Home NDC 71205-026 Quetiapine
Product NDC 71205-026
11-digit product format 712050026
Labeler code 71205
Product ID 71205-026_7a3de2bf-32a1-465e-ae85-bd7e1ad1b205
Type HUMAN PRESCRIPTION DRUG
Nonproprietary name Quetiapine
Dosage form TABLET, FILM COATED
Route ORAL
Labeler Proficient Rx LP
Application ANDA077745
Marketing category ANDA
Marketing start 2012-03-27
Substance QUETIAPINE FUMARATE
Active strength 300 mg/1
Pharmacologic classes Atypical Antipsychotic [EPC]
NDC exclude flag No
Listing certified through 2026-12-31
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 A077745-001 QUETIAPINE FUMARATE QUETIAPINE FUMARATE EQ 25MG BASE TABLET / ORAL AB 2012-03-27 A077745-002 QUETIAPINE FUMARATE QUETIAPINE FUMARATE EQ 50MG BASE TABLET / ORAL AB 2012-03-27 A077745-003 QUETIAPINE FUMARATE QUETIAPINE FUMARATE EQ 100MG BASE TABLET / ORAL AB 2012-03-27 A077745-004 QUETIAPINE FUMARATE QUETIAPINE FUMARATE EQ 150MG BASE TABLET / ORAL AB 2012-03-27 A077745-005 QUETIAPINE FUMARATE QUETIAPINE FUMARATE EQ 200MG BASE TABLET / ORAL AB 2012-03-27 A077745-006 QUETIAPINE FUMARATE QUETIAPINE FUMARATE EQ 300MG BASE TABLET / ORAL AB 2012-03-27 A077745-007 QUETIAPINE FUMARATE QUETIAPINE FUMARATE EQ 400MG BASE TABLET / ORAL AB 2012-03-27
Therapeutic equivalence codes# Current TE-code rows page 1 of 1 · 7 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 A077745-001 QUETIAPINE FUMARATE EQ 25MG BASE TABLET / ORAL AB 2012-03-27 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 A077745-002 QUETIAPINE FUMARATE EQ 50MG BASE TABLET / ORAL AB 2012-03-27 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 A077745-003 QUETIAPINE FUMARATE EQ 100MG BASE TABLET / ORAL AB 2012-03-27 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 A077745-004 QUETIAPINE FUMARATE EQ 150MG BASE TABLET / ORAL AB 2012-03-27 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 A077745-005 QUETIAPINE FUMARATE EQ 200MG BASE TABLET / ORAL AB 2012-03-27 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 A077745-006 QUETIAPINE FUMARATE EQ 300MG BASE TABLET / ORAL AB 2012-03-27 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 A077745-007 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 A077745-001 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 A077745-002 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 A077745-003 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 A077745-004 QUETIAPINE FUMARATE EQ 150MG BASE TABLET / ORAL AB 2012-03-27 31067a03dcf5…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 A077745-005 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 A077745-006 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 A077745-007 QUETIAPINE FUMARATE EQ 400MG BASE TABLET / ORAL AB 2012-03-27 31067a03dcf5…2025-08-23 18:47 UTC 2025-08 A077745-001 QUETIAPINE FUMARATE EQ 25MG BASE TABLET / ORAL AB 2012-03-27 6a471c1ec25d…2025-08-23 18:47 UTC 2025-08 A077745-002 QUETIAPINE FUMARATE EQ 50MG BASE TABLET / ORAL AB 2012-03-27 6a471c1ec25d…2025-08-23 18:47 UTC 2025-08 A077745-003 QUETIAPINE FUMARATE EQ 100MG BASE TABLET / ORAL AB 2012-03-27 6a471c1ec25d…2025-08-23 18:47 UTC 2025-08 A077745-004 QUETIAPINE FUMARATE EQ 150MG BASE TABLET / ORAL AB 2012-03-27 6a471c1ec25d…2025-08-23 18:47 UTC 2025-08 A077745-005 QUETIAPINE FUMARATE EQ 200MG BASE TABLET / ORAL AB 2012-03-27 6a471c1ec25d…2025-08-23 18:47 UTC 2025-08 A077745-006 QUETIAPINE FUMARATE EQ 300MG BASE TABLET / ORAL AB 2012-03-27 6a471c1ec25d…2025-08-23 18:47 UTC 2025-08 A077745-007 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 A077745-001 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 A077745-002 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 A077745-003 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 A077745-004 QUETIAPINE FUMARATE EQ 150MG BASE TABLET / ORAL AB 2012-03-27 fd3edfee7708…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 A077745-005 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 A077745-006 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 