, FILM COATED in 1 BOTTLE (71335-0750-4) 2018-03-260000-00-00NoNoCurrent