Fluphenazine Hydrochloride

Product NDC
64725-1438
11-digit product format
647251438
Labeler code
64725
Product ID
64725-1438_1069b2e7-e199-4a74-aa49-19a754d3b70d
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Fluphenazine Hydrochloride
Dosage form
TABLET, FILM COATED
Route
ORAL
Labeler
TYA Pharmaceuticals
Application
ANDA089586
Marketing category
ANDA
Marketing start
1987-10-16
Marketing end
0000-00-00
Substance
FLUPHENAZINE HYDROCHLORIDE
Active strength
5 mg/1
Pharmacologic classes
Phenothiazines [CS],Phenothiazine [EPC]
NDC exclude flag
E
Listing certified through
2017-12-31
Current FDA listing
Historical FDA.report record

NDC auxiliary status#

These records are reproduced from FDA’s unfinished, excluded, and compounder listings. They describe what appeared in the source files; a missing record does not establish a regulatory status. View all current auxiliary records, including entries without an NDC. · View the auxiliary file history.

Current NDC status page 1 of 1 · 2 matching rows.

Dataset, Scope, Product NDC table
DatasetScopeProduct NDCPackage NDCCodeStatusReporting periodSource date
excluded productproduct64725-1438IInactivated by FDA2026-08-11
excluded packagepackage64725-143864725-1438-1IInactivated by FDA2026-08-11

Observed NDC auxiliary status history#

This history shows the information present in each captured FDA auxiliary file. It is not a continuous regulatory timeline, and a missing record does not establish a status.

Historic NDC status page 1 of 1 · 44 matching rows.

View current auxiliary records. · View the auxiliary file history.

