Home NDC 21695-160 PAXIL
Product NDC 21695-160
11-digit product format 216950160
Labeler code 21695
Product ID 21695-160_a73cf8ee-f99b-4972-8939-0d394a527134
Type HUMAN PRESCRIPTION DRUG
Nonproprietary name paroxetine hydrochloride
Dosage form TABLET, FILM COATED, EXTENDED RELEASE
Route ORAL
Labeler Rebel Distributors Corp
Application NDA020936
Marketing category NDA
Marketing start 2002-04-09
Marketing end 0000-00-00
Substance PAROXETINE HYDROCHLORIDE
Active strength 25 mg/1
Pharmacologic classes Serotonin Reuptake Inhibitor [EPC],Serotonin Uptake Inhibitors [MoA]
NDC exclude flag E
Listing certified through 2017-12-31
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 Socrata Ingredients# Ingredient, Type, UNII table Ingredient Type UNII DailyMed label SPL version Uploaded PAROXETINE HYDROCHLORIDE ACTIVE INGREDIENT 3I3T11UD2S PAXIL CR (PAROXETINE HYDROCHLORIDE) TABLET, FILM COATED, EXTENDED RELEASE [REBEL DISTRIBUTORS CORP] 1 PAROXETINE ACTIVE MOIETY 41VRH5220H PAXIL CR (PAROXETINE HYDROCHLORIDE) TABLET, FILM COATED, EXTENDED RELEASE [REBEL DISTRIBUTORS CORP] 1 GLYCERYL BEHENATE INACTIVE INGREDIENT R8WTH25YS2 PAXIL CR (PAROXETINE HYDROCHLORIDE) TABLET, FILM COATED, EXTENDED RELEASE [REBEL DISTRIBUTORS CORP] 1 HYPROMELLOSES INACTIVE INGREDIENT 3NXW29V3WO PAXIL CR (PAROXETINE HYDROCHLORIDE) TABLET, FILM COATED, EXTENDED RELEASE [REBEL DISTRIBUTORS CORP] 1 LACTOSE MONOHYDRATE INACTIVE INGREDIENT EWQ57Q8I5X PAXIL CR (PAROXETINE HYDROCHLORIDE) TABLET, FILM COATED, EXTENDED RELEASE [REBEL DISTRIBUTORS CORP] 1 MAGNESIUM STEARATE INACTIVE INGREDIENT 70097M6I30 PAXIL CR (PAROXETINE HYDROCHLORIDE) TABLET, FILM COATED, EXTENDED RELEASE [REBEL DISTRIBUTORS CORP] 1 METHACRYLIC ACID - ETHYL ACRYLATE COPOLYMER (1:1) TYPE A INACTIVE INGREDIENT NX76LV5T8J PAXIL CR (PAROXETINE HYDROCHLORIDE) TABLET, FILM COATED, EXTENDED RELEASE [REBEL DISTRIBUTORS CORP] 1 POLYSORBATE 80 INACTIVE INGREDIENT 6OZP39ZG8H PAXIL CR (PAROXETINE HYDROCHLORIDE) TABLET, FILM COATED, EXTENDED RELEASE [REBEL DISTRIBUTORS CORP] 1 POVIDONE K30 INACTIVE INGREDIENT U725QWY32X PAXIL CR (PAROXETINE HYDROCHLORIDE) TABLET, FILM COATED, EXTENDED RELEASE [REBEL DISTRIBUTORS CORP] 1 SILICON DIOXIDE INACTIVE INGREDIENT ETJ7Z6XBU4 PAXIL CR (PAROXETINE HYDROCHLORIDE) TABLET, FILM COATED, EXTENDED RELEASE [REBEL DISTRIBUTORS CORP] 1 SODIUM LAURYL SULFATE INACTIVE INGREDIENT 368GB5141J PAXIL CR (PAROXETINE HYDROCHLORIDE) TABLET, FILM COATED, EXTENDED RELEASE [REBEL DISTRIBUTORS CORP] 1 TALC INACTIVE INGREDIENT 7SEV7J4R1U PAXIL CR (PAROXETINE HYDROCHLORIDE) TABLET, FILM COATED, EXTENDED RELEASE [REBEL DISTRIBUTORS CORP] 1 TITANIUM DIOXIDE INACTIVE INGREDIENT 15FIX9V2JP PAXIL CR (PAROXETINE HYDROCHLORIDE) TABLET, FILM COATED, EXTENDED RELEASE [REBEL DISTRIBUTORS CORP] 1 TRIETHYL CITRATE INACTIVE INGREDIENT 8Z96QXD6UM PAXIL CR (PAROXETINE HYDROCHLORIDE) TABLET, FILM COATED, EXTENDED RELEASE [REBEL DISTRIBUTORS CORP] 1