Home NDC 46708-767 Paroxetine
Product NDC 46708-767
11-digit product format 467080767
Labeler code 46708
Product ID 46708-767_e7609c36-21f5-42e2-8d74-ddaf8f94233f
Type HUMAN PRESCRIPTION DRUG
Nonproprietary name Paroxetine
Dosage form TABLET, FILM COATED, EXTENDED RELEASE
Route ORAL
Labeler Alembic Pharmaceuticals Limited
Application ANDA217280
Marketing category ANDA
Marketing start 2025-09-30
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 2027-12-31
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 A217280-001 PAROXETINE HYDROCHLORIDE PAROXETINE HYDROCHLORIDE EQ 25MG BASE TABLET, EXTENDED RELEASE / ORAL AB 2025-09-24 A217280-002 PAROXETINE HYDROCHLORIDE PAROXETINE HYDROCHLORIDE EQ 37.5MG BASE TABLET, EXTENDED RELEASE / ORAL AB 2025-09-24 A217280-003 PAROXETINE HYDROCHLORIDE PAROXETINE HYDROCHLORIDE EQ 12.5MG BASE TABLET, EXTENDED RELEASE / ORAL AB 2026-03-26
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 2026-02-19 14:30 UTC 2026-02 A217280-001 PAROXETINE HYDROCHLORIDE EQ 25MG BASE TABLET, EXTENDED RELEASE / ORAL AB 2025-09-24 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 A217280-002 PAROXETINE HYDROCHLORIDE EQ 37.5MG BASE TABLET, EXTENDED RELEASE / ORAL AB 2025-09-24 011fe1cb6892…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 A217280-001 PAROXETINE HYDROCHLORIDE EQ 25MG BASE TABLET, EXTENDED RELEASE / ORAL AB 2025-09-24 31067a03dcf5…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 A217280-002 PAROXETINE HYDROCHLORIDE EQ 37.5MG BASE TABLET, EXTENDED RELEASE / ORAL AB 2025-09-24 31067a03dcf5…2026-07-26 02:55 UTC · 3 captures of this ZIP 2026-06 A217280-001 PAROXETINE HYDROCHLORIDE EQ 25MG BASE TABLET, EXTENDED RELEASE / ORAL AB 2025-09-24 a50c72e98297…2026-07-26 02:55 UTC · 3 captures of this ZIP 2026-06 A217280-002 PAROXETINE HYDROCHLORIDE EQ 37.5MG BASE TABLET, EXTENDED RELEASE / ORAL AB 2025-09-24 a50c72e98297…2026-07-26 02:55 UTC · 3 captures of this ZIP 2026-06 A217280-003 PAROXETINE HYDROCHLORIDE EQ 12.5MG BASE TABLET, EXTENDED RELEASE / ORAL AB 2026-03-26 a50c72e98297…
Observed Orange Book normalized TE history# Additional Listing Data#
Finished product Yes
Brand name base Paroxetine
Listing expiration 2027-12-31 Active Ingredients# Ingredient, Strength table Ingredient Strength PAROXETINE HYDROCHLORIDE HEMIHYDRATE 25 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 · 3 matching rows.
Identifier, FDA.report destination table Identifier FDA.report destination 1738803 Internal RxNorm lookup 1738805 Internal RxNorm lookup 1738807 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 46708-767-30 Paroxetine 30 in 1 BOTTLE TABLET, FILM COATED, EXTENDED RE 30 2 46708-767-91 Paroxetine 1000 in 1 BOTTLE TABLET, FILM COATED, EXTENDED RE 1000 2
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 46708-767-30 46708076730 30 TABLET, FILM COATED, EXTENDED RELEASE in 1 BOTTLE (46708-767-30) 2025-09-30 No No Current 46708-767-91 46708076791 1000 TABLET, FILM COATED, EXTENDED RELEASE in 1 BOTTLE (46708-767-91) 2025-09-30 No No Current