Home DailyMed b068e8b3-c9ff-4b67-8f99-e2b3cbda9f3b 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 02:28:54 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 43 .
Orange Book products# Current product rows page 1 of 1 · 7 matching rows.
Application-product, Trade name, Ingredient table Application-product Trade name Ingredient Strength Dosage form / route TE codes RLD / RS Approval date N020639-001 SEROQUEL QUETIAPINE FUMARATE EQ 25MG BASE TABLET / ORAL AB RLD, RS 1997-09-26 N020639-002 SEROQUEL QUETIAPINE FUMARATE EQ 100MG BASE TABLET / ORAL AB RLD 1997-09-26 N020639-003 SEROQUEL QUETIAPINE FUMARATE EQ 200MG BASE TABLET / ORAL AB RLD 1997-09-26 N020639-004 SEROQUEL QUETIAPINE FUMARATE EQ 150MG BASE **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** TABLET / ORAL RLD 1998-12-20 N020639-005 SEROQUEL QUETIAPINE FUMARATE EQ 300MG BASE TABLET / ORAL AB RLD, RS 2000-07-26 N020639-006 SEROQUEL QUETIAPINE FUMARATE EQ 400MG BASE TABLET / ORAL AB RLD 2005-10-04 N020639-007 SEROQUEL QUETIAPINE FUMARATE EQ 50MG BASE TABLET / ORAL AB RLD 2005-10-04
Therapeutic equivalence codes# Current TE-code rows page 1 of 1 · 6 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 8 · 301 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 N020639-001 SEROQUEL EQ 25MG BASE TABLET / ORAL AB RLD, RS 1997-09-26 84e616aacf4f…2026-09-14 22:38:34 2026-08 N020639-002 SEROQUEL EQ 100MG BASE TABLET / ORAL AB RLD 1997-09-26 84e616aacf4f…2026-09-14 22:38:34 2026-08 N020639-003 SEROQUEL EQ 200MG BASE TABLET / ORAL AB RLD 1997-09-26 84e616aacf4f…2026-09-14 22:38:34 2026-08 N020639-004 SEROQUEL EQ 150MG BASE **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** TABLET / ORAL RLD 1998-12-20 84e616aacf4f…2026-09-14 22:38:34 2026-08 N020639-005 SEROQUEL EQ 300MG BASE TABLET / ORAL AB RLD, RS 2000-07-26 84e616aacf4f…2026-09-14 22:38:34 2026-08 N020639-006 SEROQUEL EQ 400MG BASE TABLET / ORAL AB RLD 2005-10-04 84e616aacf4f…2026-09-14 22:38:34 2026-08 N020639-007 SEROQUEL EQ 50MG BASE TABLET / ORAL AB RLD 2005-10-04 84e616aacf4f…2026-08-18 06:07:40 2026-07 N020639-001 SEROQUEL EQ 25MG BASE TABLET / ORAL AB RLD, RS 1997-09-26 caaa826d4ba7…2026-08-18 06:07:40 2026-07 N020639-002 SEROQUEL EQ 100MG BASE TABLET / ORAL AB RLD 1997-09-26 caaa826d4ba7…2026-08-18 06:07:40 2026-07 N020639-003 SEROQUEL EQ 200MG BASE TABLET / ORAL AB RLD 1997-09-26 caaa826d4ba7…2026-08-18 06:07:40 2026-07 N020639-004 SEROQUEL EQ 150MG BASE **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** TABLET / ORAL RLD 1998-12-20 caaa826d4ba7…2026-08-18 06:07:40 2026-07 N020639-005 SEROQUEL EQ 300MG BASE TABLET / ORAL AB RLD, RS 2000-07-26 caaa826d4ba7…2026-08-18 06:07:40 2026-07 N020639-006 SEROQUEL EQ 400MG BASE TABLET / ORAL AB RLD 2005-10-04 caaa826d4ba7…2026-08-18 06:07:40 2026-07 N020639-007 SEROQUEL EQ 50MG BASE TABLET / ORAL AB RLD 2005-10-04 caaa826d4ba7…2026-02-19 14:30 UTC 2026-02 N020639-001 SEROQUEL EQ 25MG BASE TABLET / ORAL AB RLD, RS 1997-09-26 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 N020639-002 SEROQUEL EQ 100MG BASE TABLET / ORAL AB RLD 1997-09-26 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 N020639-003 SEROQUEL EQ 200MG BASE TABLET / ORAL AB RLD 1997-09-26 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 N020639-004 SEROQUEL