Trifluoperazine Hydrochloride

Product NDC: 0378-2402
11-digit product format: 003782402
Labeler code: 0378
Product ID: 0378-2402_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: 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
Ingredient	Strength
TRIFLUOPERAZINE HYDROCHLORIDE	2 mg/1

Harmonized Identifiers#

Field, Values table
Field	Values
Unii	6P1Y2SNF5V
Rxcui	198322, 198323, 198324, 198325

DailyMed Product Concepts#

Product concept, Relation, Version table
Product concept	Relation	Version	Effective
f79ee509-5da6-94e3-5c99-5b799d5c6f47	Product name	1	20140508

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDC	Product	Description	Form	Quantity	Strength	SPL version
0378-2402-01	Trifluoperazine Hydrochloride	100 in 1 BOTTLE, PLASTIC	TABLET, FILM COATED	100		16

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDC	Billing unit	Product NDC	DailyMed indexing SPL	SPL version	Effective
0378-2402-01	EA - Each	0378-2402	353c2d9d-e521-4bf6-88a3-d5276874e501	1	2012-07-24

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
Ingredient	Type	UNII	DailyMed label	SPL version
TRIFLUOPERAZINE HYDROCHLORIDE	ACTIVE INGREDIENT	6P1Y2SNF5V	TRIFLUOPERAZINE HYDROCHLORIDE TABLET, FILM COATED [MYLAN PHARMACEUTICALS INC.]	7
TRIFLUOPERAZINE	ACTIVE MOIETY	214IZI85K3	TRIFLUOPERAZINE HYDROCHLORIDE TABLET, FILM COATED [MYLAN PHARMACEUTICALS INC.]	7
CELLULOSE, MICROCRYSTALLINE	INACTIVE INGREDIENT	OP1R32D61U	TRIFLUOPERAZINE HYDROCHLORIDE TABLET, FILM COATED [MYLAN PHARMACEUTICALS INC.]	7
CROSCARMELLOSE SODIUM	INACTIVE INGREDIENT	M28OL1HH48	TRIFLUOPERAZINE HYDROCHLORIDE TABLET, FILM COATED [MYLAN PHARMACEUTICALS INC.]	7
D&C RED NO. 30	INACTIVE INGREDIENT	2S42T2808B	TRIFLUOPERAZINE HYDROCHLORIDE TABLET, FILM COATED [MYLAN PHARMACEUTICALS INC.]	7
FD&C BLUE NO. 2	INACTIVE INGREDIENT	L06K8R7DQK	TRIFLUOPERAZINE HYDROCHLORIDE TABLET, FILM COATED [MYLAN PHARMACEUTICALS INC.]	7
FD&C YELLOW NO. 6	INACTIVE INGREDIENT	H77VEI93A8	TRIFLUOPERAZINE HYDROCHLORIDE TABLET, FILM COATED [MYLAN PHARMACEUTICALS INC.]	7
HYPROMELLOSES	INACTIVE INGREDIENT	3NXW29V3WO	TRIFLUOPERAZINE HYDROCHLORIDE TABLET, FILM COATED [MYLAN PHARMACEUTICALS INC.]	7
LACTOSE MONOHYDRATE	INACTIVE INGREDIENT	EWQ57Q8I5X	TRIFLUOPERAZINE HYDROCHLORIDE TABLET, FILM COATED [MYLAN PHARMACEUTICALS INC.]	7
MAGNESIUM STEARATE	INACTIVE INGREDIENT	70097M6I30	TRIFLUOPERAZINE HYDROCHLORIDE TABLET, FILM COATED [MYLAN PHARMACEUTICALS INC.]	7
POLYDEXTROSE	INACTIVE INGREDIENT	VH2XOU12IE	TRIFLUOPERAZINE HYDROCHLORIDE TABLET, FILM COATED [MYLAN PHARMACEUTICALS INC.]	7
POLYETHYLENE GLYCOLS	INACTIVE INGREDIENT	3WJQ0SDW1A	TRIFLUOPERAZINE HYDROCHLORIDE TABLET, FILM COATED [MYLAN PHARMACEUTICALS INC.]	7
