Home NDC 71335-1362 Quetiapine fumarate
Product NDC 71335-1362
11-digit product format 713351362
Labeler code 71335
Product ID 71335-1362_0a8804e2-28c3-4f92-bf7a-c26c8d00cc71
Type HUMAN PRESCRIPTION DRUG
Nonproprietary name Quetiapine fumarate
Dosage form TABLET, FILM COATED
Route ORAL
Labeler Bryant Ranch Prepack
Application ANDA203359
Marketing category ANDA
Marketing start 2016-06-14
Substance QUETIAPINE FUMARATE
Active strength 200 mg/1
Pharmacologic classes Atypical Antipsychotic [EPC]
NDC exclude flag No
Listing certified through 2026-12-31
Current FDA listing Yes 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 · 12 matching rows.
View current auxiliary records. · View the auxiliary file history.
Source provenance: Browse the complete Orange Book source catalog · source snapshot 43 .
Orange Book products# Current product rows page 1 of 1 · 6 matching rows.
Application-product, Trade name, Ingredient table Application-product Trade name Ingredient Strength Dosage form / route TE codes RLD / RS Approval date A203359-001 QUETIAPINE FUMARATE QUETIAPINE FUMARATE EQ 25MG BASE TABLET / ORAL AB 2016-05-17 A203359-002 QUETIAPINE FUMARATE QUETIAPINE FUMARATE EQ 50MG BASE TABLET / ORAL AB 2016-05-17 A203359-003 QUETIAPINE FUMARATE QUETIAPINE FUMARATE EQ 100MG BASE TABLET / ORAL AB 2016-05-17 A203359-004 QUETIAPINE FUMARATE QUETIAPINE FUMARATE EQ 200MG BASE TABLET / ORAL AB 2016-05-17 A203359-005 QUETIAPINE FUMARATE QUETIAPINE FUMARATE EQ 300MG BASE TABLET / ORAL AB 2016-05-17 A203359-006 QUETIAPINE FUMARATE QUETIAPINE FUMARATE EQ 400MG BASE TABLET / ORAL AB 2016-05-17
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 7 · 258 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 A203359-001 QUETIAPINE FUMARATE EQ 25MG BASE TABLET / ORAL AB 2016-05-17 84e616aacf4f…2026-09-14 22:38:34 2026-08 A203359-002 QUETIAPINE FUMARATE EQ 50MG BASE TABLET / ORAL AB 2016-05-17 84e616aacf4f…2026-09-14 22:38:34 2026-08 A203359-003 QUETIAPINE FUMARATE EQ 100MG BASE TABLET / ORAL AB 2016-05-17 84e616aacf4f…2026-09-14 22:38:34 2026-08 A203359-004 QUETIAPINE FUMARATE EQ 200MG BASE TABLET / ORAL AB 2016-05-17 84e616aacf4f…2026-09-14 22:38:34 2026-08 A203359-005 QUETIAPINE FUMARATE EQ 300MG BASE TABLET / ORAL AB 2016-05-17 84e616aacf4f…2026-09-14 22:38:34 2026-08 A203359-006 QUETIAPINE FUMARATE EQ 400MG BASE TABLET / ORAL AB 2016-05-17 84e616aacf4f…2026-08-18 06:07:40 2026-07 A203359-001 QUETIAPINE FUMARATE EQ 25MG BASE TABLET / ORAL AB 2016-05-17 caaa826d4ba7…2026-08-18 06:07:40 2026-07 A203359-002 QUETIAPINE FUMARATE EQ 50MG BASE TABLET / ORAL AB 2016-05-17 caaa826d4ba7…2026-08-18 06:07:40 2026-07 A203359-003 QUETIAPINE FUMARATE EQ 100MG BASE TABLET / ORAL AB 2016-05-17 caaa826d4ba7…2026-08-18 06:07:40 2026-07 A203359-004 QUETIAPINE FUMARATE EQ 200MG BASE TABLET / ORAL AB 2016-05-17 caaa826d4ba7…2026-08-18 06:07:40 2026-07 A203359-005 QUETIAPINE FUMARATE EQ 300MG BASE TABLET / ORAL AB 2016-05-17 caaa826d4ba7…2026-08-18 06:07:40 2026-07 A203359-006 QUETIAPINE FUMARATE EQ 400MG BASE TABLET / ORAL AB 2016-05-17 caaa826d4ba7…2026-02-19 14:30 UTC 2026-02 A203359-001 QUETIAPINE FUMARATE EQ 25MG BASE TABLET / ORAL AB 2016-05-17 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 A203359-002 QUETIAPINE FUMARATE EQ 50MG BASE TABLET / ORAL AB 2016-05-17 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 A203359-003 QUETIAPINE FUMARATE EQ 100MG BASE TABLET / ORAL AB 2016-05-17 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 A203359-004 QUETIAPINE FUMARATE EQ 200MG BASE TABLET / ORAL AB 2016-05-17 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 A203359-005 QUETIAPINE FUMARATE EQ 300MG