Home NDC 71610-140 Quetiapine Fumarate
Product NDC 71610-140
11-digit product format 716100140
Labeler code 71610
Product ID 71610-140_2ddf4cb0-6d16-49fa-9267-274ed1643e90
Type HUMAN PRESCRIPTION DRUG
Nonproprietary name Quetiapine Fumarate
Dosage form TABLET
Route ORAL
Labeler Aphena Pharma Solutions - Tennessee, LLC
Application ANDA090120
Marketing category ANDA
Marketing start 2012-03-27
Substance QUETIAPINE FUMARATE
Active strength 25 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 · 1 matching rows.
Application-product, Trade name, Ingredient table Application-product Trade name Ingredient Strength Dosage form / route TE codes RLD / RS Approval date A090120-001 QUETIAPINE FUMARATE QUETIAPINE FUMARATE EQ 25MG BASE TABLET / ORAL AB 2012-03-27
Therapeutic equivalence codes# Current TE-code rows page 1 of 1 · 1 matching rows.
Application-product, TE code table Application-product TE code A090120-001 AB
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 2 · 41 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 A090120-001 QUETIAPINE FUMARATE EQ 25MG BASE TABLET / ORAL AB 2012-03-27 011fe1cb6892…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 A090120-001 QUETIAPINE FUMARATE EQ 25MG BASE TABLET / ORAL AB 2012-03-27 31067a03dcf5…2025-08-23 18:47 UTC 2025-08 A090120-001 QUETIAPINE FUMARATE EQ 25MG BASE TABLET / ORAL AB 2012-03-27 6a471c1ec25d…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 A090120-001 QUETIAPINE FUMARATE EQ 25MG BASE TABLET / ORAL AB 2012-03-27 fd3edfee7708…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 A090120-001 QUETIAPINE FUMARATE EQ 25MG BASE TABLET / ORAL AB 2012-03-27 b8a1b40f171c…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 A090120-001 QUETIAPINE FUMARATE EQ 25MG BASE TABLET / ORAL AB 2012-03-27 03ed91905a0d…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 A090120-001 QUETIAPINE FUMARATE EQ 25MG BASE TABLET / ORAL AB 2012-03-27 2680178bc6a6…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 A090120-001 QUETIAPINE FUMARATE EQ 25MG BASE TABLET / ORAL AB 2012-03-27 5bbf6a4d5a75…2024-11-08 22:44 UTC · 3 captures of this ZIP 2024-11 A090120-001 QUETIAPINE FUMARATE EQ 25MG BASE TABLET / ORAL AB 2012-03-27 d8e5a09893c0…2024-10-29 15:01 UTC 2024-10 A090120-001 QUETIAPINE FUMARATE EQ 25MG BASE TABLET / ORAL AB 2012-03-27 d06236e962d9…2024-08-13 05:28 UTC · 3 captures of this ZIP 2024-08 A090120-001 QUETIAPINE FUMARATE EQ 25MG BASE TABLET / ORAL AB 2012-03-27 79d66fd596c7…2024-07-13 05:37 UTC · 2 captures of this ZIP 2024-07 A090120-001 QUETIAPINE FUMARATE EQ 25MG BASE TABLET / ORAL AB 2012-03-27 301d65b070ca…2024-06-18 03:08 UTC · 5 captures of this ZIP 2024-06 A090120-001 QUETIAPINE FUMARATE EQ 25MG BASE TABLET / ORAL AB 2012-03-27 1e350fbaab3a…2024-05-31 18:47 UTC 2024-05 A090120-001 QUETIAPINE FUMARATE EQ 25MG BASE TABLET / ORAL