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
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 HYDROCHLORIDE10 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
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

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