Home NDC 71335-9650 paroxetine hydrochloride
Product NDC 71335-9650
11-digit product format 713359650
Labeler code 71335
Product ID 71335-9650_52e74299-f193-408d-9d0d-e48398a1734a
Type HUMAN PRESCRIPTION DRUG
Nonproprietary name paroxetine hydrochloride
Dosage form TABLET, FILM COATED
Route ORAL
Labeler Bryant Ranch Prepack
Application ANDA076968
Marketing category ANDA
Marketing start 2022-11-14
Substance PAROXETINE HYDROCHLORIDE HEMIHYDRATE
Active strength 30 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 43 .
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 A076968-001 PAROXETINE HYDROCHLORIDE PAROXETINE HYDROCHLORIDE EQ 10MG BASE TABLET / ORAL AB 2010-06-21 A076968-002 PAROXETINE HYDROCHLORIDE PAROXETINE HYDROCHLORIDE EQ 20MG BASE TABLET / ORAL AB 2010-06-21 A076968-003 PAROXETINE HYDROCHLORIDE PAROXETINE HYDROCHLORIDE EQ 30MG BASE TABLET / ORAL AB 2010-06-21 A076968-004 PAROXETINE HYDROCHLORIDE PAROXETINE HYDROCHLORIDE EQ 40MG BASE TABLET / ORAL AB 2010-06-21
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 5 · 172 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 2026-09-14 22:38:34 2026-08 A076968-001 PAROXETINE HYDROCHLORIDE EQ 10MG BASE TABLET / ORAL AB 2010-06-21 84e616aacf4f…2026-09-14 22:38:34 2026-08 A076968-002 PAROXETINE HYDROCHLORIDE EQ 20MG BASE TABLET / ORAL AB 2010-06-21 84e616aacf4f…2026-09-14 22:38:34 2026-08 A076968-003 PAROXETINE HYDROCHLORIDE EQ 30MG BASE TABLET / ORAL AB 2010-06-21 84e616aacf4f…2026-09-14 22:38:34 2026-08 A076968-004 PAROXETINE HYDROCHLORIDE EQ 40MG BASE TABLET / ORAL AB 2010-06-21 84e616aacf4f…2026-08-18 06:07:40 2026-07 A076968-001 PAROXETINE HYDROCHLORIDE EQ 10MG BASE TABLET / ORAL AB 2010-06-21 caaa826d4ba7…2026-08-18 06:07:40 2026-07 A076968-002 PAROXETINE HYDROCHLORIDE EQ 20MG BASE TABLET / ORAL AB 2010-06-21 caaa826d4ba7…2026-08-18 06:07:40 2026-07 A076968-003 PAROXETINE HYDROCHLORIDE EQ 30MG BASE TABLET / ORAL AB 2010-06-21 caaa826d4ba7…2026-08-18 06:07:40 2026-07 A076968-004 PAROXETINE HYDROCHLORIDE EQ 40MG BASE TABLET / ORAL AB 2010-06-21 caaa826d4ba7…2026-02-19 14:30 UTC 2026-02 A076968-001 PAROXETINE HYDROCHLORIDE EQ 10MG BASE TABLET / ORAL AB 2010-06-21 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 A076968-002 PAROXETINE HYDROCHLORIDE EQ 20MG BASE TABLET / ORAL AB 2010-06-21 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 A076968-003 PAROXETINE HYDROCHLORIDE EQ 30MG BASE TABLET / ORAL AB 2010-06-21 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 A076968-004 PAROXETINE HYDROCHLORIDE EQ 40MG BASE TABLET / ORAL AB 2010-06-21 011fe1cb6892…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 A076968-001 PAROXETINE HYDROCHLORIDE EQ 10MG BASE TABLET / ORAL AB 2010-06-21 31067a03dcf5…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 A076968-002 PAROXETINE HYDROCHLORIDE EQ 20MG BASE TABLET / ORAL AB 2010-06-21 31067a03dcf5…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 A076968-003 PAROXETINE HYDROCHLORIDE EQ 30MG BASE TABLET / ORAL AB 2010-06-21 31067a03dcf5…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 A076968-004 PAROXETINE HYDROCHLORIDE EQ 40MG BASE TABLET / ORAL AB 2010-06-21 31067a03dcf5…2025-08-23 18:47 UTC 2025-08 A076968-001 PAROXETINE HYDROCHLORIDE EQ 10MG BASE TABLET / ORAL AB 2010-06-21 6a471c1ec25d…2025-08-23 18:47 UTC 2025-08 A076968-002 PAROXETINE HYDROCHLORIDE EQ 20MG BASE TABLET / ORAL AB 2010-06-21 6a471c1ec25d…2025-08-23 18:47 UTC 2025-08 A076968-003 PAROXETINE HYDROCHLORIDE EQ 30MG BASE TABLET / ORAL AB 2010-06-21 6a471c1ec25d…2025-08-23 18:47 UTC 2025-08 A076968-004 PAROXETINE HYDROCHLORIDE EQ 40MG BASE TABLET / ORAL AB 2010-06-21 6a471c1ec25d…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 A076968-001 PAROXETINE HYDROCHLORIDE EQ 10MG BASE TABLET / ORAL AB 2010-06-21 fd3edfee7708…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 A076968-002 PAROXETINE HYDROCHLORIDE EQ 20MG BASE TABLET / ORAL AB 2010-06-21 fd3edfee7708…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 A076968-003 PAROXETINE HYDROCHLORIDE EQ 30MG BASE TABLET / ORAL AB 2010-06-21 fd3edfee7708…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 A076968-004 