SILICON DIOXIDE	INACTIVE INGREDIENT	ETJ7Z6XBU4	TRIFLUOPERAZINE HYDROCHLORIDE TABLET, FILM COATED [MYLAN PHARMACEUTICALS INC.]	7
SODIUM LAURYL SULFATE	INACTIVE INGREDIENT	368GB5141J	TRIFLUOPERAZINE HYDROCHLORIDE TABLET, FILM COATED [MYLAN PHARMACEUTICALS INC.]	7
STARCH, CORN	INACTIVE INGREDIENT	O8232NY3SJ	TRIFLUOPERAZINE HYDROCHLORIDE TABLET, FILM COATED [MYLAN PHARMACEUTICALS INC.]	7
TITANIUM DIOXIDE	INACTIVE INGREDIENT	15FIX9V2JP	TRIFLUOPERAZINE HYDROCHLORIDE TABLET, FILM COATED [MYLAN PHARMACEUTICALS INC.]	7
TRIACETIN	INACTIVE INGREDIENT	XHX3C3X673	TRIFLUOPERAZINE HYDROCHLORIDE TABLET, FILM COATED [MYLAN PHARMACEUTICALS INC.]	7
TRIFLUOPERAZINE HYDROCHLORIDE	ACTIVE INGREDIENT	6P1Y2SNF5V	TRIFLUOPERAZINE HYDROCHLORIDE TABLET, FILM COATED [MYLAN INSTITUTIONAL INC.]	3
TRIFLUOPERAZINE	ACTIVE MOIETY	214IZI85K3	TRIFLUOPERAZINE HYDROCHLORIDE TABLET, FILM COATED [MYLAN INSTITUTIONAL INC.]	3
CELLULOSE, MICROCRYSTALLINE	INACTIVE INGREDIENT	OP1R32D61U	TRIFLUOPERAZINE HYDROCHLORIDE TABLET, FILM COATED [MYLAN INSTITUTIONAL INC.]	3
CROSCARMELLOSE SODIUM	INACTIVE INGREDIENT	M28OL1HH48	TRIFLUOPERAZINE HYDROCHLORIDE TABLET, FILM COATED [MYLAN INSTITUTIONAL INC.]	3
D&C RED NO. 30	INACTIVE INGREDIENT	2S42T2808B	TRIFLUOPERAZINE HYDROCHLORIDE TABLET, FILM COATED [MYLAN INSTITUTIONAL INC.]	3
FD&C BLUE NO. 2	INACTIVE INGREDIENT	L06K8R7DQK	TRIFLUOPERAZINE HYDROCHLORIDE TABLET, FILM COATED [MYLAN INSTITUTIONAL INC.]	3
FD&C YELLOW NO. 6	INACTIVE INGREDIENT	H77VEI93A8	TRIFLUOPERAZINE HYDROCHLORIDE TABLET, FILM COATED [MYLAN INSTITUTIONAL INC.]	3
HYPROMELLOSES	INACTIVE INGREDIENT	3NXW29V3WO	TRIFLUOPERAZINE HYDROCHLORIDE TABLET, FILM COATED [MYLAN INSTITUTIONAL INC.]	3
LACTOSE MONOHYDRATE	INACTIVE INGREDIENT	EWQ57Q8I5X	TRIFLUOPERAZINE HYDROCHLORIDE TABLET, FILM COATED [MYLAN INSTITUTIONAL INC.]	3
MAGNESIUM STEARATE	INACTIVE INGREDIENT	70097M6I30	TRIFLUOPERAZINE HYDROCHLORIDE TABLET, FILM COATED [MYLAN INSTITUTIONAL INC.]	3
POLYDEXTROSE	INACTIVE INGREDIENT	VH2XOU12IE	TRIFLUOPERAZINE HYDROCHLORIDE TABLET, FILM COATED [MYLAN INSTITUTIONAL INC.]	3
POLYETHYLENE GLYCOLS	INACTIVE INGREDIENT	3WJQ0SDW1A	TRIFLUOPERAZINE HYDROCHLORIDE TABLET, FILM COATED [MYLAN INSTITUTIONAL INC.]	3
SILICON DIOXIDE	INACTIVE INGREDIENT	ETJ7Z6XBU4	TRIFLUOPERAZINE HYDROCHLORIDE TABLET, FILM COATED [MYLAN INSTITUTIONAL INC.]	3
SODIUM LAURYL SULFATE	INACTIVE INGREDIENT	368GB5141J	TRIFLUOPERAZINE HYDROCHLORIDE TABLET, FILM COATED [MYLAN INSTITUTIONAL INC.]	3
STARCH, CORN	INACTIVE INGREDIENT	O8232NY3SJ	TRIFLUOPERAZINE HYDROCHLORIDE TABLET, FILM COATED [MYLAN INSTITUTIONAL INC.]	3
