FDA.reportPublic FDA data

Thioridazine Hydrochloride

Product NDC
51079-565
11-digit product format
510790565
Labeler code
51079
Product ID
51079-565_4358c933-3022-792d-e063-6294a90aacb6
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
thioridazine hydrochloride
Dosage form
TABLET, FILM COATED
Route
ORAL
Labeler
Mylan Institutional Inc.
Application
ANDA088004
Marketing category
ANDA
Marketing start
1998-04-29
Substance
THIORIDAZINE HYDROCHLORIDE
Active strength
10 mg/1
Pharmacologic classes
Phenothiazine [EPC], Phenothiazines [CS]
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 44.

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
A088004-001THIORIDAZINE HYDROCHLORIDETHIORIDAZINE HYDROCHLORIDE100MGTABLET / ORALRS1983-11-18
A088004-002THIORIDAZINE HYDROCHLORIDETHIORIDAZINE HYDROCHLORIDE10MGTABLET / ORAL1983-03-15
A088004-003THIORIDAZINE HYDROCHLORIDETHIORIDAZINE HYDROCHLORIDE25MGTABLET / ORAL1983-03-15
A088004-004THIORIDAZINE HYDROCHLORIDETHIORIDAZINE HYDROCHLORIDE50MGTABLET / ORAL1983-03-15

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 · 176 observed states.

Captured, Edition, Application-product table
CapturedEditionApplication-productTrade nameStrengthDosage form / routeProduct TE source textRLD / RSApproval dateSource SHA-256
2026-10-15 13:18:302026-09A088004-001THIORIDAZINE HYDROCHLORIDE100MGTABLET / ORALRS1983-11-18c2088c7a36db…
2026-10-15 13:18:302026-09A088004-002THIORIDAZINE HYDROCHLORIDE10MGTABLET / ORAL1983-03-15c2088c7a36db…
2026-10-15 13:18:302026-09A088004-003THIORIDAZINE HYDROCHLORIDE25MGTABLET / ORAL1983-03-15c2088c7a36db…
2026-10-15 13:18:302026-09A088004-004THIORIDAZINE HYDROCHLORIDE50MGTABLET / ORAL1983-03-15c2088c7a36db…
2026-09-14 22:38:342026-08A088004-001THIORIDAZINE HYDROCHLORIDE100MGTABLET / ORALRS1983-11-1884e616aacf4f…
2026-09-14 22:38:342026-08A088004-002THIORIDAZINE HYDROCHLORIDE10MGTABLET / ORAL1983-03-1584e616aacf4f…
2026-09-14 22:38:342026-08A088004-003THIORIDAZINE HYDROCHLORIDE25MGTABLET / ORAL1983-03-1584e616aacf4f…
2026-09-14 22:38:342026-08A088004-004THIORIDAZINE HYDROCHLORIDE50MGTABLET / ORAL1983-03-1584e616aacf4f…
2026-08-18 06:07:402026-07A088004-001THIORIDAZINE HYDROCHLORIDE100MGTABLET / ORALRS1983-11-18caaa826d4ba7…
2026-08-18 06:07:402026-07A088004-002THIORIDAZINE HYDROCHLORIDE10MGTABLET / ORAL1983-03-15caaa826d4ba7…
2026-08-18 06:07:402026-07A088004-003THIORIDAZINE HYDROCHLORIDE25MGTABLET / ORAL1983-03-15caaa826d4ba7…
2026-08-18 06:07:402026-07A088004-004THIORIDAZINE HYDROCHLORIDE50MGTABLET / ORAL1983-03-15caaa826d4ba7…
2026-02-19 14:30 UTC2026-02A088004-001THIORIDAZINE HYDROCHLORIDE100MGTABLET / ORALRS1983-11-18011fe1cb6892…
2026-02-19 14:30 UTC2026-02A088004-002THIORIDAZINE HYDROCHLORIDE10MGTABLET / ORAL1983-03-15011fe1cb6892…
2026-02-19 14:30 UTC2026-02A088004-003THIORIDAZINE HYDROCHLORIDE25MGTABLET / ORAL1983-03-15011fe1cb6892…
2026-02-19 14:30 UTC2026-02A088004-004THIORIDAZINE HYDROCHLORIDE50MGTABLET / ORAL1983-03-15011fe1cb6892…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A088004-001THIORIDAZINE HYDROCHLORIDE100MGTABLET / ORALRS1983-11-1831067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A088004-002THIORIDAZINE HYDROCHLORIDE10MGTABLET / ORAL1983-03-1531067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A088004-003THIORIDAZINE HYDROCHLORIDE25MGTABLET / ORAL1983-03-1531067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A088004-004THIORIDAZINE HYDROCHLORIDE50MGTABLET / ORAL1983-03-1531067a03dcf5…
2025-08-23 18:47 UTC2025-08A088004-001THIORIDAZINE HYDROCHLORIDE100MGTABLET / ORALRS1983-11-186a471c1ec25d…
2025-08-23 18:47 UTC2025-08A088004-002THIORIDAZINE HYDROCHLORIDE10MGTABLET / ORAL1983-03-156a471c1ec25d…
2025-08-23 18:47 UTC2025-08A088004-003THIORIDAZINE HYDROCHLORIDE25MGTABLET / ORAL1983-03-156a471c1ec25d…
2025-08-23 18:47 UTC2025-08A088004-004THIORIDAZINE HYDROCHLORIDE50MGTABLET / ORAL1983-03-156a471c1ec25d…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A088004-001THIORIDAZINE HYDROCHLORIDE100MGTABLET / ORALRS1983-11-18fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A088004-002THIORIDAZINE HYDROCHLORIDE10MGTABLET / ORAL1983-03-15fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A088004-003THIORIDAZINE HYDROCHLORIDE25MGTABLET / ORAL1983-03-15fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A088004-004THIORIDAZINE HYDROCHLORIDE50MGTABLET / ORAL1983-03-15fd3edfee7708…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A088004-001THIORIDAZINE HYDROCHLORIDE100MGTABLET / ORALRS1983-11-18b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A088004-002THIORIDAZINE HYDROCHLORIDE10MGTABLET / ORAL1983-03-15b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A088004-003THIORIDAZINE HYDROCHLORIDE25MGTABLET / ORAL1983-03-15b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A088004-004THIORIDAZINE HYDROCHLORIDE50MGTABLET / ORAL1983-03-15b8a1b40f171c…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A088004-001THIORIDAZINE HYDROCHLORIDE100MGTABLET / ORALRS1983-11-1803ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A088004-002THIORIDAZINE HYDROCHLORIDE10MGTABLET / ORAL1983-03-1503ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A088004-003THIORIDAZINE HYDROCHLORIDE25MGTABLET / ORAL1983-03-1503ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A088004-004THIORIDAZINE HYDROCHLORIDE50MGTABLET / ORAL1983-03-1503ed91905a0d…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A088004-001THIORIDAZINE HYDROCHLORIDE100MGTABLET / ORALRS1983-11-182680178bc6a6…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A088004-002THIORIDAZINE HYDROCHLORIDE10MGTABLET / ORAL1983-03-152680178bc6a6…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A088004-003THIORIDAZINE HYDROCHLORIDE25MGTABLET / ORAL1983-03-152680178bc6a6…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A088004-004THIORIDAZINE HYDROCHLORIDE50MGTABLET / ORAL1983-03-152680178bc6a6…

