Home NDC 55111-190-78 Quetiapine fumarate
Product NDC 55111-190
Requested package NDC 55111-190-78
11-digit product format 551110190
Labeler code 55111
Product ID 55111-190_032c7109-eeca-170e-54d0-cfb44f135f07
Type HUMAN PRESCRIPTION DRUG
Nonproprietary name Quetiapine fumarate
Dosage form TABLET, FILM COATED
Route ORAL
Labeler Dr.Reddy's Laboratories Limited
Application ANDA077380
Marketing category ANDA
Marketing start 2012-03-27
Marketing end 0000-00-00
Substance QUETIAPINE FUMARATE
Active strength 300 mg/1
Pharmacologic classes Atypical Antipsychotic [EPC]
NDC exclude flag No
Listing certified through 2020-12-31
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 · 1 matching rows.
View current auxiliary records. · View the auxiliary file history.
Captured / source date, Dataset, Scope table Captured / source date Dataset Scope Product NDC Package NDC Code Status Reporting period Archive Snapshot Source SHA-256 2025-12-14 17:58 UTC · source 2025-12-05 excluded package package 55111-190 55111-190-78 D Discontinued by firm excluded / ndc_excluded.zip d630ba8d3edf…732f749b63fb…
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 A077380-001 QUETIAPINE FUMARATE QUETIAPINE FUMARATE EQ 25MG BASE TABLET / ORAL AB 2012-03-27 A077380-002 QUETIAPINE FUMARATE QUETIAPINE FUMARATE EQ 50MG BASE TABLET / ORAL AB 2012-03-27 A077380-003 QUETIAPINE FUMARATE QUETIAPINE FUMARATE EQ 100MG BASE TABLET / ORAL AB 2012-03-27 A077380-004 QUETIAPINE FUMARATE QUETIAPINE FUMARATE EQ 150MG BASE TABLET / ORAL AB 2012-03-27 A077380-005 QUETIAPINE FUMARATE QUETIAPINE FUMARATE EQ 200MG BASE TABLET / ORAL AB 2012-03-27 A077380-006 QUETIAPINE FUMARATE QUETIAPINE FUMARATE EQ 300MG BASE TABLET / ORAL AB 2012-03-27 A077380-007 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 A077380-001 QUETIAPINE FUMARATE EQ 25MG BASE TABLET / ORAL AB 2012-03-27 84e616aacf4f…2026-09-14 22:38:34 2026-08 A077380-002 QUETIAPINE FUMARATE EQ 50MG BASE TABLET / ORAL AB 2012-03-27 84e616aacf4f…2026-09-14 22:38:34 2026-08 A077380-003 QUETIAPINE FUMARATE EQ 100MG BASE TABLET / ORAL AB 2012-03-27 84e616aacf4f…2026-09-14 22:38:34 2026-08 A077380-004 QUETIAPINE FUMARATE EQ 150MG BASE TABLET / ORAL AB 2012-03-27 84e616aacf4f…2026-09-14 22:38:34 2026-08 A077380-005 QUETIAPINE FUMARATE EQ 200MG BASE TABLET / ORAL AB 2012-03-27 84e616aacf4f…2026-09-14 22:38:34 2026-08 A077380-006 QUETIAPINE FUMARATE EQ 300MG BASE TABLET / ORAL AB 2012-03-27 84e616aacf4f…2026-09-14 22:38:34 2026-08 A077380-007 QUETIAPINE FUMARATE EQ 400MG BASE TABLET / ORAL AB 2012-03-27 84e616aacf4f…2026-08-18 06:07:40 2026-07 A077380-001 QUETIAPINE FUMARATE EQ 25MG BASE TABLET / ORAL AB 2012-03-27 caaa826d4ba7…2026-08-18 06:07:40 2026-07 A077380-002 QUETIAPINE FUMARATE EQ 50MG BASE TABLET / ORAL AB 2012-03-27 caaa826d4ba7…2026-08-18 06:07:40 2026-07 A077380-003 QUETIAPINE FUMARATE EQ 100MG BASE TABLET / ORAL AB 2012-03-27 caaa826d4ba7…2026-08-18 06:07:40 2026-07 A077380-004 QUETIAPINE FUMARATE EQ 150MG BASE TABLET / ORAL AB 2012-03-27 caaa826d4ba7…2026-08-18 06:07:40 2026-07 A077380-005 QUETIAPINE FUMARATE EQ 200MG BASE TABLET / ORAL AB 2012-03-27 caaa826d4ba7…2026-08-18 06:07:40 2026-07 A077380-006 QUETIAPINE FUMARATE EQ 300MG BASE TABLET / ORAL AB 