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: 2027-12-31
Current FDA listing: Yes

Source provenance: Browse the complete Orange Book source catalog · source snapshot 43.

Orange Book products#

Current product rows page 1 of 1 · 4 matching rows.

Application-product, Trade name, Ingredient table
Application-product	Trade name	Ingredient	Strength	Dosage form / route	TE codes	RLD / RS	Approval date
A040209-001	TRIFLUOPERAZINE HYDROCHLORIDE	TRIFLUOPERAZINE HYDROCHLORIDE	EQ 1MG BASE	TABLET / ORAL	AB		1997-07-07
A040209-002	TRIFLUOPERAZINE HYDROCHLORIDE	TRIFLUOPERAZINE HYDROCHLORIDE	EQ 2MG BASE	TABLET / ORAL	AB		1997-07-07
A040209-003	TRIFLUOPERAZINE HYDROCHLORIDE	TRIFLUOPERAZINE HYDROCHLORIDE	EQ 5MG BASE	TABLET / ORAL	AB		1997-07-07
A040209-004	TRIFLUOPERAZINE HYDROCHLORIDE	TRIFLUOPERAZINE HYDROCHLORIDE	EQ 10MG BASE	TABLET / ORAL	AB	RS	1997-07-07

Therapeutic equivalence codes#

Current TE-code rows page 1 of 1 · 4 matching rows.

Application-product, TE code table
Application-product	TE code
A040209-001	AB
A040209-002	AB
A040209-003	AB
A040209-004	AB

Observed Orange Book product history#

Observed FDA ZIP history: Each table is queried independently by exact application/product key from successfully parsed Orange Book snapshots. Capture times identify archived source observations; absence or a change between snapshots is not inferred. FDA publication files that were not recoverable as structured ZIP data are not represented as states.

Product history page 1 of 5 · 172 observed states.

