FDA.reportPublic FDA data

Thioridazine Hydrochloride

Product NDC
0378-0616
11-digit product format
003780616
Labeler code
0378
Product ID
0378-0616_6437f615-1e2b-4d0a-ba83-a0c14391693d
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
thioridazine hydrochloride
Dosage form
TABLET, FILM COATED
Route
ORAL
Labeler
Mylan Pharmaceuticals Inc.
Application
ANDA088004
Marketing category
ANDA
Marketing start
1983-03-15
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

Additional Listing Data#

Finished product
Yes
Brand name base
Thioridazine Hydrochloride
Listing expiration
2026-12-31

Active Ingredients#

Ingredient, Strength table
IngredientStrength
THIORIDAZINE HYDROCHLORIDE50 mg/1

Harmonized Identifiers#

Field, Values table
FieldValues
Unii4WCI67NK8M
Rxcui198270, 198274, 198275, 313354

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
0378-0616-01Thioridazine Hydrochloride100 in 1 BOTTLE, PLASTICTABLET, FILM COATED10015

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
0378-0616-01EA - Each0378-061621475439-87c0-4110-904d-87d42dc97aac12012-07-24
0378-0616-10EA - Each0378-06168a7ad8ed-f439-4335-9c84-9623a5cbb7fc12012-07-24