A077745-007 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 A077745-001 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 A077745-002 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 A077745-003 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 A077745-004 QUETIAPINE FUMARATE EQ 150MG BASE TABLET / ORAL AB 2012-03-27 b8a1b40f171c…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 A077745-005 QUETIAPINE FUMARATE EQ 200MG BASE TABLET / ORAL AB 2012-03-27 b8a1b40f171c…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 A077745-006 QUETIAPINE FUMARATE EQ 300MG BASE TABLET / ORAL AB 2012-03-27 b8a1b40f171c…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 A077745-007 QUETIAPINE FUMARATE EQ 400MG BASE TABLET / ORAL AB 2012-03-27 b8a1b40f171c…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 A077745-001 QUETIAPINE FUMARATE EQ 25MG BASE TABLET / ORAL AB 2012-03-27 03ed91905a0d…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 A077745-002 QUETIAPINE FUMARATE EQ 50MG BASE TABLET / ORAL AB 2012-03-27 03ed91905a0d…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 A077745-003 QUETIAPINE FUMARATE EQ 100MG BASE TABLET / ORAL AB 2012-03-27 03ed91905a0d…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 A077745-004 QUETIAPINE FUMARATE EQ 150MG BASE TABLET / ORAL AB 2012-03-27 03ed91905a0d…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 A077745-005 QUETIAPINE FUMARATE EQ 200MG BASE TABLET / ORAL AB 2012-03-27 03ed91905a0d…
Observed Orange Book normalized TE history# Normalized TE history page 1 of 8 · 287 observed states.
Additional Listing Data#
Finished product Yes
Brand name base Quetiapine
Listing expiration 2026-12-31 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 · 1 matching rows.
Identifier, FDA.report destination table Identifier FDA.report destination 312745 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 71205-026-03 Quetiapine 03 in 1 BOTTLE TABLET, FILM COATED 03 5 71205-026-30 Quetiapine 30 in 1 BOTTLE TABLET, FILM COATED 30 5 71205-026-60 Quetiapine 60 in 1 BOTTLE TABLET, FILM COATED 60 5 71205-026-90 Quetiapine 90 in 1 BOTTLE TABLET, FILM COATED 90 5
DailyMed Dashboard NDC Coverage# NDC, Dashboard title, SPL version table NDC Dashboard title SPL version Validation Dashboard ZIP 71205-026 QUETIAPINE TABLET, FILM COATED [PROFICIENT RX LP] 5 Current NDC, Legacy NDC, 4 package rows 20220924_dd6b6088-943e-413b-9886-88dd9c622be4.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 · 4 matching rows.
Brand, Generic, Manufacturer table Brand Generic Manufacturer SPL set ID Effective date Available safety fields Join Quetiapine QUETIAPINE Teva Pharmaceuticals USA, Inc. c1d4ef59-bf58-44fe-9b46-1af42e2f7f8b 2025-08-04 Boxed warning, Warnings, Adverse reactions Exact identifier application applno (ANDA): 077745 application number: ANDA077745 Quetiapine QUETIAPINE Aphena Pharma Solutions - Tennessee, LLC fdece055-aeb5-43d6-b730-54dd74bde304 2023-04-19 Boxed warning, Warnings, Adverse reactions Exact identifier application applno (ANDA): 077745 application number: ANDA077745 Quetiapine QUETIAPINE Proficient Rx LP dd6b6088-943e-413b-9886-88dd9c622be4 2022-09-01 Boxed warning, Warnings, Adverse reactions Exact identifier application applno (ANDA): 077745 application number: ANDA077745 ndc (product): 71205-026 Quetiapine QUETIAPINE Proficient Rx LP 6258bbaf-4ac0-4621-b95e-e6b032aa0518 2020-02-01 Boxed warning, Warnings, Adverse reactions Exact identifier application applno (ANDA): 077745 application number: ANDA077745
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 71205-026-03 71205002603 3 TABLET, FILM COATED in 1 BOTTLE (71205-026-03) 2018-05-01 0000-00-00 No No Current 71205-026-30 71205002630 30 TABLET, FILM COATED in 1 BOTTLE (71205-026-30) 2018-05-01 0000-00-00 No No Current 71205-026-60 71205002660 60 TABLET, FILM COATED in 1 BOTTLE (71205-026-60) 2018-05-01 0000-00-00 No No Current 71205-026-90 71205002690 90 TABLET, FILM COATED in 1 BOTTLE (71205-026-90) 2018-05-01 0000-00-00 No No Current