Home NDC 46708-135-30 Quetiapine Fumarate
Product NDC 46708-135
Requested package NDC 46708-135-30
11-digit product format 467080135
Labeler code 46708
Product ID 46708-135_1b3c037f-0cff-49a4-9ef2-5e19fdd21bc6
Type HUMAN PRESCRIPTION DRUG
Nonproprietary name quetiapine fumarate
Dosage form TABLET, FILM COATED
Route ORAL
Labeler Alembic Pharmaceuticals Limited
Application ANDA203390
Marketing category ANDA
Marketing start 2017-02-21
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 43 .
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 A203390-001 QUETIAPINE FUMARATE QUETIAPINE FUMARATE EQ 25MG BASE TABLET / ORAL 2014-10-28 A203390-002 QUETIAPINE FUMARATE QUETIAPINE FUMARATE EQ 50MG BASE TABLET / ORAL 2014-10-28 A203390-003 QUETIAPINE FUMARATE QUETIAPINE FUMARATE EQ 100MG BASE TABLET / ORAL 2014-10-28 A203390-004 QUETIAPINE FUMARATE QUETIAPINE FUMARATE EQ 200MG BASE TABLET / ORAL 2014-10-28 A203390-005 QUETIAPINE FUMARATE QUETIAPINE FUMARATE EQ 300MG BASE TABLET / ORAL 2014-10-28 A203390-006 QUETIAPINE FUMARATE QUETIAPINE FUMARATE EQ 400MG BASE TABLET / ORAL 2014-10-28
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 7 · 258 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 A203390-001 QUETIAPINE FUMARATE EQ 25MG BASE TABLET / ORAL 2014-10-28 84e616aacf4f…2026-09-14 22:38:34 2026-08 A203390-002 QUETIAPINE FUMARATE EQ 50MG BASE TABLET / ORAL 2014-10-28 84e616aacf4f…2026-09-14 22:38:34 2026-08 A203390-003 QUETIAPINE FUMARATE EQ 100MG BASE TABLET / ORAL 2014-10-28 84e616aacf4f…2026-09-14 22:38:34 2026-08 A203390-004 QUETIAPINE FUMARATE EQ 200MG BASE TABLET / ORAL 2014-10-28 84e616aacf4f…2026-09-14 22:38:34 2026-08 A203390-005 QUETIAPINE FUMARATE EQ 300MG BASE TABLET / ORAL 2014-10-28 84e616aacf4f…2026-09-14 22:38:34 2026-08 A203390-006 QUETIAPINE FUMARATE EQ 400MG BASE TABLET / ORAL 2014-10-28 84e616aacf4f…2026-08-18 06:07:40 2026-07 A203390-001 QUETIAPINE FUMARATE EQ 25MG BASE TABLET / ORAL 2014-10-28 caaa826d4ba7…2026-08-18 06:07:40 2026-07 A203390-002 QUETIAPINE FUMARATE EQ 50MG BASE TABLET / ORAL 2014-10-28 caaa826d4ba7…2026-08-18 06:07:40 2026-07 A203390-003 QUETIAPINE FUMARATE EQ 100MG BASE TABLET / ORAL 2014-10-28 caaa826d4ba7…2026-08-18 06:07:40 2026-07 A203390-004 QUETIAPINE FUMARATE EQ 200MG BASE TABLET / ORAL 2014-10-28 caaa826d4ba7…2026-08-18 06:07:40 2026-07 A203390-005 QUETIAPINE FUMARATE EQ 300MG BASE TABLET / ORAL 2014-10-28 caaa826d4ba7…2026-08-18 06:07:40 2026-07 A203390-006 QUETIAPINE FUMARATE EQ 400MG BASE TABLET / ORAL 2014-10-28 caaa826d4ba7…2026-02-19 14:30 UTC 2026-02 A203390-001 QUETIAPINE FUMARATE EQ 25MG BASE TABLET / ORAL 2014-10-28 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 A203390-002 QUETIAPINE FUMARATE EQ 50MG BASE TABLET / ORAL 2014-10-28 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 A203390-003 QUETIAPINE FUMARATE EQ 100MG BASE TABLET / ORAL 2014-10-28 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 A203390-004 QUETIAPINE FUMARATE EQ 200MG BASE TABLET / ORAL 2014-10-28 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 A203390-005 QUETIAPINE FUMARATE EQ 300MG BASE TABLET / ORAL 2014-10-28 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 A203390-006 QUETIAPINE FUMARATE EQ 400MG BASE TABLET / ORAL 2014-10-28 011fe1cb6892…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 A203390-001 QUETIAPINE FUMARATE EQ 25MG BASE TABLET / ORAL 2014-10-28 31067a03dcf5…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 A203390-002 QUETIAPINE FUMARATE EQ 50MG BASE TABLET / ORAL 2014-10-28 31067a03dcf5…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 A203390-003 QUETIAPINE FUMARATE EQ 100MG BASE TABLET / ORAL 