Home NDC 67046-1588 Quetiapine Fumarate
Product NDC 67046-1588
11-digit product format 670461588
Labeler code 67046
Product ID 67046-1588_3eed125b-9762-9c01-e063-6394a90a4ec2
Type HUMAN PRESCRIPTION DRUG
Nonproprietary name Quetiapine Fumarate
Dosage form TABLET, FILM COATED
Route ORAL
Labeler Coupler LLC
Application ANDA091388
Marketing category ANDA
Marketing start 2025-09-16
Substance QUETIAPINE FUMARATE
Active strength 50 mg/1
Pharmacologic classes Atypical Antipsychotic [EPC]
NDC exclude flag No
Listing certified through 2027-12-31
Current FDA listing Yes Source provenance: Browse the complete Orange Book source catalog · source snapshot 44 .
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 A091388-001 QUETIAPINE FUMARATE QUETIAPINE FUMARATE EQ 25MG BASE TABLET / ORAL AB 2012-03-27 A091388-002 QUETIAPINE FUMARATE QUETIAPINE FUMARATE EQ 50MG BASE TABLET / ORAL AB 2012-03-27 A091388-003 QUETIAPINE FUMARATE QUETIAPINE FUMARATE EQ 100MG BASE TABLET / ORAL AB 2012-03-27 A091388-004 QUETIAPINE FUMARATE QUETIAPINE FUMARATE EQ 150MG BASE TABLET / ORAL AB 2012-03-27 A091388-005 QUETIAPINE FUMARATE QUETIAPINE FUMARATE EQ 200MG BASE TABLET / ORAL AB 2012-03-27 A091388-006 QUETIAPINE FUMARATE QUETIAPINE FUMARATE EQ 300MG BASE TABLET / ORAL AB 2012-03-27 A091388-007 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 · 308 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 2026-10-15 13:18:30 2026-09 A091388-001 QUETIAPINE FUMARATE EQ 25MG BASE TABLET / ORAL AB 2012-03-27 c2088c7a36db…2026-10-15 13:18:30 2026-09 A091388-002 QUETIAPINE FUMARATE EQ 50MG BASE TABLET / ORAL AB 2012-03-27 c2088c7a36db…2026-10-15 13:18:30 2026-09 A091388-003 QUETIAPINE FUMARATE EQ 100MG BASE TABLET / ORAL AB 2012-03-27 c2088c7a36db…2026-10-15 13:18:30 2026-09 A091388-004 QUETIAPINE FUMARATE EQ 150MG BASE TABLET / ORAL AB 2012-03-27 c2088c7a36db…2026-10-15 13:18:30 2026-09 A091388-005 QUETIAPINE FUMARATE EQ 200MG BASE TABLET / ORAL AB 2012-03-27 c2088c7a36db…2026-10-15 13:18:30 2026-09 A091388-006 QUETIAPINE FUMARATE EQ 300MG BASE TABLET / ORAL AB 2012-03-27 c2088c7a36db…2026-10-15 13:18:30 2026-09 A091388-007 QUETIAPINE FUMARATE EQ 400MG BASE TABLET / ORAL AB 2012-03-27 c2088c7a36db…2026-09-14 22:38:34 2026-08 A091388-001 QUETIAPINE FUMARATE EQ 25MG BASE TABLET / ORAL AB 2012-03-27 84e616aacf4f…2026-09-14 22:38:34 2026-08 A091388-002 QUETIAPINE FUMARATE EQ 50MG BASE TABLET / ORAL AB 2012-03-27 84e616aacf4f…2026-09-14 22:38:34 2026-08 A091388-003 QUETIAPINE FUMARATE EQ 100MG BASE TABLET / ORAL AB 2012-03-27 84e616aacf4f…2026-09-14 22:38:34 2026-08 A091388-004 QUETIAPINE FUMARATE EQ 150MG BASE TABLET / ORAL AB 2012-03-27 84e616aacf4f…2026-09-14 22:38:34 2026-08 A091388-005 QUETIAPINE FUMARATE EQ 200MG BASE TABLET / ORAL AB 2012-03-27 84e616aacf4f…2026-09-14 22:38:34 2026-08 A091388-006 QUETIAPINE FUMARATE EQ 300MG BASE TABLET / ORAL AB 2012-03-27 84e616aacf4f…2026-09-14 22:38:34 2026-08 A091388-007 QUETIAPINE FUMARATE EQ 400MG BASE TABLET / ORAL AB 2012-03-27 84e616aacf4f…2026-08-18 06:07:40 2026-07 A091388-001 QUETIAPINE FUMARATE EQ 25MG BASE TABLET / ORAL AB 2012-03-27 caaa826d4ba7…2026-08-18 06:07:40 2026-07 A091388-002 QUETIAPINE FUMARATE EQ 50MG BASE TABLET / ORAL AB 2012-03-27 caaa826d4ba7…2026-08-18 06:07:40 2026-07 A091388-003 QUETIAPINE FUMARATE EQ 100MG BASE TABLET / ORAL AB 2012-03-27 