Fluphenazine Hydrochloride

Product NDC
50090-4740
Requested package NDC
50090-4740-0
11-digit product format
500904740
Labeler code
50090
Product ID
50090-4740_35cfc41e-9f13-4b10-a015-5643cb5d6074
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Fluphenazine Hydrochloride
Dosage form
TABLET, FILM COATED
Route
ORAL
Labeler
A-S Medication Solutions
Application
ANDA089743
Marketing category
ANDA
Marketing start
1988-08-25
Marketing end
0000-00-00
Substance
FLUPHENAZINE HYDROCHLORIDE
Active strength
5 mg/1
Pharmacologic classes
Phenothiazines [CS],Phenothiazine [EPC]
NDC exclude flag
No
Listing certified through
2022-12-31
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 · 1 matching rows.

Dataset, Scope, Product NDC table
DatasetScopeProduct NDCPackage NDCCodeStatusReporting periodSource date
excluded packagepackage50090-474050090-4740-0IInactivated 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 · 15 matching rows.

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

Captured / source date, Snapshot, Source SHA-256 table
Captured / source dateSnapshotSource SHA-256
2025-12-14 17:58 UTC · source 2025-12-05d630ba8d3edf…732f749b63fb…
2025-08-27 00:01 UTC · source 2025-08-26f5e01cc5f278…a2eaf40c39c3…
2025-04-01 02:39 UTC · source 2025-03-312ef7874e63bc…57b86245f4fa…
2025-03-28 20:22 UTC · source 2025-03-28a1b67e2a42f9…c4cf2c586c0d…
2025-03-22 03:12 UTC · source 2025-03-21cfe11265f3b6…090c488252e2…
2025-03-10 12:48 UTC · source 2025-03-10cdf11ea48f46…ba0047e9e063…
2025-02-02 03:52 UTC · source 2025-01-31302b2466d912…e7b80fea0513…
2025-01-20 13:05 UTC · source 2025-01-20ed331223b511…672a5bd82f5f…
2025-01-11 03:41 UTC · source 2025-01-100efc9e666f02…f202fb6c5f17…
2024-11-09 02:27 UTC · source 2024-11-08ad56d346431e…cc804d4bbf1e…
2024-10-04 04:10 UTC · source 2024-10-03367a005e9d99…383a685ebd0f…
2024-07-10 04:00 UTC · source 2024-07-09557ba5c1ecfa…9c80585c8c6e…
2024-05-28 21:12 UTC · source 2024-05-288af77b9d5b6f…d9bbb34c5368…
2024-05-15 03:39 UTC · source 2024-05-14834df4deac94…adcc014656a3…
2024-03-11 06:39 UTC · source 2024-03-081332a3947898…d4bfe170f9cd…

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
A089743-001FLUPHENAZINE HYDROCHLORIDEFLUPHENAZINE HYDROCHLORIDE10MGTABLET / ORALAB1988-08-25
A089743-002FLUPHENAZINE HYDROCHLORIDEFLUPHENAZINE HYDROCHLORIDE1MGTABLET / ORALAB1988-08-25
A089743-003FLUPHENAZINE HYDROCHLORIDEFLUPHENAZINE HYDROCHLORIDE2.5MGTABLET / ORALAB1988-08-25
A089743-004FLUPHENAZINE HYDROCHLORIDEFLUPHENAZINE HYDROCHLORIDE5MGTABLET / ORALABRS1988-08-25

Therapeutic equivalence codes#

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

Application-product, TE code table
Application-productTE code
A089743-001AB
A089743-002AB
A089743-003AB
A089743-004AB

