Home NDC 65862-490-01 Quetiapine Fumarate
Product NDC 65862-490
Requested package NDC 65862-490-01
11-digit product format 658620490
Labeler code 65862
Product ID 65862-490_f759dcc0-2e6c-4743-8772-3f05602db2a3
Type HUMAN PRESCRIPTION DRUG
Nonproprietary name Quetiapine Fumarate
Dosage form TABLET, FILM COATED
Route ORAL
Labeler Aurobindo Pharma Limited
Application ANDA091388
Marketing category ANDA
Marketing start 2012-03-27
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 43 .
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 · 301 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 2026-09-14 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…2025-08-23 18:47 UTC 2025-08 A091388-006 QUETIAPINE FUMARATE EQ 300MG BASE TABLET / ORAL AB 2012-03-27 6a471c1ec25d…2025-08-23 18:47 UTC 2025-08 A091388-007 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 A091388-001 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 A091388-002 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 A091388-003 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 A091388-004 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 A091388-005 QUETIAPINE FUMARATE EQ 200MG BASE TABLET / ORAL AB 2012-03-27 fd3edfee7708…
Observed Orange Book normalized TE history# Normalized TE history page 1 of 8 · 301 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 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 · 7 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 389201 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 65862-490-01 Quetiapine Fumarate 100 in 1 BOTTLE TABLET, FILM COATED 100 19 65862-490-10 Quetiapine Fumarate 10 in 1 CARTON TABLET, FILM COATED 10 19 65862-490-10 Quetiapine Fumarate 10 in 1 BLISTER PACK TABLET, FILM COATED 10 19 65862-490-99 Quetiapine Fumarate 1000 in 1 BOTTLE TABLET, FILM COATED 1000 19
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 [AUROBINDO PHARMA LIMITED] 6 QUETIAPINE ACTIVE MOIETY BGL0JSY5SI QUETIAPINE FUMARATE TABLET, FILM COATED [AUROBINDO PHARMA LIMITED] 6 CELLULOSE, MICROCRYSTALLINE INACTIVE INGREDIENT OP1R32D61U QUETIAPINE FUMARATE TABLET, FILM COATED [AUROBINDO PHARMA LIMITED] 6 DIBASIC CALCIUM PHOSPHATE DIHYDRATE INACTIVE INGREDIENT O7TSZ97GEP QUETIAPINE FUMARATE TABLET, FILM COATED [AUROBINDO PHARMA LIMITED] 6 FERRIC OXIDE RED INACTIVE INGREDIENT 1K09F3G675 QUETIAPINE FUMARATE TABLET, FILM COATED [AUROBINDO PHARMA LIMITED] 6 FERRIC OXIDE YELLOW INACTIVE INGREDIENT EX438O2MRT QUETIAPINE FUMARATE TABLET, FILM COATED [AUROBINDO PHARMA LIMITED] 6 FERROSOFERRIC OXIDE INACTIVE INGREDIENT XM0M87F357 QUETIAPINE FUMARATE TABLET, FILM COATED [AUROBINDO PHARMA LIMITED] 6 HYPROMELLOSE 2910 (6 MPA.S) INACTIVE INGREDIENT 0WZ8WG20P6 QUETIAPINE FUMARATE TABLET, FILM COATED [AUROBINDO PHARMA LIMITED] 6 LACTOSE MONOHYDRATE INACTIVE INGREDIENT EWQ57Q8I5X QUETIAPINE FUMARATE TABLET, FILM COATED [AUROBINDO PHARMA LIMITED] 6 MAGNESIUM STEARATE INACTIVE INGREDIENT 70097M6I30 QUETIAPINE FUMARATE TABLET, FILM COATED [AUROBINDO PHARMA LIMITED] 6 POLYETHYLENE GLYCOL 400 INACTIVE INGREDIENT B697894SGQ QUETIAPINE FUMARATE TABLET, FILM COATED [AUROBINDO PHARMA LIMITED] 6 POVIDONE K30 INACTIVE INGREDIENT U725QWY32X QUETIAPINE FUMARATE TABLET, FILM COATED [AUROBINDO PHARMA LIMITED] 6 SHELLAC INACTIVE INGREDIENT 46N107B71O QUETIAPINE FUMARATE TABLET, FILM COATED [AUROBINDO PHARMA LIMITED] 6 SILICON DIOXIDE INACTIVE INGREDIENT ETJ7Z6XBU4 QUETIAPINE FUMARATE TABLET, FILM COATED [AUROBINDO PHARMA LIMITED] 6 SODIUM STARCH GLYCOLATE TYPE A POTATO INACTIVE INGREDIENT 5856J3G2A2 QUETIAPINE FUMARATE TABLET, FILM COATED [AUROBINDO PHARMA LIMITED] 6 TALC INACTIVE INGREDIENT 7SEV7J4R1U QUETIAPINE FUMARATE TABLET, FILM COATED [AUROBINDO PHARMA LIMITED] 6 TITANIUM DIOXIDE INACTIVE INGREDIENT 15FIX9V2JP QUETIAPINE FUMARATE TABLET, FILM COATED [AUROBINDO PHARMA LIMITED] 6
DailyMed Dashboard NDC Coverage# NDC, Dashboard title, SPL version table NDC Dashboard title SPL version Validation Dashboard ZIP 65862-490 QUETIAPINE FUMARATE TABLET, FILM COATED [AUROBINDO PHARMA LIMITED] 18 Current NDC, Legacy NDC, 4 package rows 20250308_8df82f5a-aa0e-4f8c-bae1-2f32ede3d7b6.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 2 of 2 · 21 matching rows.
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 65862-490-01 65862049001 100 TABLET, FILM COATED in 1 BOTTLE (65862-490-01) 2012-03-27 0000-00-00 No No Current