Captured / source date, Dataset, Scope table
Captured / source dateDatasetScopePackage NDCSnapshotSource SHA-256
2025-12-14 17:58 UTC · source 2025-12-05excluded productproductd630ba8d3edf…732f749b63fb…
2025-12-14 17:58 UTC · source 2025-12-05excluded packagepackage64725-1438-1d630ba8d3edf…732f749b63fb…
2025-08-27 00:01 UTC · source 2025-08-26excluded productproductf5e01cc5f278…a2eaf40c39c3…
2025-08-27 00:01 UTC · source 2025-08-26excluded packagepackage64725-1438-1f5e01cc5f278…a2eaf40c39c3…
2025-04-01 02:39 UTC · source 2025-03-31excluded productproduct2ef7874e63bc…57b86245f4fa…
2025-04-01 02:39 UTC · source 2025-03-31excluded packagepackage64725-1438-12ef7874e63bc…57b86245f4fa…
2025-03-28 20:22 UTC · source 2025-03-28excluded productproducta1b67e2a42f9…c4cf2c586c0d…
2025-03-28 20:22 UTC · source 2025-03-28excluded packagepackage64725-1438-1a1b67e2a42f9…c4cf2c586c0d…
2025-03-22 03:12 UTC · source 2025-03-21excluded productproductcfe11265f3b6…090c488252e2…
2025-03-22 03:12 UTC · source 2025-03-21excluded packagepackage64725-1438-1cfe11265f3b6…090c488252e2…
2025-03-10 12:48 UTC · source 2025-03-10excluded productproductcdf11ea48f46…ba0047e9e063…
2025-03-10 12:48 UTC · source 2025-03-10excluded packagepackage64725-1438-1cdf11ea48f46…ba0047e9e063…
2025-02-02 03:52 UTC · source 2025-01-31excluded productproduct302b2466d912…e7b80fea0513…
2025-02-02 03:52 UTC · source 2025-01-31excluded packagepackage64725-1438-1302b2466d912…e7b80fea0513…
2025-01-20 13:05 UTC · source 2025-01-20excluded productproducted331223b511…672a5bd82f5f…
2025-01-20 13:05 UTC · source 2025-01-20excluded packagepackage64725-1438-1ed331223b511…672a5bd82f5f…
2025-01-11 03:41 UTC · source 2025-01-10excluded productproduct0efc9e666f02…f202fb6c5f17…
2025-01-11 03:41 UTC · source 2025-01-10excluded packagepackage64725-1438-10efc9e666f02…f202fb6c5f17…
2024-11-09 02:27 UTC · source 2024-11-08excluded productproductad56d346431e…cc804d4bbf1e…
2024-11-09 02:27 UTC · source 2024-11-08excluded packagepackage64725-1438-1ad56d346431e…cc804d4bbf1e…
2024-10-04 04:10 UTC · source 2024-10-03excluded productproduct367a005e9d99…383a685ebd0f…
2024-10-04 04:10 UTC · source 2024-10-03excluded packagepackage64725-1438-1367a005e9d99…383a685ebd0f…
2024-07-10 04:00 UTC · source 2024-07-09excluded productproduct557ba5c1ecfa…9c80585c8c6e…
2024-07-10 04:00 UTC · source 2024-07-09excluded packagepackage64725-1438-1557ba5c1ecfa…9c80585c8c6e…
2024-05-28 21:12 UTC · source 2024-05-28excluded productproduct8af77b9d5b6f…d9bbb34c5368…
2024-05-28 21:12 UTC · source 2024-05-28excluded packagepackage64725-1438-18af77b9d5b6f…d9bbb34c5368…
2024-05-15 03:39 UTC · source 2024-05-14excluded productproduct834df4deac94…adcc014656a3…
2024-05-15 03:39 UTC · source 2024-05-14excluded packagepackage64725-1438-1834df4deac94…adcc014656a3…
2024-03-11 06:39 UTC · source 2024-03-08excluded productproduct1332a3947898…d4bfe170f9cd…
2024-03-11 06:39 UTC · source 2024-03-08excluded packagepackage64725-1438-11332a3947898…d4bfe170f9cd…
2022-08-30 03:57 UTC · source 2022-08-29excluded productproductfb8cb913e6d1…eb8c232b6be0…
2022-08-30 03:57 UTC · source 2022-08-29excluded packagepackage64725-1438-1fb8cb913e6d1…eb8c232b6be0…
2022-04-09 23:13 UTC · source 2022-04-08excluded productproduct86f5da6cb304…a595104c45d7…
2022-04-09 23:13 UTC · source 2022-04-08excluded packagepackage64725-1438-186f5da6cb304…a595104c45d7…
2022-04-04 05:40 UTC · source 2022-04-01excluded productproductbd6a592717d7…303034d00443…
2022-04-04 05:40 UTC · source 2022-04-01excluded packagepackage64725-1438-1bd6a592717d7…303034d00443…
2021-12-27 23:28 UTC · source 2021-12-27excluded productproduct8dfbde2a14a4…c9ff85d89658…
2021-12-27 23:28 UTC · source 2021-12-27excluded packagepackage64725-1438-18dfbde2a14a4…c9ff85d89658…
2020-12-18 03:04 UTC · source 2020-12-17excluded productproducte2bbac7714bc…27bdfed8d636…
2020-12-18 03:04 UTC · source 2020-12-17excluded packagepackage64725-1438-1e2bbac7714bc…27bdfed8d636…
2020-06-10 20:45 UTC · source 2020-06-10excluded productproduct9bebd1f3094a…5416666fcb17…
2020-06-10 20:45 UTC · source 2020-06-10excluded packagepackage64725-1438-19bebd1f3094a…5416666fcb17…
2019-12-08 06:16 UTC · source 2019-12-05excluded productproduct110d247fa046…a55b01930146…
2019-12-08 06:16 UTC · source 2019-12-05excluded packagepackage64725-1438-1110d247fa046…a55b01930146…

Source provenance: Browse the complete Orange Book source catalog · source snapshot 1.

Orange Book products#

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

Application-product, Trade name, Ingredient table
Application-productTrade nameIngredientStrengthDosage form / routeTE codesRLD / RSApproval date
A089586-001FLUPHENAZINE HYDROCHLORIDEFLUPHENAZINE HYDROCHLORIDE10MGTABLET / ORAL1987-10-16
A089586-002FLUPHENAZINE HYDROCHLORIDEFLUPHENAZINE HYDROCHLORIDE1MGTABLET / ORAL1987-10-16
A089586-003FLUPHENAZINE HYDROCHLORIDEFLUPHENAZINE HYDROCHLORIDE2.5MGTABLET / ORAL1987-10-16
A089586-004FLUPHENAZINE HYDROCHLORIDEFLUPHENAZINE HYDROCHLORIDE5MGTABLET / ORAL1987-10-16

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 · 164 observed states.

