Home NDC 55289-872 SEROQUEL
Product NDC 55289-872
11-digit product format 552890872
Labeler code 55289
Product ID 55289-872_dac10978-145e-0d77-e053-2995a90a1ec7
Type HUMAN PRESCRIPTION DRUG
Nonproprietary name quetiapine fumarate
Dosage form TABLET, FILM COATED
Route ORAL
Labeler PD-Rx Pharmaceuticals, Inc.
Application NDA020639
Marketing category NDA
Marketing start 1997-10-01
Marketing end 0000-00-00
Substance QUETIAPINE FUMARATE
Active strength 25 mg/1
Pharmacologic classes Atypical Antipsychotic [EPC]
NDC exclude flag No
Listing certified through 2023-12-31
Current FDA listing Historical FDA.report record Observed NDC auxiliary status history# This history shows the information present in each captured FDA auxiliary file. It is not a continuous regulatory timeline, and a missing record does not establish a status.
Historic NDC status page 1 of 1 · 24 matching rows.
View current auxiliary records. · View the auxiliary file history.
Captured / source date, Dataset, Scope table Captured / source date Dataset Scope Package NDC Snapshot Source SHA-256 2025-12-14 17:58 UTC · source 2025-12-05 excluded product product d630ba8d3edf…732f749b63fb…2025-12-14 17:58 UTC · source 2025-12-05 excluded package package 55289-872-30 d630ba8d3edf…732f749b63fb…2025-08-27 00:01 UTC · source 2025-08-26 excluded product product f5e01cc5f278…a2eaf40c39c3…2025-08-27 00:01 UTC · source 2025-08-26 excluded package package 55289-872-30 f5e01cc5f278…a2eaf40c39c3…2025-04-01 02:39 UTC · source 2025-03-31 excluded product product 2ef7874e63bc…57b86245f4fa…2025-04-01 02:39 UTC · source 2025-03-31 excluded package package 55289-872-30 2ef7874e63bc…57b86245f4fa…2025-03-28 20:22 UTC · source 2025-03-28 excluded product product a1b67e2a42f9…c4cf2c586c0d…2025-03-28 20:22 UTC · source 2025-03-28 excluded package package 55289-872-30 a1b67e2a42f9…c4cf2c586c0d…2025-03-22 03:12 UTC · source 2025-03-21 excluded product product cfe11265f3b6…090c488252e2…2025-03-22 03:12 UTC · source 2025-03-21 excluded package package 55289-872-30 cfe11265f3b6…090c488252e2…2025-03-10 12:48 UTC · source 2025-03-10 excluded product product cdf11ea48f46…ba0047e9e063…2025-03-10 12:48 UTC · source 2025-03-10 excluded package package 55289-872-30 cdf11ea48f46…ba0047e9e063…2025-02-02 03:52 UTC · source 2025-01-31 excluded product product 302b2466d912…e7b80fea0513…2025-02-02 03:52 UTC · source 2025-01-31 excluded package package 55289-872-30 302b2466d912…e7b80fea0513…2025-01-20 13:05 UTC · source 2025-01-20 excluded product product ed331223b511…672a5bd82f5f…2025-01-20 13:05 UTC · source 2025-01-20 excluded package package 55289-872-30 ed331223b511…672a5bd82f5f…2025-01-11 03:41 UTC · source 2025-01-10 excluded product product 0efc9e666f02…f202fb6c5f17…2025-01-11 03:41 UTC · source 2025-01-10 excluded package package 55289-872-30 0efc9e666f02…f202fb6c5f17…2024-11-09 02:27 UTC · source 2024-11-08 excluded product product ad56d346431e…cc804d4bbf1e…2024-11-09 02:27 UTC · source 2024-11-08 excluded package package 55289-872-30 ad56d346431e…cc804d4bbf1e…2024-10-04 04:10 UTC · source 2024-10-03 excluded product product 367a005e9d99…383a685ebd0f…2024-10-04 04:10 UTC · source 2024-10-03 excluded package package 55289-872-30 367a005e9d99…383a685ebd0f…2024-07-10 04:00 UTC · source 2024-07-09 excluded product product 557ba5c1ecfa…9c80585c8c6e…2024-07-10 04:00 UTC · source 2024-07-09 excluded package package 55289-872-30 557ba5c1ecfa…9c80585c8c6e…
Source provenance: Browse the complete Orange Book source catalog · source snapshot 1 .
