Home NDC 62135-542 PAROXETINE
Product NDC 62135-542
11-digit product format 621350542
Labeler code 62135
Product ID 62135-542_4687b126-663e-b64a-e063-6294a90affa1
Type HUMAN PRESCRIPTION DRUG
Nonproprietary name PAROXETINE
Dosage form TABLET, FILM COATED
Route ORAL
Labeler Chartwell RX, LLC.
Application ANDA211248
Marketing category ANDA
Marketing start 2021-11-02
Substance PAROXETINE HYDROCHLORIDE HEMIHYDRATE
Active strength 20 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 · 4 matching rows.
Application-product, Trade name, Ingredient table Application-product Trade name Ingredient Strength Dosage form / route TE codes RLD / RS Approval date A211248-001 PAROXETINE HYDROCHLORIDE PAROXETINE HYDROCHLORIDE EQ 10MG BASE TABLET / ORAL AB 2021-11-02 A211248-002 PAROXETINE HYDROCHLORIDE PAROXETINE HYDROCHLORIDE EQ 20MG BASE TABLET / ORAL AB 2021-11-02 A211248-003 PAROXETINE HYDROCHLORIDE PAROXETINE HYDROCHLORIDE EQ 30MG BASE TABLET / ORAL AB 2021-11-02 A211248-004 PAROXETINE HYDROCHLORIDE PAROXETINE HYDROCHLORIDE EQ 40MG BASE TABLET / ORAL AB 2021-11-02
Therapeutic equivalence codes# Current TE-code rows page 1 of 1 · 4 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.
Product history page 1 of 4 · 132 observed 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 2026-02-19 14:30 UTC 2026-02 A211248-001 PAROXETINE HYDROCHLORIDE EQ 10MG BASE TABLET / ORAL AB 2021-11-02 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 A211248-002 PAROXETINE HYDROCHLORIDE EQ 20MG BASE TABLET / ORAL AB 2021-11-02 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 A211248-003 PAROXETINE HYDROCHLORIDE EQ 30MG BASE TABLET / ORAL AB 2021-11-02 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 A211248-004 PAROXETINE HYDROCHLORIDE EQ 40MG BASE TABLET / ORAL AB 2021-11-02 011fe1cb6892…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 A211248-001 PAROXETINE HYDROCHLORIDE EQ 10MG BASE TABLET / ORAL AB 2021-11-02 31067a03dcf5…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 A211248-002 PAROXETINE HYDROCHLORIDE EQ 20MG BASE TABLET / ORAL AB 2021-11-02 31067a03dcf5…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 A211248-003 PAROXETINE HYDROCHLORIDE EQ 30MG BASE TABLET / ORAL AB 2021-11-02 31067a03dcf5…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 A211248-004 PAROXETINE HYDROCHLORIDE EQ 40MG BASE TABLET / ORAL AB 2021-11-02 31067a03dcf5…2025-08-23 18:47 UTC 2025-08 A211248-001 PAROXETINE HYDROCHLORIDE EQ 10MG BASE TABLET / ORAL AB 2021-11-02 6a471c1ec25d…2025-08-23 18:47 UTC 2025-08 A211248-002 PAROXETINE HYDROCHLORIDE EQ 20MG BASE TABLET / ORAL AB 2021-11-02 6a471c1ec25d…2025-08-23 18:47 UTC 2025-08 A211248-003 PAROXETINE HYDROCHLORIDE EQ 30MG BASE TABLET / ORAL AB 2021-11-02 6a471c1ec25d…2025-08-23 18:47 UTC 2025-08 A211248-004 PAROXETINE HYDROCHLORIDE EQ 40MG BASE TABLET / ORAL AB 2021-11-02 6a471c1ec25d…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 A211248-001 PAROXETINE HYDROCHLORIDE EQ 10MG BASE TABLET / ORAL AB 2021-11-02 fd3edfee7708…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 A211248-002 PAROXETINE HYDROCHLORIDE EQ 20MG BASE TABLET / ORAL AB 2021-11-02 fd3edfee7708…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 A211248-003 PAROXETINE HYDROCHLORIDE EQ 30MG BASE TABLET / ORAL AB 2021-11-02 fd3edfee7708…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 A211248-004 PAROXETINE HYDROCHLORIDE EQ 40MG BASE TABLET / ORAL AB 2021-11-02 fd3edfee7708…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 A211248-001 PAROXETINE HYDROCHLORIDE EQ 10MG BASE TABLET / ORAL AB 2021-11-02 b8a1b40f171c…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 A211248-002 PAROXETINE HYDROCHLORIDE EQ 20MG BASE TABLET / ORAL AB 2021-11-02 b8a1b40f171c…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 A211248-003 PAROXETINE HYDROCHLORIDE EQ 30MG BASE TABLET / ORAL AB 2021-11-02 b8a1b40f171c…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 A211248-004 PAROXETINE HYDROCHLORIDE EQ 40MG BASE TABLET / ORAL AB 2021-11-02 b8a1b40f171c…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 A211248-001 PAROXETINE HYDROCHLORIDE EQ 10MG BASE TABLET / ORAL AB 2021-11-02 