Trifluoperazine Hydrochloride

Product NDC
48433-140
11-digit product format
484330140
Labeler code
48433
Product ID
48433-140_51015912-4104-ed2c-e063-6294a90ab288
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
trifluoperazine hydrochloride
Dosage form
TABLET, FILM COATED
Route
ORAL
Labeler
Safecor Health LLC
Application
ANDA040209
Marketing category
ANDA
Marketing start
2026-04-07
Substance
TRIFLUOPERAZINE HYDROCHLORIDE
Active strength
1 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
Trifluoperazine Hydrochloride
Listing expiration
2027-12-31

Active Ingredients#

Ingredient, Strength table
IngredientStrength
TRIFLUOPERAZINE HYDROCHLORIDE1 mg/1

Harmonized Identifiers#

Field, Values table
FieldValues
Unii6P1Y2SNF5V
Rxcui198322, 198323, 198324, 198325

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
f79ee509-5da6-94e3-5c99-5b799d5c6f47Product name120140508

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
48433-140-01Trifluoperazine Hydrochloride1 in 1 BLISTER PACKTABLET, FILM COATED13
48433-140-20Trifluoperazine Hydrochloride100 in 1 CARTONTABLET, FILM COATED1003

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
198322trifluoperazine HCl 1 MG Oral TabletPSN8501543b-0c74-4087-9946-e7198400814a3
198323trifluoperazine HCl 10 MG Oral TabletPSN8501543b-0c74-4087-9946-e7198400814a3
198324trifluoperazine HCl 2 MG Oral TabletPSN8501543b-0c74-4087-9946-e7198400814a3
198325trifluoperazine HCl 5 MG Oral TabletPSN8501543b-0c74-4087-9946-e7198400814a3
198322trifluoperazine 1 MG Oral TabletSCD8501543b-0c74-4087-9946-e7198400814a3
198323trifluoperazine 10 MG Oral TabletSCD8501543b-0c74-4087-9946-e7198400814a3
198324trifluoperazine 2 MG Oral TabletSCD8501543b-0c74-4087-9946-e7198400814a3
198325trifluoperazine 5 MG Oral TabletSCD8501543b-0c74-4087-9946-e7198400814a3
198322trifluoperazine (as trifluoperazine hydrochloride) 1 MG Oral TabletSY8501543b-0c74-4087-9946-e7198400814a3
198323trifluoperazine (as trifluoperazine hydrochloride) 10 MG Oral TabletSY8501543b-0c74-4087-9946-e7198400814a3
198324trifluoperazine (as trifluoperazine hydrochloride) 2 MG Oral TabletSY8501543b-0c74-4087-9946-e7198400814a3
198325trifluoperazine (as trifluoperazine hydrochloride) 5 MG Oral TabletSY8501543b-0c74-4087-9946-e7198400814a3

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startSampleExclude flagStatus
48433-140-01484330140011 in 1 BLISTER PACKHistorical
48433-140-2048433014020100 BLISTER PACK in 1 CARTON (48433-140-20) / 1 TABLET, FILM COATED in 1 BLISTER PACK (48433-140-01) 100 blister pack2026-04-07NoNoCurrent