Home NDC 60505-4377 PAXIL
Product NDC 60505-4377
11-digit product format 605054377
Labeler code 60505
Product ID 60505-4377_57998b73-87c9-7fed-ffa8-7e43620bd98a
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
Marketing start 2011-01-01
Substance PAROXETINE HYDROCHLORIDE
Active strength 12.5 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 Source provenance: Browse the complete Orange Book source catalog · source snapshot 1 .
Orange Book products# Current product rows page 1 of 1 · 3 matching rows.
Application-product, Trade name, Ingredient table Application-product Trade name Ingredient Strength Dosage form / route TE codes RLD / RS Approval date N020936-001 PAXIL CR PAROXETINE HYDROCHLORIDE EQ 12.5MG BASE TABLET, EXTENDED RELEASE / ORAL AB RLD 1999-02-16 N020936-002 PAXIL CR PAROXETINE HYDROCHLORIDE EQ 25MG BASE TABLET, EXTENDED RELEASE / ORAL AB RLD 1999-02-16 N020936-003 PAXIL CR PAROXETINE HYDROCHLORIDE EQ 37.5MG BASE TABLET, EXTENDED RELEASE / ORAL AB RLD, RS 2000-12-06
Therapeutic equivalence codes# Current TE-code rows page 1 of 1 · 3 matching rows.
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 Captured Edition Application-product Trade name Strength Dosage form / route Product TE source text RLD / RS Approval date Source SHA-256 2026-08-01 22:54:32 2026-06 N020936-001 PAXIL CR EQ 12.5MG BASE TABLET, EXTENDED RELEASE / ORAL AB RLD 1999-02-16 a50c72e98297…2026-08-01 22:54:32 2026-06 N020936-002 PAXIL CR EQ 25MG BASE TABLET, EXTENDED RELEASE / ORAL AB RLD 1999-02-16 a50c72e98297…2026-08-01 22:54:32 2026-06 N020936-003 PAXIL CR EQ 37.5MG BASE TABLET, EXTENDED RELEASE / ORAL AB RLD, RS 2000-12-06 a50c72e98297…
Observed Orange Book normalized TE history# 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 · 2 matching rows.
Additional Listing Data#
Finished product Yes
Brand name base PAXIL
Brand name suffix CR
Listing expiration 2026-12-31 Active Ingredients# Ingredient, Strength table Ingredient Strength PAROXETINE HYDROCHLORIDE 12.5 mg/1
Harmonized UNII identifiers# UNII identifiers page 1 of 1 · 1 matching rows.
Identifier, FDA.report destination table Identifier FDA.report destination X2ELS050D8 Internal UNII lookup
Harmonized RxCUI identifiers# RxCUI identifiers page 1 of 1 · 6 matching rows.
Identifier, FDA.report destination table Identifier FDA.report destination 1738803 Internal RxNorm lookup 1738804 Internal RxNorm lookup 1738805 Internal RxNorm lookup 1738806 Internal RxNorm lookup 1738807 Internal RxNorm lookup 1738808 Internal RxNorm lookup
Harmonized SPL set identifiers# SPL set identifiers page 1 of 1 · 1 matching rows.