2012-03-27 caaa826d4ba7…2026-08-18 06:07:40 2026-07 A077380-007 QUETIAPINE FUMARATE EQ 400MG BASE TABLET / ORAL AB 2012-03-27 caaa826d4ba7…2026-02-19 14:30 UTC 2026-02 A077380-001 QUETIAPINE FUMARATE EQ 25MG BASE TABLET / ORAL AB 2012-03-27 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 A077380-002 QUETIAPINE FUMARATE EQ 50MG BASE TABLET / ORAL AB 2012-03-27 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 A077380-003 QUETIAPINE FUMARATE EQ 100MG BASE TABLET / ORAL AB 2012-03-27 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 A077380-004 QUETIAPINE FUMARATE EQ 150MG BASE TABLET / ORAL AB 2012-03-27 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 A077380-005 QUETIAPINE FUMARATE EQ 200MG BASE TABLET / ORAL AB 2012-03-27 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 A077380-006 QUETIAPINE FUMARATE EQ 300MG BASE TABLET / ORAL AB 2012-03-27 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 A077380-007 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 A077380-001 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 A077380-002 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 A077380-003 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 A077380-004 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 A077380-005 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 A077380-006 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 A077380-007 QUETIAPINE FUMARATE EQ 400MG BASE TABLET / ORAL AB 2012-03-27 31067a03dcf5…2025-08-23 18:47 UTC 2025-08 A077380-001 QUETIAPINE FUMARATE EQ 25MG BASE TABLET / ORAL AB 2012-03-27 6a471c1ec25d…2025-08-23 18:47 UTC 2025-08 A077380-002 QUETIAPINE FUMARATE EQ 50MG BASE TABLET / ORAL AB 2012-03-27 6a471c1ec25d…2025-08-23 18:47 UTC 2025-08 A077380-003 QUETIAPINE FUMARATE EQ 100MG BASE TABLET / ORAL AB 2012-03-27 6a471c1ec25d…2025-08-23 18:47 UTC 2025-08 A077380-004 QUETIAPINE FUMARATE EQ 150MG BASE TABLET / ORAL AB 2012-03-27 6a471c1ec25d…2025-08-23 18:47 UTC 2025-08 A077380-005 QUETIAPINE FUMARATE EQ 200MG BASE TABLET / ORAL AB 2012-03-27 6a471c1ec25d…2025-08-23 18:47 UTC 2025-08 A077380-006 QUETIAPINE FUMARATE EQ 300MG BASE TABLET / ORAL AB 2012-03-27 6a471c1ec25d…2025-08-23 18:47 UTC 2025-08 A077380-007 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 A077380-001 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 A077380-002 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 A077380-003 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 A077380-004 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 A077380-005 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.
DailyMed Product Concepts# 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 [DR.REDDY'S LABORATORIES LIMITED ] 10 QUETIAPINE ACTIVE MOIETY BGL0JSY5SI QUETIAPINE FUMARATE TABLET, FILM COATED [DR.REDDY'S LABORATORIES LIMITED ] 10 CELLULOSE, MICROCRYSTALLINE INACTIVE INGREDIENT OP1R32D61U QUETIAPINE FUMARATE TABLET, FILM COATED [DR.REDDY'S LABORATORIES LIMITED ] 10 colloidal silicon dioxide INACTIVE INGREDIENT ETJ7Z6XBU4 QUETIAPINE FUMARATE TABLET, FILM COATED [DR.REDDY'S LABORATORIES LIMITED ] 10 DIBASIC CALCIUM PHOSPHATE DIHYDRATE INACTIVE INGREDIENT O7TSZ97GEP QUETIAPINE FUMARATE TABLET, FILM COATED [DR.REDDY'S LABORATORIES LIMITED ] 10 FERRIC OXIDE YELLOW INACTIVE INGREDIENT EX438O2MRT QUETIAPINE FUMARATE TABLET, FILM COATED [DR.REDDY'S LABORATORIES LIMITED ] 10 HYPROMELLOSE 2910 (5 MPA.S) INACTIVE INGREDIENT R75537T0T4 QUETIAPINE FUMARATE TABLET, FILM COATED [DR.REDDY'S LABORATORIES LIMITED ] 10 lactose monohydrate INACTIVE INGREDIENT EWQ57Q8I5X QUETIAPINE FUMARATE TABLET, FILM COATED [DR.REDDY'S LABORATORIES LIMITED ] 10 magnesium stearate INACTIVE INGREDIENT 70097M6I30 QUETIAPINE FUMARATE TABLET, FILM COATED [DR.REDDY'S LABORATORIES LIMITED ] 10 polyethylene glycol 400 INACTIVE INGREDIENT B697894SGQ QUETIAPINE FUMARATE TABLET, FILM COATED [DR.REDDY'S LABORATORIES LIMITED ] 10 POVIDONE INACTIVE INGREDIENT FZ989GH94E QUETIAPINE FUMARATE TABLET, FILM COATED [DR.REDDY'S LABORATORIES LIMITED ] 10 SODIUM STARCH GLYCOLATE TYPE A POTATO INACTIVE INGREDIENT 5856J3G2A2 QUETIAPINE FUMARATE TABLET, FILM COATED [DR.REDDY'S LABORATORIES LIMITED ] 10 titanium dioxide INACTIVE INGREDIENT 15FIX9V2JP QUETIAPINE FUMARATE TABLET, FILM COATED [DR.REDDY'S LABORATORIES LIMITED ] 10 QUETIAPINE FUMARATE ACTIVE INGREDIENT 2S3PL1B6UJ QUETIAPINE FUMARATE TABLET, FILM COATED [PHYSICIANS TOTAL CARE, INC.] 2 QUETIAPINE ACTIVE MOIETY BGL0JSY5SI QUETIAPINE FUMARATE TABLET, FILM COATED [PHYSICIANS TOTAL CARE, INC.] 2 CELLULOSE, MICROCRYSTALLINE INACTIVE INGREDIENT OP1R32D61U QUETIAPINE FUMARATE TABLET, FILM COATED [PHYSICIANS TOTAL CARE, INC.] 2 colloidal silicon dioxide INACTIVE INGREDIENT ETJ7Z6XBU4 QUETIAPINE FUMARATE TABLET, FILM COATED [PHYSICIANS TOTAL CARE, INC.] 2 DIBASIC CALCIUM PHOSPHATE DIHYDRATE INACTIVE INGREDIENT O7TSZ97GEP QUETIAPINE FUMARATE TABLET, FILM COATED [PHYSICIANS TOTAL CARE, INC.] 2 FERRIC OXIDE YELLOW INACTIVE INGREDIENT EX438O2MRT QUETIAPINE FUMARATE TABLET, FILM COATED [PHYSICIANS TOTAL CARE, INC.] 2 HYPROMELLOSE 2910 (5 MPA.S) INACTIVE INGREDIENT R75537T0T4 QUETIAPINE FUMARATE TABLET, FILM COATED [PHYSICIANS TOTAL CARE, INC.] 2 lactose monohydrate INACTIVE INGREDIENT EWQ57Q8I5X QUETIAPINE FUMARATE TABLET, FILM COATED [PHYSICIANS TOTAL CARE, INC.] 2 magnesium stearate INACTIVE INGREDIENT 70097M6I30 QUETIAPINE FUMARATE TABLET, FILM COATED [PHYSICIANS TOTAL CARE, INC.] 2 polyethylene glycol 400 INACTIVE INGREDIENT B697894SGQ QUETIAPINE FUMARATE TABLET, FILM COATED [PHYSICIANS TOTAL CARE, INC.] 2 POVIDONE INACTIVE INGREDIENT FZ989GH94E QUETIAPINE FUMARATE TABLET, FILM COATED [PHYSICIANS TOTAL CARE, INC.] 2 SODIUM STARCH GLYCOLATE TYPE A POTATO INACTIVE INGREDIENT 5856J3G2A2 QUETIAPINE FUMARATE TABLET, FILM COATED [PHYSICIANS TOTAL CARE, INC.] 2 titanium dioxide INACTIVE INGREDIENT 15FIX9V2JP QUETIAPINE FUMARATE TABLET, FILM COATED [PHYSICIANS TOTAL CARE, INC.] 2
DailyMed Dashboard NDC Coverage# NDC, Dashboard title, SPL version table NDC Dashboard title SPL version Validation Dashboard ZIP 55111-190 QUETIAPINE FUMARATE TABLET, FILM COATED [DR.REDDY'S LABORATORIES LIMITED ] 16 Legacy NDC 20190503_26d92d06-44c5-51ac-27f2-cb1376f6bb68.zip
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 55111-190-78 55111019078 10 BLISTER PACK in 1 CARTON (55111-190-78) > 10 TABLET, FILM COATED in 1 BLISTER PACK (55111-190-79) 10 blister pack 2012-03-27 0000-00-00 No No Current