2014-10-28 31067a03dcf5…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 A203390-004 QUETIAPINE FUMARATE EQ 200MG BASE TABLET / ORAL 2014-10-28 31067a03dcf5…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 A203390-005 QUETIAPINE FUMARATE EQ 300MG BASE TABLET / ORAL 2014-10-28 31067a03dcf5…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 A203390-006 QUETIAPINE FUMARATE EQ 400MG BASE TABLET / ORAL 2014-10-28 31067a03dcf5…2025-08-23 18:47 UTC 2025-08 A203390-001 QUETIAPINE FUMARATE EQ 25MG BASE TABLET / ORAL 2014-10-28 6a471c1ec25d…2025-08-23 18:47 UTC 2025-08 A203390-002 QUETIAPINE FUMARATE EQ 50MG BASE TABLET / ORAL 2014-10-28 6a471c1ec25d…2025-08-23 18:47 UTC 2025-08 A203390-003 QUETIAPINE FUMARATE EQ 100MG BASE TABLET / ORAL 2014-10-28 6a471c1ec25d…2025-08-23 18:47 UTC 2025-08 A203390-004 QUETIAPINE FUMARATE EQ 200MG BASE TABLET / ORAL 2014-10-28 6a471c1ec25d…2025-08-23 18:47 UTC 2025-08 A203390-005 QUETIAPINE FUMARATE EQ 300MG BASE TABLET / ORAL 2014-10-28 6a471c1ec25d…2025-08-23 18:47 UTC 2025-08 A203390-006 QUETIAPINE FUMARATE EQ 400MG BASE TABLET / ORAL 2014-10-28 6a471c1ec25d…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 A203390-001 QUETIAPINE FUMARATE EQ 25MG BASE TABLET / ORAL 2014-10-28 fd3edfee7708…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 A203390-002 QUETIAPINE FUMARATE EQ 50MG BASE TABLET / ORAL 2014-10-28 fd3edfee7708…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 A203390-003 QUETIAPINE FUMARATE EQ 100MG BASE TABLET / ORAL 2014-10-28 fd3edfee7708…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 A203390-004 QUETIAPINE FUMARATE EQ 200MG BASE TABLET / ORAL 2014-10-28 fd3edfee7708…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 A203390-005 QUETIAPINE FUMARATE EQ 300MG BASE TABLET / ORAL 2014-10-28 fd3edfee7708…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 A203390-006 QUETIAPINE FUMARATE EQ 400MG BASE TABLET / ORAL 2014-10-28 fd3edfee7708…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 A203390-001 QUETIAPINE FUMARATE EQ 25MG BASE TABLET / ORAL 2014-10-28 b8a1b40f171c…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 A203390-002 QUETIAPINE FUMARATE EQ 50MG BASE TABLET / ORAL 2014-10-28 b8a1b40f171c…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 A203390-003 QUETIAPINE FUMARATE EQ 100MG BASE TABLET / ORAL 2014-10-28 b8a1b40f171c…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 A203390-004 QUETIAPINE FUMARATE EQ 200MG BASE TABLET / ORAL 2014-10-28 b8a1b40f171c…
Observed Orange Book normalized TE history# 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 · 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# FDA-Initiated Inactive NDC Indexing# NDC, Effective, Related label table NDC Effective Related label 46708-135-10 2023-02-01 These highlights do not include all the information needed to use QUETIAPINE FUMARATE TABLETS safely and effectively. See full prescribing information for QUETIAPINE FUMARATE TABLETS. QUETIAPINE FUMARATE tablets, for oral use Initial U.S. Approval: 1997 46708-135-30 2023-02-01 These highlights do not include all the information needed to use QUETIAPINE FUMARATE TABLETS safely and effectively. See full prescribing information for QUETIAPINE FUMARATE TABLETS. QUETIAPINE FUMARATE tablets, for oral use Initial U.S. Approval: 1997 46708-135-31 2023-02-01 These highlights do not include all the information needed to use QUETIAPINE FUMARATE TABLETS safely and effectively. See full prescribing information for QUETIAPINE FUMARATE TABLETS. QUETIAPINE FUMARATE tablets, for oral use Initial U.S. Approval: 1997 46708-135-91 2023-02-01 These highlights do not include all the information