Trifluoperazine Hydrochloride

Product NDC
72162-2205
11-digit product format
721622205
Labeler code
72162
Product ID
72162-2205_df3e0bef-1032-405d-bd18-f65c27af94eb
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Trifluoperazine Hydrochloride
Dosage form
TABLET, FILM COATED
Route
ORAL
Labeler
Bryant Ranch Prepack
Application
ANDA085788
Marketing category
ANDA
Marketing start
1981-11-20
Marketing end
2027-03-19
Substance
TRIFLUOPERAZINE HYDROCHLORIDE
Active strength
10 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-productTrade nameIngredientStrengthDosage form / routeTE codesRLD / RSApproval date
A085788-001TRIFLUOPERAZINE HYDROCHLORIDETRIFLUOPERAZINE HYDROCHLORIDEEQ 10MG BASETABLET / ORALABApproved before 1982

Therapeutic equivalence codes#

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

Application-product, TE code table
Application-productTE code
A085788-001AB

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
CapturedEditionApplication-productTrade nameStrengthDosage form / routeProduct TE source textRLD / RSApproval dateSource SHA-256
2026-09-14 22:38:342026-08A085788-001TRIFLUOPERAZINE HYDROCHLORIDEEQ 10MG BASETABLET / ORALABApproved before 198284e616aacf4f…
2026-08-18 06:07:402026-07A085788-001TRIFLUOPERAZINE HYDROCHLORIDEEQ 10MG BASETABLET / ORALABApproved before 1982caaa826d4ba7…
2026-02-19 14:30 UTC2026-02A085788-001TRIFLUOPERAZINE HYDROCHLORIDEEQ 10MG BASETABLET / ORALABApproved before 1982011fe1cb6892…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A085788-001TRIFLUOPERAZINE HYDROCHLORIDEEQ 10MG BASETABLET / ORALABApproved before 198231067a03dcf5…
2025-08-23 18:47 UTC2025-08A085788-001TRIFLUOPERAZINE HYDROCHLORIDEEQ 10MG BASETABLET / ORALABApproved before 19826a471c1ec25d…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A085788-001TRIFLUOPERAZINE HYDROCHLORIDEEQ 10MG BASETABLET / ORALABApproved before 1982fd3edfee7708…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A085788-001TRIFLUOPERAZINE HYDROCHLORIDEEQ 10MG BASETABLET / ORALABApproved before 1982b8a1b40f171c…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A085788-001TRIFLUOPERAZINE HYDROCHLORIDEEQ 10MG BASETABLET / ORALABApproved before 198203ed91905a0d…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A085788-001TRIFLUOPERAZINE HYDROCHLORIDEEQ 10MG BASETABLET / ORALABApproved before 19822680178bc6a6…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A085788-001TRIFLUOPERAZINE HYDROCHLORIDEEQ 10MG BASETABLET / ORALABApproved before 19825bbf6a4d5a75…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A085788-001TRIFLUOPERAZINE HYDROCHLORIDEEQ 10MG BASETABLET / ORALABApproved before 1982d8e5a09893c0…
2024-10-29 15:01 UTC2024-10A085788-001TRIFLUOPERAZINE HYDROCHLORIDEEQ 10MG BASETABLET / ORALABApproved before 1982d06236e962d9…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08A085788-001TRIFLUOPERAZINE HYDROCHLORIDEEQ 10MG BASETABLET / ORALABApproved before 198279d66fd596c7…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07A085788-001TRIFLUOPERAZINE HYDROCHLORIDEEQ 10MG BASETABLET / ORALABApproved before 1982301d65b070ca…
2024-06-18 03:08 UTC · 5 captures of this ZIP2024-06A085788-001TRIFLUOPERAZINE HYDROCHLORIDEEQ 10MG BASETABLET / ORALABApproved before 19821e350fbaab3a…
2024-05-31 18:47 UTC2024-05A085788-001TRIFLUOPERAZINE HYDROCHLORIDEEQ 10MG BASETABLET / ORALABApproved before 19828072bd15b7f6…
