FDA.reportPublic FDA data

Trifluoperazine Hydrochloride

Product NDC
0781-8032
11-digit product format
007818032
Labeler code
0781
Product ID
0781-8032_79bbd43c-c3f3-4fa5-a2a4-88868251febb
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Trifluoperazine Hydrochloride
Dosage form
TABLET, FILM COATED
Route
ORAL
Labeler
Sandoz Inc.
Application
ANDA085786
Marketing category
ANDA
Marketing start
1981-11-20
Substance
TRIFLUOPERAZINE HYDROCHLORIDE
Active strength
2 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
Trifluoperazine Hydrochloride
Listing expiration
2026-12-31

Active Ingredients#

Ingredient, Strength table
IngredientStrength
TRIFLUOPERAZINE HYDROCHLORIDE2 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
0781-8032-01Trifluoperazine Hydrochloride100 in 1 BOTTLETABLET, FILM COATED1007

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
0781-8032-01EA - Each0781-8032f3aee136-d7b3-4b4d-97c8-f63a5e76152c12019-02-13

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
0781-8032TRIFLUOPERAZINE HYDROCHLORIDE TABLET, FILM COATED [SANDOZ INC.]7Current NDC, Legacy NDC, 1 package rows20250214_ae43c10e-cfa9-4298-8af5-7a3e6524bbda.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
198324trifluoperazine HCl 2 MG Oral TabletPSNe63617bb-8186-43d3-9d01-aa53217343e4102
198324trifluoperazine 2 MG Oral TabletSCDe63617bb-8186-43d3-9d01-aa53217343e4102
198324trifluoperazine (as trifluoperazine hydrochloride) 2 MG Oral TabletSYe63617bb-8186-43d3-9d01-aa53217343e4102
198322trifluoperazine HCl 1 MG Oral TabletPSNae43c10e-cfa9-4298-8af5-7a3e6524bbda7
198323trifluoperazine HCl 10 MG Oral TabletPSNae43c10e-cfa9-4298-8af5-7a3e6524bbda7
198324trifluoperazine HCl 2 MG Oral TabletPSNae43c10e-cfa9-4298-8af5-7a3e6524bbda7
198325trifluoperazine HCl 5 MG Oral TabletPSNae43c10e-cfa9-4298-8af5-7a3e6524bbda7
198322trifluoperazine 1 MG Oral TabletSCDae43c10e-cfa9-4298-8af5-7a3e6524bbda7
198323trifluoperazine 10 MG Oral TabletSCDae43c10e-cfa9-4298-8af5-7a3e6524bbda7
198324trifluoperazine 2 MG Oral TabletSCDae43c10e-cfa9-4298-8af5-7a3e6524bbda7
198325trifluoperazine 5 MG Oral TabletSCDae43c10e-cfa9-4298-8af5-7a3e6524bbda7
198322trifluoperazine (as trifluoperazine hydrochloride) 1 MG Oral TabletSYae43c10e-cfa9-4298-8af5-7a3e6524bbda7
198323trifluoperazine (as trifluoperazine hydrochloride) 10 MG Oral TabletSYae43c10e-cfa9-4298-8af5-7a3e6524bbda7
198324trifluoperazine (as trifluoperazine hydrochloride) 2 MG Oral TabletSYae43c10e-cfa9-4298-8af5-7a3e6524bbda7
198325trifluoperazine (as trifluoperazine hydrochloride) 5 MG Oral TabletSYae43c10e-cfa9-4298-8af5-7a3e6524bbda7
198324trifluoperazine HCl 2 MG Oral TabletPSN069d3469-138b-4e4f-a7bb-6acac5f86abb1
198324trifluoperazine 2 MG Oral TabletSCD069d3469-138b-4e4f-a7bb-6acac5f86abb1
198324trifluoperazine (as trifluoperazine hydrochloride) 2 MG Oral TabletSY069d3469-138b-4e4f-a7bb-6acac5f86abb1

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionMarketing startMarketing endSampleExclude flagStatus
0781-8032-0100781803201100 TABLET, FILM COATED in 1 BOTTLE (0781-8032-01) 2019-01-140000-00-00NoNoCurrent