FDA.reportPublic FDA data

PAROXETINE HYDROCHLORIDE

Product NDC
60505-1318
11-digit product format
605051318
Labeler code
60505
Product ID
60505-1318_f641c7b3-f7d2-9446-e589-074ac368853a
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
paroxetine hydrochloride
Dosage form
TABLET, FILM COATED, EXTENDED RELEASE
Route
ORAL
Labeler
Apotex Corp
Application
NDA020936
Marketing category
NDA AUTHORIZED GENERIC
Marketing start
2019-08-09
Substance
PAROXETINE HYDROCHLORIDE HEMIHYDRATE
Active strength
37.5 mg/1
Pharmacologic classes
Serotonin Reuptake Inhibitor [EPC], Serotonin Uptake Inhibitors [MoA]
NDC exclude flag
No
Listing certified through
2026-12-31
Current FDA listing
Yes

Additional Listing Data#

Finished product
Yes
Brand name base
PAROXETINE HYDROCHLORIDE
Listing expiration
2026-12-31

Active Ingredients#

Ingredient, Strength table
IngredientStrength
PAROXETINE HYDROCHLORIDE HEMIHYDRATE37.5 mg/1

Harmonized Identifiers#

Field, Values table
FieldValues
UniiX2ELS050D8
Rxcui1738803, 1738805, 1738807

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

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
60505-1318-3PAROXETINE HYDROCHLORIDE30 in 1 BOTTLETABLET, FILM COATED, EXTENDED RE3018

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
60505-1318-3EA - Each60505-1318f30bdb98-522a-4342-b069-68c5149c88a212020-07-13

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIIDailyMed labelSPL versionUploaded
PAROXETINE HYDROCHLORIDE HEMIHYDRATEACTIVE INGREDIENTX2ELS050D8PAROXETINE HYDROCHLORIDE TABLET, FILM COATED, EXTENDED RELEASE [APOTEX CORP]8
PAROXETINEACTIVE MOIETY41VRH5220HPAROXETINE HYDROCHLORIDE TABLET, FILM COATED, EXTENDED RELEASE [APOTEX CORP]8
GLYCERYL DIBEHENATEINACTIVE INGREDIENTR8WTH25YS2PAROXETINE HYDROCHLORIDE TABLET, FILM COATED, EXTENDED RELEASE [APOTEX CORP]8
HYPROMELLOSESINACTIVE INGREDIENT3NXW29V3WOPAROXETINE HYDROCHLORIDE TABLET, FILM COATED, EXTENDED RELEASE [APOTEX CORP]8
LACTOSE MONOHYDRATEINACTIVE INGREDIENTEWQ57Q8I5XPAROXETINE HYDROCHLORIDE TABLET, FILM COATED, EXTENDED RELEASE [APOTEX CORP]8
MAGNESIUM STEARATEINACTIVE INGREDIENT70097M6I30PAROXETINE HYDROCHLORIDE TABLET, FILM COATED, EXTENDED RELEASE [APOTEX CORP]8
METHACRYLIC ACID - ETHYL ACRYLATE COPOLYMER (1:1) TYPE AINACTIVE INGREDIENTNX76LV5T8JPAROXETINE HYDROCHLORIDE TABLET, FILM COATED, EXTENDED RELEASE [APOTEX CORP]8
POLYSORBATE 80INACTIVE INGREDIENT6OZP39ZG8HPAROXETINE HYDROCHLORIDE TABLET, FILM COATED, EXTENDED RELEASE [APOTEX CORP]8
POVIDONE K30INACTIVE INGREDIENTU725QWY32XPAROXETINE HYDROCHLORIDE TABLET, FILM COATED, EXTENDED RELEASE [APOTEX CORP]8
SILICON DIOXIDEINACTIVE INGREDIENTETJ7Z6XBU4PAROXETINE HYDROCHLORIDE TABLET, FILM COATED, EXTENDED RELEASE [APOTEX CORP]8
SODIUM LAURYL SULFATEINACTIVE INGREDIENT368GB5141JPAROXETINE HYDROCHLORIDE TABLET, FILM COATED, EXTENDED RELEASE [APOTEX CORP]8
TALCINACTIVE INGREDIENT7SEV7J4R1UPAROXETINE HYDROCHLORIDE TABLET, FILM COATED, EXTENDED RELEASE [APOTEX CORP]8
TITANIUM DIOXIDEINACTIVE INGREDIENT15FIX9V2JPPAROXETINE HYDROCHLORIDE TABLET, FILM COATED, EXTENDED RELEASE [APOTEX CORP]8
TRIETHYL CITRATEINACTIVE INGREDIENT8Z96QXD6UMPAROXETINE HYDROCHLORIDE TABLET, FILM COATED, EXTENDED RELEASE [APOTEX CORP]8

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
60505-1318PAROXETINE HYDROCHLORIDE TABLET, FILM COATED, EXTENDED RELEASE [APOTEX CORP]17Current NDC, Legacy NDC, 1 package rows20240504_087ff0d3-1761-47ea-a8c1-7c4cb679af97.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
1738803PARoxetine HCl 12.5 MG 24HR Extended Release Oral TabletPSN087ff0d3-1761-47ea-a8c1-7c4cb679af9718
1738805PARoxetine HCl 25 MG 24HR Extended Release Oral TabletPSN087ff0d3-1761-47ea-a8c1-7c4cb679af9718
1738807PARoxetine HCl 37.5 MG 24HR Extended Release Oral TabletPSN087ff0d3-1761-47ea-a8c1-7c4cb679af9718
173880324 HR paroxetine hydrochloride 12.5 MG Extended Release Oral TabletSCD087ff0d3-1761-47ea-a8c1-7c4cb679af9718
173880524 HR paroxetine hydrochloride 25 MG Extended Release Oral TabletSCD087ff0d3-1761-47ea-a8c1-7c4cb679af9718
173880724 HR paroxetine hydrochloride 37.5 MG Extended Release Oral TabletSCD087ff0d3-1761-47ea-a8c1-7c4cb679af9718
1738803paroxetine hydrochloride 12.5 MG 24 HR Extended Release Oral TabletSY087ff0d3-1761-47ea-a8c1-7c4cb679af9718
1738805paroxetine hydrochloride 25 MG 24 HR Extended Release Oral TabletSY087ff0d3-1761-47ea-a8c1-7c4cb679af9718
1738807paroxetine hydrochloride 37.5 MG 24 HR Extended Release Oral TabletSY087ff0d3-1761-47ea-a8c1-7c4cb679af9718

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionMarketing startMarketing endSampleExclude flagStatus
60505-1318-36050513180330 TABLET, FILM COATED, EXTENDED RELEASE in 1 BOTTLE (60505-1318-3) 2019-08-090000-00-00NoNoCurrent