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 UTC2026-02A089743-001FLUPHENAZINE HYDROCHLORIDE10MGTABLET / ORALAB1988-08-25011fe1cb6892…
2026-02-19 14:30 UTC2026-02A089743-002FLUPHENAZINE HYDROCHLORIDE1MGTABLET / ORALAB1988-08-25011fe1cb6892…
2026-02-19 14:30 UTC2026-02A089743-003FLUPHENAZINE HYDROCHLORIDE2.5MGTABLET / ORALAB1988-08-25011fe1cb6892…
2026-02-19 14:30 UTC2026-02A089743-004FLUPHENAZINE HYDROCHLORIDE5MGTABLET / ORALABRS1988-08-25011fe1cb6892…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A089743-001FLUPHENAZINE HYDROCHLORIDE10MGTABLET / ORALAB1988-08-2531067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A089743-002FLUPHENAZINE HYDROCHLORIDE1MGTABLET / ORALAB1988-08-2531067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A089743-003FLUPHENAZINE HYDROCHLORIDE2.5MGTABLET / ORALAB1988-08-2531067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A089743-004FLUPHENAZINE HYDROCHLORIDE5MGTABLET / ORALABRS1988-08-2531067a03dcf5…
2025-08-23 18:47 UTC2025-08A089743-001FLUPHENAZINE HYDROCHLORIDE10MGTABLET / ORALAB1988-08-256a471c1ec25d…
2025-08-23 18:47 UTC2025-08A089743-002FLUPHENAZINE HYDROCHLORIDE1MGTABLET / ORALAB1988-08-256a471c1ec25d…
2025-08-23 18:47 UTC2025-08A089743-003FLUPHENAZINE HYDROCHLORIDE2.5MGTABLET / ORALAB1988-08-256a471c1ec25d…
2025-08-23 18:47 UTC2025-08A089743-004FLUPHENAZINE HYDROCHLORIDE5MGTABLET / ORALABRS1988-08-256a471c1ec25d…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A089743-001FLUPHENAZINE HYDROCHLORIDE10MGTABLET / ORALAB1988-08-25fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A089743-002FLUPHENAZINE HYDROCHLORIDE1MGTABLET / ORALAB1988-08-25fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A089743-003FLUPHENAZINE HYDROCHLORIDE2.5MGTABLET / ORALAB1988-08-25fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A089743-004FLUPHENAZINE HYDROCHLORIDE5MGTABLET / ORALABRS1988-08-25fd3edfee7708…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A089743-001FLUPHENAZINE HYDROCHLORIDE10MGTABLET / ORALAB1988-08-25b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A089743-002FLUPHENAZINE HYDROCHLORIDE1MGTABLET / ORALAB1988-08-25b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A089743-003FLUPHENAZINE HYDROCHLORIDE2.5MGTABLET / ORALAB1988-08-25b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A089743-004FLUPHENAZINE HYDROCHLORIDE5MGTABLET / ORALABRS1988-08-25b8a1b40f171c…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A089743-001FLUPHENAZINE HYDROCHLORIDE10MGTABLET / ORALAB1988-08-2503ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A089743-002FLUPHENAZINE HYDROCHLORIDE1MGTABLET / ORALAB1988-08-2503ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A089743-003FLUPHENAZINE HYDROCHLORIDE2.5MGTABLET / ORALAB1988-08-2503ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A089743-004FLUPHENAZINE HYDROCHLORIDE5MGTABLET / ORALABRS1988-08-2503ed91905a0d…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A089743-001FLUPHENAZINE HYDROCHLORIDE10MGTABLET / ORALAB1988-08-252680178bc6a6…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A089743-002FLUPHENAZINE HYDROCHLORIDE1MGTABLET / ORALAB1988-08-252680178bc6a6…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A089743-003FLUPHENAZINE HYDROCHLORIDE2.5MGTABLET / ORALAB1988-08-252680178bc6a6…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A089743-004FLUPHENAZINE HYDROCHLORIDE5MGTABLET / ORALABRS1988-08-252680178bc6a6…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A089743-001FLUPHENAZINE HYDROCHLORIDE10MGTABLET / ORALAB1988-08-255bbf6a4d5a75…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A089743-002FLUPHENAZINE HYDROCHLORIDE1MGTABLET / ORALAB1988-08-255bbf6a4d5a75…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A089743-003FLUPHENAZINE HYDROCHLORIDE2.5MGTABLET / ORALAB1988-08-255bbf6a4d5a75…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A089743-004FLUPHENAZINE HYDROCHLORIDE5MGTABLET / ORALABRS1988-08-255bbf6a4d5a75…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A089743-001FLUPHENAZINE HYDROCHLORIDE10MGTABLET / ORALAB1988-08-25d8e5a09893c0…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A089743-002FLUPHENAZINE HYDROCHLORIDE1MGTABLET / ORALAB1988-08-25d8e5a09893c0…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A089743-003FLUPHENAZINE HYDROCHLORIDE2.5MGTABLET / ORALAB1988-08-25d8e5a09893c0…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A089743-004FLUPHENAZINE HYDROCHLORIDE5MGTABLET / ORALABRS1988-08-25d8e5a09893c0…
2024-10-29 15:01 UTC2024-10A089743-001FLUPHENAZINE HYDROCHLORIDE10MGTABLET / ORALAB1988-08-25d06236e962d9…
2024-10-29 15:01 UTC2024-10A089743-002FLUPHENAZINE HYDROCHLORIDE1MGTABLET / ORALAB1988-08-25d06236e962d9…
2024-10-29 15:01 UTC2024-10A089743-003FLUPHENAZINE HYDROCHLORIDE2.5MGTABLET / ORALAB1988-08-25d06236e962d9…
2024-10-29 15:01 UTC2024-10A089743-004FLUPHENAZINE HYDROCHLORIDE5MGTABLET / ORALABRS1988-08-25d06236e962d9…

Observed Orange Book normalized TE history#

Normalized TE history page 1 of 5 · 164 observed states.

