Paroxetine

Product NDC
55700-503
11-digit product format
557000503
Labeler code
55700
Product ID
55700-503_3993aa59-7a19-4e7b-a834-eacf49671eae
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
paroxetine hydrochloride hemihydrate
Dosage form
TABLET, FILM COATED
Route
ORAL
Labeler
Lake Erie Medical DBA Quality Care Products LLC
Application
ANDA203854
Marketing category
ANDA
Marketing start
2014-11-01
Marketing end
0000-00-00
Substance
PAROXETINE HYDROCHLORIDE HEMIHYDRATE
Active strength
40 mg/1
Pharmacologic classes
Serotonin Reuptake Inhibitor [EPC], Serotonin Uptake Inhibitors [MoA]
NDC exclude flag
No
Listing certified through
2023-12-31
Current FDA listing
Historical FDA.report record

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDCEffectiveActionDocumentIndexing SPLRelated label
55700-503-302021-04-15C16284748780-1ba0f9c33-1bc8-a910-e053-dadaa90a0b85fbd36eba-45d2-451b-bbcb-d7c75a4087e4
55700-503-302021-01-29C16284748780-1ba0f9c33-1bc8-a910-e053-dadaa90a0b85fbd36eba-45d2-451b-bbcb-d7c75a4087e4

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
55700-503-30EA - Each55700-503007c0cb7-321f-412f-a6d7-df42f91ee07b12017-04-05

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionMarketing startMarketing endSampleExclude flagStatus
55700-503-305570005033030 TABLET, FILM COATED in 1 BOTTLE (55700-503-30) 2017-02-100000-00-00NoNoCurrent