Fluphenazine Hydrochloride

Product NDC
70518-3095
11-digit product format
705183095
Labeler code
70518
Product ID
70518-3095_c28a6582-b4c0-1f4a-e053-2a95a90a41d6
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Fluphenazine Hydrochloride
Dosage form
TABLET
Route
ORAL
Labeler
REMEDYREPACK INC.
Application
ANDA214674
Marketing category
ANDA
Marketing start
2021-05-17
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 · 2 matching rows.

Dataset, Scope, Product NDC table
DatasetScopeProduct NDCPackage NDCCodeStatusReporting periodSource date
excluded productproduct70518-3095DDiscontinued by firm2026-08-10
excluded packagepackage70518-309570518-3095-0DDiscontinued 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 · 22 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 packagepackage70518-3095-0d630ba8d3edf…732f749b63fb…
2025-08-27 00:01 UTC · source 2025-08-26excluded productproductf5e01cc5f278…a2eaf40c39c3…
2025-08-27 00:01 UTC · source 2025-08-26excluded packagepackage70518-3095-0f5e01cc5f278…a2eaf40c39c3…
2025-04-01 02:39 UTC · source 2025-03-31excluded productproduct2ef7874e63bc…57b86245f4fa…
2025-04-01 02:39 UTC · source 2025-03-31excluded packagepackage70518-3095-02ef7874e63bc…57b86245f4fa…
2025-03-28 20:22 UTC · source 2025-03-28excluded productproducta1b67e2a42f9…c4cf2c586c0d…
2025-03-28 20:22 UTC · source 2025-03-28excluded packagepackage70518-3095-0a1b67e2a42f9…c4cf2c586c0d…
2025-03-22 03:12 UTC · source 2025-03-21excluded productproductcfe11265f3b6…090c488252e2…
2025-03-22 03:12 UTC · source 2025-03-21excluded packagepackage70518-3095-0cfe11265f3b6…090c488252e2…
2025-03-10 12:48 UTC · source 2025-03-10excluded productproductcdf11ea48f46…ba0047e9e063…
2025-03-10 12:48 UTC · source 2025-03-10excluded packagepackage70518-3095-0cdf11ea48f46…ba0047e9e063…
2025-02-02 03:52 UTC · source 2025-01-31excluded productproduct302b2466d912…e7b80fea0513…
2025-02-02 03:52 UTC · source 2025-01-31excluded packagepackage70518-3095-0302b2466d912…e7b80fea0513…
2025-01-20 13:05 UTC · source 2025-01-20excluded productproducted331223b511…672a5bd82f5f…
2025-01-20 13:05 UTC · source 2025-01-20excluded packagepackage70518-3095-0ed331223b511…672a5bd82f5f…
2025-01-11 03:41 UTC · source 2025-01-10excluded productproduct0efc9e666f02…f202fb6c5f17…
2025-01-11 03:41 UTC · source 2025-01-10excluded packagepackage70518-3095-00efc9e666f02…f202fb6c5f17…
2024-11-09 02:27 UTC · source 2024-11-08excluded productproductad56d346431e…cc804d4bbf1e…
2024-11-09 02:27 UTC · source 2024-11-08excluded packagepackage70518-3095-0ad56d346431e…cc804d4bbf1e…
2024-10-04 04:10 UTC · source 2024-10-03excluded productproduct367a005e9d99…383a685ebd0f…
2024-10-04 04:10 UTC · source 2024-10-03excluded packagepackage70518-3095-0367a005e9d99…383a685ebd0f…

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
A214674-001FLUPHENAZINE HYDROCHLORIDEFLUPHENAZINE HYDROCHLORIDE1MGTABLET / ORALAB2021-03-01
A214674-002FLUPHENAZINE HYDROCHLORIDEFLUPHENAZINE HYDROCHLORIDE2.5MGTABLET / ORALAB2021-03-01
A214674-003FLUPHENAZINE HYDROCHLORIDEFLUPHENAZINE HYDROCHLORIDE5MGTABLET / ORALAB2021-03-01
A214674-004FLUPHENAZINE HYDROCHLORIDEFLUPHENAZINE HYDROCHLORIDE10MGTABLET / ORALAB2021-03-01

Therapeutic equivalence codes#

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

Application-product, TE code table
Application-productTE code
A214674-001AB
A214674-002AB
A214674-003AB
A214674-004AB

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 4 · 136 observed states.

