FDA.reportPublic FDA data

Trifluoperazine Hydrochloride

Product NDC
0378-2401
11-digit product format
003782401
Labeler code
0378
Product ID
0378-2401_7586125c-d9c7-4c56-8ca8-8add657a91db
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
trifluoperazine hydrochloride
Dosage form
TABLET, FILM COATED
Route
ORAL
Labeler
Mylan Pharmaceuticals Inc.
Application
ANDA040209
Marketing category
ANDA
Marketing start
1997-08-29
Substance
TRIFLUOPERAZINE HYDROCHLORIDE
Active strength
1 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 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
0378-2401-01Trifluoperazine Hydrochloride100 in 1 BOTTLE, PLASTICTABLET, FILM COATED10016

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
0378-2401-01EA - Each0378-240190946182-64c8-413a-8116-3c3f9d4160f412012-07-24

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIIDailyMed labelSPL versionUploaded
TRIFLUOPERAZINE HYDROCHLORIDEACTIVE INGREDIENT6P1Y2SNF5VTRIFLUOPERAZINE HYDROCHLORIDE TABLET, FILM COATED [MYLAN PHARMACEUTICALS INC.]7
TRIFLUOPERAZINEACTIVE MOIETY214IZI85K3TRIFLUOPERAZINE HYDROCHLORIDE TABLET, FILM COATED [MYLAN PHARMACEUTICALS INC.]7
CELLULOSE, MICROCRYSTALLINEINACTIVE INGREDIENTOP1R32D61UTRIFLUOPERAZINE HYDROCHLORIDE TABLET, FILM COATED [MYLAN PHARMACEUTICALS INC.]7
CROSCARMELLOSE SODIUMINACTIVE INGREDIENTM28OL1HH48TRIFLUOPERAZINE HYDROCHLORIDE TABLET, FILM COATED [MYLAN PHARMACEUTICALS INC.]7
D&C RED NO. 30INACTIVE INGREDIENT2S42T2808BTRIFLUOPERAZINE HYDROCHLORIDE TABLET, FILM COATED [MYLAN PHARMACEUTICALS INC.]7
FD&C BLUE NO. 2INACTIVE INGREDIENTL06K8R7DQKTRIFLUOPERAZINE HYDROCHLORIDE TABLET, FILM COATED [MYLAN PHARMACEUTICALS INC.]7
FD&C YELLOW NO. 6INACTIVE INGREDIENTH77VEI93A8TRIFLUOPERAZINE HYDROCHLORIDE TABLET, FILM COATED [MYLAN PHARMACEUTICALS INC.]7
HYPROMELLOSESINACTIVE INGREDIENT3NXW29V3WOTRIFLUOPERAZINE HYDROCHLORIDE TABLET, FILM COATED [MYLAN PHARMACEUTICALS INC.]7
LACTOSE MONOHYDRATEINACTIVE INGREDIENTEWQ57Q8I5XTRIFLUOPERAZINE HYDROCHLORIDE TABLET, FILM COATED [MYLAN PHARMACEUTICALS INC.]7
MAGNESIUM STEARATEINACTIVE INGREDIENT70097M6I30TRIFLUOPERAZINE HYDROCHLORIDE TABLET, FILM COATED [MYLAN PHARMACEUTICALS INC.]7
POLYDEXTROSEINACTIVE INGREDIENTVH2XOU12IETRIFLUOPERAZINE HYDROCHLORIDE TABLET, FILM COATED [MYLAN PHARMACEUTICALS INC.]7
POLYETHYLENE GLYCOLSINACTIVE INGREDIENT3WJQ0SDW1ATRIFLUOPERAZINE HYDROCHLORIDE TABLET, FILM COATED [MYLAN PHARMACEUTICALS INC.]7
SILICON DIOXIDEINACTIVE INGREDIENTETJ7Z6XBU4TRIFLUOPERAZINE HYDROCHLORIDE TABLET, FILM COATED [MYLAN PHARMACEUTICALS INC.]7
