FDA.reportPublic FDA data

Paroxetine

Product NDC
50268-640
11-digit product format
502680640
Labeler code
50268
Product ID
50268-640_4dc86e5a-77b7-8cfe-e063-6394a90a7289
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Paroxetine
Dosage form
TABLET, FILM COATED
Route
ORAL
Labeler
AvPAK
Application
ANDA078406
Marketing category
ANDA
Marketing start
2016-03-11
Substance
PAROXETINE HYDROCHLORIDE HEMIHYDRATE
Active strength
10 mg/1
Pharmacologic classes
Serotonin Reuptake Inhibitor [EPC], Serotonin Uptake Inhibitors [MoA]
NDC exclude flag
No
Listing certified through
2027-12-31
Current FDA listing
Yes

Additional Listing Data#

Finished product
Yes
Brand name base
Paroxetine
Listing expiration
2027-12-31

Active Ingredients#

Ingredient, Strength table
IngredientStrength
PAROXETINE HYDROCHLORIDE HEMIHYDRATE10 mg/1

Harmonized Identifiers#

Field, Values table
FieldValues
UniiX2ELS050D8
Rxcui1738483, 1738495, 1738503, 1738511

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
2ace441e-5ed1-9a56-64e5-302d887093bdProduct name720250107
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
50268-640-152022-02-03C16284748780-1d6a99b39-8572-a426-e053-dadaa90af4c2Paroxetine Tablets, USP
50268-640-152022-02-03C16284748780-1d6a99b39-8572-a426-e053-dadaa90af4c2Paroxetine Tablets, USP
50268-640-152022-01-28C16284748780-1d6a99b39-8572-a426-e053-dadaa90af4c2Paroxetine Tablets, USP
50268-640-152022-01-28C16284748780-1d6a99b39-8572-a426-e053-dadaa90af4c2Paroxetine Tablets, USP

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
50268-640-11Paroxetine1 in 1 BLISTER PACKTABLET, FILM COATED19
50268-640-15Paroxetine50 in 1 BOX, UNIT-DOSETABLET, FILM COATED509

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
50268-640-11EA - Each50268-640d90e567b-d2e5-4288-9583-f36057380f5312016-04-04
50268-640-15EA - Each50268-640a39f0ebc-2c16-42f8-b748-6a6c851b274912016-04-04

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
50268-640PAROXETINE TABLET, FILM COATED [AVPAK]7Current NDC, Legacy NDC, 2 package rows20220507_d9a5e0aa-e638-5d6e-75c2-20cb78fc4f43.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
1738483PARoxetine HCl 10 MG Oral TabletPSNd9a5e0aa-e638-5d6e-75c2-20cb78fc4f439
1738495PARoxetine HCl 20 MG Oral TabletPSNd9a5e0aa-e638-5d6e-75c2-20cb78fc4f439
1738503PARoxetine HCl 30 MG Oral TabletPSNd9a5e0aa-e638-5d6e-75c2-20cb78fc4f439
1738511PARoxetine HCl 40 MG Oral TabletPSNd9a5e0aa-e638-5d6e-75c2-20cb78fc4f439
1738483paroxetine hydrochloride 10 MG Oral TabletSCDd9a5e0aa-e638-5d6e-75c2-20cb78fc4f439
1738495paroxetine hydrochloride 20 MG Oral TabletSCDd9a5e0aa-e638-5d6e-75c2-20cb78fc4f439
1738503paroxetine hydrochloride 30 MG Oral TabletSCDd9a5e0aa-e638-5d6e-75c2-20cb78fc4f439
1738511paroxetine hydrochloride 40 MG Oral TabletSCDd9a5e0aa-e638-5d6e-75c2-20cb78fc4f439

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
50268-640-11502680640111 in 1 BLISTER PACKHistorical
50268-640-155026806401550 BLISTER PACK in 1 BOX, UNIT-DOSE (50268-640-15) / 1 TABLET, FILM COATED in 1 BLISTER PACK (50268-640-11) 50 blister pack2016-03-110000-00-00NoNoCurrent