2022-06-29 02:47 UTC · 2 captures of this ZIP2022-06A085788-001TRIFLUOPERAZINE HYDROCHLORIDEEQ 10MG BASETABLET / ORALABApproved before 19825c6f7cd8ea54…
2022-04-08 23:34 UTC2022-04A085788-001TRIFLUOPERAZINE HYDROCHLORIDEEQ 10MG BASETABLET / ORALABApproved before 19825d02ea3f76ae…
2022-04-04 05:41 UTC2022-04A085788-001TRIFLUOPERAZINE HYDROCHLORIDEEQ 10MG BASETABLET / ORALABApproved before 19824b0b4de00fa7…
2019-12-13 00:20 UTC2019-12A085788-001TRIFLUOPERAZINE HYDROCHLORIDEEQ 10MG BASETABLET / ORALABApproved before 198274a2ff9319b5…
2022-03-09 01:35 UTC2022-03A085788-001TRIFLUOPERAZINE HYDROCHLORIDEEQ 10MG BASETABLET / ORALABApproved before 1982bb7c543d1eb4…
2021-12-28 21:50 UTC2021-12A085788-001TRIFLUOPERAZINE HYDROCHLORIDEEQ 10MG BASETABLET / ORALABApproved before 1982782e0a99824c…
2021-05-05 16:15 UTC · 3 captures of this ZIP2021-05A085788-001TRIFLUOPERAZINE HYDROCHLORIDEEQ 10MG BASETABLET / ORALABApproved before 198287673890dc5c…
2021-03-12 10:30 UTC2021-03A085788-001TRIFLUOPERAZINE HYDROCHLORIDEEQ 10MG BASETABLET / ORALABApproved before 19825aa47cf7b7d7…
2020-12-22 03:56 UTC2020-12A085788-001TRIFLUOPERAZINE HYDROCHLORIDEEQ 10MG BASETABLET / ORALABApproved before 19828869cabd3fbd…
2020-11-12 02:37 UTC2020-11A085788-001TRIFLUOPERAZINE HYDROCHLORIDEEQ 10MG BASETABLET / ORALABApproved before 1982c0c555d07b60…
2019-12-14 00:12 UTC2019-12A085788-001TRIFLUOPERAZINE HYDROCHLORIDEEQ 10MG BASETABLET / ORALABApproved before 19823f01610625f2…
2019-09-15 20:21 UTC2019-09A085788-001TRIFLUOPERAZINE HYDROCHLORIDEEQ 10MG BASETABLET / ORALABApproved before 1982b00525d2431f…
2019-07-19 19:46 UTC2019-07A085788-001TRIFLUOPERAZINE HYDROCHLORIDEEQ 10MG BASETABLET / ORALABApproved before 1982ea99ee380514…
2024-03-16 18:09 UTC · 4 captures of this ZIP2024-03A085788-001TRIFLUOPERAZINE HYDROCHLORIDEEQ 10MG BASETABLET / ORALABApproved before 19826a51e52b5d6a…
2024-02-18 07:12 UTC2024-02A085788-001TRIFLUOPERAZINE HYDROCHLORIDEEQ 10MG BASETABLET / ORALABApproved before 19821c564ffb4f44…
2023-12-20 04:57 UTC2023-12A085788-001TRIFLUOPERAZINE HYDROCHLORIDEEQ 10MG BASETABLET / ORALABApproved before 1982ea1830bbd6c7…
2023-11-28 05:40 UTC · 2 captures of this ZIP2023-11A085788-001TRIFLUOPERAZINE HYDROCHLORIDEEQ 10MG BASETABLET / ORALABApproved before 1982a72a2bbeb626…
2023-10-25 00:34 UTC · 2 captures of this ZIP2023-10A085788-001TRIFLUOPERAZINE HYDROCHLORIDEEQ 10MG BASETABLET / ORALABApproved before 19829b2671bbb829…
2023-07-15 15:27 UTC · 2 captures of this ZIP2023-07A085788-001TRIFLUOPERAZINE HYDROCHLORIDEEQ 10MG BASETABLET / ORALABApproved before 1982a67488948f0b…
2023-06-13 01:57 UTC · 3 captures of this ZIP2023-06A085788-001TRIFLUOPERAZINE HYDROCHLORIDEEQ 10MG BASETABLET / ORALABApproved before 19823f0d92c62455…
2023-05-13 08:27 UTC2023-05A085788-001TRIFLUOPERAZINE HYDROCHLORIDEEQ 10MG BASETABLET / ORALABApproved before 1982053a50430f4f…
2023-01-26 05:58 UTC2023-01A085788-001TRIFLUOPERAZINE HYDROCHLORIDEEQ 10MG BASETABLET / ORALABApproved before 19823bdfa0b2c4d7…
2022-11-12 20:34 UTC · 5 captures of this ZIP2022-11A085788-001TRIFLUOPERAZINE HYDROCHLORIDEEQ 10MG BASETABLET / ORALABApproved before 19823a93d1ddd44b…
2022-10-28 04:53 UTC2022-10A085788-001TRIFLUOPERAZINE HYDROCHLORIDEEQ 10MG BASETABLET / ORALABApproved before 1982f41ea6bd6efb…