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 · 287 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 2026-02-19 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…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 N020639-006 SEROQUEL EQ 400MG BASE TABLET / ORAL AB RLD 2005-10-04 fd3edfee7708…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 N020639-007 SEROQUEL EQ 50MG BASE TABLET / ORAL AB RLD 2005-10-04 fd3edfee7708…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 N020639-001 SEROQUEL EQ 25MG BASE TABLET / ORAL AB RLD, RS 1997-09-26 b8a1b40f171c…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 N020639-002 SEROQUEL EQ 100MG BASE TABLET / ORAL AB RLD 1997-09-26 b8a1b40f171c…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 N020639-003 SEROQUEL EQ 200MG BASE TABLET / ORAL AB RLD 1997-09-26 b8a1b40f171c…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 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 b8a1b40f171c…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 N020639-005 SEROQUEL EQ 300MG BASE TABLET / ORAL AB RLD, RS 2000-07-26 b8a1b40f171c…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 N020639-006 SEROQUEL EQ 400MG BASE TABLET / ORAL AB RLD 2005-10-04 b8a1b40f171c…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 N020639-007 SEROQUEL EQ 50MG BASE TABLET / ORAL AB RLD 2005-10-04 b8a1b40f171c…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 N020639-001 SEROQUEL EQ 25MG BASE TABLET / ORAL AB RLD, RS 1997-09-26 03ed91905a0d…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 N020639-002 SEROQUEL EQ 100MG BASE TABLET / ORAL AB RLD 1997-09-26 03ed91905a0d…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 N020639-003 SEROQUEL EQ 200MG BASE TABLET / ORAL AB RLD 1997-09-26 03ed91905a0d…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 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 03ed91905a0d…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 N020639-005 SEROQUEL EQ 300MG BASE TABLET / ORAL AB RLD, RS 2000-07-26 03ed91905a0d…
Observed Orange Book normalized TE history# Normalized TE history page 1 of 7 · 246 observed states.
DailyMed Socrata Ingredients# Ingredient, Type, UNII table Ingredient Type UNII DailyMed label SPL version Uploaded QUETIAPINE FUMARATE ACTIVE INGREDIENT 2S3PL1B6UJ SEROQUEL (QUETIAPINE FUMARATE) TABLET, FILM COATED [PD-RX PHARMACEUTICALS, INC.] 18 QUETIAPINE ACTIVE MOIETY BGL0JSY5SI SEROQUEL (QUETIAPINE FUMARATE) TABLET, FILM COATED [PD-RX PHARMACEUTICALS, INC.] 18 CELLULOSE, MICROCRYSTALLINE INACTIVE INGREDIENT OP1R32D61U SEROQUEL (QUETIAPINE FUMARATE) TABLET, FILM COATED [PD-RX PHARMACEUTICALS, INC.] 18 DIBASIC CALCIUM PHOSPHATE DIHYDRATE INACTIVE INGREDIENT O7TSZ97GEP SEROQUEL (QUETIAPINE FUMARATE) TABLET, FILM COATED [PD-RX PHARMACEUTICALS, INC.] 18 FERRIC OXIDE RED INACTIVE INGREDIENT 1K09F3G675 SEROQUEL (QUETIAPINE FUMARATE) TABLET, FILM COATED [PD-RX PHARMACEUTICALS, INC.] 18 FERRIC OXIDE YELLOW INACTIVE INGREDIENT EX438O2MRT SEROQUEL (QUETIAPINE FUMARATE) TABLET, FILM COATED [PD-RX PHARMACEUTICALS, INC.] 18 HYPROMELLOSES INACTIVE INGREDIENT 3NXW29V3WO SEROQUEL (QUETIAPINE FUMARATE) TABLET, FILM COATED [PD-RX PHARMACEUTICALS, INC.] 18 LACTOSE MONOHYDRATE INACTIVE INGREDIENT EWQ57Q8I5X SEROQUEL (QUETIAPINE FUMARATE) TABLET, FILM COATED [PD-RX PHARMACEUTICALS, INC.] 18 MAGNESIUM STEARATE INACTIVE INGREDIENT 70097M6I30 SEROQUEL (QUETIAPINE FUMARATE) TABLET, FILM COATED [PD-RX PHARMACEUTICALS, INC.] 18 POLYETHYLENE GLYCOL INACTIVE INGREDIENT 3WJQ0SDW1A SEROQUEL (QUETIAPINE FUMARATE) TABLET, FILM COATED [PD-RX PHARMACEUTICALS, INC.] 18 POVIDONE INACTIVE INGREDIENT FZ989GH94E SEROQUEL (QUETIAPINE FUMARATE) TABLET, FILM COATED [PD-RX PHARMACEUTICALS, INC.] 18 SODIUM STARCH GLYCOLATE TYPE A POTATO INACTIVE INGREDIENT 5856J3G2A2 SEROQUEL (QUETIAPINE FUMARATE) TABLET, FILM COATED [PD-RX PHARMACEUTICALS, INC.] 18 TITANIUM DIOXIDE INACTIVE INGREDIENT 15FIX9V2JP SEROQUEL (QUETIAPINE FUMARATE) TABLET, FILM COATED [PD-RX PHARMACEUTICALS, INC.] 18 WATER INACTIVE INGREDIENT 059QF0KO0R SEROQUEL (QUETIAPINE FUMARATE) TABLET, FILM COATED [PD-RX PHARMACEUTICALS, INC.] 18
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.
Packages# Package NDC, 11-digit format, Description table Package NDC 11-digit format Description Marketing start Marketing end Sample Exclude flag Status 55289-872-30 55289087230 30 TABLET, FILM COATED in 1 BOTTLE, PLASTIC (55289-872-30) 2011-07-13 0000-00-00 No No Current