Trifluoperazine Hydrochloride

Product NDC: 48433-142
11-digit product format: 484330142
Labeler code: 48433
Product ID: 48433-142_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: 5 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	5 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
8501543b-0c74-4087-9946-e7198400814a	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
48433-142-01	Trifluoperazine Hydrochloride	1 in 1 BLISTER PACK	TABLET, FILM COATED	1		3
48433-142-20	Trifluoperazine Hydrochloride	100 in 1 CARTON	TABLET, FILM COATED	100		3

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 ndc (product): 48433-142
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

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	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	Units	Marketing start	Sample	Exclude flag	Status
48433-142-01	48433014201	1 in 1 BLISTER PACK					Historical
48433-142-20	48433014220	100 BLISTER PACK in 1 CARTON (48433-142-20) / 1 TABLET, FILM COATED in 1 BLISTER PACK (48433-142-01)	100 blister pack	2026-04-07	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