Observed Orange Book normalized TE history#

Normalized TE history page 1 of 2 · 43 observed states.

Captured, Edition, Application-product table
CapturedEditionApplication-productTE codeOrderSource SHA-256
2026-09-14 22:38:342026-08A085788-001AB184e616aacf4f…
2026-08-18 06:07:402026-07A085788-001AB1caaa826d4ba7…
2026-02-19 14:30 UTC2026-02A085788-001AB1011fe1cb6892…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A085788-001AB131067a03dcf5…
2025-08-23 18:47 UTC2025-08A085788-001AB16a471c1ec25d…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A085788-001AB1fd3edfee7708…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A085788-001AB1b8a1b40f171c…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A085788-001AB103ed91905a0d…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A085788-001AB12680178bc6a6…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A085788-001AB15bbf6a4d5a75…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A085788-001AB1d8e5a09893c0…
2024-10-29 15:01 UTC2024-10A085788-001AB1d06236e962d9…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08A085788-001AB179d66fd596c7…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07A085788-001AB1301d65b070ca…
2024-06-18 03:08 UTC · 5 captures of this ZIP2024-06A085788-001AB11e350fbaab3a…
2024-05-31 18:47 UTC2024-05A085788-001AB18072bd15b7f6…
2022-06-29 02:47 UTC · 2 captures of this ZIP2022-06A085788-001AB15c6f7cd8ea54…
2022-04-08 23:34 UTC2022-04A085788-001AB15d02ea3f76ae…
2022-04-04 05:41 UTC2022-04A085788-001AB14b0b4de00fa7…
2019-12-13 00:20 UTC2019-12A085788-001AB174a2ff9319b5…
2022-03-09 01:35 UTC2022-03A085788-001AB1bb7c543d1eb4…
2021-12-28 21:50 UTC2021-12A085788-001AB1782e0a99824c…
2021-05-05 16:15 UTC · 3 captures of this ZIP2021-05A085788-001AB187673890dc5c…
2021-03-12 10:30 UTC2021-03A085788-001AB15aa47cf7b7d7…
2020-12-22 03:56 UTC2020-12A085788-001AB18869cabd3fbd…
2020-11-12 02:37 UTC2020-11A085788-001AB1c0c555d07b60…
2019-12-14 00:12 UTC2019-12A085788-001AB13f01610625f2…
2019-09-15 20:21 UTC2019-09A085788-001AB1b00525d2431f…
2019-07-19 19:46 UTC2019-07A085788-001AB1ea99ee380514…
2024-03-16 18:09 UTC · 4 captures of this ZIP2024-03A085788-001AB16a51e52b5d6a…
2024-02-18 07:12 UTC2024-02A085788-001AB11c564ffb4f44…
2023-12-20 04:57 UTC2023-12A085788-001AB1ea1830bbd6c7…
2023-11-28 05:40 UTC · 2 captures of this ZIP2023-11A085788-001AB1a72a2bbeb626…
2023-10-25 00:34 UTC · 2 captures of this ZIP2023-10A085788-001AB19b2671bbb829…
2023-07-15 15:27 UTC · 2 captures of this ZIP2023-07A085788-001AB1a67488948f0b…
2023-06-13 01:57 UTC · 3 captures of this ZIP2023-06A085788-001AB13f0d92c62455…
2023-05-13 08:27 UTC2023-05A085788-001AB1053a50430f4f…
2023-01-26 05:58 UTC2023-01A085788-001AB13bdfa0b2c4d7…
2022-11-12 20:34 UTC · 5 captures of this ZIP2022-11A085788-001AB13a93d1ddd44b…
2022-10-28 04:53 UTC2022-10A085788-001AB1f41ea6bd6efb…

