Trifluoperazine Hydrochloride

Product NDC: 72162-2206
11-digit product format: 721622206
Labeler code: 72162
Product ID: 72162-2206_28c04846-a867-4043-9adc-ca3cf5bfc947
Type: HUMAN PRESCRIPTION DRUG
Nonproprietary name: Trifluoperazine Hydrochloride
Dosage form: TABLET, FILM COATED
Route: ORAL
Labeler: Bryant Ranch Prepack
Application: ANDA085786
Marketing category: ANDA
Marketing start: 1981-11-20
Marketing end: 2027-03-19
Substance: TRIFLUOPERAZINE HYDROCHLORIDE
Active strength: 2 mg/1
Pharmacologic classes: Phenothiazine [EPC], Phenothiazines [CS]
NDC exclude flag: No
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 · 1 matching rows.

Application-product, Trade name, Ingredient table
Application-product	Trade name	Ingredient	Strength	Dosage form / route	TE codes	RLD / RS	Approval date
A085786-001	TRIFLUOPERAZINE HYDROCHLORIDE	TRIFLUOPERAZINE HYDROCHLORIDE	EQ 2MG BASE	TABLET / ORAL	AB	Approved before 1982

Therapeutic equivalence codes#

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

Application-product, TE code table
Application-product	TE code
A085786-001	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 2 · 43 observed states.

