Home NDC 60505-3674-3 PAROXETINE HYDROCHLORIDE
Product NDC 60505-3674
Requested package NDC 60505-3674-3
11-digit product format 605053674
Labeler code 60505
Product ID 60505-3674_97c5413a-415b-55a7-245b-33a8c519ee5d
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 2010-09-13
Marketing end 2023-01-31
Substance PAROXETINE HYDROCHLORIDE HEMIHYDRATE
Active strength 25 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 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.
DailyMed Product Concepts# FDA-Initiated Inactive NDC Indexing# DailyMed Package Descriptions# Package NDC, Product, Description table Package NDC Product Description Form Quantity Strength SPL version 60505-3674-3 PAROXETINE HYDROCHLORIDE 30 in 1 BOTTLE TABLET, FILM COATED, EXTENDED RE 30 18
DailyMed Socrata Ingredients# Ingredient, Type, UNII table Ingredient Type UNII DailyMed label SPL version Uploaded PAROXETINE HYDROCHLORIDE HEMIHYDRATE ACTIVE INGREDIENT X2ELS050D8 PAROXETINE HYDROCHLORIDE TABLET, FILM COATED, EXTENDED RELEASE [APOTEX CORP] 8 PAROXETINE ACTIVE MOIETY 41VRH5220H PAROXETINE HYDROCHLORIDE TABLET, FILM COATED, EXTENDED RELEASE [APOTEX CORP] 8 GLYCERYL DIBEHENATE INACTIVE INGREDIENT R8WTH25YS2 PAROXETINE HYDROCHLORIDE TABLET, FILM COATED, EXTENDED RELEASE [APOTEX CORP] 8 HYPROMELLOSES INACTIVE INGREDIENT 3NXW29V3WO PAROXETINE HYDROCHLORIDE TABLET, FILM COATED, EXTENDED RELEASE [APOTEX CORP] 8 LACTOSE MONOHYDRATE INACTIVE INGREDIENT EWQ57Q8I5X PAROXETINE HYDROCHLORIDE TABLET, FILM COATED, EXTENDED RELEASE [APOTEX CORP] 8 MAGNESIUM STEARATE INACTIVE INGREDIENT 70097M6I30 PAROXETINE HYDROCHLORIDE TABLET, FILM COATED, EXTENDED RELEASE [APOTEX CORP] 8 METHACRYLIC ACID - ETHYL ACRYLATE COPOLYMER (1:1) TYPE A INACTIVE INGREDIENT NX76LV5T8J PAROXETINE HYDROCHLORIDE TABLET, FILM COATED, EXTENDED RELEASE [APOTEX CORP] 8 POLYSORBATE 80 INACTIVE INGREDIENT 6OZP39ZG8H PAROXETINE HYDROCHLORIDE TABLET, FILM COATED, EXTENDED RELEASE [APOTEX CORP] 8 POVIDONE K30 INACTIVE INGREDIENT U725QWY32X PAROXETINE HYDROCHLORIDE TABLET, FILM COATED, EXTENDED RELEASE [APOTEX CORP] 8 SILICON DIOXIDE INACTIVE INGREDIENT ETJ7Z6XBU4 PAROXETINE HYDROCHLORIDE TABLET, FILM COATED, EXTENDED RELEASE [APOTEX CORP] 8 SODIUM LAURYL SULFATE INACTIVE INGREDIENT 368GB5141J PAROXETINE HYDROCHLORIDE TABLET, FILM COATED, EXTENDED RELEASE [APOTEX CORP] 8 TALC INACTIVE INGREDIENT 7SEV7J4R1U PAROXETINE HYDROCHLORIDE TABLET, FILM COATED, EXTENDED RELEASE [APOTEX CORP] 8 TITANIUM DIOXIDE INACTIVE INGREDIENT 15FIX9V2JP PAROXETINE HYDROCHLORIDE TABLET, FILM COATED, EXTENDED RELEASE [APOTEX CORP] 8 TRIETHYL CITRATE INACTIVE INGREDIENT 8Z96QXD6UM PAROXETINE HYDROCHLORIDE TABLET, FILM COATED, EXTENDED RELEASE [APOTEX CORP] 8
DailyMed Dashboard NDC Coverage# NDC, Dashboard title, SPL version table NDC Dashboard title SPL version Validation Dashboard ZIP 60505-3674 PAROXETINE HYDROCHLORIDE TABLET, FILM COATED, EXTENDED RELEASE [APOTEX CORP] 17 Legacy NDC, 1 package rows 20240504_087ff0d3-1761-47ea-a8c1-7c4cb679af97.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 60505-3674-3 60505367403 30 TABLET, FILM COATED, EXTENDED RELEASE in 1 BOTTLE (60505-3674-3) 2010-09-13 2023-01-31 No No Current