FDA.reportPublic FDA data

Thioridazine Hydrochloride

Product NDC
53489-148
11-digit product format
534890148
Labeler code
53489
Product ID
53489-148_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
10 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-productTrade nameIngredientStrengthDosage form / routeTE codesRLD / RSApproval date
A089953-001THIORIDAZINE HYDROCHLORIDETHIORIDAZINE HYDROCHLORIDE100MGTABLET / ORAL1988-10-07
A089953-002THIORIDAZINE HYDROCHLORIDETHIORIDAZINE HYDROCHLORIDE50MGTABLET / ORAL1986-08-01
A089953-003THIORIDAZINE HYDROCHLORIDETHIORIDAZINE HYDROCHLORIDE25MGTABLET / ORAL1986-08-01
A089953-004THIORIDAZINE HYDROCHLORIDETHIORIDAZINE HYDROCHLORIDE10MGTABLET / ORAL1986-08-01

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
CapturedEditionApplication-productTrade nameStrengthDosage form / routeProduct TE source textRLD / RSApproval dateSource SHA-256
2026-09-14 22:38:342026-08A089953-001THIORIDAZINE HYDROCHLORIDE100MGTABLET / ORAL1988-10-0784e616aacf4f…
2026-09-14 22:38:342026-08A089953-002THIORIDAZINE HYDROCHLORIDE50MGTABLET / ORAL1986-08-0184e616aacf4f…
2026-09-14 22:38:342026-08A089953-003THIORIDAZINE HYDROCHLORIDE25MGTABLET / ORAL1986-08-0184e616aacf4f…
2026-09-14 22:38:342026-08A089953-004THIORIDAZINE HYDROCHLORIDE10MGTABLET / ORAL1986-08-0184e616aacf4f…
2026-08-18 06:07:402026-07A089953-001THIORIDAZINE HYDROCHLORIDE100MGTABLET / ORAL1988-10-07caaa826d4ba7…
2026-08-18 06:07:402026-07A089953-002THIORIDAZINE HYDROCHLORIDE50MGTABLET / ORAL1986-08-01caaa826d4ba7…
2026-08-18 06:07:402026-07A089953-003THIORIDAZINE HYDROCHLORIDE25MGTABLET / ORAL1986-08-01caaa826d4ba7…
2026-08-18 06:07:402026-07A089953-004THIORIDAZINE HYDROCHLORIDE10MGTABLET / ORAL1986-08-01caaa826d4ba7…
2026-02-19 14:30 UTC2026-02A089953-001THIORIDAZINE HYDROCHLORIDE100MGTABLET / ORAL1988-10-07011fe1cb6892…
2026-02-19 14:30 UTC2026-02A089953-002THIORIDAZINE HYDROCHLORIDE50MGTABLET / ORAL1986-08-01011fe1cb6892…
2026-02-19 14:30 UTC2026-02A089953-003THIORIDAZINE HYDROCHLORIDE25MGTABLET / ORAL1986-08-01011fe1cb6892…
2026-02-19 14:30 UTC2026-02A089953-004THIORIDAZINE HYDROCHLORIDE10MGTABLET / ORAL1986-08-01011fe1cb6892…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A089953-001THIORIDAZINE HYDROCHLORIDE100MGTABLET / ORAL1988-10-0731067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A089953-002THIORIDAZINE HYDROCHLORIDE50MGTABLET / ORAL1986-08-0131067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A089953-003THIORIDAZINE HYDROCHLORIDE25MGTABLET / ORAL1986-08-0131067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A089953-004THIORIDAZINE HYDROCHLORIDE10MGTABLET / ORAL1986-08-0131067a03dcf5…
2025-08-23 18:47 UTC2025-08A089953-001THIORIDAZINE HYDROCHLORIDE100MGTABLET / ORAL1988-10-076a471c1ec25d…
2025-08-23 18:47 UTC2025-08A089953-002THIORIDAZINE HYDROCHLORIDE50MGTABLET / ORAL1986-08-016a471c1ec25d…
2025-08-23 18:47 UTC2025-08A089953-003THIORIDAZINE HYDROCHLORIDE25MGTABLET / ORAL1986-08-016a471c1ec25d…
2025-08-23 18:47 UTC2025-08A089953-004THIORIDAZINE HYDROCHLORIDE10MGTABLET / ORAL1986-08-016a471c1ec25d…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A089953-001THIORIDAZINE HYDROCHLORIDE100MGTABLET / ORAL1988-10-07fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A089953-002THIORIDAZINE HYDROCHLORIDE50MGTABLET / ORAL1986-08-01fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A089953-003THIORIDAZINE HYDROCHLORIDE25MGTABLET / ORAL1986-08-01fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A089953-004THIORIDAZINE HYDROCHLORIDE10MGTABLET / ORAL1986-08-01fd3edfee7708…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A089953-001THIORIDAZINE HYDROCHLORIDE100MGTABLET / ORAL1988-10-07b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A089953-002THIORIDAZINE HYDROCHLORIDE50MGTABLET / ORAL1986-08-01b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A089953-003THIORIDAZINE HYDROCHLORIDE25MGTABLET / ORAL1986-08-01b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A089953-004THIORIDAZINE HYDROCHLORIDE10MGTABLET / ORAL1986-08-01b8a1b40f171c…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A089953-001THIORIDAZINE HYDROCHLORIDE100MGTABLET / ORAL1988-10-0703ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A089953-002THIORIDAZINE HYDROCHLORIDE50MGTABLET / ORAL1986-08-0103ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A089953-003THIORIDAZINE HYDROCHLORIDE25MGTABLET / ORAL1986-08-0103ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A089953-004THIORIDAZINE HYDROCHLORIDE10MGTABLET / ORAL1986-08-0103ed91905a0d…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A089953-001THIORIDAZINE HYDROCHLORIDE100MGTABLET / ORAL1988-10-072680178bc6a6…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A089953-002THIORIDAZINE HYDROCHLORIDE50MGTABLET / ORAL1986-08-012680178bc6a6…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A089953-003THIORIDAZINE HYDROCHLORIDE25MGTABLET / ORAL1986-08-012680178bc6a6…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A089953-004THIORIDAZINE HYDROCHLORIDE10MGTABLET / ORAL1986-08-012680178bc6a6…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A089953-001THIORIDAZINE HYDROCHLORIDE100MGTABLET / ORAL1988-10-075bbf6a4d5a75…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A089953-002THIORIDAZINE HYDROCHLORIDE50MGTABLET / ORAL1986-08-015bbf6a4d5a75…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A089953-003THIORIDAZINE HYDROCHLORIDE25MGTABLET / ORAL1986-08-015bbf6a4d5a75…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A089953-004THIORIDAZINE HYDROCHLORIDE10MGTABLET / ORAL1986-08-015bbf6a4d5a75…

