Home NDC 43353-785 quetiapine fumarate
Product NDC 43353-785
11-digit product format 433530785
Labeler code 43353
Product ID 43353-785_f8e096c7-a9df-4f0a-8b74-a8d85c8b257a
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 2012-03-27
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 · 147 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 1 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# DailyMed Package Descriptions# Package NDC, Product, Description table Package NDC Product Description Form Quantity Strength SPL version 43353-785-15 quetiapine fumarate 15 in 1 BOTTLE, PLASTIC TABLET, FILM COATED 15 2 43353-785-16 quetiapine fumarate 6000 in 1 BOTTLE, PLASTIC TABLET, FILM COATED 6000 2 43353-785-30 quetiapine fumarate 30 in 1 BOTTLE, PLASTIC TABLET, FILM COATED 30 2 43353-785-45 quetiapine fumarate 45 in 1 BOTTLE, PLASTIC TABLET, FILM COATED 45 2 43353-785-53 quetiapine fumarate 60 in 1 BOTTLE, PLASTIC TABLET, FILM COATED 60 2 43353-785-60 quetiapine fumarate 90 in 1 BOTTLE, PLASTIC TABLET, FILM COATED 90 2
DailyMed Socrata Ingredients# Ingredient, Type, UNII table Ingredient Type UNII DailyMed label SPL version Uploaded QUETIAPINE FUMARATE ACTIVE INGREDIENT 2S3PL1B6UJ QUETIAPINE FUMARATE TABLET, FILM COATED [APHENA PHARMA SOLUTIONS - TENNESSEE, LLC] 2 QUETIAPINE ACTIVE MOIETY BGL0JSY5SI QUETIAPINE FUMARATE TABLET, FILM COATED [APHENA PHARMA SOLUTIONS - TENNESSEE, LLC] 2 CROSCARMELLOSE SODIUM INACTIVE INGREDIENT M28OL1HH48 QUETIAPINE FUMARATE TABLET, FILM COATED [APHENA PHARMA SOLUTIONS - TENNESSEE, LLC] 2 ETHYLCELLULOSES INACTIVE INGREDIENT 7Z8S9VYZ4B QUETIAPINE FUMARATE TABLET, FILM COATED [APHENA PHARMA SOLUTIONS - TENNESSEE, LLC] 2 FERRIC OXIDE RED INACTIVE INGREDIENT 1K09F3G675 QUETIAPINE FUMARATE TABLET, FILM COATED [APHENA PHARMA SOLUTIONS - TENNESSEE, LLC] 2 FERRIC OXIDE YELLOW INACTIVE INGREDIENT EX438O2MRT QUETIAPINE FUMARATE TABLET, FILM COATED [APHENA PHARMA SOLUTIONS - TENNESSEE, LLC] 2 FUMARIC ACID INACTIVE INGREDIENT 88XHZ13131 QUETIAPINE FUMARATE TABLET, FILM COATED [APHENA PHARMA SOLUTIONS - TENNESSEE, LLC] 2 HYDROXYPROPYL CELLULOSE INACTIVE INGREDIENT RFW2ET671P QUETIAPINE FUMARATE TABLET, FILM COATED [APHENA PHARMA SOLUTIONS - TENNESSEE, LLC] 2 HYPROMELLOSES INACTIVE INGREDIENT 3NXW29V3WO QUETIAPINE FUMARATE TABLET, FILM COATED [APHENA PHARMA SOLUTIONS - TENNESSEE, LLC] 2 MAGNESIUM STEARATE INACTIVE INGREDIENT 70097M6I30 QUETIAPINE FUMARATE TABLET, FILM COATED [APHENA PHARMA SOLUTIONS - TENNESSEE, LLC] 2 POLYETHYLENE GLYCOLS INACTIVE INGREDIENT 3WJQ0SDW1A QUETIAPINE FUMARATE TABLET, FILM COATED [APHENA PHARMA SOLUTIONS - TENNESSEE, LLC] 2 SILICON DIOXIDE INACTIVE INGREDIENT ETJ7Z6XBU4 QUETIAPINE FUMARATE TABLET, FILM COATED [APHENA PHARMA SOLUTIONS - TENNESSEE, LLC] 2 TITANIUM DIOXIDE INACTIVE INGREDIENT 15FIX9V2JP QUETIAPINE FUMARATE TABLET, FILM COATED [APHENA PHARMA SOLUTIONS - TENNESSEE, LLC] 2
DailyMed Dashboard NDC Coverage# NDC, Dashboard title, SPL version table NDC Dashboard title SPL version Validation Dashboard ZIP 43353-785 QUETIAPINE FUMARATE TABLET, FILM COATED [APHENA PHARMA SOLUTIONS - TENNESSEE, LLC] 2 Legacy NDC, 6 package rows 20140429_94dfc588-1fd9-4435-93ec-c6dd4700aef5.zip
DailyMed RxNorm Mappings# Packages# Package NDC, 11-digit format, Description table Package NDC 11-digit format Description Status 43353-785-15 43353078515 15 in 1 BOTTLE, PLASTIC Historical 43353-785-16 43353078516 6000 in 1 BOTTLE, PLASTIC Historical 43353-785-30 43353078530 30 in 1 BOTTLE, PLASTIC Historical 43353-785-45 43353078545 45 in 1 BOTTLE, PLASTIC Historical 43353-785-53 43353078553 60 in 1 BOTTLE, PLASTIC Historical 43353-785-60 43353078560 90 in 1 BOTTLE, PLASTIC Historical