Captured, Edition, Application-product table
Captured	Edition	Application-product	Trade name	Strength	Dosage form / route	Product TE source text	RLD / RS	Source SHA-256
2026-09-14 22:38:34	2026-08	A085786-001	TRIFLUOPERAZINE HYDROCHLORIDE	EQ 2MG BASE	TABLET / ORAL	AB	Approved before 1982	`84e616aacf4f…`
2026-08-18 06:07:40	2026-07	A085786-001	TRIFLUOPERAZINE HYDROCHLORIDE	EQ 2MG BASE	TABLET / ORAL	AB	Approved before 1982	`caaa826d4ba7…`
2026-02-19 14:30 UTC	2026-02	A085786-001	TRIFLUOPERAZINE HYDROCHLORIDE	EQ 2MG BASE	TABLET / ORAL	AB	Approved before 1982	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A085786-001	TRIFLUOPERAZINE HYDROCHLORIDE	EQ 2MG BASE	TABLET / ORAL	AB	Approved before 1982	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A085786-001	TRIFLUOPERAZINE HYDROCHLORIDE	EQ 2MG BASE	TABLET / ORAL	AB	Approved before 1982	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A085786-001	TRIFLUOPERAZINE HYDROCHLORIDE	EQ 2MG BASE	TABLET / ORAL	AB	Approved before 1982	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A085786-001	TRIFLUOPERAZINE HYDROCHLORIDE	EQ 2MG BASE	TABLET / ORAL	AB	Approved before 1982	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A085786-001	TRIFLUOPERAZINE HYDROCHLORIDE	EQ 2MG BASE	TABLET / ORAL	AB	Approved before 1982	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A085786-001	TRIFLUOPERAZINE HYDROCHLORIDE	EQ 2MG BASE	TABLET / ORAL	AB	Approved before 1982	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A085786-001	TRIFLUOPERAZINE HYDROCHLORIDE	EQ 2MG BASE	TABLET / ORAL	AB	Approved before 1982	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A085786-001	TRIFLUOPERAZINE HYDROCHLORIDE	EQ 2MG BASE	TABLET / ORAL	AB	Approved before 1982	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A085786-001	TRIFLUOPERAZINE HYDROCHLORIDE	EQ 2MG BASE	TABLET / ORAL	AB	Approved before 1982	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A085786-001	TRIFLUOPERAZINE HYDROCHLORIDE	EQ 2MG BASE	TABLET / ORAL	AB	Approved before 1982	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A085786-001	TRIFLUOPERAZINE HYDROCHLORIDE	EQ 2MG BASE	TABLET / ORAL	AB	Approved before 1982	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A085786-001	TRIFLUOPERAZINE HYDROCHLORIDE	EQ 2MG BASE	TABLET / ORAL	AB	Approved before 1982	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	A085786-001	TRIFLUOPERAZINE HYDROCHLORIDE	EQ 2MG BASE	TABLET / ORAL	AB	Approved before 1982	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A085786-001	TRIFLUOPERAZINE HYDROCHLORIDE	EQ 2MG BASE	TABLET / ORAL	AB	Approved before 1982	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	A085786-001	TRIFLUOPERAZINE HYDROCHLORIDE	EQ 2MG BASE	TABLET / ORAL	AB	Approved before 1982	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	A085786-001	TRIFLUOPERAZINE HYDROCHLORIDE	EQ 2MG BASE	TABLET / ORAL	AB	Approved before 1982	`4b0b4de00fa7…`
2019-12-13 00:20 UTC	2019-12	A085786-001	TRIFLUOPERAZINE HYDROCHLORIDE	EQ 2MG BASE	TABLET / ORAL	AB	Approved before 1982	`74a2ff9319b5…`
2022-03-09 01:35 UTC	2022-03	A085786-001	TRIFLUOPERAZINE HYDROCHLORIDE	EQ 2MG BASE	TABLET / ORAL	AB	Approved before 1982	`bb7c543d1eb4…`
2021-12-28 21:50 UTC	2021-12	A085786-001	TRIFLUOPERAZINE HYDROCHLORIDE	EQ 2MG BASE	TABLET / ORAL	AB	Approved before 1982	`782e0a99824c…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	A085786-001	TRIFLUOPERAZINE HYDROCHLORIDE	EQ 2MG BASE	TABLET / ORAL	AB	Approved before 1982	`87673890dc5c…`
2021-03-12 10:30 UTC	2021-03	A085786-001	TRIFLUOPERAZINE HYDROCHLORIDE	EQ 2MG BASE	TABLET / ORAL	AB	Approved before 1982	`5aa47cf7b7d7…`
2020-12-22 03:56 UTC	2020-12	A085786-001	TRIFLUOPERAZINE HYDROCHLORIDE	EQ 2MG BASE	TABLET / ORAL	AB	Approved before 1982	`8869cabd3fbd…`
2020-11-12 02:37 UTC	2020-11	A085786-001	TRIFLUOPERAZINE HYDROCHLORIDE	EQ 2MG BASE	TABLET / ORAL	AB	Approved before 1982	`c0c555d07b60…`
2019-12-14 00:12 UTC	2019-12	A085786-001	TRIFLUOPERAZINE HYDROCHLORIDE	EQ 2MG BASE	TABLET / ORAL	AB	Approved before 1982	`3f01610625f2…`
2019-09-15 20:21 UTC	2019-09	A085786-001	TRIFLUOPERAZINE HYDROCHLORIDE	EQ 2MG BASE	TABLET / ORAL	AB	Approved before 1982	`b00525d2431f…`
2019-07-19 19:46 UTC	2019-07	A085786-001	TRIFLUOPERAZINE HYDROCHLORIDE	EQ 2MG BASE	TABLET / ORAL	AB	Approved before 1982	`ea99ee380514…`
2024-03-16 18:09 UTC · 4 captures of this ZIP	2024-03	A085786-001	TRIFLUOPERAZINE HYDROCHLORIDE	EQ 2MG BASE	TABLET / ORAL	AB	Approved before 1982	`6a51e52b5d6a…`
2024-02-18 07:12 UTC	2024-02	A085786-001	TRIFLUOPERAZINE HYDROCHLORIDE	EQ 2MG BASE	TABLET / ORAL	AB	Approved before 1982	`1c564ffb4f44…`
2023-12-20 04:57 UTC	2023-12	A085786-001	TRIFLUOPERAZINE HYDROCHLORIDE	EQ 2MG BASE	TABLET / ORAL	AB	Approved before 1982	`ea1830bbd6c7…`
2023-11-28 05:40 UTC · 2 captures of this ZIP	2023-11	A085786-001	TRIFLUOPERAZINE HYDROCHLORIDE	EQ 2MG BASE	TABLET / ORAL	AB	Approved before 1982	`a72a2bbeb626…`
2023-10-25 00:34 UTC · 2 captures of this ZIP	2023-10	A085786-001	TRIFLUOPERAZINE HYDROCHLORIDE	EQ 2MG BASE	TABLET / ORAL	AB	Approved before 1982	`9b2671bbb829…`
2023-07-15 15:27 UTC · 2 captures of this ZIP	2023-07	A085786-001	TRIFLUOPERAZINE HYDROCHLORIDE	EQ 2MG BASE	TABLET / ORAL	AB	Approved before 1982	`a67488948f0b…`
2023-06-13 01:57 UTC · 3 captures of this ZIP	2023-06	A085786-001	TRIFLUOPERAZINE HYDROCHLORIDE	EQ 2MG BASE	TABLET / ORAL	AB	Approved before 1982	`3f0d92c62455…`
2023-05-13 08:27 UTC	2023-05	A085786-001	TRIFLUOPERAZINE HYDROCHLORIDE	EQ 2MG BASE	TABLET / ORAL	AB	Approved before 1982	`053a50430f4f…`
2023-01-26 05:58 UTC	2023-01	A085786-001	TRIFLUOPERAZINE HYDROCHLORIDE	EQ 2MG BASE	TABLET / ORAL	AB	Approved before 1982	`3bdfa0b2c4d7…`
2022-11-12 20:34 UTC · 5 captures of this ZIP	2022-11	A085786-001	TRIFLUOPERAZINE HYDROCHLORIDE	EQ 2MG BASE	TABLET / ORAL	AB	Approved before 1982	`3a93d1ddd44b…`
2022-10-28 04:53 UTC	2022-10	A085786-001	TRIFLUOPERAZINE HYDROCHLORIDE	EQ 2MG BASE	TABLET / ORAL	AB	Approved before 1982	`f41ea6bd6efb…`

