Fluphenazine Hydrochloride

Product NDC
68084-950
11-digit product format
680840950
Labeler code
68084
Product ID
68084-950_ea3f5929-0eeb-517b-e053-2995a90a1f33
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Fluphenazine Hydrochloride
Dosage form
TABLET, FILM COATED
Route
ORAL
Labeler
American Health Packaging
Application
ANDA089743
Marketing category
ANDA
Marketing start
2015-10-01
Marketing end
0000-00-00
Substance
FLUPHENAZINE HYDROCHLORIDE
Active strength
10 mg/1
Pharmacologic classes
Phenothiazine [EPC], Phenothiazines [CS]
NDC exclude flag
No
Listing certified through
2023-12-31
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 productproduct68084-950DDiscontinued by firm2026-08-10
excluded packagepackage68084-95068084-950-01DDiscontinued by firm2026-08-10

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 · 4 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 packagepackage68084-950-01d630ba8d3edf…732f749b63fb…
2025-08-27 00:01 UTC · source 2025-08-26excluded productproductf5e01cc5f278…a2eaf40c39c3…
2025-08-27 00:01 UTC · source 2025-08-26excluded packagepackage68084-950-01f5e01cc5f278…a2eaf40c39c3…

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 Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
68084-950-01EA - Each68084-9504ecc5888-9697-442a-88f9-3e7ebcf3594112021-03-02
68084-950-11EA - Each68084-950065568d9-3d83-4f5e-9dad-64c1e345878e12021-03-02
68084-950-25EA - Each68084-9506c139089-e776-4b4e-ab38-472f0fa14e1012015-12-02
68084-950-95EA - Each68084-950cea770e2-9a11-4ca1-a32a-9ed6e0aac84412015-12-02

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIIDailyMed labelSPL versionUploaded
FLUPHENAZINE HYDROCHLORIDEACTIVE INGREDIENTZOU145W1XLFLUPHENAZINE HYDROCHLORIDE TABLET, FILM COATED [AMERICAN HEALTH PACKAGING]3
FLUPHENAZINEACTIVE MOIETYS79426A41ZFLUPHENAZINE HYDROCHLORIDE TABLET, FILM COATED [AMERICAN HEALTH PACKAGING]3
CALCIUM PHOSPHATE, DIBASIC, DIHYDRATEINACTIVE INGREDIENTO7TSZ97GEPFLUPHENAZINE HYDROCHLORIDE TABLET, FILM COATED [AMERICAN HEALTH PACKAGING]3
D&C RED NO. 27INACTIVE INGREDIENT2LRS185U6KFLUPHENAZINE HYDROCHLORIDE TABLET, FILM COATED [AMERICAN HEALTH PACKAGING]3
D&C RED NO. 30INACTIVE INGREDIENT2S42T2808BFLUPHENAZINE HYDROCHLORIDE TABLET, FILM COATED [AMERICAN HEALTH PACKAGING]3
D&C YELLOW NO. 10INACTIVE INGREDIENT35SW5USQ3GFLUPHENAZINE HYDROCHLORIDE TABLET, FILM COATED [AMERICAN HEALTH PACKAGING]3
FD&C BLUE NO. 1INACTIVE INGREDIENTH3R47K3TBDFLUPHENAZINE HYDROCHLORIDE TABLET, FILM COATED [AMERICAN HEALTH PACKAGING]3
FD&C RED NO. 40INACTIVE INGREDIENTWZB9127XOAFLUPHENAZINE HYDROCHLORIDE TABLET, FILM COATED [AMERICAN HEALTH PACKAGING]3
FD&C YELLOW NO. 6INACTIVE INGREDIENTH77VEI93A8FLUPHENAZINE HYDROCHLORIDE TABLET, FILM COATED [AMERICAN HEALTH PACKAGING]3
HYPROMELLOSESINACTIVE INGREDIENT3NXW29V3WOFLUPHENAZINE HYDROCHLORIDE TABLET, FILM COATED [AMERICAN HEALTH PACKAGING]3
LACTOSE MONOHYDRATEINACTIVE INGREDIENTEWQ57Q8I5XFLUPHENAZINE HYDROCHLORIDE TABLET, FILM COATED [AMERICAN HEALTH PACKAGING]3
MAGNESIUM STEARATEINACTIVE INGREDIENT70097M6I30FLUPHENAZINE HYDROCHLORIDE TABLET, FILM COATED [AMERICAN HEALTH PACKAGING]3
POLYETHYLENE GLYCOLSINACTIVE INGREDIENT3WJQ0SDW1AFLUPHENAZINE HYDROCHLORIDE TABLET, FILM COATED [AMERICAN HEALTH PACKAGING]3
POLYSORBATE 80INACTIVE INGREDIENT6OZP39ZG8HFLUPHENAZINE HYDROCHLORIDE TABLET, FILM COATED [AMERICAN HEALTH PACKAGING]3
STARCH, CORNINACTIVE INGREDIENTO8232NY3SJFLUPHENAZINE HYDROCHLORIDE TABLET, FILM COATED [AMERICAN HEALTH PACKAGING]3
TITANIUM DIOXIDEINACTIVE INGREDIENT15FIX9V2JPFLUPHENAZINE HYDROCHLORIDE TABLET, FILM COATED [AMERICAN HEALTH PACKAGING]3
WATERINACTIVE INGREDIENT059QF0KO0RFLUPHENAZINE HYDROCHLORIDE TABLET, FILM COATED [AMERICAN HEALTH PACKAGING]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 · 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

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
68084-950-0168084095001100 BLISTER PACK in 1 BOX, UNIT-DOSE (68084-950-01) > 1 TABLET, FILM COATED in 1 BLISTER PACK (68084-950-11) 100 blister pack2020-12-010000-00-00NoNoCurrent