Captured, Edition, Application-product table
CapturedEditionApplication-productTrade nameStrengthDosage form / routeProduct TE source textRLD / RSApproval dateSource SHA-256
2026-02-19 14:30 UTC2026-02A089586-001FLUPHENAZINE HYDROCHLORIDE10MGTABLET / ORAL1987-10-16011fe1cb6892…
2026-02-19 14:30 UTC2026-02A089586-002FLUPHENAZINE HYDROCHLORIDE1MGTABLET / ORAL1987-10-16011fe1cb6892…
2026-02-19 14:30 UTC2026-02A089586-003FLUPHENAZINE HYDROCHLORIDE2.5MGTABLET / ORAL1987-10-16011fe1cb6892…
2026-02-19 14:30 UTC2026-02A089586-004FLUPHENAZINE HYDROCHLORIDE5MGTABLET / ORAL1987-10-16011fe1cb6892…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A089586-001FLUPHENAZINE HYDROCHLORIDE10MGTABLET / ORAL1987-10-1631067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A089586-002FLUPHENAZINE HYDROCHLORIDE1MGTABLET / ORAL1987-10-1631067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A089586-003FLUPHENAZINE HYDROCHLORIDE2.5MGTABLET / ORAL1987-10-1631067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A089586-004FLUPHENAZINE HYDROCHLORIDE5MGTABLET / ORAL1987-10-1631067a03dcf5…
2025-08-23 18:47 UTC2025-08A089586-001FLUPHENAZINE HYDROCHLORIDE10MGTABLET / ORAL1987-10-166a471c1ec25d…
2025-08-23 18:47 UTC2025-08A089586-002FLUPHENAZINE HYDROCHLORIDE1MGTABLET / ORAL1987-10-166a471c1ec25d…
2025-08-23 18:47 UTC2025-08A089586-003FLUPHENAZINE HYDROCHLORIDE2.5MGTABLET / ORAL1987-10-166a471c1ec25d…
2025-08-23 18:47 UTC2025-08A089586-004FLUPHENAZINE HYDROCHLORIDE5MGTABLET / ORAL1987-10-166a471c1ec25d…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A089586-001FLUPHENAZINE HYDROCHLORIDE10MGTABLET / ORAL1987-10-16fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A089586-002FLUPHENAZINE HYDROCHLORIDE1MGTABLET / ORAL1987-10-16fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A089586-003FLUPHENAZINE HYDROCHLORIDE2.5MGTABLET / ORAL1987-10-16fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A089586-004FLUPHENAZINE HYDROCHLORIDE5MGTABLET / ORAL1987-10-16fd3edfee7708…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A089586-001FLUPHENAZINE HYDROCHLORIDE10MGTABLET / ORAL1987-10-16b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A089586-002FLUPHENAZINE HYDROCHLORIDE1MGTABLET / ORAL1987-10-16b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A089586-003FLUPHENAZINE HYDROCHLORIDE2.5MGTABLET / ORAL1987-10-16b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A089586-004FLUPHENAZINE HYDROCHLORIDE5MGTABLET / ORAL1987-10-16b8a1b40f171c…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A089586-001FLUPHENAZINE HYDROCHLORIDE10MGTABLET / ORAL1987-10-1603ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A089586-002FLUPHENAZINE HYDROCHLORIDE1MGTABLET / ORAL1987-10-1603ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A089586-003FLUPHENAZINE HYDROCHLORIDE2.5MGTABLET / ORAL1987-10-1603ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A089586-004FLUPHENAZINE HYDROCHLORIDE5MGTABLET / ORAL1987-10-1603ed91905a0d…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A089586-001FLUPHENAZINE HYDROCHLORIDE10MGTABLET / ORAL1987-10-162680178bc6a6…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A089586-002FLUPHENAZINE HYDROCHLORIDE1MGTABLET / ORAL1987-10-162680178bc6a6…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A089586-003FLUPHENAZINE HYDROCHLORIDE2.5MGTABLET / ORAL1987-10-162680178bc6a6…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A089586-004FLUPHENAZINE HYDROCHLORIDE5MGTABLET / ORAL1987-10-162680178bc6a6…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A089586-001FLUPHENAZINE HYDROCHLORIDE10MGTABLET / ORAL1987-10-165bbf6a4d5a75…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A089586-002FLUPHENAZINE HYDROCHLORIDE1MGTABLET / ORAL1987-10-165bbf6a4d5a75…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A089586-003FLUPHENAZINE HYDROCHLORIDE2.5MGTABLET / ORAL1987-10-165bbf6a4d5a75…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A089586-004FLUPHENAZINE HYDROCHLORIDE5MGTABLET / ORAL1987-10-165bbf6a4d5a75…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A089586-001FLUPHENAZINE HYDROCHLORIDE10MGTABLET / ORAL1987-10-16d8e5a09893c0…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A089586-002FLUPHENAZINE HYDROCHLORIDE1MGTABLET / ORAL1987-10-16d8e5a09893c0…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A089586-003FLUPHENAZINE HYDROCHLORIDE2.5MGTABLET / ORAL1987-10-16d8e5a09893c0…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A089586-004FLUPHENAZINE HYDROCHLORIDE5MGTABLET / ORAL1987-10-16d8e5a09893c0…
2024-10-29 15:01 UTC2024-10A089586-001FLUPHENAZINE HYDROCHLORIDE10MGTABLET / ORAL1987-10-16d06236e962d9…
2024-10-29 15:01 UTC2024-10A089586-002FLUPHENAZINE HYDROCHLORIDE1MGTABLET / ORAL1987-10-16d06236e962d9…
2024-10-29 15:01 UTC2024-10A089586-003FLUPHENAZINE HYDROCHLORIDE2.5MGTABLET / ORAL1987-10-16d06236e962d9…
2024-10-29 15:01 UTC2024-10A089586-004FLUPHENAZINE HYDROCHLORIDE5MGTABLET / ORAL1987-10-16d06236e962d9…

