Home NDC 53489-150 Thioridazine Hydrochloride
Product NDC 53489-150
11-digit product format 534890150
Labeler code 53489
Product ID 53489-150_2c96c6f9-3008-48ba-86ea-e9b83502da67
Type HUMAN PRESCRIPTION DRUG
Nonproprietary name Thioridazine Hydrochloride
Dosage form TABLET, FILM COATED
Route ORAL
Labeler Sun Pharmaceutical Industries, Inc.
Application ANDA089953
Marketing category ANDA
Marketing start 1988-10-07
Substance THIORIDAZINE HYDROCHLORIDE
Active strength 50 mg/1
Pharmacologic classes Phenothiazine [EPC], Phenothiazines [CS]
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 · 4 matching rows.
Application-product, Trade name, Ingredient table Application-product Trade name Ingredient Strength Dosage form / route TE codes RLD / RS Approval date A089953-001 THIORIDAZINE HYDROCHLORIDE THIORIDAZINE HYDROCHLORIDE 100MG TABLET / ORAL 1988-10-07 A089953-002 THIORIDAZINE HYDROCHLORIDE THIORIDAZINE HYDROCHLORIDE 50MG TABLET / ORAL 1986-08-01 A089953-003 THIORIDAZINE HYDROCHLORIDE THIORIDAZINE HYDROCHLORIDE 25MG TABLET / ORAL 1986-08-01 A089953-004 THIORIDAZINE HYDROCHLORIDE THIORIDAZINE HYDROCHLORIDE 10MG TABLET / ORAL 1986-08-01
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 · 172 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 A089953-001 THIORIDAZINE HYDROCHLORIDE 100MG TABLET / ORAL 1988-10-07 84e616aacf4f…2026-09-14 22:38:34 2026-08 A089953-002 THIORIDAZINE HYDROCHLORIDE 50MG TABLET / ORAL 1986-08-01 84e616aacf4f…2026-09-14 22:38:34 2026-08 A089953-003 THIORIDAZINE HYDROCHLORIDE 25MG TABLET / ORAL 1986-08-01 84e616aacf4f…2026-09-14 22:38:34 2026-08 A089953-004 THIORIDAZINE HYDROCHLORIDE 10MG TABLET / ORAL 1986-08-01 84e616aacf4f…2026-08-18 06:07:40 2026-07 A089953-001 THIORIDAZINE HYDROCHLORIDE 100MG TABLET / ORAL 1988-10-07 caaa826d4ba7…2026-08-18 06:07:40 2026-07 A089953-002 THIORIDAZINE HYDROCHLORIDE 50MG TABLET / ORAL 1986-08-01 caaa826d4ba7…2026-08-18 06:07:40 2026-07 A089953-003 THIORIDAZINE HYDROCHLORIDE 25MG TABLET / ORAL 1986-08-01 caaa826d4ba7…2026-08-18 06:07:40 2026-07 A089953-004 THIORIDAZINE HYDROCHLORIDE 10MG TABLET / ORAL 1986-08-01 caaa826d4ba7…2026-02-19 14:30 UTC 2026-02 A089953-001 THIORIDAZINE HYDROCHLORIDE 100MG TABLET / ORAL 1988-10-07 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 A089953-002 THIORIDAZINE HYDROCHLORIDE 50MG TABLET / ORAL 1986-08-01 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 A089953-003 THIORIDAZINE HYDROCHLORIDE 25MG TABLET / ORAL 1986-08-01 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 A089953-004 THIORIDAZINE HYDROCHLORIDE 10MG TABLET / ORAL 1986-08-01 011fe1cb6892…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 A089953-001 THIORIDAZINE HYDROCHLORIDE 100MG TABLET / ORAL 1988-10-07 31067a03dcf5…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 A089953-002 THIORIDAZINE HYDROCHLORIDE 50MG TABLET / ORAL 1986-08-01 31067a03dcf5…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 A089953-003 THIORIDAZINE HYDROCHLORIDE 25MG TABLET / ORAL 1986-08-01 31067a03dcf5…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 A089953-004 THIORIDAZINE HYDROCHLORIDE 10MG TABLET / ORAL 1986-08-01 31067a03dcf5…2025-08-23 18:47 UTC 2025-08 A089953-001 THIORIDAZINE HYDROCHLORIDE 100MG TABLET / ORAL 1988-10-07 6a471c1ec25d…2025-08-23 18:47 UTC 2025-08 A089953-002 THIORIDAZINE HYDROCHLORIDE 50MG TABLET / ORAL 1986-08-01 6a471c1ec25d…2025-08-23 18:47 UTC 2025-08 A089953-003 THIORIDAZINE HYDROCHLORIDE 25MG TABLET / ORAL 1986-08-01 6a471c1ec25d…2025-08-23 18:47 UTC 2025-08 A089953-004 THIORIDAZINE HYDROCHLORIDE 10MG TABLET / ORAL 1986-08-01 6a471c1ec25d…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 A089953-001 THIORIDAZINE HYDROCHLORIDE 100MG TABLET / ORAL 1988-10-07 fd3edfee7708…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 A089953-002 THIORIDAZINE HYDROCHLORIDE 50MG TABLET / ORAL 1986-08-01 fd3edfee7708…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 