BASE TABLET / ORAL AB 2016-05-17 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 A203359-006 QUETIAPINE FUMARATE EQ 400MG BASE TABLET / ORAL AB 2016-05-17 011fe1cb6892…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 A203359-001 QUETIAPINE FUMARATE EQ 25MG BASE TABLET / ORAL AB 2016-05-17 31067a03dcf5…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 A203359-002 QUETIAPINE FUMARATE EQ 50MG BASE TABLET / ORAL AB 2016-05-17 31067a03dcf5…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 A203359-003 QUETIAPINE FUMARATE EQ 100MG BASE TABLET / ORAL AB 2016-05-17 31067a03dcf5…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 A203359-004 QUETIAPINE FUMARATE EQ 200MG BASE TABLET / ORAL AB 2016-05-17 31067a03dcf5…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 A203359-005 QUETIAPINE FUMARATE EQ 300MG BASE TABLET / ORAL AB 2016-05-17 31067a03dcf5…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 A203359-006 QUETIAPINE FUMARATE EQ 400MG BASE TABLET / ORAL AB 2016-05-17 31067a03dcf5…2025-08-23 18:47 UTC 2025-08 A203359-001 QUETIAPINE FUMARATE EQ 25MG BASE TABLET / ORAL AB 2016-05-17 6a471c1ec25d…2025-08-23 18:47 UTC 2025-08 A203359-002 QUETIAPINE FUMARATE EQ 50MG BASE TABLET / ORAL AB 2016-05-17 6a471c1ec25d…2025-08-23 18:47 UTC 2025-08 A203359-003 QUETIAPINE FUMARATE EQ 100MG BASE TABLET / ORAL AB 2016-05-17 6a471c1ec25d…2025-08-23 18:47 UTC 2025-08 A203359-004 QUETIAPINE FUMARATE EQ 200MG BASE TABLET / ORAL AB 2016-05-17 6a471c1ec25d…2025-08-23 18:47 UTC 2025-08 A203359-005 QUETIAPINE FUMARATE EQ 300MG BASE TABLET / ORAL AB 2016-05-17 6a471c1ec25d…2025-08-23 18:47 UTC 2025-08 A203359-006 QUETIAPINE FUMARATE EQ 400MG BASE TABLET / ORAL AB 2016-05-17 6a471c1ec25d…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 A203359-001 QUETIAPINE FUMARATE EQ 25MG BASE TABLET / ORAL AB 2016-05-17 fd3edfee7708…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 A203359-002 QUETIAPINE FUMARATE EQ 50MG BASE TABLET / ORAL AB 2016-05-17 fd3edfee7708…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 A203359-003 QUETIAPINE FUMARATE EQ 100MG BASE TABLET / ORAL AB 2016-05-17 fd3edfee7708…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 A203359-004 QUETIAPINE FUMARATE EQ 200MG BASE TABLET / ORAL AB 2016-05-17 fd3edfee7708…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 A203359-005 QUETIAPINE FUMARATE EQ 300MG BASE TABLET / ORAL AB 2016-05-17 fd3edfee7708…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 A203359-006 QUETIAPINE FUMARATE EQ 400MG BASE TABLET / ORAL AB 2016-05-17 fd3edfee7708…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 A203359-001 QUETIAPINE FUMARATE EQ 25MG BASE TABLET / ORAL AB 2016-05-17 b8a1b40f171c…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 A203359-002 QUETIAPINE FUMARATE EQ 50MG BASE TABLET / ORAL AB 2016-05-17 b8a1b40f171c…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 A203359-003 QUETIAPINE FUMARATE EQ 100MG BASE TABLET / ORAL AB 2016-05-17 b8a1b40f171c…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 A203359-004 QUETIAPINE FUMARATE EQ 200MG BASE TABLET / ORAL AB 2016-05-17 b8a1b40f171c…
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.
Additional Listing Data#
Finished product Yes
Brand name base Quetiapine fumarate
Listing expiration 2026-12-31 Active Ingredients# Ingredient, Strength table Ingredient Strength QUETIAPINE FUMARATE 200 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 · 1 matching rows.
Identifier, FDA.report destination table Identifier FDA.report destination 317174 Internal RxNorm lookup
Harmonized SPL set identifiers# SPL set identifiers page 1 of 1 · 1 matching rows.