Observed Orange Book normalized TE history#

Captured, Edition, Application-product table
CapturedEditionApplication-productTE codeOrderSource SHA-256
2019-12-13 00:20 UTC2019-12A089586-001AB174a2ff9319b5…
2019-12-13 00:20 UTC2019-12A089586-002AB174a2ff9319b5…
2019-12-13 00:20 UTC2019-12A089586-003AB174a2ff9319b5…
2019-12-13 00:20 UTC2019-12A089586-004AB174a2ff9319b5…
2019-12-14 00:12 UTC2019-12A089586-001AB13f01610625f2…
2019-12-14 00:12 UTC2019-12A089586-002AB13f01610625f2…
2019-12-14 00:12 UTC2019-12A089586-003AB13f01610625f2…
2019-12-14 00:12 UTC2019-12A089586-004AB13f01610625f2…
2019-09-15 20:21 UTC2019-09A089586-001AB1b00525d2431f…
2019-09-15 20:21 UTC2019-09A089586-002AB1b00525d2431f…
2019-09-15 20:21 UTC2019-09A089586-003AB1b00525d2431f…
2019-09-15 20:21 UTC2019-09A089586-004AB1b00525d2431f…
2019-07-19 19:46 UTC2019-07A089586-001AB1ea99ee380514…
2019-07-19 19:46 UTC2019-07A089586-002AB1ea99ee380514…
2019-07-19 19:46 UTC2019-07A089586-003AB1ea99ee380514…
2019-07-19 19:46 UTC2019-07A089586-004AB1ea99ee380514…

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
4255c821-309e-3e59-d8e2-48974bad3552Product name820250626
817a13b7-685c-6d80-08bc-347c9a7530c4Product name420240419
817a13b7-685c-6d80-08bc-347c9a7530c4Product name320171211
adfcae9b-bddd-ca49-dfd9-a2e8267a7d37Product name120140508

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDCEffectiveActionDocumentIndexing SPLRelated label
64725-1438-12019-11-27C16284748780-19855e2a2-38e5-60a7-e053-dbdaa90a05bdFluphenazine Hydrochloride Tablets, USP