Captured, Edition, Application-product table
CapturedEditionApplication-productTrade nameStrengthDosage form / routeProduct TE source textRLD / RSApproval dateSource SHA-256
2026-02-19 14:30 UTC2026-02A214674-001FLUPHENAZINE HYDROCHLORIDE1MGTABLET / ORALAB2021-03-01011fe1cb6892…
2026-02-19 14:30 UTC2026-02A214674-002FLUPHENAZINE HYDROCHLORIDE2.5MGTABLET / ORALAB2021-03-01011fe1cb6892…
2026-02-19 14:30 UTC2026-02A214674-003FLUPHENAZINE HYDROCHLORIDE5MGTABLET / ORALAB2021-03-01011fe1cb6892…
2026-02-19 14:30 UTC2026-02A214674-004FLUPHENAZINE HYDROCHLORIDE10MGTABLET / ORALAB2021-03-01011fe1cb6892…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A214674-001FLUPHENAZINE HYDROCHLORIDE1MGTABLET / ORALAB2021-03-0131067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A214674-002FLUPHENAZINE HYDROCHLORIDE2.5MGTABLET / ORALAB2021-03-0131067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A214674-003FLUPHENAZINE HYDROCHLORIDE5MGTABLET / ORALAB2021-03-0131067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A214674-004FLUPHENAZINE HYDROCHLORIDE10MGTABLET / ORALAB2021-03-0131067a03dcf5…
2025-08-23 18:47 UTC2025-08A214674-001FLUPHENAZINE HYDROCHLORIDE1MGTABLET / ORALAB2021-03-016a471c1ec25d…
2025-08-23 18:47 UTC2025-08A214674-002FLUPHENAZINE HYDROCHLORIDE2.5MGTABLET / ORALAB2021-03-016a471c1ec25d…
2025-08-23 18:47 UTC2025-08A214674-003FLUPHENAZINE HYDROCHLORIDE5MGTABLET / ORALAB2021-03-016a471c1ec25d…
2025-08-23 18:47 UTC2025-08A214674-004FLUPHENAZINE HYDROCHLORIDE10MGTABLET / ORALAB2021-03-016a471c1ec25d…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A214674-001FLUPHENAZINE HYDROCHLORIDE1MGTABLET / ORALAB2021-03-01fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A214674-002FLUPHENAZINE HYDROCHLORIDE2.5MGTABLET / ORALAB2021-03-01fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A214674-003FLUPHENAZINE HYDROCHLORIDE5MGTABLET / ORALAB2021-03-01fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A214674-004FLUPHENAZINE HYDROCHLORIDE10MGTABLET / ORALAB2021-03-01fd3edfee7708…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A214674-001FLUPHENAZINE HYDROCHLORIDE1MGTABLET / ORALAB2021-03-01b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A214674-002FLUPHENAZINE HYDROCHLORIDE2.5MGTABLET / ORALAB2021-03-01b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A214674-003FLUPHENAZINE HYDROCHLORIDE5MGTABLET / ORALAB2021-03-01b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A214674-004FLUPHENAZINE HYDROCHLORIDE10MGTABLET / ORALAB2021-03-01b8a1b40f171c…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A214674-001FLUPHENAZINE HYDROCHLORIDE1MGTABLET / ORALAB2021-03-0103ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A214674-002FLUPHENAZINE HYDROCHLORIDE2.5MGTABLET / ORALAB2021-03-0103ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A214674-003FLUPHENAZINE HYDROCHLORIDE5MGTABLET / ORALAB2021-03-0103ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A214674-004FLUPHENAZINE HYDROCHLORIDE10MGTABLET / ORALAB2021-03-0103ed91905a0d…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A214674-001FLUPHENAZINE HYDROCHLORIDE1MGTABLET / ORALAB2021-03-012680178bc6a6…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A214674-002FLUPHENAZINE HYDROCHLORIDE2.5MGTABLET / ORALAB2021-03-012680178bc6a6…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A214674-003FLUPHENAZINE HYDROCHLORIDE5MGTABLET / ORALAB2021-03-012680178bc6a6…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A214674-004FLUPHENAZINE HYDROCHLORIDE10MGTABLET / ORALAB2021-03-012680178bc6a6…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A214674-001FLUPHENAZINE HYDROCHLORIDE1MGTABLET / ORALAB2021-03-015bbf6a4d5a75…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A214674-002FLUPHENAZINE HYDROCHLORIDE2.5MGTABLET / ORALAB2021-03-015bbf6a4d5a75…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A214674-003FLUPHENAZINE HYDROCHLORIDE5MGTABLET / ORALAB2021-03-015bbf6a4d5a75…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A214674-004FLUPHENAZINE HYDROCHLORIDE10MGTABLET / ORALAB2021-03-015bbf6a4d5a75…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A214674-001FLUPHENAZINE HYDROCHLORIDE1MGTABLET / ORALAB2021-03-01d8e5a09893c0…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A214674-002FLUPHENAZINE HYDROCHLORIDE2.5MGTABLET / ORALAB2021-03-01d8e5a09893c0…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A214674-003FLUPHENAZINE HYDROCHLORIDE5MGTABLET / ORALAB2021-03-01d8e5a09893c0…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A214674-004FLUPHENAZINE HYDROCHLORIDE10MGTABLET / ORALAB2021-03-01d8e5a09893c0…
2024-10-29 15:01 UTC2024-10A214674-001FLUPHENAZINE HYDROCHLORIDE1MGTABLET / ORALAB2021-03-01d06236e962d9…
2024-10-29 15:01 UTC2024-10A214674-002FLUPHENAZINE HYDROCHLORIDE2.5MGTABLET / ORALAB2021-03-01d06236e962d9…
2024-10-29 15:01 UTC2024-10A214674-003FLUPHENAZINE HYDROCHLORIDE5MGTABLET / ORALAB2021-03-01d06236e962d9…
2024-10-29 15:01 UTC2024-10A214674-004FLUPHENAZINE HYDROCHLORIDE10MGTABLET / ORALAB2021-03-01d06236e962d9…