DailyMed Product Concepts# FDA-Initiated Inactive NDC Indexing# NDC, Effective, Related label table NDC Effective Related label 71335-1362-1 2024-05-20 These highlights do not include all the information needed to use QUETIAPINE TABLETS safely and effectively. See full prescribing information for QUETIAPINE TABLETS. QUETIAPINE tablets, for oral use Initial U.S. Approval: 1997 71335-1362-2 2024-05-20 These highlights do not include all the information needed to use QUETIAPINE TABLETS safely and effectively. See full prescribing information for QUETIAPINE TABLETS. QUETIAPINE tablets, for oral use Initial U.S. Approval: 1997 71335-1362-3 2024-05-20 These highlights do not include all the information needed to use QUETIAPINE TABLETS safely and effectively. See full prescribing information for QUETIAPINE TABLETS. QUETIAPINE tablets, for oral use Initial U.S. Approval: 1997 71335-1362-4 2024-05-20 These highlights do not include all the information needed to use QUETIAPINE TABLETS safely and effectively. See full prescribing information for QUETIAPINE TABLETS. QUETIAPINE tablets, for oral use Initial U.S. Approval: 1997 71335-1362-5 2024-05-20 These highlights do not include all the information needed to use QUETIAPINE TABLETS safely and effectively. See full prescribing information for QUETIAPINE TABLETS. QUETIAPINE tablets, for oral use Initial U.S. Approval: 1997 71335-1362-1 2024-01-30 These highlights do not include all the information needed to use QUETIAPINE TABLETS safely and effectively. See full prescribing information for QUETIAPINE TABLETS. QUETIAPINE tablets, for oral use Initial U.S. Approval: 1997 71335-1362-2 2024-01-30 These highlights do not include all the information needed to use QUETIAPINE TABLETS safely and effectively. See full prescribing information for QUETIAPINE TABLETS. QUETIAPINE tablets, for oral use Initial U.S. Approval: 1997 71335-1362-3 2024-01-30 These highlights do not include all the information needed to use QUETIAPINE TABLETS safely and effectively. See full prescribing information for QUETIAPINE TABLETS. QUETIAPINE tablets, for oral use Initial U.S. Approval: 1997 71335-1362-4 2024-01-30 These highlights do not include all the information needed to use QUETIAPINE TABLETS safely and effectively. See full prescribing information for QUETIAPINE TABLETS. QUETIAPINE tablets, for oral use Initial U.S. Approval: 1997 71335-1362-5 2024-01-30 These highlights do not include all the information needed to use QUETIAPINE TABLETS safely and effectively. See full prescribing information for QUETIAPINE TABLETS. QUETIAPINE tablets, for oral use Initial U.S. Approval: 1997
DailyMed Package Descriptions# Package NDC, Product, Description table Package NDC Product Description Form Quantity Strength SPL version 71335-1362-1 Quetiapine fumarate 30 in 1 BOTTLE TABLET, FILM COATED 30 4 71335-1362-2 Quetiapine fumarate 100 in 1 BOTTLE TABLET, FILM COATED 100 4 71335-1362-3 Quetiapine fumarate 120 in 1 BOTTLE TABLET, FILM COATED 120 4 71335-1362-4 Quetiapine fumarate 90 in 1 BOTTLE TABLET, FILM COATED 90 4 71335-1362-5 Quetiapine fumarate 60 in 1 BOTTLE TABLET, FILM COATED 60 4
DailyMed Dashboard NDC Coverage# NDC, Dashboard title, SPL version table NDC Dashboard title SPL version Validation Dashboard ZIP 71335-1362 QUETIAPINE FUMARATE TABLET, FILM COATED [BRYANT RANCH PREPACK] 4 Current NDC, Legacy NDC, 5 package rows 20240522_293a9857-d138-4583-abc9-35b75660e324.zip
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 Marketing end Sample Exclude flag Status 71335-1362-1 71335136201 30 TABLET, FILM COATED in 1 BOTTLE (71335-1362-1) 2019-10-03 0000-00-00 No No Current 71335-1362-2 71335136202 100 TABLET, FILM COATED in 1 BOTTLE (71335-1362-2) 2024-05-20 0000-00-00 No No Current 71335-1362-3 71335136203 120 TABLET, FILM COATED in 1 BOTTLE (71335-1362-3) 2024-05-20 0000-00-00 No No Current 71335-1362-4 71335136204 90 TABLET, FILM COATED in 1 BOTTLE (71335-1362-4) 2024-05-20 0000-00-00 No No Current 71335-1362-5 71335136205 60 TABLET, FILM COATED in 1 BOTTLE (71335-1362-5) 2024-05-20 0000-00-00 No No Current