TITANIUM DIOXIDE	INACTIVE INGREDIENT	15FIX9V2JP	TRIFLUOPERAZINE HYDROCHLORIDE TABLET, FILM COATED [MYLAN INSTITUTIONAL INC.]	3
TRIACETIN	INACTIVE INGREDIENT	XHX3C3X673	TRIFLUOPERAZINE HYDROCHLORIDE TABLET, FILM COATED [MYLAN INSTITUTIONAL INC.]	3
TRIFLUOPERAZINE HYDROCHLORIDE	ACTIVE INGREDIENT	6P1Y2SNF5V	TRIFLUOPERAZINE HYDROCHLORIDE TABLET, FILM COATED [STATE OF FLORIDA DOH CENTRAL PHARMACY]	1
TRIFLUOPERAZINE	ACTIVE MOIETY	214IZI85K3	TRIFLUOPERAZINE HYDROCHLORIDE TABLET, FILM COATED [STATE OF FLORIDA DOH CENTRAL PHARMACY]	1
CELLULOSE, MICROCRYSTALLINE	INACTIVE INGREDIENT	OP1R32D61U	TRIFLUOPERAZINE HYDROCHLORIDE TABLET, FILM COATED [STATE OF FLORIDA DOH CENTRAL PHARMACY]	1
COLLOIDAL SILICON DIOXIDE	INACTIVE INGREDIENT	ETJ7Z6XBU4	TRIFLUOPERAZINE HYDROCHLORIDE TABLET, FILM COATED [STATE OF FLORIDA DOH CENTRAL PHARMACY]	1
CROSCARMELLOSE SODIUM	INACTIVE INGREDIENT	M28OL1HH48	TRIFLUOPERAZINE HYDROCHLORIDE TABLET, FILM COATED [STATE OF FLORIDA DOH CENTRAL PHARMACY]	1
D&C RED NO. 30	INACTIVE INGREDIENT	2S42T2808B	TRIFLUOPERAZINE HYDROCHLORIDE TABLET, FILM COATED [STATE OF FLORIDA DOH CENTRAL PHARMACY]	1
FD&C BLUE NO. 2	INACTIVE INGREDIENT	L06K8R7DQK	TRIFLUOPERAZINE HYDROCHLORIDE TABLET, FILM COATED [STATE OF FLORIDA DOH CENTRAL PHARMACY]	1
FD&C YELLOW NO. 6	INACTIVE INGREDIENT	H77VEI93A8	TRIFLUOPERAZINE HYDROCHLORIDE TABLET, FILM COATED [STATE OF FLORIDA DOH CENTRAL PHARMACY]	1
HYPROMELLOSES	INACTIVE INGREDIENT	3NXW29V3WO	TRIFLUOPERAZINE HYDROCHLORIDE TABLET, FILM COATED [STATE OF FLORIDA DOH CENTRAL PHARMACY]	1
LACTOSE MONOHYDRATE	INACTIVE INGREDIENT	EWQ57Q8I5X	TRIFLUOPERAZINE HYDROCHLORIDE TABLET, FILM COATED [STATE OF FLORIDA DOH CENTRAL PHARMACY]	1
MAGNESIUM STEARATE	INACTIVE INGREDIENT	70097M6I30	TRIFLUOPERAZINE HYDROCHLORIDE TABLET, FILM COATED [STATE OF FLORIDA DOH CENTRAL PHARMACY]	1
POLYDEXTROSE	INACTIVE INGREDIENT	VH2XOU12IE	TRIFLUOPERAZINE HYDROCHLORIDE TABLET, FILM COATED [STATE OF FLORIDA DOH CENTRAL PHARMACY]	1
POLYETHYLENE GLYCOLS	INACTIVE INGREDIENT	3WJQ0SDW1A	TRIFLUOPERAZINE HYDROCHLORIDE TABLET, FILM COATED [STATE OF FLORIDA DOH CENTRAL PHARMACY]	1
SODIUM LAURYL SULFATE	INACTIVE INGREDIENT	368GB5141J	TRIFLUOPERAZINE HYDROCHLORIDE TABLET, FILM COATED [STATE OF FLORIDA DOH CENTRAL PHARMACY]	1
STARCH, CORN	INACTIVE INGREDIENT	O8232NY3SJ	TRIFLUOPERAZINE HYDROCHLORIDE TABLET, FILM COATED [STATE OF FLORIDA DOH CENTRAL PHARMACY]	1
TITANIUM DIOXIDE	INACTIVE INGREDIENT	15FIX9V2JP	TRIFLUOPERAZINE HYDROCHLORIDE TABLET, FILM COATED [STATE OF FLORIDA DOH CENTRAL PHARMACY]	1
TRIACETIN	INACTIVE INGREDIENT	XHX3C3X673	TRIFLUOPERAZINE HYDROCHLORIDE TABLET, FILM COATED [STATE OF FLORIDA DOH CENTRAL PHARMACY]	1