needed to use QUETIAPINE FUMARATE TABLETS safely and effectively. See full prescribing information for QUETIAPINE FUMARATE TABLETS. QUETIAPINE FUMARATE tablets, for oral use Initial U.S. Approval: 1997 46708-135-10 2023-01-30 These highlights do not include all the information needed to use QUETIAPINE FUMARATE TABLETS safely and effectively. See full prescribing information for QUETIAPINE FUMARATE TABLETS. QUETIAPINE FUMARATE tablets, for oral use Initial U.S. Approval: 1997 46708-135-30 2023-01-30 These highlights do not include all the information needed to use QUETIAPINE FUMARATE TABLETS safely and effectively. See full prescribing information for QUETIAPINE FUMARATE TABLETS. QUETIAPINE FUMARATE tablets, for oral use Initial U.S. Approval: 1997 46708-135-31 2023-01-30 These highlights do not include all the information needed to use QUETIAPINE FUMARATE TABLETS safely and effectively. See full prescribing information for QUETIAPINE FUMARATE TABLETS. QUETIAPINE FUMARATE tablets, for oral use Initial U.S. Approval: 1997 46708-135-91 2023-01-30 These highlights do not include all the information needed to use QUETIAPINE FUMARATE TABLETS safely and effectively. See full prescribing information for QUETIAPINE FUMARATE TABLETS. QUETIAPINE FUMARATE tablets, for oral use Initial U.S. Approval: 1997
DailyMed Package Descriptions# Package NDC, Product, Description table Package NDC Product Description Form Quantity Strength SPL version 46708-135-10 Quetiapine Fumarate 100 in 1 CARTON TABLET, FILM COATED 100 7 46708-135-30 Quetiapine Fumarate 30 in 1 BOTTLE TABLET, FILM COATED 30 7 46708-135-31 Quetiapine Fumarate 100 in 1 BOTTLE TABLET, FILM COATED 100 7 46708-135-91 Quetiapine Fumarate 1000 in 1 BOTTLE TABLET, FILM COATED 1000 7
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 [ALEMBIC PHARMACEUTICALS LIMITED] 1 QUETIAPINE ACTIVE MOIETY BGL0JSY5SI QUETIAPINE FUMARATE TABLET, FILM COATED [ALEMBIC PHARMACEUTICALS LIMITED] 1 ANHYDROUS DIBASIC CALCIUM PHOSPHATE INACTIVE INGREDIENT L11K75P92J QUETIAPINE FUMARATE TABLET, FILM COATED [ALEMBIC PHARMACEUTICALS LIMITED] 1 CELLULOSE, MICROCRYSTALLINE INACTIVE INGREDIENT OP1R32D61U QUETIAPINE FUMARATE TABLET, FILM COATED [ALEMBIC PHARMACEUTICALS LIMITED] 1 HYDROXYPROPYL CELLULOSE INACTIVE INGREDIENT RFW2ET671P QUETIAPINE FUMARATE TABLET, FILM COATED [ALEMBIC PHARMACEUTICALS LIMITED] 1 HYPROMELLOSES INACTIVE INGREDIENT 3NXW29V3WO QUETIAPINE FUMARATE TABLET, FILM COATED [ALEMBIC PHARMACEUTICALS LIMITED] 1 LACTOSE MONOHYDRATE INACTIVE INGREDIENT EWQ57Q8I5X QUETIAPINE FUMARATE TABLET, FILM COATED [ALEMBIC PHARMACEUTICALS LIMITED] 1 MAGNESIUM STEARATE INACTIVE INGREDIENT 70097M6I30 QUETIAPINE FUMARATE TABLET, FILM COATED [ALEMBIC PHARMACEUTICALS LIMITED] 1 POVIDONE K30 INACTIVE INGREDIENT U725QWY32X QUETIAPINE FUMARATE TABLET, FILM COATED [ALEMBIC PHARMACEUTICALS LIMITED] 1 SODIUM STARCH GLYCOLATE TYPE A POTATO INACTIVE INGREDIENT 5856J3G2A2 QUETIAPINE FUMARATE TABLET, FILM COATED [ALEMBIC PHARMACEUTICALS LIMITED] 1 TITANIUM DIOXIDE INACTIVE INGREDIENT 15FIX9V2JP QUETIAPINE FUMARATE TABLET, FILM COATED [ALEMBIC PHARMACEUTICALS LIMITED] 1
DailyMed Dashboard NDC Coverage# NDC, Dashboard title, SPL version table NDC Dashboard title SPL version Validation Dashboard ZIP 46708-135 QUETIAPINE FUMARATE TABLET, FILM COATED [ALEMBIC PHARMACEUTICALS LIMITED] 7 Current NDC, Legacy NDC, 4 package rows 20230202_93ab6237-321e-4a2c-b0ca-3fc9acb31f9a.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 Marketing start Marketing end Sample Exclude flag Status 46708-135-30 46708013530 30 TABLET, FILM COATED in 1 BOTTLE (46708-135-30) 2017-02-21 0000-00-00 No No Current