Thioridazine Hydrochloride

Product NDC
48433-096
11-digit product format
484330096
Labeler code
48433
Product ID
48433-096_4c13278f-8a01-f1b7-e063-6394a90ac5b7
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
thioridazine hydrochloride
Dosage form
TABLET, FILM COATED
Route
ORAL
Labeler
Safecor Health LLC
Application
ANDA088004
Marketing category
ANDA
Marketing start
2026-02-19
Substance
THIORIDAZINE HYDROCHLORIDE
Active strength
25 mg/1
Pharmacologic classes
Phenothiazine [EPC], Phenothiazines [CS]
NDC exclude flag
No
Listing certified through
2027-12-31
Current FDA listing
Yes

Additional Listing Data#

Finished product
Yes
Brand name base
Thioridazine Hydrochloride
Listing expiration
2027-12-31

Active Ingredients#

Ingredient, Strength table
IngredientStrength
THIORIDAZINE HYDROCHLORIDE25 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
48433-096-01Thioridazine Hydrochloride1 in 1 BLISTER PACKTABLET, FILM COATED12
48433-096-20Thioridazine Hydrochloride100 in 1 CARTONTABLET, FILM COATED1002

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
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 formatDescriptionUnitsMarketing startSampleExclude flagStatus
48433-096-01484330096011 in 1 BLISTER PACKHistorical
48433-096-2048433009620100 BLISTER PACK in 1 CARTON (48433-096-20) / 1 TABLET, FILM COATED in 1 BLISTER PACK (48433-096-01) 100 blister pack2026-02-19NoNoHistorical