Home NDC 61269-254 SEROQUEL
Product NDC 61269-254
11-digit product format 612690254
Labeler code 61269
Product ID 61269-254_1fc7d584-a2f0-47f7-9506-5ecb2bfebb65
Type HUMAN PRESCRIPTION DRUG
Nonproprietary name quetiapine
Dosage form TABLET, FILM COATED
Route ORAL
Labeler H2-Pharma, LLC
Application NDA020639
Marketing category NDA
Marketing start 2000-11-13
Substance QUETIAPINE FUMARATE
Active strength 300 mg/1
Pharmacologic classes Atypical Antipsychotic [EPC]
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 · 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SEROQUEL QUETIAPINE FUMARATE EQ 150MG BASE **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** TABLET / ORAL RLD 1998-12-20 N020639-005 SEROQUEL QUETIAPINE FUMARATE EQ 300MG BASE TABLET / ORAL AB RLD, RS 2000-07-26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.
Additional Listing Data#
Finished product Yes
Brand name base SEROQUEL
Listing expiration 2027-12-31 Active Ingredients# Ingredient, Strength table Ingredient Strength QUETIAPINE FUMARATE 300 mg/1
Harmonized UNII identifiers# UNII identifiers page 1 of 1 · 1 matching rows.
Identifier, FDA.report destination table Identifier FDA.report destination 2S3PL1B6UJ Internal UNII lookup
Harmonized RxCUI identifiers# RxCUI identifiers page 1 of 1 · 12 matching rows.
Identifier, FDA.report destination table Identifier FDA.report destination 153638 Internal RxNorm lookup 153639 Internal RxNorm lookup 153640 Internal RxNorm lookup 284509 Internal RxNorm lookup 312743 Internal RxNorm lookup 312744 Internal RxNorm lookup 312745 Internal RxNorm lookup 317174 Internal RxNorm lookup 616483 Internal RxNorm lookup 616485 Internal RxNorm lookup 616487 Internal RxNorm lookup 616489 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 61269-254-60 SEROQUEL 60 in 1 BOTTLE TABLET, FILM COATED 60 53
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 61269-254-60 61269025460 60 TABLET, FILM COATED in 1 BOTTLE (61269-254-60) 2000-11-13 No No Current