Observed Orange Book normalized TE history#

Captured, Edition, Application-product table
CapturedEditionApplication-productTE codeOrderSource SHA-256
2020-12-22 03:56 UTC2020-12A088004-001AB18869cabd3fbd…
2020-12-22 03:56 UTC2020-12A088004-002AB18869cabd3fbd…
2020-12-22 03:56 UTC2020-12A088004-003AB18869cabd3fbd…
2020-12-22 03:56 UTC2020-12A088004-004AB18869cabd3fbd…
2020-11-12 02:37 UTC2020-11A088004-001AB1c0c555d07b60…
2020-11-12 02:37 UTC2020-11A088004-002AB1c0c555d07b60…
2020-11-12 02:37 UTC2020-11A088004-003AB1c0c555d07b60…
2020-11-12 02:37 UTC2020-11A088004-004AB1c0c555d07b60…
2019-09-15 20:21 UTC2019-09A088004-001AB1b00525d2431f…
2019-09-15 20:21 UTC2019-09A088004-002AB1b00525d2431f…
2019-09-15 20:21 UTC2019-09A088004-003AB1b00525d2431f…
2019-09-15 20:21 UTC2019-09A088004-004AB1b00525d2431f…
2019-07-19 19:46 UTC2019-07A088004-001AB1ea99ee380514…
2019-07-19 19:46 UTC2019-07A088004-002AB1ea99ee380514…
2019-07-19 19:46 UTC2019-07A088004-003AB1ea99ee380514…
2019-07-19 19:46 UTC2019-07A088004-004AB1ea99ee380514…

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
2027-12-31

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
52fea941-0b47-41c1-b00d-f88150e8ab93Available 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
51079-565-01Thioridazine Hydrochloride1 in 1 BLISTER PACKTABLET, FILM COATED115
51079-565-20Thioridazine Hydrochloride100 in 1 CARTONTABLET, FILM COATED10015

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
51079-565-01EA - Each51079-565be9b6b5f-0a37-494c-9aa9-8116a43b01c512012-07-24
51079-565-20EA - Each51079-565ed70e177-5b52-4ff7-9066-e83eb98381cb12012-07-24