caaa826d4ba7…2026-08-18 06:07:40 2026-07 A091388-004 QUETIAPINE FUMARATE EQ 150MG BASE TABLET / ORAL AB 2012-03-27 caaa826d4ba7…2026-08-18 06:07:40 2026-07 A091388-005 QUETIAPINE FUMARATE EQ 200MG BASE TABLET / ORAL AB 2012-03-27 caaa826d4ba7…2026-08-18 06:07:40 2026-07 A091388-006 QUETIAPINE FUMARATE EQ 300MG BASE TABLET / ORAL AB 2012-03-27 caaa826d4ba7…2026-08-18 06:07:40 2026-07 A091388-007 QUETIAPINE FUMARATE EQ 400MG BASE TABLET / ORAL AB 2012-03-27 caaa826d4ba7…2026-02-19 14:30 UTC 2026-02 A091388-001 QUETIAPINE FUMARATE EQ 25MG BASE TABLET / ORAL AB 2012-03-27 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 A091388-002 QUETIAPINE FUMARATE EQ 50MG BASE TABLET / ORAL AB 2012-03-27 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 A091388-003 QUETIAPINE FUMARATE EQ 100MG BASE TABLET / ORAL AB 2012-03-27 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 A091388-004 QUETIAPINE FUMARATE EQ 150MG BASE TABLET / ORAL AB 2012-03-27 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 A091388-005 QUETIAPINE FUMARATE EQ 200MG BASE TABLET / ORAL AB 2012-03-27 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 A091388-006 QUETIAPINE FUMARATE EQ 300MG BASE TABLET / ORAL AB 2012-03-27 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 A091388-007 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 A091388-001 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 A091388-002 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 A091388-003 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 A091388-004 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 A091388-005 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 A091388-006 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 A091388-007 QUETIAPINE FUMARATE EQ 400MG BASE TABLET / ORAL AB 2012-03-27 31067a03dcf5…2025-08-23 18:47 UTC 2025-08 A091388-001 QUETIAPINE FUMARATE EQ 25MG BASE TABLET / ORAL AB 2012-03-27 6a471c1ec25d…2025-08-23 18:47 UTC 2025-08 A091388-002 QUETIAPINE FUMARATE EQ 50MG BASE TABLET / ORAL AB 2012-03-27 6a471c1ec25d…2025-08-23 18:47 UTC 2025-08 A091388-003 QUETIAPINE FUMARATE EQ 100MG BASE TABLET / ORAL AB 2012-03-27 6a471c1ec25d…2025-08-23 18:47 UTC 2025-08 A091388-004 QUETIAPINE FUMARATE EQ 150MG BASE TABLET / ORAL AB 2012-03-27 6a471c1ec25d…2025-08-23 18:47 UTC 2025-08 A091388-005 QUETIAPINE FUMARATE EQ 200MG BASE TABLET / ORAL AB 2012-03-27 6a471c1ec25d…
Observed Orange Book normalized TE history# Normalized TE history page 1 of 8 · 308 observed states.
Reported adverse events (FAERS/openFDA)# Adverse event summaries are temporarily unavailable. Other product information remains available.
Additional Listing Data#
Finished product Yes
Brand name base Quetiapine Fumarate
Listing expiration 2027-12-31 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 · 1 matching rows.
Identifier, FDA.report destination table Identifier FDA.report destination 616487 Internal RxNorm lookup
Harmonized SPL set identifiers# SPL set identifiers page 1 of 1 · 1 matching rows.
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 2 of 2 · 21 matching rows.
Packages# Package NDC, 11-digit format, Description table Package NDC 11-digit format Description Marketing start Sample Exclude flag Status 67046-1588-3 67046158803 30 TABLET, FILM COATED in 1 BLISTER PACK (67046-1588-3) 2025-09-16 No No Current