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
64725-1438-1Fluphenazine Hydrochloride100 in 1 CONTAINERTABLET, FILM COATED1002

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIIDailyMed labelSPL versionUploaded
FLUPHENAZINE HYDROCHLORIDEACTIVE INGREDIENTZOU145W1XLFLUPHENAZINE HYDROCHLORIDE TABLET, FILM COATED [TYA PHARMACEUTICALS]2
FLUPHENAZINEACTIVE MOIETYS79426A41ZFLUPHENAZINE HYDROCHLORIDE TABLET, FILM COATED [TYA PHARMACEUTICALS]2
CELLULOSE, MICROCRYSTALLINEINACTIVE INGREDIENTOP1R32D61UFLUPHENAZINE HYDROCHLORIDE TABLET, FILM COATED [TYA PHARMACEUTICALS]2
D&C YELLOW NO. 10INACTIVE INGREDIENT35SW5USQ3GFLUPHENAZINE HYDROCHLORIDE TABLET, FILM COATED [TYA PHARMACEUTICALS]2
FD&C BLUE NO. 2INACTIVE INGREDIENTL06K8R7DQKFLUPHENAZINE HYDROCHLORIDE TABLET, FILM COATED [TYA PHARMACEUTICALS]2
FD&C RED NO. 40INACTIVE INGREDIENTWZB9127XOAFLUPHENAZINE HYDROCHLORIDE TABLET, FILM COATED [TYA PHARMACEUTICALS]2
HYDROXYPROPYL CELLULOSE (TYPE H)INACTIVE INGREDIENTRFW2ET671PFLUPHENAZINE HYDROCHLORIDE TABLET, FILM COATED [TYA PHARMACEUTICALS]2
HYPROMELLOSE 2910 (3 MPA.S)INACTIVE INGREDIENT0VUT3PMY82FLUPHENAZINE HYDROCHLORIDE TABLET, FILM COATED [TYA PHARMACEUTICALS]2
HYPROMELLOSESINACTIVE INGREDIENT3NXW29V3WOFLUPHENAZINE HYDROCHLORIDE TABLET, FILM COATED [TYA PHARMACEUTICALS]2
LACTOSE MONOHYDRATEINACTIVE INGREDIENTEWQ57Q8I5XFLUPHENAZINE HYDROCHLORIDE TABLET, FILM COATED [TYA PHARMACEUTICALS]2
MAGNESIUM STEARATEINACTIVE INGREDIENT70097M6I30FLUPHENAZINE HYDROCHLORIDE TABLET, FILM COATED [TYA PHARMACEUTICALS]2
POLYETHYLENE GLYCOLSINACTIVE INGREDIENT3WJQ0SDW1AFLUPHENAZINE HYDROCHLORIDE TABLET, FILM COATED [TYA PHARMACEUTICALS]2
POLYSORBATE 80INACTIVE INGREDIENT6OZP39ZG8HFLUPHENAZINE HYDROCHLORIDE TABLET, FILM COATED [TYA PHARMACEUTICALS]2
STARCH, CORNINACTIVE INGREDIENTO8232NY3SJFLUPHENAZINE HYDROCHLORIDE TABLET, FILM COATED [TYA PHARMACEUTICALS]2
TITANIUM DIOXIDEINACTIVE INGREDIENT15FIX9V2JPFLUPHENAZINE HYDROCHLORIDE TABLET, FILM COATED [TYA PHARMACEUTICALS]2

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
64725-1438FLUPHENAZINE HYDROCHLORIDE TABLET, FILM COATED [TYA PHARMACEUTICALS]2Legacy NDC, 1 package rows20140901_50c7e742-1165-4c45-bbf6-172cf70a387a.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
860918fluPHENAZine HCl 5 MG Oral TabletPSN50c7e742-1165-4c45-bbf6-172cf70a387a2
860918fluphenazine hydrochloride 5 MG Oral TabletSCD50c7e742-1165-4c45-bbf6-172cf70a387a2

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionStatus
64725-1438-164725143801100 in 1 CONTAINERHistorical