Captured, Edition, Application-product table
Captured	Edition	Application-product	Trade name	Strength	Dosage form / route	Product TE source text	RLD / RS	Approval date	Source SHA-256
2026-09-14 22:38:34	2026-08	A040209-001	TRIFLUOPERAZINE HYDROCHLORIDE	EQ 1MG BASE	TABLET / ORAL	AB		1997-07-07	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	A040209-002	TRIFLUOPERAZINE HYDROCHLORIDE	EQ 2MG BASE	TABLET / ORAL	AB		1997-07-07	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	A040209-003	TRIFLUOPERAZINE HYDROCHLORIDE	EQ 5MG BASE	TABLET / ORAL	AB		1997-07-07	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	A040209-004	TRIFLUOPERAZINE HYDROCHLORIDE	EQ 10MG BASE	TABLET / ORAL	AB	RS	1997-07-07	`84e616aacf4f…`
2026-08-18 06:07:40	2026-07	A040209-001	TRIFLUOPERAZINE HYDROCHLORIDE	EQ 1MG BASE	TABLET / ORAL	AB		1997-07-07	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	A040209-002	TRIFLUOPERAZINE HYDROCHLORIDE	EQ 2MG BASE	TABLET / ORAL	AB		1997-07-07	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	A040209-003	TRIFLUOPERAZINE HYDROCHLORIDE	EQ 5MG BASE	TABLET / ORAL	AB		1997-07-07	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	A040209-004	TRIFLUOPERAZINE HYDROCHLORIDE	EQ 10MG BASE	TABLET / ORAL	AB	RS	1997-07-07	`caaa826d4ba7…`
2026-02-19 14:30 UTC	2026-02	A040209-001	TRIFLUOPERAZINE HYDROCHLORIDE	EQ 1MG BASE	TABLET / ORAL	AB		1997-07-07	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A040209-002	TRIFLUOPERAZINE HYDROCHLORIDE	EQ 2MG BASE	TABLET / ORAL	AB		1997-07-07	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A040209-003	TRIFLUOPERAZINE HYDROCHLORIDE	EQ 5MG BASE	TABLET / ORAL	AB		1997-07-07	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A040209-004	TRIFLUOPERAZINE HYDROCHLORIDE	EQ 10MG BASE	TABLET / ORAL	AB	RS	1997-07-07	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A040209-001	TRIFLUOPERAZINE HYDROCHLORIDE	EQ 1MG BASE	TABLET / ORAL	AB		1997-07-07	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A040209-002	TRIFLUOPERAZINE HYDROCHLORIDE	EQ 2MG BASE	TABLET / ORAL	AB		1997-07-07	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A040209-003	TRIFLUOPERAZINE HYDROCHLORIDE	EQ 5MG BASE	TABLET / ORAL	AB		1997-07-07	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A040209-004	TRIFLUOPERAZINE HYDROCHLORIDE	EQ 10MG BASE	TABLET / ORAL	AB	RS	1997-07-07	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A040209-001	TRIFLUOPERAZINE HYDROCHLORIDE	EQ 1MG BASE	TABLET / ORAL	AB		1997-07-07	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A040209-002	TRIFLUOPERAZINE HYDROCHLORIDE	EQ 2MG BASE	TABLET / ORAL	AB		1997-07-07	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A040209-003	TRIFLUOPERAZINE HYDROCHLORIDE	EQ 5MG BASE	TABLET / ORAL	AB		1997-07-07	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A040209-004	TRIFLUOPERAZINE HYDROCHLORIDE	EQ 10MG BASE	TABLET / ORAL	AB	RS	1997-07-07	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A040209-001	TRIFLUOPERAZINE HYDROCHLORIDE	EQ 1MG BASE	TABLET / ORAL	AB		1997-07-07	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A040209-002	TRIFLUOPERAZINE HYDROCHLORIDE	EQ 2MG BASE	TABLET / ORAL	AB		1997-07-07	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A040209-003	TRIFLUOPERAZINE HYDROCHLORIDE	EQ 5MG BASE	TABLET / ORAL	AB		1997-07-07	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A040209-004	TRIFLUOPERAZINE HYDROCHLORIDE	EQ 10MG BASE	TABLET / ORAL	AB	RS	1997-07-07	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A040209-001	TRIFLUOPERAZINE HYDROCHLORIDE	EQ 1MG BASE	TABLET / ORAL	AB		1997-07-07	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A040209-002	TRIFLUOPERAZINE HYDROCHLORIDE	EQ 2MG BASE	TABLET / ORAL	AB		1997-07-07	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A040209-003	TRIFLUOPERAZINE HYDROCHLORIDE	EQ 5MG BASE	TABLET / ORAL	AB		1997-07-07	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A040209-004	TRIFLUOPERAZINE HYDROCHLORIDE	EQ 10MG BASE	TABLET / ORAL	AB	RS	1997-07-07	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A040209-001	TRIFLUOPERAZINE HYDROCHLORIDE	EQ 1MG BASE	TABLET / ORAL	AB		1997-07-07	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A040209-002	TRIFLUOPERAZINE HYDROCHLORIDE	EQ 2MG BASE	TABLET / ORAL	AB		1997-07-07	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A040209-003	TRIFLUOPERAZINE HYDROCHLORIDE	EQ 5MG BASE	TABLET / ORAL	AB		1997-07-07	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A040209-004	TRIFLUOPERAZINE HYDROCHLORIDE	EQ 10MG BASE	TABLET / ORAL	AB	RS	1997-07-07	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A040209-001	TRIFLUOPERAZINE HYDROCHLORIDE	EQ 1MG BASE	TABLET / ORAL	AB		1997-07-07	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A040209-002	TRIFLUOPERAZINE HYDROCHLORIDE	EQ 2MG BASE	TABLET / ORAL	AB		1997-07-07	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A040209-003	TRIFLUOPERAZINE HYDROCHLORIDE	EQ 5MG BASE	TABLET / ORAL	AB		1997-07-07	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A040209-004	TRIFLUOPERAZINE HYDROCHLORIDE	EQ 10MG BASE	TABLET / ORAL	AB	RS	1997-07-07	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A040209-001	TRIFLUOPERAZINE HYDROCHLORIDE	EQ 1MG BASE	TABLET / ORAL	AB		1997-07-07	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A040209-002	TRIFLUOPERAZINE HYDROCHLORIDE	EQ 2MG BASE	TABLET / ORAL	AB		1997-07-07	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A040209-003	TRIFLUOPERAZINE HYDROCHLORIDE	EQ 5MG BASE	TABLET / ORAL	AB		1997-07-07	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A040209-004	TRIFLUOPERAZINE HYDROCHLORIDE	EQ 10MG BASE	TABLET / ORAL	AB	RS	1997-07-07	`5bbf6a4d5a75…`

Observed Orange Book normalized TE history#

Normalized TE history page 1 of 5 · 172 observed states.