AB 2012-03-27 8072bd15b7f6…2022-06-29 02:47 UTC · 2 captures of this ZIP 2022-06 A090120-001 QUETIAPINE FUMARATE EQ 25MG BASE TABLET / ORAL AB 2012-03-27 5c6f7cd8ea54…2022-04-08 23:34 UTC 2022-04 A090120-001 QUETIAPINE FUMARATE EQ 25MG BASE TABLET / ORAL AB 2012-03-27 5d02ea3f76ae…2022-04-04 05:41 UTC 2022-04 A090120-001 QUETIAPINE FUMARATE EQ 25MG BASE TABLET / ORAL AB 2012-03-27 4b0b4de00fa7…2019-12-13 00:20 UTC 2019-12 A090120-001 QUETIAPINE FUMARATE EQ 25MG BASE TABLET / ORAL AB 2012-03-27 74a2ff9319b5…2022-03-09 01:35 UTC 2022-03 A090120-001 QUETIAPINE FUMARATE EQ 25MG BASE TABLET / ORAL AB 2012-03-27 bb7c543d1eb4…2021-12-28 21:50 UTC 2021-12 A090120-001 QUETIAPINE FUMARATE EQ 25MG BASE TABLET / ORAL AB 2012-03-27 782e0a99824c…2021-05-05 16:15 UTC · 3 captures of this ZIP 2021-05 A090120-001 QUETIAPINE FUMARATE EQ 25MG BASE TABLET / ORAL AB 2012-03-27 87673890dc5c…2021-03-12 10:30 UTC 2021-03 A090120-001 QUETIAPINE FUMARATE EQ 25MG BASE TABLET / ORAL AB 2012-03-27 5aa47cf7b7d7…2020-12-22 03:56 UTC 2020-12 A090120-001 QUETIAPINE FUMARATE EQ 25MG BASE TABLET / ORAL AB 2012-03-27 8869cabd3fbd…2020-11-12 02:37 UTC 2020-11 A090120-001 QUETIAPINE FUMARATE EQ 25MG BASE TABLET / ORAL AB 2012-03-27 c0c555d07b60…2019-12-14 00:12 UTC 2019-12 A090120-001 QUETIAPINE FUMARATE EQ 25MG BASE TABLET / ORAL AB 2012-03-27 3f01610625f2…2019-09-15 20:21 UTC 2019-09 A090120-001 QUETIAPINE FUMARATE EQ 25MG BASE TABLET / ORAL AB 2012-03-27 b00525d2431f…2019-07-19 19:46 UTC 2019-07 A090120-001 QUETIAPINE FUMARATE EQ 25MG BASE TABLET / ORAL AB 2012-03-27 ea99ee380514…2024-03-16 18:09 UTC · 4 captures of this ZIP 2024-03 A090120-001 QUETIAPINE FUMARATE EQ 25MG BASE TABLET / ORAL AB 2012-03-27 6a51e52b5d6a…2024-02-18 07:12 UTC 2024-02 A090120-001 QUETIAPINE FUMARATE EQ 25MG BASE TABLET / ORAL AB 2012-03-27 1c564ffb4f44…2023-12-20 04:57 UTC 2023-12 A090120-001 QUETIAPINE FUMARATE EQ 25MG BASE TABLET / ORAL AB 2012-03-27 ea1830bbd6c7…2023-11-28 05:40 UTC · 2 captures of this ZIP 2023-11 A090120-001 QUETIAPINE FUMARATE EQ 25MG BASE TABLET / ORAL AB 2012-03-27 a72a2bbeb626…2023-10-25 00:34 UTC · 2 captures of this ZIP 2023-10 A090120-001 QUETIAPINE FUMARATE EQ 25MG BASE TABLET / ORAL AB 2012-03-27 9b2671bbb829…2023-07-15 15:27 UTC · 2 captures of this ZIP 2023-07 A090120-001 QUETIAPINE FUMARATE EQ 25MG BASE TABLET / ORAL AB 2012-03-27 a67488948f0b…2023-06-13 01:57 UTC · 3 captures of this ZIP 2023-06 A090120-001 QUETIAPINE FUMARATE EQ 25MG BASE TABLET / ORAL AB 2012-03-27 3f0d92c62455…2023-05-13 08:27 UTC 2023-05 A090120-001 QUETIAPINE FUMARATE EQ 25MG BASE TABLET / ORAL AB 2012-03-27 053a50430f4f…2023-01-26 05:58 UTC 2023-01 A090120-001 QUETIAPINE FUMARATE EQ 25MG BASE TABLET / ORAL AB 2012-03-27 3bdfa0b2c4d7…2022-11-12 20:34 UTC · 5 captures of this ZIP 2022-11 A090120-001 QUETIAPINE FUMARATE EQ 25MG BASE TABLET / ORAL AB 2012-03-27 3a93d1ddd44b…2022-10-28 04:53 UTC 2022-10 A090120-001 QUETIAPINE FUMARATE EQ 25MG BASE TABLET / ORAL AB 2012-03-27 f41ea6bd6efb…2022-09-29 23:25 UTC 2022-09 A090120-001 QUETIAPINE FUMARATE EQ 25MG BASE TABLET / ORAL AB 2012-03-27 e64feba35796…2022-07-09 03:26 UTC · 3 captures of this ZIP 2022-07 A090120-001 QUETIAPINE FUMARATE EQ 25MG BASE TABLET / ORAL AB 2012-03-27 cb3db0bc1861…