SODIUM LAURYL SULFATEINACTIVE INGREDIENT368GB5141JTRIFLUOPERAZINE HYDROCHLORIDE TABLET, FILM COATED [MYLAN PHARMACEUTICALS INC.]7
STARCH, CORNINACTIVE INGREDIENTO8232NY3SJTRIFLUOPERAZINE HYDROCHLORIDE TABLET, FILM COATED [MYLAN PHARMACEUTICALS INC.]7
TITANIUM DIOXIDEINACTIVE INGREDIENT15FIX9V2JPTRIFLUOPERAZINE HYDROCHLORIDE TABLET, FILM COATED [MYLAN PHARMACEUTICALS INC.]7
TRIACETININACTIVE INGREDIENTXHX3C3X673TRIFLUOPERAZINE HYDROCHLORIDE TABLET, FILM COATED [MYLAN PHARMACEUTICALS INC.]7
TRIFLUOPERAZINE HYDROCHLORIDEACTIVE INGREDIENT6P1Y2SNF5VTRIFLUOPERAZINE HYDROCHLORIDE TABLET, FILM COATED [MYLAN INSTITUTIONAL INC.]3
TRIFLUOPERAZINEACTIVE MOIETY214IZI85K3TRIFLUOPERAZINE HYDROCHLORIDE TABLET, FILM COATED [MYLAN INSTITUTIONAL INC.]3
CELLULOSE, MICROCRYSTALLINEINACTIVE INGREDIENTOP1R32D61UTRIFLUOPERAZINE HYDROCHLORIDE TABLET, FILM COATED [MYLAN INSTITUTIONAL INC.]3
CROSCARMELLOSE SODIUMINACTIVE INGREDIENTM28OL1HH48TRIFLUOPERAZINE HYDROCHLORIDE TABLET, FILM COATED [MYLAN INSTITUTIONAL INC.]3
D&C RED NO. 30INACTIVE INGREDIENT2S42T2808BTRIFLUOPERAZINE HYDROCHLORIDE TABLET, FILM COATED [MYLAN INSTITUTIONAL INC.]3
FD&C BLUE NO. 2INACTIVE INGREDIENTL06K8R7DQKTRIFLUOPERAZINE HYDROCHLORIDE TABLET, FILM COATED [MYLAN INSTITUTIONAL INC.]3
FD&C YELLOW NO. 6INACTIVE INGREDIENTH77VEI93A8TRIFLUOPERAZINE HYDROCHLORIDE TABLET, FILM COATED [MYLAN INSTITUTIONAL INC.]3
HYPROMELLOSESINACTIVE INGREDIENT3NXW29V3WOTRIFLUOPERAZINE HYDROCHLORIDE TABLET, FILM COATED [MYLAN INSTITUTIONAL INC.]3
LACTOSE MONOHYDRATEINACTIVE INGREDIENTEWQ57Q8I5XTRIFLUOPERAZINE HYDROCHLORIDE TABLET, FILM COATED [MYLAN INSTITUTIONAL INC.]3
MAGNESIUM STEARATEINACTIVE INGREDIENT70097M6I30TRIFLUOPERAZINE HYDROCHLORIDE TABLET, FILM COATED [MYLAN INSTITUTIONAL INC.]3
POLYDEXTROSEINACTIVE INGREDIENTVH2XOU12IETRIFLUOPERAZINE HYDROCHLORIDE TABLET, FILM COATED [MYLAN INSTITUTIONAL INC.]3
POLYETHYLENE GLYCOLSINACTIVE INGREDIENT3WJQ0SDW1ATRIFLUOPERAZINE HYDROCHLORIDE TABLET, FILM COATED [MYLAN INSTITUTIONAL INC.]3
SILICON DIOXIDEINACTIVE INGREDIENTETJ7Z6XBU4TRIFLUOPERAZINE HYDROCHLORIDE TABLET, FILM COATED [MYLAN INSTITUTIONAL INC.]3
SODIUM LAURYL SULFATEINACTIVE INGREDIENT368GB5141JTRIFLUOPERAZINE HYDROCHLORIDE TABLET, FILM COATED [MYLAN INSTITUTIONAL INC.]3
STARCH, CORNINACTIVE INGREDIENTO8232NY3SJTRIFLUOPERAZINE HYDROCHLORIDE TABLET, FILM COATED [MYLAN INSTITUTIONAL INC.]3
TITANIUM DIOXIDEINACTIVE INGREDIENT15FIX9V2JPTRIFLUOPERAZINE HYDROCHLORIDE TABLET, FILM COATED [MYLAN INSTITUTIONAL INC.]3
TRIACETININACTIVE INGREDIENTXHX3C3X673TRIFLUOPERAZINE HYDROCHLORIDE TABLET, FILM COATED [MYLAN INSTITUTIONAL INC.]3

