Home NDC 43547-519 QUETIAPINE
Product NDC 43547-519
11-digit product format 435470519
Labeler code 43547
Product ID 43547-519_c91f8a6b-86e3-40a5-befe-4617aa36c718
Type HUMAN PRESCRIPTION DRUG
Nonproprietary name quetiapine
Dosage form TABLET
Route ORAL
Labeler Solco Healthcare US, LLC
Application ANDA206954
Marketing category ANDA
Marketing start 2022-04-12
Substance QUETIAPINE FUMARATE
Active strength 50 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 · 6 matching rows.
Application-product, Trade name, Ingredient table Application-product Trade name Ingredient Strength Dosage form / route TE codes RLD / RS Approval date A206954-001 QUETIAPINE FUMARATE QUETIAPINE FUMARATE EQ 25MG BASE TABLET / ORAL AB 2022-08-24 A206954-002 QUETIAPINE FUMARATE QUETIAPINE FUMARATE EQ 50MG BASE TABLET / ORAL AB 2022-08-24 A206954-003 QUETIAPINE FUMARATE QUETIAPINE FUMARATE EQ 100MG BASE TABLET / ORAL AB 2022-08-24 A206954-004 QUETIAPINE FUMARATE QUETIAPINE FUMARATE EQ 200MG BASE TABLET / ORAL AB 2022-08-24 A206954-005 QUETIAPINE FUMARATE QUETIAPINE FUMARATE EQ 300MG BASE TABLET / ORAL AB 2022-08-24 A206954-006 QUETIAPINE FUMARATE QUETIAPINE FUMARATE EQ 400MG BASE TABLET / ORAL AB 2022-08-24
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 5 · 162 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 A206954-001 QUETIAPINE FUMARATE EQ 25MG BASE TABLET / ORAL AB 2022-08-24 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 A206954-002 QUETIAPINE FUMARATE EQ 50MG BASE TABLET / ORAL AB 2022-08-24 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 A206954-003 QUETIAPINE FUMARATE EQ 100MG BASE TABLET / ORAL AB 2022-08-24 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 A206954-004 QUETIAPINE FUMARATE EQ 200MG BASE TABLET / ORAL AB 2022-08-24 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 A206954-005 QUETIAPINE FUMARATE EQ 300MG BASE TABLET / ORAL AB 2022-08-24 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 A206954-006 QUETIAPINE FUMARATE EQ 400MG BASE TABLET / ORAL AB 2022-08-24 011fe1cb6892…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 A206954-001 QUETIAPINE FUMARATE EQ 25MG BASE TABLET / ORAL AB 2022-08-24 31067a03dcf5…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 A206954-002 QUETIAPINE FUMARATE EQ 50MG BASE TABLET / ORAL AB 2022-08-24 31067a03dcf5…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 A206954-003 QUETIAPINE FUMARATE EQ 100MG BASE TABLET / ORAL AB 2022-08-24 31067a03dcf5…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 A206954-004 QUETIAPINE FUMARATE EQ 200MG BASE TABLET / ORAL AB 2022-08-24 31067a03dcf5…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 A206954-005 QUETIAPINE FUMARATE EQ 300MG BASE TABLET / ORAL AB 2022-08-24 31067a03dcf5…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 A206954-006 QUETIAPINE FUMARATE EQ 400MG BASE TABLET / ORAL AB 2022-08-24 31067a03dcf5…2025-08-23 18:47 UTC 2025-08 A206954-001 QUETIAPINE FUMARATE EQ 25MG BASE TABLET / ORAL AB 2022-08-24 6a471c1ec25d…2025-08-23 18:47 UTC 2025-08 A206954-002 QUETIAPINE FUMARATE EQ 50MG BASE TABLET / ORAL AB 2022-08-24 6a471c1ec25d…2025-08-23 18:47 UTC 2025-08 A206954-003 QUETIAPINE FUMARATE EQ 100MG BASE TABLET / ORAL AB 2022-08-24 6a471c1ec25d…2025-08-23 18:47 UTC 2025-08 A206954-004 QUETIAPINE FUMARATE EQ 200MG BASE TABLET / ORAL AB 2022-08-24 6a471c1ec25d…2025-08-23 18:47 UTC 2025-08 A206954-005 QUETIAPINE FUMARATE EQ 300MG BASE TABLET / ORAL AB 2022-08-24 6a471c1ec25d…2025-08-23 18:47 UTC 2025-08 A206954-006 QUETIAPINE FUMARATE EQ 400MG BASE TABLET / ORAL AB 2022-08-24 6a471c1ec25d…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 A206954-001 QUETIAPINE FUMARATE EQ 25MG BASE TABLET / ORAL AB 2022-08-24 fd3edfee7708…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 A206954-002 QUETIAPINE FUMARATE EQ 50MG BASE TABLET / ORAL AB 2022-08-24 