Home NDC 43353-155 quetiapine fumarate
Product NDC 43353-155
11-digit product format 433530155
Labeler code 43353
Product ID 43353-155_8b6810b1-c1d9-499e-82b9-95e6e30dd8e8
Type HUMAN PRESCRIPTION DRUG
Nonproprietary name quetiapine fumarate
Dosage form TABLET, FILM COATED
Route ORAL
Labeler Aphena Pharma Solutions - Tennessee, LLC
Application ANDA090960
Marketing category ANDA
Marketing start 2015-07-21
Marketing end 0000-00-00
Substance QUETIAPINE FUMARATE
Active strength 100 mg/1
Pharmacologic classes Atypical Antipsychotic [EPC]
NDC exclude flag No
Listing certified through 2019-12-31
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 3 · 126 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 A090960-001 QUETIAPINE FUMARATE QUETIAPINE FUMARATE EQ 25MG BASE TABLET / ORAL AB 2012-03-27 A090960-002 QUETIAPINE FUMARATE QUETIAPINE FUMARATE EQ 50MG BASE TABLET / ORAL AB 2012-03-27 A090960-003 QUETIAPINE FUMARATE QUETIAPINE FUMARATE EQ 100MG BASE TABLET / ORAL AB 2012-03-27 A090960-004 QUETIAPINE FUMARATE QUETIAPINE FUMARATE EQ 200MG BASE TABLET / ORAL AB 2012-03-27 A090960-005 QUETIAPINE FUMARATE QUETIAPINE FUMARATE EQ 300MG BASE TABLET / ORAL AB 2012-03-27 A090960-006 QUETIAPINE FUMARATE QUETIAPINE FUMARATE EQ 400MG BASE TABLET / ORAL AB 2012-03-27
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 A090960-001 QUETIAPINE FUMARATE EQ 25MG BASE TABLET / ORAL AB 2012-03-27 84e616aacf4f…2026-09-14 22:38:34 2026-08 A090960-002 QUETIAPINE FUMARATE EQ 50MG BASE TABLET / ORAL AB 2012-03-27 84e616aacf4f…2026-09-14 22:38:34 2026-08 A090960-003 QUETIAPINE FUMARATE EQ 100MG BASE TABLET / ORAL AB 2012-03-27 84e616aacf4f…2026-09-14 22:38:34 2026-08 A090960-004 QUETIAPINE FUMARATE EQ 200MG BASE TABLET / ORAL AB 2012-03-27 84e616aacf4f…2026-09-14 22:38:34 2026-08 A090960-005 QUETIAPINE FUMARATE EQ 300MG BASE TABLET / ORAL AB 2012-03-27 84e616aacf4f…2026-09-14 22:38:34 2026-08 A090960-006 QUETIAPINE FUMARATE EQ 400MG BASE TABLET / ORAL AB 2012-03-27 84e616aacf4f…2026-08-18 06:07:40 2026-07 A090960-001 QUETIAPINE FUMARATE EQ 25MG BASE TABLET / ORAL AB 2012-03-27 caaa826d4ba7…2026-08-18 06:07:40 2026-07 A090960-002 QUETIAPINE FUMARATE EQ 50MG BASE TABLET / ORAL AB 2012-03-27 caaa826d4ba7…2026-08-18 06:07:40 2026-07 A090960-003 QUETIAPINE FUMARATE EQ 100MG BASE TABLET / ORAL AB 2012-03-27 caaa826d4ba7…2026-08-18 06:07:40 2026-07 A090960-004 QUETIAPINE FUMARATE EQ 200MG BASE TABLET / ORAL AB 2012-03-27 caaa826d4ba7…2026-08-18 06:07:40 2026-07 A090960-005 QUETIAPINE FUMARATE EQ 300MG BASE TABLET / ORAL AB 2012-03-27 caaa826d4ba7…2026-08-18 06:07:40 2026-07 A090960-006 QUETIAPINE FUMARATE EQ 400MG BASE TABLET / ORAL AB 2012-03-27 caaa826d4ba7…2026-02-19 14:30 UTC 2026-02 A090960-001 QUETIAPINE FUMARATE EQ 25MG BASE TABLET / ORAL AB 2012-03-27 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 A090960-002 QUETIAPINE FUMARATE EQ 50MG BASE TABLET / ORAL AB 2012-03-27 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 A090960-003 QUETIAPINE FUMARATE EQ 100MG BASE TABLET / ORAL AB 2012-03-27 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 A090960-004 QUETIAPINE FUMARATE EQ 200MG BASE TABLET / ORAL AB 2012-03-27 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 A090960-005 QUETIAPINE FUMARATE EQ 300MG BASE TABLET / ORAL AB 2012-03-27 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 A090960-006 QUETIAPINE FUMARATE EQ 400MG BASE TABLET / ORAL AB 2012-03-27 011fe1cb6892…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 A090960-001 QUETIAPINE FUMARATE EQ 25MG BASE TABLET / ORAL AB 2012-03-27 31067a03dcf5…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 A090960-002 QUETIAPINE FUMARATE EQ 50MG BASE TABLET / ORAL AB 2012-03-27 31067a03dcf5…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 A090960-003 QUETIAPINE FUMARATE EQ 100MG BASE TABLET / ORAL AB 2012-03-27 31067a03dcf5…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 A090960-004 QUETIAPINE FUMARATE EQ 200MG BASE TABLET / ORAL AB 2012-03-27 31067a03dcf5…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 A090960-005 QUETIAPINE FUMARATE EQ 300MG BASE TABLET / ORAL AB 2012-03-27 31067a03dcf5…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 A090960-006 QUETIAPINE FUMARATE EQ 400MG BASE TABLET / ORAL AB 2012-03-27 31067a03dcf5…2025-08-23 18:47 UTC 2025-08 A090960-001 QUETIAPINE FUMARATE EQ 25MG BASE TABLET / ORAL AB 2012-03-27 6a471c1ec25d…2025-08-23 18:47 UTC 2025-08 A090960-002 QUETIAPINE FUMARATE EQ 50MG BASE TABLET / ORAL AB 2012-03-27 6a471c1ec25d…2025-08-23 