FDA.reportPublic FDA data

PAXIL

Product NDC
60505-3666
11-digit product format
605053666
Labeler code
60505
Product ID
60505-3666_2063c19d-13c4-7185-b321-732164db8236
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
paroxetine hydrochloride
Dosage form
TABLET, FILM COATED
Route
ORAL
Labeler
Apotex Corp
Application
NDA020031
Marketing category
NDA
Marketing start
2011-01-01
Marketing end
2021-05-31
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
0000-00-00
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 productproduct60505-3666DDiscontinued by firm2026-07-31
excluded packagepackage60505-366660505-3666-3DDiscontinued 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 · 5 matching rows.

Application-product, Trade name, Ingredient table
Application-productTrade nameIngredientStrengthDosage form / routeTE codesRLD / RSApproval date
N020031-001PAXILPAROXETINE HYDROCHLORIDEEQ 10MG BASETABLET / ORALABRLD1992-12-29
N020031-002PAXILPAROXETINE HYDROCHLORIDEEQ 20MG BASETABLET / ORALABRLD1992-12-29
N020031-003PAXILPAROXETINE HYDROCHLORIDEEQ 30MG BASETABLET / ORALABRLD1992-12-29
N020031-004PAXILPAROXETINE HYDROCHLORIDEEQ 50MG BASETABLET / ORAL1992-12-29
N020031-005PAXILPAROXETINE HYDROCHLORIDEEQ 40MG BASETABLET / ORALABRLD, RS1992-12-29

Therapeutic equivalence codes#

Current TE-code rows page 1 of 1 · 4 matching rows.

Application-product, TE code table
Application-productTE code
N020031-001AB
N020031-002AB
N020031-003AB
N020031-005AB

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 22:54:322026-06N020031-001PAXILEQ 10MG BASETABLET / ORALABRLD1992-12-29a50c72e98297…
2026-08-01 22:54:322026-06N020031-002PAXILEQ 20MG BASETABLET / ORALABRLD1992-12-29a50c72e98297…
2026-08-01 22:54:322026-06N020031-003PAXILEQ 30MG BASETABLET / ORALABRLD1992-12-29a50c72e98297…
2026-08-01 22:54:322026-06N020031-004PAXILEQ 50MG BASETABLET / ORAL1992-12-29a50c72e98297…
2026-08-01 22:54:322026-06N020031-005PAXILEQ 40MG BASETABLET / ORALABRLD, RS1992-12-29a50c72e98297…

Observed Orange Book normalized TE history#

Captured, Edition, Application-product table
CapturedEditionApplication-productTE codeOrderSource SHA-256
2026-08-01 22:54:322026-06N020031-001AB1a50c72e98297…
2026-08-01 22:54:322026-06N020031-002AB1a50c72e98297…
2026-08-01 22:54:322026-06N020031-003AB1a50c72e98297…
2026-08-01 22:54:322026-06N020031-005AB1a50c72e98297…

openFDA label cross-check#

Cross-check layer: openFDA label JSON enriches search and identifies hydration gaps. The DailyMed Structured Product Label remains the canonical label presentation on FDA.report. Every label matching the complete exact-identifier union is deduplicated and paginated below.

Matched openFDA labels page 1 of 1 · 1 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
PAXILPAROXETINE HYDROCHLORIDEApotex Corpef3b5cbe-f9e1-c1ac-79da-cfe14e3a7e7e2024-10-22Boxed warning, Warnings, Adverse reactionsExact identifier
application applno (NDA): 020031
application number: NDA020031

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
60505-3666-3EA - Each60505-36662641ba39-e84e-4407-afbf-06f72d34743d12012-07-24

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 formatDescriptionMarketing startMarketing endSampleExclude flagStatus
60505-3666-36050536660330 TABLET, FILM COATED in 1 BOTTLE (60505-3666-3) 2011-01-012021-05-31NoNoCurrent