Captured, Edition, Application-product table
Captured	Edition	Application-product	TE code	Order	Source SHA-256
2026-09-14 22:38:34	2026-08	A040209-001	AB	1	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	A040209-002	AB	1	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	A040209-003	AB	1	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	A040209-004	AB	1	`84e616aacf4f…`
2026-08-18 06:07:40	2026-07	A040209-001	AB	1	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	A040209-002	AB	1	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	A040209-003	AB	1	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	A040209-004	AB	1	`caaa826d4ba7…`
2026-02-19 14:30 UTC	2026-02	A040209-001	AB	1	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A040209-002	AB	1	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A040209-003	AB	1	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A040209-004	AB	1	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A040209-001	AB	1	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A040209-002	AB	1	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A040209-003	AB	1	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A040209-004	AB	1	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A040209-001	AB	1	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A040209-002	AB	1	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A040209-003	AB	1	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A040209-004	AB	1	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A040209-001	AB	1	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A040209-002	AB	1	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A040209-003	AB	1	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A040209-004	AB	1	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A040209-001	AB	1	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A040209-002	AB	1	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A040209-003	AB	1	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A040209-004	AB	1	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A040209-001	AB	1	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A040209-002	AB	1	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A040209-003	AB	1	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A040209-004	AB	1	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A040209-001	AB	1	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A040209-002	AB	1	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A040209-003	AB	1	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A040209-004	AB	1	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A040209-001	AB	1	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A040209-002	AB	1	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A040209-003	AB	1	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A040209-004	AB	1	`5bbf6a4d5a75…`

Reported adverse events (FAERS/openFDA)#

Adverse event summaries are temporarily unavailable. Other product information remains available.

Additional Listing Data#

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

Active Ingredients#

Ingredient, Strength table
Ingredient	Strength
TRIFLUOPERAZINE HYDROCHLORIDE	1 mg/1

Harmonized UNII identifiers#

UNII identifiers page 1 of 1 · 1 matching rows.

Identifier, FDA.report destination table
Identifier	FDA.report destination
6P1Y2SNF5V	Internal UNII lookup

Harmonized RxCUI identifiers#

RxCUI identifiers page 1 of 1 · 4 matching rows.

Identifier, FDA.report destination table
Identifier	FDA.report destination
198322	Internal RxNorm lookup
198323	Internal RxNorm lookup
198324	Internal RxNorm lookup
198325	Internal RxNorm lookup

Harmonized SPL set identifiers#

SPL set identifiers page 1 of 1 · 1 matching rows.

Identifier, FDA.report destination table
Identifier	FDA.report destination
c2575a86-19e5-44df-8603-ff066bb9c9c5	Available on FDA.report

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
0378-2401-01	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
0378-2401-01	EA - Each	0378-2401	90946182-64c8-413a-8116-3c3f9d4160f4	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

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDC	Dashboard title	SPL version	Validation	Dashboard ZIP
0378-2401	TRIFLUOPERAZINE HYDROCHLORIDE TABLET, FILM COATED [MYLAN PHARMACEUTICALS INC.]	16	Current NDC, Legacy NDC, 1 package rows	20250406_c2575a86-19e5-44df-8603-ff066bb9c9c5.zip

openFDA label cross-check#

OpenFDA label data provides additional search and identifier links. DailyMed’s Structured Product Label is the canonical label on FDA.report. Matching records are deduplicated before they are shown below.

Matched openFDA labels page 1 of 1 · 5 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
Trifluoperazine Hydrochloride	TRIFLUOPERAZINE HYDROCHLORIDE	Safecor Health LLC	8501543b-0c74-4087-9946-e7198400814a	2026-05-04	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 040209 application number: ANDA040209
Trifluoperazine Hydrochloride	TRIFLUOPERAZINE HYDROCHLORIDE	REMEDYREPACK INC.	339ceb53-3b1c-459f-84eb-77bd4315c998	2026-01-30	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 040209 application number: ANDA040209
Trifluoperazine Hydrochloride	TRIFLUOPERAZINE HYDROCHLORIDE	REMEDYREPACK INC.	6a05900b-ca43-483a-a460-8ac378653f12	2026-01-30	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 040209 application number: ANDA040209
Trifluoperazine Hydrochloride	TRIFLUOPERAZINE HYDROCHLORIDE	Mylan Institutional Inc.	f742a579-411a-4140-91c4-edc735d638fa	2025-07-22	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 040209 application number: ANDA040209
Trifluoperazine Hydrochloride	TRIFLUOPERAZINE HYDROCHLORIDE	Mylan Pharmaceuticals Inc.	c2575a86-19e5-44df-8603-ff066bb9c9c5	2025-01-15	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 040209 application number: ANDA040209 ndc (product): 0378-2401

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
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

Packages#

Package NDC, 11-digit format, Description table
Package NDC	11-digit format	Description	Marketing start	Marketing end	Sample	Exclude flag	Status
0378-2401-01	00378240101	100 TABLET, FILM COATED in 1 BOTTLE, PLASTIC (0378-2401-01)	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 - 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