EQ 150MG BASE **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** TABLET / ORAL RLD 1998-12-20 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 N020639-005 SEROQUEL EQ 300MG BASE TABLET / ORAL AB RLD, RS 2000-07-26 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 N020639-006 SEROQUEL EQ 400MG BASE TABLET / ORAL AB RLD 2005-10-04 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 N020639-007 SEROQUEL EQ 50MG BASE TABLET / ORAL AB RLD 2005-10-04 011fe1cb6892…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 N020639-001 SEROQUEL EQ 25MG BASE TABLET / ORAL AB RLD, RS 1997-09-26 31067a03dcf5…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 N020639-002 SEROQUEL EQ 100MG BASE TABLET / ORAL AB RLD 1997-09-26 31067a03dcf5…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 N020639-003 SEROQUEL EQ 200MG BASE TABLET / ORAL AB RLD 1997-09-26 31067a03dcf5…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 N020639-004 SEROQUEL EQ 150MG BASE **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** TABLET / ORAL RLD 1998-12-20 31067a03dcf5…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 N020639-005 SEROQUEL EQ 300MG BASE TABLET / ORAL AB RLD, RS 2000-07-26 31067a03dcf5…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 N020639-006 SEROQUEL EQ 400MG BASE TABLET / ORAL AB RLD 2005-10-04 31067a03dcf5…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 N020639-007 SEROQUEL EQ 50MG BASE TABLET / ORAL AB RLD 2005-10-04 31067a03dcf5…2025-08-23 18:47 UTC 2025-08 N020639-001 SEROQUEL EQ 25MG BASE TABLET / ORAL AB RLD, RS 1997-09-26 6a471c1ec25d…2025-08-23 18:47 UTC 2025-08 N020639-002 SEROQUEL EQ 100MG BASE TABLET / ORAL AB RLD 1997-09-26 6a471c1ec25d…2025-08-23 18:47 UTC 2025-08 N020639-003 SEROQUEL EQ 200MG BASE TABLET / ORAL AB RLD 1997-09-26 6a471c1ec25d…2025-08-23 18:47 UTC 2025-08 N020639-004 SEROQUEL EQ 150MG BASE **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** TABLET / ORAL RLD 1998-12-20 6a471c1ec25d…2025-08-23 18:47 UTC 2025-08 N020639-005 SEROQUEL EQ 300MG BASE TABLET / ORAL AB RLD, RS 2000-07-26 6a471c1ec25d…2025-08-23 18:47 UTC 2025-08 N020639-006 SEROQUEL EQ 400MG BASE TABLET / ORAL AB RLD 2005-10-04 6a471c1ec25d…2025-08-23 18:47 UTC 2025-08 N020639-007 SEROQUEL EQ 50MG BASE TABLET / ORAL AB RLD 2005-10-04 6a471c1ec25d…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 N020639-001 SEROQUEL EQ 25MG BASE TABLET / ORAL AB RLD, RS 1997-09-26 fd3edfee7708…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 N020639-002 SEROQUEL EQ 100MG BASE TABLET / ORAL AB RLD 1997-09-26 fd3edfee7708…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 N020639-003 SEROQUEL EQ 200MG BASE TABLET / ORAL AB RLD 1997-09-26 fd3edfee7708…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 N020639-004 SEROQUEL EQ 150MG BASE **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** TABLET / ORAL RLD 1998-12-20 fd3edfee7708…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 N020639-005 SEROQUEL EQ 300MG BASE TABLET / ORAL AB RLD, RS 2000-07-26 fd3edfee7708…
Observed Orange Book normalized TE history# Normalized TE history page 1 of 7 · 258 observed states.
Reported adverse events (FAERS/openFDA)# Adverse event summaries are temporarily unavailable. Other product information remains available.