Observed Orange Book normalized TE history# Normalized TE history page 1 of 2 · 41 observed states.
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 25 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 · 5 matching rows.
Identifier, FDA.report destination table Identifier FDA.report destination 312743 Internal RxNorm lookup 312744 Internal RxNorm lookup 312745 Internal RxNorm lookup 317174 Internal RxNorm lookup 616483 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 71610-140-30 Quetiapine Fumarate 30 in 1 BOTTLE TABLET 30 2 71610-140-53 Quetiapine Fumarate 60 in 1 BOTTLE TABLET 60 2 71610-140-60 Quetiapine Fumarate 90 in 1 BOTTLE TABLET 90 2
DailyMed Dashboard NDC Coverage# NDC, Dashboard title, SPL version table NDC Dashboard title SPL version Validation Dashboard ZIP 71610-140 QUETIAPINE FUMARATE TABLET [APHENA PHARMA SOLUTIONS - TENNESSEE, LLC] 2 Current NDC, Legacy NDC, 3 package rows 20211016_60316ccd-c042-4ea0-9d05-3caf7cc2cab1.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 · 3 matching rows.
Brand, Generic, Manufacturer table Brand Generic Manufacturer SPL set ID Effective date Available safety fields Join Quetiapine Fumarate QUETIAPINE FUMARATE Golden State Medical Supply, Inc. 6fc9c8e2-6f34-aa43-e053-2a91aa0ac377 2025-04-03 Boxed warning, Warnings, Adverse reactions Exact identifier application applno (ANDA): 090120 application number: ANDA090120 Quetiapine Fumarate QUETIAPINE FUMARATE Hikma Pharmaceuticals USA Inc. 271e9fb7-3c70-43fc-8279-5adf189f3c22 2025-02-10 Boxed warning, Warnings, Adverse reactions Exact identifier application applno (ANDA): 090120 application number: ANDA090120 Quetiapine Fumarate QUETIAPINE FUMARATE Aphena Pharma Solutions - Tennessee, LLC 60316ccd-c042-4ea0-9d05-3caf7cc2cab1 2021-10-15 Boxed warning, Warnings, Adverse reactions Exact identifier application applno (ANDA): 090120 application number: ANDA090120 ndc (product): 71610-140
DailyMed RxNorm Mappings# Packages# Package NDC, 11-digit format, Description table Package NDC 11-digit format Description Units Marketing start Marketing end Sample Exclude flag Status 71610-140-30 71610014030 30 TABLET in 1 BOTTLE (71610-140-30) 30 tablet 2018-08-30 0000-00-00 No No Current 71610-140-53 71610014053 60 TABLET in 1 BOTTLE (71610-140-53) 60 tablet 2018-08-30 0000-00-00 No No Current 71610-140-60 71610014060 90 TABLET in 1 BOTTLE (71610-140-60) 90 tablet 2018-08-30 0000-00-00 No No Current