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
IngredientStrength
TRIFLUOPERAZINE HYDROCHLORIDE10 mg/1

Harmonized UNII identifiers#

UNII identifiers page 1 of 1 · 1 matching rows.

Identifier, FDA.report destination table
IdentifierFDA.report destination
6P1Y2SNF5VInternal UNII lookup

Harmonized RxCUI identifiers#

RxCUI identifiers page 1 of 1 · 1 matching rows.

Identifier, FDA.report destination table
IdentifierFDA.report destination
198323Internal RxNorm lookup

Harmonized SPL set identifiers#

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

Identifier, FDA.report destination table
IdentifierFDA.report destination
df3e0bef-1032-405d-bd18-f65c27af94ebAvailable on FDA.report

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
72162-2205-1Trifluoperazine Hydrochloride100 in 1 BOTTLETABLET, FILM COATED100101

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
72162-2205-1EA - Each72162-2205fbe1662a-d28e-4e74-bda2-8016c9fb2e1b12024-02-14

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
72162-2205TRIFLUOPERAZINE HYDROCHLORIDE TABLET, FILM COATED [BRYANT RANCH PREPACK]101Current NDC, 1 package rows20240406_df3e0bef-1032-405d-bd18-f65c27af94eb.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
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
Trifluoperazine HydrochlorideTRIFLUOPERAZINE HYDROCHLORIDESandoz Inc.ae43c10e-cfa9-4298-8af5-7a3e6524bbda2024-11-30Boxed warning, Warnings, Adverse reactionsExact identifier
application applno (ANDA): 085788
application number: ANDA085788
Trifluoperazine HydrochlorideTRIFLUOPERAZINE HYDROCHLORIDEBryant Ranch Prepackdf3e0bef-1032-405d-bd18-f65c27af94eb2024-04-02Boxed warning, Warnings, Adverse reactionsExact identifier
application applno (ANDA): 085788
application number: ANDA085788
ndc (product): 72162-2205

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
198323trifluoperazine HCl 10 MG Oral TabletPSNdf3e0bef-1032-405d-bd18-f65c27af94eb101
198323trifluoperazine 10 MG Oral TabletSCDdf3e0bef-1032-405d-bd18-f65c27af94eb101
198323trifluoperazine (as trifluoperazine hydrochloride) 10 MG Oral TabletSYdf3e0bef-1032-405d-bd18-f65c27af94eb101

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionMarketing startMarketing endSampleExclude flagStatus
72162-2205-172162220501100 TABLET, FILM COATED in 1 BOTTLE (72162-2205-1) 2024-04-022027-03-19NoNoHistorical