FDA.reportPublic FDA data

Thioridazine Hydrochloride

Product NDC
53489-500
11-digit product format
534890500
Labeler code
53489
Product ID
53489-500_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
100 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 HYDROCHLORIDE100 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
53489-500-01Thioridazine Hydrochloride100 in 1 BOTTLE, PLASTICTABLET, FILM COATED1007
53489-500-02Thioridazine Hydrochloride50 in 1 BOTTLE, PLASTICTABLET, FILM COATED507
53489-500-03Thioridazine Hydrochloride250 in 1 BOTTLE, PLASTICTABLET, FILM COATED2507
53489-500-05Thioridazine Hydrochloride500 in 1 BOTTLE, PLASTICTABLET, FILM COATED5007
53489-500-06Thioridazine Hydrochloride60 in 1 BOTTLE, PLASTICTABLET, FILM COATED607
53489-500-10Thioridazine Hydrochloride1000 in 1 BOTTLE, PLASTICTABLET, FILM COATED10007
53489-500-60Thioridazine Hydrochloride20 in 1 BOTTLE, PLASTICTABLET, FILM COATED207

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
53489-500-01EA - Each53489-50036b65ca7-0a3e-4fca-8cca-64fef70d422612012-07-24

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
53489-500THIORIDAZINE HYDROCHLORIDE TABLET, FILM COATED [SUN PHARMACEUTICAL INDUSTRIES, INC.]7Current NDC, Legacy NDC, 7 package rows20171101_9c4bedb4-2d59-4fcd-aad7-fce988cd96d8.zip

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
53489-500-0153489050001100 TABLET, FILM COATED in 1 BOTTLE, PLASTIC (53489-500-01) 1988-10-070000-00-00NoNoCurrent
53489-500-025348905000250 TABLET, FILM COATED in 1 BOTTLE, PLASTIC (53489-500-02) 1988-10-070000-00-00NoNoCurrent
53489-500-0353489050003250 TABLET, FILM COATED in 1 BOTTLE, PLASTIC (53489-500-03) 1988-10-070000-00-00NoNoCurrent
53489-500-0553489050005500 TABLET, FILM COATED in 1 BOTTLE, PLASTIC (53489-500-05) 1988-10-070000-00-00NoNoCurrent
53489-500-065348905000660 TABLET, FILM COATED in 1 BOTTLE, PLASTIC (53489-500-06) 1988-10-070000-00-00NoNoCurrent
53489-500-10534890500101000 TABLET, FILM COATED in 1 BOTTLE, PLASTIC (53489-500-10) 1988-10-070000-00-00NoNoCurrent
53489-500-605348905006020 TABLET, FILM COATED in 1 BOTTLE, PLASTIC (53489-500-60) 1988-10-070000-00-00NoNoCurrent