Paroxetine

Product NDC
21695-104
11-digit product format
216950104
Labeler code
21695
Product ID
21695-104_0d4fb45b-e45b-4519-96a3-a8a106450f87
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Paroxetine Hydrochloride
Dosage form
TABLET, FILM COATED
Route
ORAL
Labeler
Rebel Distributors Corp
Application
ANDA077584
Marketing category
ANDA
Marketing start
2007-04-13
Marketing end
0000-00-00
Substance
PAROXETINE HYDROCHLORIDE
Active strength
40 mg/1
Pharmacologic classes
Serotonin Reuptake Inhibitor [EPC],Serotonin Uptake Inhibitors [MoA]
NDC exclude flag
E
Listing certified through
2017-12-31
Current FDA listing
Historical FDA.report record

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
2ace441e-5ed1-9a56-64e5-302d887093bdProduct name720250107
594e2c86-3079-4e6e-96c9-48f7a8afc78dProduct name120230718
ba9fc237-0e76-4ac8-d3c5-cdb4df9e9f7fProduct name420220524
200c61bf-0879-1df7-72b7-b72a8497b114Product name320171006
b430fc19-562d-420b-53a2-64d42b938631Product name120140508

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDCEffectiveActionDocumentIndexing SPLRelated label
21695-104-302019-09-24C16284748780-1934fe258-482d-48b1-e053-8cdaa90a720aParoxetine Tablets, USP
21695-104-602019-09-24C16284748780-1934fe258-482d-48b1-e053-8cdaa90a720aParoxetine Tablets, USP
21695-104-902019-09-24C16284748780-1934fe258-482d-48b1-e053-8cdaa90a720aParoxetine Tablets, USP

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
21695-104-30Paroxetine30 in 1 BOTTLETABLET, FILM COATED301
21695-104-60Paroxetine60 in 1 BOTTLETABLET, FILM COATED601
21695-104-90Paroxetine90 in 1 BOTTLETABLET, FILM COATED901

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
21695-104PAROXETINE (PAROXETINE HYDROCHLORIDE) TABLET, FILM COATED [REBEL DISTRIBUTORS CORP]1Legacy NDC, 3 package rows20110113_0d4fb45b-e45b-4519-96a3-a8a106450f87.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
1738483PARoxetine HCl 10 MG Oral TabletPSN0d4fb45b-e45b-4519-96a3-a8a106450f871
1738495PARoxetine HCl 20 MG Oral TabletPSN0d4fb45b-e45b-4519-96a3-a8a106450f871
1738503PARoxetine HCl 30 MG Oral TabletPSN0d4fb45b-e45b-4519-96a3-a8a106450f871
1738511PARoxetine HCl 40 MG Oral TabletPSN0d4fb45b-e45b-4519-96a3-a8a106450f871
1738483paroxetine hydrochloride 10 MG Oral TabletSCD0d4fb45b-e45b-4519-96a3-a8a106450f871
1738495paroxetine hydrochloride 20 MG Oral TabletSCD0d4fb45b-e45b-4519-96a3-a8a106450f871
1738503paroxetine hydrochloride 30 MG Oral TabletSCD0d4fb45b-e45b-4519-96a3-a8a106450f871
1738511paroxetine hydrochloride 40 MG Oral TabletSCD0d4fb45b-e45b-4519-96a3-a8a106450f871

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionStatus
21695-104-302169501043030 in 1 BOTTLEHistorical
21695-104-602169501046060 in 1 BOTTLEHistorical
21695-104-902169501049090 in 1 BOTTLEHistorical