Home DailyMed 643b5fde-e89f-40ef-b28d-bcd68e9c43ef National Council for Prescription Drug Programs indexing - billing unit Drug label information. FDA.report displays public Structured Product Labeling data from DailyMed and legacy FDA.report DailyMed cache rows. This page is not medical advice, prescribing advice, or a substitute for the official label reviewed by a qualified healthcare professional. Labeling can change; when a current hydrated DailyMed SPL record is available, FDA.report shows that newer record before legacy cached files.
Manufacturer National Council for Prescription Drug Programs
Effective date 2012-07-24
Label type Indexing - Billing Unit
Version 1
Source full-release
Hydrated at 2026-06-05 01:55:55 Orange Book application contexts# All distinct exact application/product contexts derived from this label’s complete NDC list are paginated below.
Orange Book application contexts page 1 of 1 · 1 matching rows.
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 · 1 matching rows.