Observed Orange Book normalized TE history#

Captured, Edition, Application-product table
CapturedEditionApplication-productTE codeOrderSource SHA-256
2020-12-22 03:56 UTC2020-12A089953-001AB18869cabd3fbd…
2020-12-22 03:56 UTC2020-12A089953-002AB18869cabd3fbd…
2020-12-22 03:56 UTC2020-12A089953-003AB18869cabd3fbd…
2020-12-22 03:56 UTC2020-12A089953-004AB18869cabd3fbd…
2020-11-12 02:37 UTC2020-11A089953-001AB1c0c555d07b60…
2020-11-12 02:37 UTC2020-11A089953-002AB1c0c555d07b60…
2020-11-12 02:37 UTC2020-11A089953-003AB1c0c555d07b60…
2020-11-12 02:37 UTC2020-11A089953-004AB1c0c555d07b60…
2019-09-15 20:21 UTC2019-09A089953-001AB1b00525d2431f…
2019-09-15 20:21 UTC2019-09A089953-002AB1b00525d2431f…
2019-09-15 20:21 UTC2019-09A089953-003AB1b00525d2431f…
2019-09-15 20:21 UTC2019-09A089953-004AB1b00525d2431f…
2019-07-19 19:46 UTC2019-07A089953-001AB1ea99ee380514…
2019-07-19 19:46 UTC2019-07A089953-002AB1ea99ee380514…
2019-07-19 19:46 UTC2019-07A089953-003AB1ea99ee380514…
2019-07-19 19:46 UTC2019-07A089953-004AB1ea99ee380514…

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
IngredientStrength
THIORIDAZINE HYDROCHLORIDE10 mg/1

Harmonized UNII identifiers#

UNII identifiers page 1 of 1 · 1 matching rows.