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIIDailyMed labelSPL versionUploaded
THIORIDAZINE HYDROCHLORIDEACTIVE INGREDIENT4WCI67NK8MTHIORIDAZINE HYDROCHLORIDE TABLET, FILM COATED [MYLAN INSTITUTIONAL INC.]4
THIORIDAZINEACTIVE MOIETYN3D6TG58NITHIORIDAZINE HYDROCHLORIDE TABLET, FILM COATED [MYLAN INSTITUTIONAL INC.]4
CELLULOSE, MICROCRYSTALLINEINACTIVE INGREDIENTOP1R32D61UTHIORIDAZINE HYDROCHLORIDE TABLET, FILM COATED [MYLAN INSTITUTIONAL INC.]4
CROSCARMELLOSE SODIUMINACTIVE INGREDIENTM28OL1HH48THIORIDAZINE HYDROCHLORIDE TABLET, FILM COATED [MYLAN INSTITUTIONAL INC.]4
FD&C YELLOW NO. 6INACTIVE INGREDIENTH77VEI93A8THIORIDAZINE HYDROCHLORIDE TABLET, FILM COATED [MYLAN INSTITUTIONAL INC.]4
HYDROXYPROPYL CELLULOSE (TYPE H)INACTIVE INGREDIENTRFW2ET671PTHIORIDAZINE HYDROCHLORIDE TABLET, FILM COATED [MYLAN INSTITUTIONAL INC.]4
HYPROMELLOSESINACTIVE INGREDIENT3NXW29V3WOTHIORIDAZINE HYDROCHLORIDE TABLET, FILM COATED [MYLAN INSTITUTIONAL INC.]4
MAGNESIUM STEARATEINACTIVE INGREDIENT70097M6I30THIORIDAZINE HYDROCHLORIDE TABLET, FILM COATED [MYLAN INSTITUTIONAL INC.]4
POLYETHYLENE GLYCOLSINACTIVE INGREDIENT3WJQ0SDW1ATHIORIDAZINE HYDROCHLORIDE TABLET, FILM COATED [MYLAN INSTITUTIONAL INC.]4
SILICON DIOXIDEINACTIVE INGREDIENTETJ7Z6XBU4THIORIDAZINE HYDROCHLORIDE TABLET, FILM COATED [MYLAN INSTITUTIONAL INC.]4
SODIUM LAURYL SULFATEINACTIVE INGREDIENT368GB5141JTHIORIDAZINE HYDROCHLORIDE TABLET, FILM COATED [MYLAN INSTITUTIONAL INC.]4
TITANIUM DIOXIDEINACTIVE INGREDIENT15FIX9V2JPTHIORIDAZINE HYDROCHLORIDE TABLET, FILM COATED [MYLAN INSTITUTIONAL INC.]4

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
51079-565THIORIDAZINE HYDROCHLORIDE TABLET, FILM COATED [MYLAN INSTITUTIONAL INC.]13Current NDC, Legacy NDC, 2 package rows20211217_52fea941-0b47-41c1-b00d-f88150e8ab93.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 · 3 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
Thioridazine HydrochlorideTHIORIDAZINE HYDROCHLORIDESafecor Health LLC1fd16a99-e856-4a37-9dae-c443714fac142026-03-02Boxed warning, Warnings, Adverse reactionsExact identifier
application applno (ANDA): 088004
application number: ANDA088004
Thioridazine HydrochlorideTHIORIDAZINE HYDROCHLORIDEMylan Institutional Inc.52fea941-0b47-41c1-b00d-f88150e8ab932025-11-11Boxed warning, Warnings, Adverse reactionsExact identifier
application applno (ANDA): 088004
application number: ANDA088004
ndc (product): 51079-565
Thioridazine HydrochlorideTHIORIDAZINE HYDROCHLORIDEMylan Pharmaceuticals Inc.56b3f4c2-52af-4947-b225-6808ae9f26f52025-01-15Boxed warning, Warnings, Adverse reactionsExact identifier
application applno (ANDA): 088004
application number: ANDA088004

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
313354thioridazine HCl 10 MG Oral TabletPSN52fea941-0b47-41c1-b00d-f88150e8ab9315
198270thioridazine HCl 100 MG Oral TabletPSN52fea941-0b47-41c1-b00d-f88150e8ab9315
198274thioridazine HCl 25 MG Oral TabletPSN52fea941-0b47-41c1-b00d-f88150e8ab9315
198275thioridazine HCl 50 MG Oral TabletPSN52fea941-0b47-41c1-b00d-f88150e8ab9315
313354thioridazine 10 MG Oral TabletSCD52fea941-0b47-41c1-b00d-f88150e8ab9315
198270thioridazine 100 MG Oral TabletSCD52fea941-0b47-41c1-b00d-f88150e8ab9315
198274thioridazine 25 MG Oral TabletSCD52fea941-0b47-41c1-b00d-f88150e8ab9315
198275thioridazine 50 MG Oral TabletSCD52fea941-0b47-41c1-b00d-f88150e8ab9315
198274thioridazine (as thioridazine hydrochloride) 25 MG Oral TabletSY52fea941-0b47-41c1-b00d-f88150e8ab9315
198275thioridazine (as thioridazine hydrochloride) 50 MG Oral TabletSY52fea941-0b47-41c1-b00d-f88150e8ab9315

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
51079-565-01510790565011 in 1 BLISTER PACKHistorical
51079-565-2051079056520100 BLISTER PACK in 1 CARTON (51079-565-20) / 1 TABLET, FILM COATED in 1 BLISTER PACK (51079-565-01) 100 blister pack1998-04-290000-00-00NoNoCurrent