A089953-003 THIORIDAZINE HYDROCHLORIDE 25MG TABLET / ORAL 1986-08-01 fd3edfee7708…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 A089953-004 THIORIDAZINE HYDROCHLORIDE 10MG TABLET / ORAL 1986-08-01 fd3edfee7708…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 A089953-001 THIORIDAZINE HYDROCHLORIDE 100MG TABLET / ORAL 1988-10-07 b8a1b40f171c…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 A089953-002 THIORIDAZINE HYDROCHLORIDE 50MG TABLET / ORAL 1986-08-01 b8a1b40f171c…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 A089953-003 THIORIDAZINE HYDROCHLORIDE 25MG TABLET / ORAL 1986-08-01 b8a1b40f171c…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 A089953-004 THIORIDAZINE HYDROCHLORIDE 10MG TABLET / ORAL 1986-08-01 b8a1b40f171c…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 A089953-001 THIORIDAZINE HYDROCHLORIDE 100MG TABLET / ORAL 1988-10-07 03ed91905a0d…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 A089953-002 THIORIDAZINE HYDROCHLORIDE 50MG TABLET / ORAL 1986-08-01 03ed91905a0d…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 A089953-003 THIORIDAZINE HYDROCHLORIDE 25MG TABLET / ORAL 1986-08-01 03ed91905a0d…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 A089953-004 THIORIDAZINE HYDROCHLORIDE 10MG TABLET / ORAL 1986-08-01 03ed91905a0d…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 A089953-001 THIORIDAZINE HYDROCHLORIDE 100MG TABLET / ORAL 1988-10-07 2680178bc6a6…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 A089953-002 THIORIDAZINE HYDROCHLORIDE 50MG TABLET / ORAL 1986-08-01 2680178bc6a6…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 A089953-003 THIORIDAZINE HYDROCHLORIDE 25MG TABLET / ORAL 1986-08-01 2680178bc6a6…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 A089953-004 THIORIDAZINE HYDROCHLORIDE 10MG TABLET / ORAL 1986-08-01 2680178bc6a6…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 A089953-001 THIORIDAZINE HYDROCHLORIDE 100MG TABLET / ORAL 1988-10-07 5bbf6a4d5a75…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 A089953-002 THIORIDAZINE HYDROCHLORIDE 50MG TABLET / ORAL 1986-08-01 5bbf6a4d5a75…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 A089953-003 THIORIDAZINE HYDROCHLORIDE 25MG TABLET / ORAL 1986-08-01 5bbf6a4d5a75…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 A089953-004 THIORIDAZINE HYDROCHLORIDE 10MG TABLET / ORAL 1986-08-01 5bbf6a4d5a75…
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 Thioridazine Hydrochloride
Listing expiration 2026-12-31 Active Ingredients# Ingredient, Strength table Ingredient Strength THIORIDAZINE HYDROCHLORIDE 50 mg/1
Harmonized UNII identifiers# UNII identifiers page 1 of 1 · 1 matching rows.
Identifier, FDA.report destination table Identifier FDA.report destination 4WCI67NK8M Internal UNII lookup
Harmonized RxCUI identifiers# RxCUI identifiers page 1 of 1 · 4 matching rows.
Identifier, FDA.report destination table Identifier FDA.report destination 198270 Internal RxNorm lookup 198274 Internal RxNorm lookup 198275 Internal RxNorm lookup 313354 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 53489-150-01 Thioridazine Hydrochloride 100 in 1 BOTTLE, PLASTIC TABLET, FILM COATED 100 7 53489-150-10 Thioridazine Hydrochloride 1000 in 1 BOTTLE, PLASTIC TABLET, FILM COATED 1000 7
DailyMed Socrata Ingredients# DailyMed Dashboard NDC Coverage# NDC, Dashboard title, SPL version table NDC Dashboard title SPL version Validation Dashboard ZIP 53489-150 THIORIDAZINE HYDROCHLORIDE TABLET, FILM COATED [SUN PHARMACEUTICAL INDUSTRIES, INC.] 7 Current NDC, Legacy NDC, 2 package rows 20171101_9c4bedb4-2d59-4fcd-aad7-fce988cd96d8.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 53489-150-01 53489015001 100 TABLET, FILM COATED in 1 BOTTLE, PLASTIC (53489-150-01) 1988-10-07 0000-00-00 No No Current 53489-150-10 53489015010 1000 TABLET, FILM COATED in 1 BOTTLE, PLASTIC (53489-150-10) 1988-10-07 0000-00-00 No No Current