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
0378-2401TRIFLUOPERAZINE HYDROCHLORIDE TABLET, FILM COATED [MYLAN PHARMACEUTICALS INC.]16Current NDC, Legacy NDC, 1 package rows20250406_c2575a86-19e5-44df-8603-ff066bb9c9c5.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
198322trifluoperazine HCl 1 MG Oral TabletPSNc2575a86-19e5-44df-8603-ff066bb9c9c516
198323trifluoperazine HCl 10 MG Oral TabletPSNc2575a86-19e5-44df-8603-ff066bb9c9c516
198324trifluoperazine HCl 2 MG Oral TabletPSNc2575a86-19e5-44df-8603-ff066bb9c9c516
198325trifluoperazine HCl 5 MG Oral TabletPSNc2575a86-19e5-44df-8603-ff066bb9c9c516
198322trifluoperazine 1 MG Oral TabletSCDc2575a86-19e5-44df-8603-ff066bb9c9c516
198323trifluoperazine 10 MG Oral TabletSCDc2575a86-19e5-44df-8603-ff066bb9c9c516
198324trifluoperazine 2 MG Oral TabletSCDc2575a86-19e5-44df-8603-ff066bb9c9c516
198325trifluoperazine 5 MG Oral TabletSCDc2575a86-19e5-44df-8603-ff066bb9c9c516
198322trifluoperazine (as trifluoperazine hydrochloride) 1 MG Oral TabletSYc2575a86-19e5-44df-8603-ff066bb9c9c516
198323trifluoperazine (as trifluoperazine hydrochloride) 10 MG Oral TabletSYc2575a86-19e5-44df-8603-ff066bb9c9c516
198324trifluoperazine (as trifluoperazine hydrochloride) 2 MG Oral TabletSYc2575a86-19e5-44df-8603-ff066bb9c9c516
198325trifluoperazine (as trifluoperazine hydrochloride) 5 MG Oral TabletSYc2575a86-19e5-44df-8603-ff066bb9c9c516
198322trifluoperazine HCl 1 MG Oral TabletPSNf742a579-411a-4140-91c4-edc735d638fa11
198323trifluoperazine HCl 10 MG Oral TabletPSNf742a579-411a-4140-91c4-edc735d638fa11
198324trifluoperazine HCl 2 MG Oral TabletPSNf742a579-411a-4140-91c4-edc735d638fa11
198325trifluoperazine HCl 5 MG Oral TabletPSNf742a579-411a-4140-91c4-edc735d638fa11
198322trifluoperazine 1 MG Oral TabletSCDf742a579-411a-4140-91c4-edc735d638fa11
198323trifluoperazine 10 MG Oral TabletSCDf742a579-411a-4140-91c4-edc735d638fa11
198324trifluoperazine 2 MG Oral TabletSCDf742a579-411a-4140-91c4-edc735d638fa11
198325trifluoperazine 5 MG Oral TabletSCDf742a579-411a-4140-91c4-edc735d638fa11
198322trifluoperazine (as trifluoperazine hydrochloride) 1 MG Oral TabletSYf742a579-411a-4140-91c4-edc735d638fa11
198323trifluoperazine (as trifluoperazine hydrochloride) 10 MG Oral TabletSYf742a579-411a-4140-91c4-edc735d638fa11
198324trifluoperazine (as trifluoperazine hydrochloride) 2 MG Oral TabletSYf742a579-411a-4140-91c4-edc735d638fa11
198325trifluoperazine (as trifluoperazine hydrochloride) 5 MG Oral TabletSYf742a579-411a-4140-91c4-edc735d638fa11
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 formatDescriptionMarketing startMarketing endSampleExclude flagStatus
0378-2401-0100378240101100 TABLET, FILM COATED in 1 BOTTLE, PLASTIC (0378-2401-01) 1997-08-290000-00-00NoNoCurrent