DailyMed Product Concepts# DailyMed Package Descriptions# Package NDC, Product, Description table Package NDC Product Description Form Quantity Strength SPL version 60505-4377-3 PAXIL CR 30 in 1 BOTTLE TABLET, FILM COATED, EXTENDED RE 30 32
DailyMed Socrata Ingredients# Ingredient, Type, UNII table Ingredient Type UNII DailyMed label SPL version Uploaded PAROXETINE HYDROCHLORIDE HEMIHYDRATE ACTIVE INGREDIENT X2ELS050D8 PAXIL CR (PAROXETINE HYDROCHLORIDE) TABLET, FILM COATED, EXTENDED RELEASE [APOTEX CORP] 11 PAROXETINE ACTIVE MOIETY 41VRH5220H PAXIL CR (PAROXETINE HYDROCHLORIDE) TABLET, FILM COATED, EXTENDED RELEASE [APOTEX CORP] 11 GLYCERYL DIBEHENATE INACTIVE INGREDIENT R8WTH25YS2 PAXIL CR (PAROXETINE HYDROCHLORIDE) TABLET, FILM COATED, EXTENDED RELEASE [APOTEX CORP] 11 HYPROMELLOSES INACTIVE INGREDIENT 3NXW29V3WO PAXIL CR (PAROXETINE HYDROCHLORIDE) TABLET, FILM COATED, EXTENDED RELEASE [APOTEX CORP] 11 LACTOSE MONOHYDRATE INACTIVE INGREDIENT EWQ57Q8I5X PAXIL CR (PAROXETINE HYDROCHLORIDE) TABLET, FILM COATED, EXTENDED RELEASE [APOTEX CORP] 11 MAGNESIUM STEARATE INACTIVE INGREDIENT 70097M6I30 PAXIL CR (PAROXETINE HYDROCHLORIDE) TABLET, FILM COATED, EXTENDED RELEASE [APOTEX CORP] 11 METHACRYLIC ACID - ETHYL ACRYLATE COPOLYMER (1:1) TYPE A INACTIVE INGREDIENT NX76LV5T8J PAXIL CR (PAROXETINE HYDROCHLORIDE) TABLET, FILM COATED, EXTENDED RELEASE [APOTEX CORP] 11 POLYSORBATE 80 INACTIVE INGREDIENT 6OZP39ZG8H PAXIL CR (PAROXETINE HYDROCHLORIDE) TABLET, FILM COATED, EXTENDED RELEASE [APOTEX CORP] 11 POVIDONE K30 INACTIVE INGREDIENT U725QWY32X PAXIL CR (PAROXETINE HYDROCHLORIDE) TABLET, FILM COATED, EXTENDED RELEASE [APOTEX CORP] 11 SILICON DIOXIDE INACTIVE INGREDIENT ETJ7Z6XBU4 PAXIL CR (PAROXETINE HYDROCHLORIDE) TABLET, FILM COATED, EXTENDED RELEASE [APOTEX CORP] 11 SODIUM LAURYL SULFATE INACTIVE INGREDIENT 368GB5141J PAXIL CR (PAROXETINE HYDROCHLORIDE) TABLET, FILM COATED, EXTENDED RELEASE [APOTEX CORP] 11 TALC INACTIVE INGREDIENT 7SEV7J4R1U PAXIL CR (PAROXETINE HYDROCHLORIDE) TABLET, FILM COATED, EXTENDED RELEASE [APOTEX CORP] 11 TITANIUM DIOXIDE INACTIVE INGREDIENT 15FIX9V2JP PAXIL CR (PAROXETINE HYDROCHLORIDE) TABLET, FILM COATED, EXTENDED RELEASE [APOTEX CORP] 11 TRIETHYL CITRATE INACTIVE INGREDIENT 8Z96QXD6UM PAXIL CR (PAROXETINE HYDROCHLORIDE) TABLET, FILM COATED, EXTENDED RELEASE [APOTEX CORP] 11
DailyMed Dashboard NDC Coverage# NDC, Dashboard title, SPL version table NDC Dashboard title SPL version Validation Dashboard ZIP 60505-4377 PAXIL CR (PAROXETINE HYDROCHLORIDE) TABLET, FILM COATED, EXTENDED RELEASE [APOTEX CORP] 31 Current NDC, Legacy NDC, 1 package rows 20240911_483bd97f-c4d0-4e23-aaa8-6334f4471e0c.zip
DailyMed RxNorm Mappings# Packages# Package NDC, 11-digit format, Description table Package NDC 11-digit format Description Marketing start Marketing end Sample Exclude flag Status 60505-4377-3 60505437703 30 TABLET, FILM COATED, EXTENDED RELEASE in 1 BOTTLE (60505-4377-3) 2011-01-01 0000-00-00 No No Current