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIIDailyMed labelSPL versionUploaded
THIORIDAZINE HYDROCHLORIDEACTIVE INGREDIENT4WCI67NK8MTHIORIDAZINE HYDROCHLORIDE TABLET, FILM COATED [MYLAN PHARMACEUTICALS INC.]7
THIORIDAZINEACTIVE MOIETYN3D6TG58NITHIORIDAZINE HYDROCHLORIDE TABLET, FILM COATED [MYLAN PHARMACEUTICALS INC.]7
CELLULOSE, MICROCRYSTALLINEINACTIVE INGREDIENTOP1R32D61UTHIORIDAZINE HYDROCHLORIDE TABLET, FILM COATED [MYLAN PHARMACEUTICALS INC.]7
CROSCARMELLOSE SODIUMINACTIVE INGREDIENTM28OL1HH48THIORIDAZINE HYDROCHLORIDE TABLET, FILM COATED [MYLAN PHARMACEUTICALS INC.]7
FD&C YELLOW NO. 6INACTIVE INGREDIENTH77VEI93A8THIORIDAZINE HYDROCHLORIDE TABLET, FILM COATED [MYLAN PHARMACEUTICALS INC.]7
HYDROXYPROPYL CELLULOSE (TYPE H)INACTIVE INGREDIENTRFW2ET671PTHIORIDAZINE HYDROCHLORIDE TABLET, FILM COATED [MYLAN PHARMACEUTICALS INC.]7
HYPROMELLOSESINACTIVE INGREDIENT3NXW29V3WOTHIORIDAZINE HYDROCHLORIDE TABLET, FILM COATED [MYLAN PHARMACEUTICALS INC.]7
MAGNESIUM STEARATEINACTIVE INGREDIENT70097M6I30THIORIDAZINE HYDROCHLORIDE TABLET, FILM COATED [MYLAN PHARMACEUTICALS INC.]7
POLYETHYLENE GLYCOLSINACTIVE INGREDIENT3WJQ0SDW1ATHIORIDAZINE HYDROCHLORIDE TABLET, FILM COATED [MYLAN PHARMACEUTICALS INC.]7
SILICON DIOXIDEINACTIVE INGREDIENTETJ7Z6XBU4THIORIDAZINE HYDROCHLORIDE TABLET, FILM COATED [MYLAN PHARMACEUTICALS INC.]7
SODIUM LAURYL SULFATEINACTIVE INGREDIENT368GB5141JTHIORIDAZINE HYDROCHLORIDE TABLET, FILM COATED [MYLAN PHARMACEUTICALS INC.]7
TITANIUM DIOXIDEINACTIVE INGREDIENT15FIX9V2JPTHIORIDAZINE HYDROCHLORIDE TABLET, FILM COATED [MYLAN PHARMACEUTICALS INC.]7
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
0378-0616THIORIDAZINE HYDROCHLORIDE TABLET, FILM COATED [MYLAN PHARMACEUTICALS INC.]15Current NDC, Legacy NDC, 1 package rows20250214_56b3f4c2-52af-4947-b225-6808ae9f26f5.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
313354thioridazine HCl 10 MG Oral TabletPSN56b3f4c2-52af-4947-b225-6808ae9f26f515
313354thioridazine HCl 10 MG Oral TabletPSN52fea941-0b47-41c1-b00d-f88150e8ab9315
198270thioridazine HCl 100 MG Oral TabletPSN52fea941-0b47-41c1-b00d-f88150e8ab9315
198270thioridazine HCl 100 MG Oral TabletPSN56b3f4c2-52af-4947-b225-6808ae9f26f515
198274thioridazine HCl 25 MG Oral TabletPSN56b3f4c2-52af-4947-b225-6808ae9f26f515
198274thioridazine HCl 25 MG Oral TabletPSN52fea941-0b47-41c1-b00d-f88150e8ab9315
198275thioridazine HCl 50 MG Oral TabletPSN56b3f4c2-52af-4947-b225-6808ae9f26f515
198275thioridazine HCl 50 MG Oral TabletPSN52fea941-0b47-41c1-b00d-f88150e8ab9315
313354thioridazine 10 MG Oral TabletSCD52fea941-0b47-41c1-b00d-f88150e8ab9315
313354thioridazine 10 MG Oral TabletSCD56b3f4c2-52af-4947-b225-6808ae9f26f515
198270thioridazine 100 MG Oral TabletSCD56b3f4c2-52af-4947-b225-6808ae9f26f515
198270thioridazine 100 MG Oral TabletSCD52fea941-0b47-41c1-b00d-f88150e8ab9315
198274thioridazine 25 MG Oral TabletSCD56b3f4c2-52af-4947-b225-6808ae9f26f515
198274thioridazine 25 MG Oral TabletSCD52fea941-0b47-41c1-b00d-f88150e8ab9315
198275thioridazine 50 MG Oral TabletSCD56b3f4c2-52af-4947-b225-6808ae9f26f515
198275thioridazine 50 MG Oral TabletSCD52fea941-0b47-41c1-b00d-f88150e8ab9315
198274thioridazine (as thioridazine hydrochloride) 25 MG Oral TabletSY56b3f4c2-52af-4947-b225-6808ae9f26f515
198274thioridazine (as thioridazine hydrochloride) 25 MG Oral TabletSY52fea941-0b47-41c1-b00d-f88150e8ab9315
198275thioridazine (as thioridazine hydrochloride) 50 MG Oral TabletSY52fea941-0b47-41c1-b00d-f88150e8ab9315
198275thioridazine (as thioridazine hydrochloride) 50 MG Oral TabletSY56b3f4c2-52af-4947-b225-6808ae9f26f515
313354thioridazine HCl 10 MG Oral TabletPSN1fd16a99-e856-4a37-9dae-c443714fac142
198270thioridazine HCl 100 MG Oral TabletPSN1fd16a99-e856-4a37-9dae-c443714fac142
198274thioridazine HCl 25 MG Oral TabletPSN1fd16a99-e856-4a37-9dae-c443714fac142
198275thioridazine HCl 50 MG Oral TabletPSN1fd16a99-e856-4a37-9dae-c443714fac142
313354thioridazine 10 MG Oral TabletSCD1fd16a99-e856-4a37-9dae-c443714fac142
198270thioridazine 100 MG Oral TabletSCD1fd16a99-e856-4a37-9dae-c443714fac142
198274thioridazine 25 MG Oral TabletSCD1fd16a99-e856-4a37-9dae-c443714fac142
198275thioridazine 50 MG Oral TabletSCD1fd16a99-e856-4a37-9dae-c443714fac142
198274thioridazine (as thioridazine hydrochloride) 25 MG Oral TabletSY1fd16a99-e856-4a37-9dae-c443714fac142
198275thioridazine (as thioridazine hydrochloride) 50 MG Oral TabletSY1fd16a99-e856-4a37-9dae-c443714fac142

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionMarketing startMarketing endSampleExclude flagStatus
0378-0616-0100378061601100 TABLET, FILM COATED in 1 BOTTLE, PLASTIC (0378-0616-01) 1983-03-150000-00-00NoNoCurrent