fd3edfee7708…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 A206954-003 QUETIAPINE FUMARATE EQ 100MG BASE TABLET / ORAL AB 2022-08-24 fd3edfee7708…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 A206954-004 QUETIAPINE FUMARATE EQ 200MG BASE TABLET / ORAL AB 2022-08-24 fd3edfee7708…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 A206954-005 QUETIAPINE FUMARATE EQ 300MG BASE TABLET / ORAL AB 2022-08-24 fd3edfee7708…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 A206954-006 QUETIAPINE FUMARATE EQ 400MG BASE TABLET / ORAL AB 2022-08-24 fd3edfee7708…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 A206954-001 QUETIAPINE FUMARATE EQ 25MG BASE TABLET / ORAL AB 2022-08-24 b8a1b40f171c…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 A206954-002 QUETIAPINE FUMARATE EQ 50MG BASE TABLET / ORAL AB 2022-08-24 b8a1b40f171c…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 A206954-003 QUETIAPINE FUMARATE EQ 100MG BASE TABLET / ORAL AB 2022-08-24 b8a1b40f171c…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 A206954-004 QUETIAPINE FUMARATE EQ 200MG BASE TABLET / ORAL AB 2022-08-24 b8a1b40f171c…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 A206954-005 QUETIAPINE FUMARATE EQ 300MG BASE TABLET / ORAL AB 2022-08-24 b8a1b40f171c…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 A206954-006 QUETIAPINE FUMARATE EQ 400MG BASE TABLET / ORAL AB 2022-08-24 b8a1b40f171c…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 A206954-001 QUETIAPINE FUMARATE EQ 25MG BASE TABLET / ORAL AB 2022-08-24 03ed91905a0d…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 A206954-002 QUETIAPINE FUMARATE EQ 50MG BASE TABLET / ORAL AB 2022-08-24 03ed91905a0d…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 A206954-003 QUETIAPINE FUMARATE EQ 100MG BASE TABLET / ORAL AB 2022-08-24 03ed91905a0d…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 A206954-004 QUETIAPINE FUMARATE EQ 200MG BASE TABLET / ORAL AB 2022-08-24 03ed91905a0d…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 A206954-005 QUETIAPINE FUMARATE EQ 300MG BASE TABLET / ORAL AB 2022-08-24 03ed91905a0d…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 A206954-006 QUETIAPINE FUMARATE EQ 400MG BASE TABLET / ORAL AB 2022-08-24 03ed91905a0d…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 A206954-001 QUETIAPINE FUMARATE EQ 25MG BASE TABLET / ORAL AB 2022-08-24 2680178bc6a6…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 A206954-002 QUETIAPINE FUMARATE EQ 50MG BASE TABLET / ORAL AB 2022-08-24 2680178bc6a6…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 A206954-003 QUETIAPINE FUMARATE EQ 100MG BASE TABLET / ORAL AB 2022-08-24 2680178bc6a6…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 A206954-004 QUETIAPINE FUMARATE EQ 200MG BASE TABLET / ORAL AB 2022-08-24 2680178bc6a6…
Observed Orange Book normalized TE history# Normalized TE history page 1 of 5 · 162 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 50 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 · 6 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 616487 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 43547-519-10 QUETIAPINE 100 in 1 BOTTLE TABLET 100 3 43547-519-11 QUETIAPINE 1000 in 1 BOTTLE TABLET 1000 3
DailyMed Dashboard NDC Coverage# NDC, Dashboard title, SPL version table NDC Dashboard title SPL version Validation Dashboard ZIP 43547-519 QUETIAPINE TABLET [SOLCO HEALTHCARE US, LLC] 2 Current NDC, Legacy NDC, 2 package rows 20240925_61b1230e-c0dc-46c6-a577-7d5dd2515eb7.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 · 1 matching rows.
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 43547-519-10 43547051910 100 TABLET in 1 BOTTLE (43547-519-10) 100 tablet 2022-04-12 0000-00-00 No No Current 43547-519-11 43547051911 1000 TABLET in 1 BOTTLE (43547-519-11) 1000 tablet 2022-04-12 0000-00-00 No No Current