FDA.reportPublic FDA data

PAXIL

Product NDC
60505-0402
11-digit product format
605050402
Labeler code
60505
Product ID
60505-0402_b9b9d7bd-6d4a-a0f1-36fa-3418c9de5a4f
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
paroxetine hydrochloride
Dosage form
SUSPENSION
Route
ORAL
Labeler
Apotex Corp
Application
NDA020710
Marketing category
NDA
Marketing start
2011-01-01
Marketing end
0000-00-00
Substance
PAROXETINE HYDROCHLORIDE
Active strength
10 mg/5mL
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

NDC auxiliary status#

Explicit status records from FDA unfinished, excluded, and compounder auxiliary files. Absence of a row is not itself a regulatory status. Browse every current auxiliary row, including rows without a usable NDC. · Browse every captured source and parsed snapshot.

Current NDC status page 1 of 1 · 2 matching rows.

Dataset, Scope, Product NDC table
DatasetScopeProduct NDCPackage NDCCodeStatusReporting periodSource date
excluded productproduct60505-0402DDiscontinued by firm2026-07-31
excluded packagepackage60505-040260505-0402-5DDiscontinued by firm2026-07-31

Source provenance: Browse the complete Orange Book source catalog · source snapshot 1.

Orange Book products#

Current product rows page 1 of 1 · 1 matching rows.

Application-product, Trade name, Ingredient table
Application-productTrade nameIngredientStrengthDosage form / routeTE codesRLD / RSApproval date
N020710-001PAXILPAROXETINE HYDROCHLORIDEEQ 10MG BASE/5ML **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**SUSPENSION / ORALRLD1997-06-25

Observed Orange Book product history#

Observed FDA ZIP history: Each table is queried independently by exact application/product key from successfully parsed Orange Book snapshots. Capture times identify archived source observations; absence or a change between snapshots is not inferred. FDA publication files that were not recoverable as structured ZIP data are not represented as states.

Captured, Edition, Application-product table
CapturedEditionApplication-productTrade nameStrengthDosage form / routeProduct TE source textRLD / RSApproval dateSource SHA-256
2026-08-01 22:54:322026-06N020710-001PAXILEQ 10MG BASE/5ML **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**SUSPENSION / ORALRLD1997-06-25a50c72e98297…

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
60505-0402-5ML - Milliliter60505-0402ee87dc93-263f-4dfd-84bb-3e47fe1333a712012-07-24