03ed91905a0d…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 A211248-002 PAROXETINE HYDROCHLORIDE EQ 20MG BASE TABLET / ORAL AB 2021-11-02 03ed91905a0d…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 A211248-003 PAROXETINE HYDROCHLORIDE EQ 30MG BASE TABLET / ORAL AB 2021-11-02 03ed91905a0d…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 A211248-004 PAROXETINE HYDROCHLORIDE EQ 40MG BASE TABLET / ORAL AB 2021-11-02 03ed91905a0d…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 A211248-001 PAROXETINE HYDROCHLORIDE EQ 10MG BASE TABLET / ORAL AB 2021-11-02 2680178bc6a6…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 A211248-002 PAROXETINE HYDROCHLORIDE EQ 20MG BASE TABLET / ORAL AB 2021-11-02 2680178bc6a6…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 A211248-003 PAROXETINE HYDROCHLORIDE EQ 30MG BASE TABLET / ORAL AB 2021-11-02 2680178bc6a6…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 A211248-004 PAROXETINE HYDROCHLORIDE EQ 40MG BASE TABLET / ORAL AB 2021-11-02 2680178bc6a6…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 A211248-001 PAROXETINE HYDROCHLORIDE EQ 10MG BASE TABLET / ORAL AB 2021-11-02 5bbf6a4d5a75…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 A211248-002 PAROXETINE HYDROCHLORIDE EQ 20MG BASE TABLET / ORAL AB 2021-11-02 5bbf6a4d5a75…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 A211248-003 PAROXETINE HYDROCHLORIDE EQ 30MG BASE TABLET / ORAL AB 2021-11-02 5bbf6a4d5a75…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 A211248-004 PAROXETINE HYDROCHLORIDE EQ 40MG BASE TABLET / ORAL AB 2021-11-02 5bbf6a4d5a75…2024-11-08 22:44 UTC · 3 captures of this ZIP 2024-11 A211248-001 PAROXETINE HYDROCHLORIDE EQ 10MG BASE TABLET / ORAL AB 2021-11-02 d8e5a09893c0…2024-11-08 22:44 UTC · 3 captures of this ZIP 2024-11 A211248-002 PAROXETINE HYDROCHLORIDE EQ 20MG BASE TABLET / ORAL AB 2021-11-02 d8e5a09893c0…2024-11-08 22:44 UTC · 3 captures of this ZIP 2024-11 A211248-003 PAROXETINE HYDROCHLORIDE EQ 30MG BASE TABLET / ORAL AB 2021-11-02 d8e5a09893c0…2024-11-08 22:44 UTC · 3 captures of this ZIP 2024-11 A211248-004 PAROXETINE HYDROCHLORIDE EQ 40MG BASE TABLET / ORAL AB 2021-11-02 d8e5a09893c0…2024-10-29 15:01 UTC 2024-10 A211248-001 PAROXETINE HYDROCHLORIDE EQ 10MG BASE TABLET / ORAL AB 2021-11-02 d06236e962d9…2024-10-29 15:01 UTC 2024-10 A211248-002 PAROXETINE HYDROCHLORIDE EQ 20MG BASE TABLET / ORAL AB 2021-11-02 d06236e962d9…2024-10-29 15:01 UTC 2024-10 A211248-003 PAROXETINE HYDROCHLORIDE EQ 30MG BASE TABLET / ORAL AB 2021-11-02 d06236e962d9…2024-10-29 15:01 UTC 2024-10 A211248-004 PAROXETINE HYDROCHLORIDE EQ 40MG BASE TABLET / ORAL AB 2021-11-02 d06236e962d9…
Observed Orange Book normalized TE history# Normalized TE history page 1 of 4 · 132 observed states.
Additional Listing Data#
Finished product Yes
Brand name base PAROXETINE
Listing expiration 2026-12-31 Active Ingredients# Ingredient, Strength table Ingredient Strength PAROXETINE HYDROCHLORIDE HEMIHYDRATE 20 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 · 4 matching rows.
Identifier, FDA.report destination table Identifier FDA.report destination 1738483 Internal RxNorm lookup 1738495 Internal RxNorm lookup 1738503 Internal RxNorm lookup 1738511 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 62135-542-90 PAROXETINE 90 in 1 BOTTLE TABLET, FILM COATED 90 3
DailyMed Dashboard NDC Coverage# NDC, Dashboard title, SPL version table NDC Dashboard title SPL version Validation Dashboard ZIP 62135-542 PAROXETINE TABLET, FILM COATED [CHARTWELL RX, LLC.] 2 Current NDC, 1 package rows 20241013_69699d40-4a64-4337-8664-e4e093437fbf.zip
openFDA label cross-check# OpenFDA label data provides additional search and identifier links. DailyMed’s Structured Product Label is the canonical label on FDA.report. Matching records are deduplicated before they are shown below.
Matched openFDA labels page 1 of 1 · 2 matching rows.
DailyMed RxNorm Mappings# Packages# Package NDC, 11-digit format, Description table Package NDC 11-digit format Description Marketing start Sample Exclude flag Status 62135-542-90 62135054290 90 TABLET, FILM COATED in 1 BOTTLE (62135-542-90) 2023-04-11 No No Current