Identifier, FDA.report destination table
IdentifierFDA.report destination
4WCI67NK8MInternal UNII lookup

Harmonized RxCUI identifiers#

RxCUI identifiers page 1 of 1 · 4 matching rows.

Identifier, FDA.report destination table
IdentifierFDA.report destination
198270Internal RxNorm lookup
198274Internal RxNorm lookup
198275Internal RxNorm lookup
313354Internal RxNorm lookup

Harmonized SPL set identifiers#

SPL set identifiers page 1 of 1 · 1 matching rows.

Identifier, FDA.report destination table
IdentifierFDA.report destination
9c4bedb4-2d59-4fcd-aad7-fce988cd96d8Available on FDA.report

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
92b3bc4b-cbea-b9aa-f31b-a4133eb6e99bProduct name120140508

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
53489-148-01Thioridazine Hydrochloride100 in 1 BOTTLE, PLASTICTABLET, FILM COATED1007
53489-148-10Thioridazine Hydrochloride1000 in 1 BOTTLE, PLASTICTABLET, FILM COATED10007

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
53489-148-01EA - Each53489-1484e829639-1e66-400c-a4d8-43430565f8f712012-07-24
53489-148-10EA - Each53489-1486e07f063-654e-4782-b925-f8d09a3e9d8a12012-07-24

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIIDailyMed labelSPL versionUploaded
Thioridazine HydrochlorideACTIVE INGREDIENT4WCI67NK8MTHIORIDAZINE HYDROCHLORIDE TABLET, FILM COATED [MUTUAL PHARMACEUTICAL]5
ThioridazineACTIVE MOIETYN3D6TG58NITHIORIDAZINE HYDROCHLORIDE TABLET, FILM COATED [MUTUAL PHARMACEUTICAL]5

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
53489-148THIORIDAZINE HYDROCHLORIDE TABLET, FILM COATED [SUN PHARMACEUTICAL INDUSTRIES, INC.]7Current NDC, Legacy NDC, 2 package rows20171101_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.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
Thioridazine HydrochlorideTHIORIDAZINE HYDROCHLORIDESun Pharmaceutical Industries, Inc.9c4bedb4-2d59-4fcd-aad7-fce988cd96d82017-10-20Boxed warning, Warnings, Adverse reactionsExact identifier
application applno (ANDA): 089953
application number: ANDA089953
ndc (product): 53489-148

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
313354thioridazine HCl 10 MG Oral TabletPSN9c4bedb4-2d59-4fcd-aad7-fce988cd96d87
198270thioridazine HCl 100 MG Oral TabletPSN9c4bedb4-2d59-4fcd-aad7-fce988cd96d87
198274thioridazine HCl 25 MG Oral TabletPSN9c4bedb4-2d59-4fcd-aad7-fce988cd96d87
198275thioridazine HCl 50 MG Oral TabletPSN9c4bedb4-2d59-4fcd-aad7-fce988cd96d87
313354thioridazine 10 MG Oral TabletSCD9c4bedb4-2d59-4fcd-aad7-fce988cd96d87
198270thioridazine 100 MG Oral TabletSCD9c4bedb4-2d59-4fcd-aad7-fce988cd96d87
198274thioridazine 25 MG Oral TabletSCD9c4bedb4-2d59-4fcd-aad7-fce988cd96d87
198275thioridazine 50 MG Oral TabletSCD9c4bedb4-2d59-4fcd-aad7-fce988cd96d87
198274thioridazine (as thioridazine hydrochloride) 25 MG Oral TabletSY9c4bedb4-2d59-4fcd-aad7-fce988cd96d87
198275thioridazine (as thioridazine hydrochloride) 50 MG Oral TabletSY9c4bedb4-2d59-4fcd-aad7-fce988cd96d87

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionMarketing startMarketing endSampleExclude flagStatus
53489-148-0153489014801100 TABLET, FILM COATED in 1 BOTTLE, PLASTIC (53489-148-01) 1988-10-070000-00-00NoNoCurrent
53489-148-10534890148101000 TABLET, FILM COATED in 1 BOTTLE, PLASTIC (53489-148-10) 1988-10-070000-00-00NoNoCurrent