Home NDC 64725-8166 Quetiapine Fumarate
Product NDC 64725-8166
11-digit product format 647258166
Labeler code 64725
Product ID 64725-8166_bf422cc2-9c69-4cf2-9a5b-22adee95ccf6
Type HUMAN PRESCRIPTION DRUG
Nonproprietary name Quetiapine Fumarate
Dosage form TABLET, FILM COATED
Route ORAL
Labeler TYA Pharmaceuticals
Application ANDA077745
Marketing category ANDA
Marketing start 2012-03-27
Marketing end 0000-00-00
Substance QUETIAPINE FUMARATE
Active strength 50 mg/1
Pharmacologic classes Atypical Antipsychotic [EPC]
NDC exclude flag E
Listing certified through 2017-12-31
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 1 · 44 matching rows.
View current auxiliary records. · View the auxiliary file history.
Captured / source date, Dataset, Scope table Captured / source date Dataset Scope Package NDC Snapshot Source SHA-256 2025-12-14 17:58 UTC · source 2025-12-05 excluded product product d630ba8d3edf…732f749b63fb…2025-12-14 17:58 UTC · source 2025-12-05 excluded package package 64725-8166-1 d630ba8d3edf…732f749b63fb…2025-08-27 00:01 UTC · source 2025-08-26 excluded product product f5e01cc5f278…a2eaf40c39c3…2025-08-27 00:01 UTC · source 2025-08-26 excluded package package 64725-8166-1 f5e01cc5f278…a2eaf40c39c3…2025-04-01 02:39 UTC · source 2025-03-31 excluded product product 2ef7874e63bc…57b86245f4fa…2025-04-01 02:39 UTC · source 2025-03-31 excluded package package 64725-8166-1 2ef7874e63bc…57b86245f4fa…2025-03-28 20:22 UTC · source 2025-03-28 excluded product product a1b67e2a42f9…c4cf2c586c0d…2025-03-28 20:22 UTC · source 2025-03-28 excluded package package 64725-8166-1 a1b67e2a42f9…c4cf2c586c0d…2025-03-22 03:12 UTC · source 2025-03-21 excluded product product cfe11265f3b6…090c488252e2…2025-03-22 03:12 UTC · source 2025-03-21 excluded package package 64725-8166-1 cfe11265f3b6…090c488252e2…2025-03-10 12:48 UTC · source 2025-03-10 excluded product product cdf11ea48f46…ba0047e9e063…2025-03-10 12:48 UTC · source 2025-03-10 excluded package package 64725-8166-1 cdf11ea48f46…ba0047e9e063…2025-02-02 03:52 UTC · source 2025-01-31 excluded product product 302b2466d912…e7b80fea0513…2025-02-02 03:52 UTC · source 2025-01-31 excluded package package 64725-8166-1 302b2466d912…e7b80fea0513…2025-01-20 13:05 UTC · source 2025-01-20 excluded product product ed331223b511…672a5bd82f5f…2025-01-20 13:05 UTC · source 2025-01-20 excluded package package 64725-8166-1 ed331223b511…672a5bd82f5f…2025-01-11 03:41 UTC · source 2025-01-10 excluded product product 0efc9e666f02…f202fb6c5f17…2025-01-11 03:41 UTC · source 2025-01-10 excluded package package 64725-8166-1 0efc9e666f02…f202fb6c5f17…2024-11-09 02:27 UTC · source 2024-11-08 excluded product product ad56d346431e…cc804d4bbf1e…2024-11-09 02:27 UTC · source 2024-11-08 excluded package package 64725-8166-1 ad56d346431e…cc804d4bbf1e…2024-10-04 04:10 UTC · source 2024-10-03 excluded product product 367a005e9d99…383a685ebd0f…2024-10-04 04:10 UTC · source 2024-10-03 excluded package package 64725-8166-1 367a005e9d99…383a685ebd0f…2024-07-10 04:00 UTC · source 2024-07-09 excluded product product 557ba5c1ecfa…9c80585c8c6e…2024-07-10 04:00 UTC · source 2024-07-09 excluded package package 64725-8166-1 557ba5c1ecfa…9c80585c8c6e…2024-05-28 21:12 UTC · source 2024-05-28 excluded product product 8af77b9d5b6f…d9bbb34c5368…2024-05-28 21:12 UTC · source 2024-05-28 excluded package package 64725-8166-1 8af77b9d5b6f…d9bbb34c5368…2024-05-15 03:39 UTC · source 2024-05-14 excluded product product 834df4deac94…adcc014656a3…2024-05-15 03:39 UTC · source 2024-05-14 excluded package package 64725-8166-1 834df4deac94…adcc014656a3…2024-03-11 06:39 UTC · source 2024-03-08 excluded product product 1332a3947898…d4bfe170f9cd…2024-03-11 06:39 UTC · source 2024-03-08 excluded package package 64725-8166-1 1332a3947898…d4bfe170f9cd…2022-08-30 03:57 UTC · source 2022-08-29 excluded product product fb8cb913e6d1…eb8c232b6be0…2022-08-30 03:57 UTC · source 2022-08-29 excluded package package 64725-8166-1 fb8cb913e6d1…eb8c232b6be0…2022-04-09 23:13 UTC · source 2022-04-08 excluded product product 86f5da6cb304…a595104c45d7…2022-04-09 23:13 UTC · source 2022-04-08 excluded package package 64725-8166-1 86f5da6cb304…a595104c45d7…2022-04-04 05:40 UTC · source 2022-04-01 excluded product product bd6a592717d7…303034d00443…2022-04-04 05:40 UTC · source 2022-04-01 excluded package package 64725-8166-1 bd6a592717d7…303034d00443…2021-12-27 23:28 UTC · source 2021-12-27 excluded product product 8dfbde2a14a4…c9ff85d89658…2021-12-27 23:28 UTC · source 2021-12-27 excluded package package 64725-8166-1 8dfbde2a14a4…c9ff85d89658…2020-12-18 03:04 UTC · source 2020-12-17 excluded product product e2bbac7714bc…27bdfed8d636…2020-12-18 03:04 UTC · source 2020-12-17 excluded package package 64725-8166-1 e2bbac7714bc…27bdfed8d636…2020-06-10 20:45 UTC · source 2020-06-10 excluded product product 9bebd1f3094a…5416666fcb17…2020-06-10 20:45 UTC · source 2020-06-10 excluded package package 64725-8166-1 9bebd1f3094a…5416666fcb17…2019-12-08 06:16 UTC · source 2019-12-05 excluded product product 110d247fa046…a55b01930146…2019-12-08 06:16 UTC · source 2019-12-05 excluded package package 64725-8166-1 110d247fa046…a55b01930146…
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.