Observed Orange Book normalized TE history#

Normalized TE history page 1 of 2 · 43 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	A085786-001	AB	1	`84e616aacf4f…`
2026-08-18 06:07:40	2026-07	A085786-001	AB	1	`caaa826d4ba7…`
2026-02-19 14:30 UTC	2026-02	A085786-001	AB	1	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A085786-001	AB	1	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A085786-001	AB	1	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A085786-001	AB	1	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A085786-001	AB	1	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A085786-001	AB	1	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A085786-001	AB	1	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A085786-001	AB	1	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A085786-001	AB	1	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A085786-001	AB	1	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A085786-001	AB	1	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A085786-001	AB	1	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A085786-001	AB	1	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	A085786-001	AB	1	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A085786-001	AB	1	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	A085786-001	AB	1	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	A085786-001	AB	1	`4b0b4de00fa7…`
2019-12-13 00:20 UTC	2019-12	A085786-001	AB	1	`74a2ff9319b5…`
2022-03-09 01:35 UTC	2022-03	A085786-001	AB	1	`bb7c543d1eb4…`
2021-12-28 21:50 UTC	2021-12	A085786-001	AB	1	`782e0a99824c…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	A085786-001	AB	1	`87673890dc5c…`
2021-03-12 10:30 UTC	2021-03	A085786-001	AB	1	`5aa47cf7b7d7…`
2020-12-22 03:56 UTC	2020-12	A085786-001	AB	1	`8869cabd3fbd…`
2020-11-12 02:37 UTC	2020-11	A085786-001	AB	1	`c0c555d07b60…`
2019-12-14 00:12 UTC	2019-12	A085786-001	AB	1	`3f01610625f2…`
2019-09-15 20:21 UTC	2019-09	A085786-001	AB	1	`b00525d2431f…`
2019-07-19 19:46 UTC	2019-07	A085786-001	AB	1	`ea99ee380514…`
2024-03-16 18:09 UTC · 4 captures of this ZIP	2024-03	A085786-001	AB	1	`6a51e52b5d6a…`
2024-02-18 07:12 UTC	2024-02	A085786-001	AB	1	`1c564ffb4f44…`
2023-12-20 04:57 UTC	2023-12	A085786-001	AB	1	`ea1830bbd6c7…`
2023-11-28 05:40 UTC · 2 captures of this ZIP	2023-11	A085786-001	AB	1	`a72a2bbeb626…`
2023-10-25 00:34 UTC · 2 captures of this ZIP	2023-10	A085786-001	AB	1	`9b2671bbb829…`
2023-07-15 15:27 UTC · 2 captures of this ZIP	2023-07	A085786-001	AB	1	`a67488948f0b…`
2023-06-13 01:57 UTC · 3 captures of this ZIP	2023-06	A085786-001	AB	1	`3f0d92c62455…`
2023-05-13 08:27 UTC	2023-05	A085786-001	AB	1	`053a50430f4f…`
2023-01-26 05:58 UTC	2023-01	A085786-001	AB	1	`3bdfa0b2c4d7…`
2022-11-12 20:34 UTC · 5 captures of this ZIP	2022-11	A085786-001	AB	1	`3a93d1ddd44b…`
2022-10-28 04:53 UTC	2022-10	A085786-001	AB	1	`f41ea6bd6efb…`