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDC	Dashboard title	SPL version	Validation	Dashboard ZIP
0378-2402	TRIFLUOPERAZINE HYDROCHLORIDE TABLET, FILM COATED [MYLAN PHARMACEUTICALS INC.]	16	Current NDC, Legacy NDC, 1 package rows	20250406_c2575a86-19e5-44df-8603-ff066bb9c9c5.zip

UNII, Preferred term, Registry number table
UNII	Preferred term	Registry number	Matched term
6P1Y2SNF5V	TRIFLUOPERAZINE HYDROCHLORIDE	440-17-5	TRIFLUOPERAZINE HYDROCHLORIDE

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUI	RxNorm string	TTY	DailyMed	SPL version
198322	trifluoperazine HCl 1 MG Oral Tablet	PSN	c2575a86-19e5-44df-8603-ff066bb9c9c5	16
198323	trifluoperazine HCl 10 MG Oral Tablet	PSN	c2575a86-19e5-44df-8603-ff066bb9c9c5	16
198324	trifluoperazine HCl 2 MG Oral Tablet	PSN	c2575a86-19e5-44df-8603-ff066bb9c9c5	16
198325	trifluoperazine HCl 5 MG Oral Tablet	PSN	c2575a86-19e5-44df-8603-ff066bb9c9c5	16
198322	trifluoperazine 1 MG Oral Tablet	SCD	c2575a86-19e5-44df-8603-ff066bb9c9c5	16
198323	trifluoperazine 10 MG Oral Tablet	SCD	c2575a86-19e5-44df-8603-ff066bb9c9c5	16
198324	trifluoperazine 2 MG Oral Tablet	SCD	c2575a86-19e5-44df-8603-ff066bb9c9c5	16
198325	trifluoperazine 5 MG Oral Tablet	SCD	c2575a86-19e5-44df-8603-ff066bb9c9c5	16
198322	trifluoperazine (as trifluoperazine hydrochloride) 1 MG Oral Tablet	SY	c2575a86-19e5-44df-8603-ff066bb9c9c5	16
198323	trifluoperazine (as trifluoperazine hydrochloride) 10 MG Oral Tablet	SY	c2575a86-19e5-44df-8603-ff066bb9c9c5	16
198324	trifluoperazine (as trifluoperazine hydrochloride) 2 MG Oral Tablet	SY	c2575a86-19e5-44df-8603-ff066bb9c9c5	16
198325	trifluoperazine (as trifluoperazine hydrochloride) 5 MG Oral Tablet	SY	c2575a86-19e5-44df-8603-ff066bb9c9c5	16
198324	trifluoperazine HCl 2 MG Oral Tablet	PSN	339ceb53-3b1c-459f-84eb-77bd4315c998	12
198324	trifluoperazine 2 MG Oral Tablet	SCD	339ceb53-3b1c-459f-84eb-77bd4315c998	12
198324	trifluoperazine (as trifluoperazine hydrochloride) 2 MG Oral Tablet	SY	339ceb53-3b1c-459f-84eb-77bd4315c998	12
198322	trifluoperazine HCl 1 MG Oral Tablet	PSN	f742a579-411a-4140-91c4-edc735d638fa	11
198323	trifluoperazine HCl 10 MG Oral Tablet	PSN	f742a579-411a-4140-91c4-edc735d638fa	11
198324	trifluoperazine HCl 2 MG Oral Tablet	PSN	f742a579-411a-4140-91c4-edc735d638fa	11
198325	trifluoperazine HCl 5 MG Oral Tablet	PSN	f742a579-411a-4140-91c4-edc735d638fa	11
198322	trifluoperazine 1 MG Oral Tablet	SCD	f742a579-411a-4140-91c4-edc735d638fa	11
198323	trifluoperazine 10 MG Oral Tablet	SCD	f742a579-411a-4140-91c4-edc735d638fa	11
198324	trifluoperazine 2 MG Oral Tablet	SCD	f742a579-411a-4140-91c4-edc735d638fa	11
198325	trifluoperazine 5 MG Oral Tablet	SCD	f742a579-411a-4140-91c4-edc735d638fa	11
198322	trifluoperazine (as trifluoperazine hydrochloride) 1 MG Oral Tablet	SY	f742a579-411a-4140-91c4-edc735d638fa	11
198323	trifluoperazine (as trifluoperazine hydrochloride) 10 MG Oral Tablet	SY	f742a579-411a-4140-91c4-edc735d638fa	11
198324	trifluoperazine (as trifluoperazine hydrochloride) 2 MG Oral Tablet	SY	f742a579-411a-4140-91c4-edc735d638fa	11
198325	trifluoperazine (as trifluoperazine hydrochloride) 5 MG Oral Tablet	SY	f742a579-411a-4140-91c4-edc735d638fa	11
198322	trifluoperazine HCl 1 MG Oral Tablet	PSN	8501543b-0c74-4087-9946-e7198400814a	3
198323	trifluoperazine HCl 10 MG Oral Tablet	PSN	8501543b-0c74-4087-9946-e7198400814a	3
198324	trifluoperazine HCl 2 MG Oral Tablet	PSN	8501543b-0c74-4087-9946-e7198400814a	3
198325	trifluoperazine HCl 5 MG Oral Tablet	PSN	8501543b-0c74-4087-9946-e7198400814a	3
198322	trifluoperazine 1 MG Oral Tablet	SCD	8501543b-0c74-4087-9946-e7198400814a	3
198323	trifluoperazine 10 MG Oral Tablet	SCD	8501543b-0c74-4087-9946-e7198400814a	3
198324	trifluoperazine 2 MG Oral Tablet	SCD	8501543b-0c74-4087-9946-e7198400814a	3
198325	trifluoperazine 5 MG Oral Tablet	SCD	8501543b-0c74-4087-9946-e7198400814a	3
198322	trifluoperazine (as trifluoperazine hydrochloride) 1 MG Oral Tablet	SY	8501543b-0c74-4087-9946-e7198400814a	3
198323	trifluoperazine (as trifluoperazine hydrochloride) 10 MG Oral Tablet	SY	8501543b-0c74-4087-9946-e7198400814a	3
198324	trifluoperazine (as trifluoperazine hydrochloride) 2 MG Oral Tablet	SY	8501543b-0c74-4087-9946-e7198400814a	3
198325	trifluoperazine (as trifluoperazine hydrochloride) 5 MG Oral Tablet	SY	8501543b-0c74-4087-9946-e7198400814a	3
198323	trifluoperazine HCl 10 MG Oral Tablet	PSN	dc9f4282-1cd8-4f67-9dfc-ad627453256c	1
198324	trifluoperazine HCl 2 MG Oral Tablet	PSN	dc9f4282-1cd8-4f67-9dfc-ad627453256c	1
198323	trifluoperazine 10 MG Oral Tablet	SCD	dc9f4282-1cd8-4f67-9dfc-ad627453256c	1
198324	trifluoperazine 2 MG Oral Tablet	SCD	dc9f4282-1cd8-4f67-9dfc-ad627453256c	1
198323	trifluoperazine (as trifluoperazine hydrochloride) 10 MG Oral Tablet	SY	dc9f4282-1cd8-4f67-9dfc-ad627453256c	1
198324	trifluoperazine (as trifluoperazine hydrochloride) 2 MG Oral Tablet	SY	dc9f4282-1cd8-4f67-9dfc-ad627453256c	1