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 64725-8166-1 Quetiapine Fumarate 100 in 1 BOTTLE TABLET, FILM COATED 100 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 [TYA PHARMACEUTICALS] 2 QUETIAPINE ACTIVE MOIETY BGL0JSY5SI QUETIAPINE FUMARATE TABLET, FILM COATED [TYA PHARMACEUTICALS] 2 CALCIUM PHOSPHATE, DIBASIC, DIHYDRATE INACTIVE INGREDIENT O7TSZ97GEP QUETIAPINE FUMARATE TABLET, FILM COATED [TYA PHARMACEUTICALS] 2 CELLULOSE, MICROCRYSTALLINE INACTIVE INGREDIENT OP1R32D61U QUETIAPINE FUMARATE TABLET, FILM COATED [TYA PHARMACEUTICALS] 2 HYPROMELLOSE 2910 (3 MPA.S) INACTIVE INGREDIENT 0VUT3PMY82 QUETIAPINE FUMARATE TABLET, FILM COATED [TYA PHARMACEUTICALS] 2 HYPROMELLOSE 2910 (50 MPA.S) INACTIVE INGREDIENT 1IVH67816N QUETIAPINE FUMARATE TABLET, FILM COATED [TYA PHARMACEUTICALS] 2 HYPROMELLOSE 2910 (6 MPA.S) INACTIVE INGREDIENT 0WZ8WG20P6 QUETIAPINE FUMARATE TABLET, FILM COATED [TYA PHARMACEUTICALS] 2 LACTOSE MONOHYDRATE INACTIVE INGREDIENT EWQ57Q8I5X QUETIAPINE FUMARATE TABLET, FILM COATED [TYA PHARMACEUTICALS] 2 MAGNESIUM STEARATE INACTIVE INGREDIENT 70097M6I30 QUETIAPINE FUMARATE TABLET, FILM COATED [TYA PHARMACEUTICALS] 2 POLYDEXTROSE INACTIVE INGREDIENT VH2XOU12IE QUETIAPINE FUMARATE TABLET, FILM COATED [TYA PHARMACEUTICALS] 2 POLYETHYLENE GLYCOL 8000 INACTIVE INGREDIENT Q662QK8M3B QUETIAPINE FUMARATE TABLET, FILM COATED [TYA PHARMACEUTICALS] 2 POVIDONE K25 INACTIVE INGREDIENT K0KQV10C35 QUETIAPINE FUMARATE TABLET, FILM COATED [TYA PHARMACEUTICALS] 2 SILICON DIOXIDE INACTIVE INGREDIENT ETJ7Z6XBU4 QUETIAPINE FUMARATE TABLET, FILM COATED [TYA PHARMACEUTICALS] 2 SODIUM STARCH GLYCOLATE TYPE A POTATO INACTIVE INGREDIENT 5856J3G2A2 QUETIAPINE FUMARATE TABLET, FILM COATED [TYA PHARMACEUTICALS] 2 TITANIUM DIOXIDE INACTIVE INGREDIENT 15FIX9V2JP QUETIAPINE FUMARATE TABLET, FILM COATED [TYA PHARMACEUTICALS] 2 TRIACETIN INACTIVE INGREDIENT XHX3C3X673 QUETIAPINE FUMARATE TABLET, FILM COATED [TYA PHARMACEUTICALS] 2
DailyMed Dashboard NDC Coverage# NDC, Dashboard title, SPL version table NDC Dashboard title SPL version Validation Dashboard ZIP 64725-8166 QUETIAPINE FUMARATE TABLET, FILM COATED [TYA PHARMACEUTICALS] 2 Legacy NDC, 1 package rows 20140927_daec35ae-a9e7-494a-90a6-c8aff1c65c71.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 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 Status 64725-8166-1 64725816601 100 in 1 BOTTLE Historical