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

Active Ingredients#

Ingredient, Strength table
Ingredient	Strength
TRIFLUOPERAZINE HYDROCHLORIDE	2 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 · 1 matching rows.

Identifier, FDA.report destination table
Identifier	FDA.report destination
198324	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
e63617bb-8186-43d3-9d01-aa53217343e4	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
72162-2206-1	Trifluoperazine Hydrochloride	100 in 1 BOTTLE	TABLET, FILM COATED	100		102

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDC	Billing unit	Product NDC	DailyMed indexing SPL	SPL version	Effective
72162-2206-1	EA - Each	72162-2206	c08089b7-15b2-4f85-a503-ac20875621d1	1	2024-02-14

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDC	Dashboard title	SPL version	Validation	Dashboard ZIP
72162-2206	TRIFLUOPERAZINE HYDROCHLORIDE TABLET, FILM COATED [BRYANT RANCH PREPACK]	102	Current NDC, 1 package rows	20241019_e63617bb-8186-43d3-9d01-aa53217343e4.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 · 2 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
Trifluoperazine Hydrochloride	TRIFLUOPERAZINE HYDROCHLORIDE	Sandoz Inc.	ae43c10e-cfa9-4298-8af5-7a3e6524bbda	2024-11-30	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 085786 application number: ANDA085786
Trifluoperazine Hydrochloride	TRIFLUOPERAZINE HYDROCHLORIDE	Bryant Ranch Prepack	e63617bb-8186-43d3-9d01-aa53217343e4	2024-10-17	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 085786 application number: ANDA085786 ndc (product): 72162-2206

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
198324	trifluoperazine HCl 2 MG Oral Tablet	PSN	e63617bb-8186-43d3-9d01-aa53217343e4	102
198324	trifluoperazine 2 MG Oral Tablet	SCD	e63617bb-8186-43d3-9d01-aa53217343e4	102
198324	trifluoperazine (as trifluoperazine hydrochloride) 2 MG Oral Tablet	SY	e63617bb-8186-43d3-9d01-aa53217343e4	102

Packages#

Package NDC, 11-digit format, Description table
Package NDC	11-digit format	Description	Marketing start	Marketing end	Sample	Exclude flag	Status
72162-2206-1	72162220601	100 TABLET, FILM COATED in 1 BOTTLE (72162-2206-1)	2024-04-02	2027-03-19	No	No	Historical

Title, Manufacturer, Effective date table
Title	Manufacturer	Effective date	Type	Version
Trifluoperazine Hydrochloride Tablets, USP	Bryant Ranch Prepack	2024-10-17	HUMAN PRESCRIPTION DRUG LABEL	102