PAROXETINE HYDROCHLORIDE EQ 40MG BASE TABLET / ORAL AB 2010-06-21 fd3edfee7708…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 A076968-001 PAROXETINE HYDROCHLORIDE EQ 10MG BASE TABLET / ORAL AB 2010-06-21 b8a1b40f171c…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 A076968-002 PAROXETINE HYDROCHLORIDE EQ 20MG BASE TABLET / ORAL AB 2010-06-21 b8a1b40f171c…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 A076968-003 PAROXETINE HYDROCHLORIDE EQ 30MG BASE TABLET / ORAL AB 2010-06-21 b8a1b40f171c…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 A076968-004 PAROXETINE HYDROCHLORIDE EQ 40MG BASE TABLET / ORAL AB 2010-06-21 b8a1b40f171c…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 A076968-001 PAROXETINE HYDROCHLORIDE EQ 10MG BASE TABLET / ORAL AB 2010-06-21 03ed91905a0d…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 A076968-002 PAROXETINE HYDROCHLORIDE EQ 20MG BASE TABLET / ORAL AB 2010-06-21 03ed91905a0d…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 A076968-003 PAROXETINE HYDROCHLORIDE EQ 30MG BASE TABLET / ORAL AB 2010-06-21 03ed91905a0d…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 A076968-004 PAROXETINE HYDROCHLORIDE EQ 40MG BASE TABLET / ORAL AB 2010-06-21 03ed91905a0d…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 A076968-001 PAROXETINE HYDROCHLORIDE EQ 10MG BASE TABLET / ORAL AB 2010-06-21 2680178bc6a6…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 A076968-002 PAROXETINE HYDROCHLORIDE EQ 20MG BASE TABLET / ORAL AB 2010-06-21 2680178bc6a6…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 A076968-003 PAROXETINE HYDROCHLORIDE EQ 30MG BASE TABLET / ORAL AB 2010-06-21 2680178bc6a6…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 A076968-004 PAROXETINE HYDROCHLORIDE EQ 40MG BASE TABLET / ORAL AB 2010-06-21 2680178bc6a6…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 A076968-001 PAROXETINE HYDROCHLORIDE EQ 10MG BASE TABLET / ORAL AB 2010-06-21 5bbf6a4d5a75…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 A076968-002 PAROXETINE HYDROCHLORIDE EQ 20MG BASE TABLET / ORAL AB 2010-06-21 5bbf6a4d5a75…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 A076968-003 PAROXETINE HYDROCHLORIDE EQ 30MG BASE TABLET / ORAL AB 2010-06-21 5bbf6a4d5a75…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 A076968-004 PAROXETINE HYDROCHLORIDE EQ 40MG BASE TABLET / ORAL AB 2010-06-21 5bbf6a4d5a75…
Observed Orange Book normalized TE history# Normalized TE history page 1 of 5 · 172 observed states.
Reported adverse events (FAERS/openFDA)# Adverse event summaries are temporarily unavailable. Other product information remains available.
Additional Listing Data#
Finished product Yes
Brand name base paroxetine hydrochloride
Listing expiration 2026-12-31 Active Ingredients# Ingredient, Strength table Ingredient Strength PAROXETINE HYDROCHLORIDE HEMIHYDRATE 30 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 · 1 matching rows.
Identifier, FDA.report destination table Identifier FDA.report destination 1738503 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 71335-9650-1 paroxetine hydrochloride 30 in 1 BOTTLE TABLET, FILM COATED 30 102 71335-9650-2 paroxetine hydrochloride 60 in 1 BOTTLE TABLET, FILM COATED 60 102 71335-9650-3 paroxetine hydrochloride 90 in 1 BOTTLE TABLET, FILM COATED 90 102 71335-9650-4 paroxetine hydrochloride 180 in 1 BOTTLE TABLET, FILM COATED 180 102
DailyMed Dashboard NDC Coverage# NDC, Dashboard title, SPL version table NDC Dashboard title SPL version Validation Dashboard ZIP 71335-9650 PAROXETINE HYDROCHLORIDE TABLET, FILM COATED [BRYANT RANCH PREPACK] 102 Current NDC, 4 package rows 20240918_c3c204df-6b7d-42fb-8794-4f38064ed963.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 71335-9650-1 71335965001 30 TABLET, FILM COATED in 1 BOTTLE (71335-9650-1) 2023-03-28 No No Current 71335-9650-2 71335965002 60 TABLET, FILM COATED in 1 BOTTLE (71335-9650-2) 2024-09-06 No No Current 71335-9650-3 71335965003 90 TABLET, FILM COATED in 1 BOTTLE (71335-9650-3) 2024-09-06 No No Current 71335-9650-4 71335965004 180 TABLET, FILM COATED in 1 BOTTLE (71335-9650-4) 2024-09-06 No No Current