Captured, Edition, Application-product table
CapturedEditionApplication-productTE codeOrderSource SHA-256
2026-02-19 14:30 UTC2026-02A089743-001AB1011fe1cb6892…
2026-02-19 14:30 UTC2026-02A089743-002AB1011fe1cb6892…
2026-02-19 14:30 UTC2026-02A089743-003AB1011fe1cb6892…
2026-02-19 14:30 UTC2026-02A089743-004AB1011fe1cb6892…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A089743-001AB131067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A089743-002AB131067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A089743-003AB131067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A089743-004AB131067a03dcf5…
2025-08-23 18:47 UTC2025-08A089743-001AB16a471c1ec25d…
2025-08-23 18:47 UTC2025-08A089743-002AB16a471c1ec25d…
2025-08-23 18:47 UTC2025-08A089743-003AB16a471c1ec25d…
2025-08-23 18:47 UTC2025-08A089743-004AB16a471c1ec25d…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A089743-001AB1fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A089743-002AB1fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A089743-003AB1fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A089743-004AB1fd3edfee7708…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A089743-001AB1b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A089743-002AB1b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A089743-003AB1b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A089743-004AB1b8a1b40f171c…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A089743-001AB103ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A089743-002AB103ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A089743-003AB103ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A089743-004AB103ed91905a0d…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A089743-001AB12680178bc6a6…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A089743-002AB12680178bc6a6…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A089743-003AB12680178bc6a6…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A089743-004AB12680178bc6a6…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A089743-001AB15bbf6a4d5a75…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A089743-002AB15bbf6a4d5a75…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A089743-003AB15bbf6a4d5a75…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A089743-004AB15bbf6a4d5a75…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A089743-001AB1d8e5a09893c0…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A089743-002AB1d8e5a09893c0…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A089743-003AB1d8e5a09893c0…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A089743-004AB1d8e5a09893c0…
2024-10-29 15:01 UTC2024-10A089743-001AB1d06236e962d9…
2024-10-29 15:01 UTC2024-10A089743-002AB1d06236e962d9…
2024-10-29 15:01 UTC2024-10A089743-003AB1d06236e962d9…
2024-10-29 15:01 UTC2024-10A089743-004AB1d06236e962d9…

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
50090-4740-02023-01-30C16284748780-1f386c64a-2256-0266-e053-dadaa90a7c1aFluphenazine Hydrochloride Tablets, USP

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
50090-4740-0Fluphenazine Hydrochloride1 in 1 BLISTER PACKTABLET, FILM COATED13
50090-4740-0Fluphenazine Hydrochloride32 in 1 CARTONTABLET, FILM COATED323

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
50090-4740FLUPHENAZINE HYDROCHLORIDE TABLET, FILM COATED [A-S MEDICATION SOLUTIONS]3Legacy NDC, 2 package rows20210416_a8360aca-5f69-4ad0-b2ed-99a66b601198.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
Fluphenazine HydrochlorideFLUPHENAZINE HYDROCHLORIDEMajor Pharmaceuticalse8d4065a-45fc-4adf-9406-2122ca131d992025-09-11Boxed warning, Warnings, Adverse reactionsExact identifier
application applno (ANDA): 089743
application number: ANDA089743
Fluphenazine HydrochlorideFLUPHENAZINE HYDROCHLORIDELannett Company, Inc.6cd6ba35-3481-48c1-87db-dc74ce9d7d752024-11-13Boxed warning, Warnings, Adverse reactionsExact identifier
application applno (ANDA): 089743
application number: ANDA089743

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
860918fluPHENAZine HCl 5 MG Oral TabletPSNa8360aca-5f69-4ad0-b2ed-99a66b6011983
860918fluphenazine hydrochloride 5 MG Oral TabletSCDa8360aca-5f69-4ad0-b2ed-99a66b6011983

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
50090-4740-05009047400032 BLISTER PACK in 1 CARTON (50090-4740-0) > 1 TABLET, FILM COATED in 1 BLISTER PACK32 blister pack2019-11-200000-00-00NoNoCurrent