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIIDailyMed labelSPL versionUploaded
PAROXETINE HYDROCHLORIDE HEMIHYDRATEACTIVE INGREDIENTX2ELS050D8PAXIL (PAROXETINE HYDROCHLORIDE) TABLET, FILM COATED PAXIL (PAROXETINE HYDROCHLORIDE) SUSPENSION [APOTEX CORP]9
PAROXETINEACTIVE MOIETY41VRH5220HPAXIL (PAROXETINE HYDROCHLORIDE) TABLET, FILM COATED PAXIL (PAROXETINE HYDROCHLORIDE) SUSPENSION [APOTEX CORP]9
ANHYDROUS CITRIC ACIDINACTIVE INGREDIENTXF417D3PSLPAXIL (PAROXETINE HYDROCHLORIDE) TABLET, FILM COATED PAXIL (PAROXETINE HYDROCHLORIDE) SUSPENSION [APOTEX CORP]9
CALCIUM PHOSPHATE, DIBASIC, DIHYDRATEINACTIVE INGREDIENTO7TSZ97GEPPAXIL (PAROXETINE HYDROCHLORIDE) TABLET, FILM COATED PAXIL (PAROXETINE HYDROCHLORIDE) SUSPENSION [APOTEX CORP]9
CELLULOSE, MICROCRYSTALLINEINACTIVE INGREDIENTOP1R32D61UPAXIL (PAROXETINE HYDROCHLORIDE) TABLET, FILM COATED PAXIL (PAROXETINE HYDROCHLORIDE) SUSPENSION [APOTEX CORP]9
DIMETHICONE 410INACTIVE INGREDIENTTYU5GP6XGEPAXIL (PAROXETINE HYDROCHLORIDE) TABLET, FILM COATED PAXIL (PAROXETINE HYDROCHLORIDE) SUSPENSION [APOTEX CORP]9
FD&C YELLOW NO. 6INACTIVE INGREDIENTH77VEI93A8PAXIL (PAROXETINE HYDROCHLORIDE) TABLET, FILM COATED PAXIL (PAROXETINE HYDROCHLORIDE) SUSPENSION [APOTEX CORP]9
GLYCERININACTIVE INGREDIENTPDC6A3C0OXPAXIL (PAROXETINE HYDROCHLORIDE) TABLET, FILM COATED PAXIL (PAROXETINE HYDROCHLORIDE) SUSPENSION [APOTEX CORP]9
HYPROMELLOSESINACTIVE INGREDIENT3NXW29V3WOPAXIL (PAROXETINE HYDROCHLORIDE) TABLET, FILM COATED PAXIL (PAROXETINE HYDROCHLORIDE) SUSPENSION [APOTEX CORP]9
MAGNESIUM STEARATEINACTIVE INGREDIENT70097M6I30PAXIL (PAROXETINE HYDROCHLORIDE) TABLET, FILM COATED PAXIL (PAROXETINE HYDROCHLORIDE) SUSPENSION [APOTEX CORP]9
METHYLPARABENINACTIVE INGREDIENTA2I8C7HI9TPAXIL (PAROXETINE HYDROCHLORIDE) TABLET, FILM COATED PAXIL (PAROXETINE HYDROCHLORIDE) SUSPENSION [APOTEX CORP]9
POLACRILIN POTASSIUMINACTIVE INGREDIENT0BZ5A00FQUPAXIL (PAROXETINE HYDROCHLORIDE) TABLET, FILM COATED PAXIL (PAROXETINE HYDROCHLORIDE) SUSPENSION [APOTEX CORP]9
POLYSORBATE 80INACTIVE INGREDIENT6OZP39ZG8HPAXIL (PAROXETINE HYDROCHLORIDE) TABLET, FILM COATED PAXIL (PAROXETINE HYDROCHLORIDE) SUSPENSION [APOTEX CORP]9
PROPYLENE GLYCOLINACTIVE INGREDIENT6DC9Q167V3PAXIL (PAROXETINE HYDROCHLORIDE) TABLET, FILM COATED PAXIL (PAROXETINE HYDROCHLORIDE) SUSPENSION [APOTEX CORP]9
PROPYLPARABENINACTIVE INGREDIENTZ8IX2SC1OHPAXIL (PAROXETINE HYDROCHLORIDE) TABLET, FILM COATED PAXIL (PAROXETINE HYDROCHLORIDE) SUSPENSION [APOTEX CORP]9
SACCHARIN SODIUM ANHYDROUSINACTIVE INGREDIENTI4807BK602PAXIL (PAROXETINE HYDROCHLORIDE) TABLET, FILM COATED PAXIL (PAROXETINE HYDROCHLORIDE) SUSPENSION [APOTEX CORP]9
SODIUM CITRATEINACTIVE INGREDIENT1Q73Q2JULRPAXIL (PAROXETINE HYDROCHLORIDE) TABLET, FILM COATED PAXIL (PAROXETINE HYDROCHLORIDE) SUSPENSION [APOTEX CORP]9
SODIUM STARCH GLYCOLATE TYPE A POTATOINACTIVE INGREDIENT5856J3G2A2PAXIL (PAROXETINE HYDROCHLORIDE) TABLET, FILM COATED PAXIL (PAROXETINE HYDROCHLORIDE) SUSPENSION [APOTEX CORP]9
SORBITOLINACTIVE INGREDIENT506T60A25RPAXIL (PAROXETINE HYDROCHLORIDE) TABLET, FILM COATED PAXIL (PAROXETINE HYDROCHLORIDE) SUSPENSION [APOTEX CORP]9
TITANIUM DIOXIDEINACTIVE INGREDIENT15FIX9V2JPPAXIL (PAROXETINE HYDROCHLORIDE) TABLET, FILM COATED PAXIL (PAROXETINE HYDROCHLORIDE) SUSPENSION [APOTEX CORP]9

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
60505-0402-560505040205250 mL in 1 BOTTLE (60505-0402-5) 250 ml2011-01-010000-00-00NoNoCurrent