Packages#

Package NDC, 11-digit format, Description table
Package NDC	11-digit format	Description	Marketing start	Marketing end	Sample	Exclude flag	Status
0378-2402-01	00378240201	100 TABLET, FILM COATED in 1 BOTTLE, PLASTIC (0378-2402-01)	1997-08-29	0000-00-00	No	No	Current

Title, Manufacturer, Effective date table
Title	Manufacturer	Effective date	Type	Version
Trifluoperazine Hydrochloride - Safecor Health LLC	Safecor Health LLC	2026-05-04	HUMAN PRESCRIPTION DRUG LABEL	3
Trifluoperazine Hydrochloride - REMEDYREPACK INC.	REMEDYREPACK INC.	2026-01-30	HUMAN PRESCRIPTION DRUG LABEL	12
Trifluoperazine Hydrochloride - Mylan Institutional Inc.	Mylan Institutional Inc.	2025-07-22	HUMAN PRESCRIPTION DRUG LABEL	11
Trifluoperazine Hydrochloride - Mylan Pharmaceuticals Inc.	Mylan Pharmaceuticals Inc.	2025-01-15	HUMAN PRESCRIPTION DRUG LABEL	16
Trifluoperazine Hydrochloride - State of Florida DOH Central Pharmacy	State of Florida DOH Central Pharmacy	2013-09-30	HUMAN PRESCRIPTION DRUG LABEL	1

Trifluoperazine Hydrochloride

Additional Listing Data#

Related Records#

Active Ingredients#

Harmonized Identifiers#

DailyMed Product Concepts#

DailyMed Package Descriptions#

DailyMed Billing Units#

DailyMed Socrata Ingredients#

DailyMed Dashboard NDC Coverage#

Related Records#

Related UNII Ingredients#

DailyMed RxNorm Mappings#

Packages#

Related DailyMed Labels#