18:47 UTC 2025-08 A090960-003 QUETIAPINE FUMARATE EQ 100MG BASE TABLET / ORAL AB 2012-03-27 6a471c1ec25d…2025-08-23 18:47 UTC 2025-08 A090960-004 QUETIAPINE FUMARATE EQ 200MG BASE TABLET / ORAL AB 2012-03-27 6a471c1ec25d…2025-08-23 18:47 UTC 2025-08 A090960-005 QUETIAPINE FUMARATE EQ 300MG BASE TABLET / ORAL AB 2012-03-27 6a471c1ec25d…2025-08-23 18:47 UTC 2025-08 A090960-006 QUETIAPINE FUMARATE EQ 400MG BASE TABLET / ORAL AB 2012-03-27 6a471c1ec25d…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 A090960-001 QUETIAPINE FUMARATE EQ 25MG BASE TABLET / ORAL AB 2012-03-27 fd3edfee7708…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 A090960-002 QUETIAPINE FUMARATE EQ 50MG BASE TABLET / ORAL AB 2012-03-27 fd3edfee7708…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 A090960-003 QUETIAPINE FUMARATE EQ 100MG BASE TABLET / ORAL AB 2012-03-27 fd3edfee7708…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 A090960-004 QUETIAPINE FUMARATE EQ 200MG BASE TABLET / ORAL AB 2012-03-27 fd3edfee7708…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 A090960-005 QUETIAPINE FUMARATE EQ 300MG BASE TABLET / ORAL AB 2012-03-27 fd3edfee7708…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 A090960-006 QUETIAPINE FUMARATE EQ 400MG BASE TABLET / ORAL AB 2012-03-27 fd3edfee7708…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 A090960-001 QUETIAPINE FUMARATE EQ 25MG BASE TABLET / ORAL AB 2012-03-27 b8a1b40f171c…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 A090960-002 QUETIAPINE FUMARATE EQ 50MG BASE TABLET / ORAL AB 2012-03-27 b8a1b40f171c…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 A090960-003 QUETIAPINE FUMARATE EQ 100MG BASE TABLET / ORAL AB 2012-03-27 b8a1b40f171c…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 A090960-004 QUETIAPINE FUMARATE EQ 200MG BASE TABLET / ORAL AB 2012-03-27 b8a1b40f171c…
Observed Orange Book normalized TE history# Normalized TE history page 7 of 7 · 258 observed states.
Reported adverse events (FAERS/openFDA)# Adverse event summaries are temporarily unavailable. Other product information remains available.
DailyMed Product Concepts# FDA-Initiated Inactive NDC Indexing# NDC, Related label table NDC Related label 43353-155-15 These highlights do not include all the information needed to use QUETIAPINE TABLETS, USP safely and effectively. See full prescribing information for QUETIAPINE TABLETS, USP. QUETIAPINE tablets, for oral use Initial U.S. Approval: 1997 43353-155-30 These highlights do not include all the information needed to use QUETIAPINE TABLETS, USP safely and effectively. See full prescribing information for QUETIAPINE TABLETS, USP. QUETIAPINE tablets, for oral use Initial U.S. Approval: 1997 43353-155-45 These highlights do not include all the information needed to use QUETIAPINE TABLETS, USP safely and effectively. See full prescribing information for QUETIAPINE TABLETS, USP. QUETIAPINE tablets, for oral use Initial U.S. Approval: 1997 43353-155-53 These highlights do not include all the information needed to use QUETIAPINE TABLETS, USP safely and effectively. See full prescribing information for QUETIAPINE TABLETS, USP. QUETIAPINE tablets, for oral use Initial U.S. Approval: 1997 43353-155-60 These highlights do not include all the information needed to use QUETIAPINE TABLETS, USP safely and effectively. See full prescribing information for QUETIAPINE TABLETS, USP. 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 43353-155-15 quetiapine fumarate 15 in 1 BOTTLE TABLET, FILM COATED 15 1 43353-155-30 quetiapine fumarate 30 in 1 BOTTLE TABLET, FILM COATED 30 1 43353-155-45 quetiapine fumarate 45 in 1 BOTTLE TABLET, FILM COATED 45 1 43353-155-53 quetiapine fumarate 60 in 1 BOTTLE TABLET, FILM COATED 60 1 43353-155-60 quetiapine fumarate 90 in 1 BOTTLE TABLET, FILM COATED 90 1
DailyMed Dashboard NDC Coverage# NDC, Dashboard title, SPL version table NDC Dashboard title SPL version Validation Dashboard ZIP 43353-155 QUETIAPINE FUMARATE TABLET, FILM COATED [APHENA PHARMA SOLUTIONS - TENNESSEE, LLC] 1 Legacy NDC, 5 package rows 20160713_448cbd68-ab4f-447c-8e47-0f874fb5bcb4.zip
DailyMed RxNorm Mappings# Packages# Package NDC, 11-digit format, Description table Package NDC 11-digit format Description Status 43353-155-15 43353015515 15 in 1 BOTTLE Historical 43353-155-30 43353015530 30 in 1 BOTTLE Historical 43353-155-45 43353015545 45 in 1 BOTTLE Historical 43353-155-53 43353015553 60 in 1 BOTTLE Historical 43353-155-60 43353015560 90 in 1 BOTTLE Historical