Observed Orange Book normalized TE history#

Normalized TE history page 1 of 4 · 136 observed states.

Captured, Edition, Application-product table
CapturedEditionApplication-productTE codeOrderSource SHA-256
2026-02-19 14:30 UTC2026-02A214674-001AB1011fe1cb6892…
2026-02-19 14:30 UTC2026-02A214674-002AB1011fe1cb6892…
2026-02-19 14:30 UTC2026-02A214674-003AB1011fe1cb6892…
2026-02-19 14:30 UTC2026-02A214674-004AB1011fe1cb6892…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A214674-001AB131067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A214674-002AB131067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A214674-003AB131067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A214674-004AB131067a03dcf5…
2025-08-23 18:47 UTC2025-08A214674-001AB16a471c1ec25d…
2025-08-23 18:47 UTC2025-08A214674-002AB16a471c1ec25d…
2025-08-23 18:47 UTC2025-08A214674-003AB16a471c1ec25d…
2025-08-23 18:47 UTC2025-08A214674-004AB16a471c1ec25d…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A214674-001AB1fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A214674-002AB1fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A214674-003AB1fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A214674-004AB1fd3edfee7708…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A214674-001AB1b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A214674-002AB1b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A214674-003AB1b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A214674-004AB1b8a1b40f171c…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A214674-001AB103ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A214674-002AB103ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A214674-003AB103ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A214674-004AB103ed91905a0d…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A214674-001AB12680178bc6a6…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A214674-002AB12680178bc6a6…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A214674-003AB12680178bc6a6…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A214674-004AB12680178bc6a6…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A214674-001AB15bbf6a4d5a75…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A214674-002AB15bbf6a4d5a75…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A214674-003AB15bbf6a4d5a75…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A214674-004AB15bbf6a4d5a75…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A214674-001AB1d8e5a09893c0…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A214674-002AB1d8e5a09893c0…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A214674-003AB1d8e5a09893c0…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A214674-004AB1d8e5a09893c0…
2024-10-29 15:01 UTC2024-10A214674-001AB1d06236e962d9…
2024-10-29 15:01 UTC2024-10A214674-002AB1d06236e962d9…
2024-10-29 15:01 UTC2024-10A214674-003AB1d06236e962d9…
2024-10-29 15:01 UTC2024-10A214674-004AB1d06236e962d9…

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDCEffectiveActionDocumentIndexing SPLRelated label
70518-3095-02023-03-16C16284748780-1f386c64a-0878-0266-e053-dadaa90a7c1aFluphenazine Hydrochloride Tablets, USP Rx only
70518-3095-02023-01-30C16284748780-1f386c64a-0878-0266-e053-dadaa90a7c1aFluphenazine Hydrochloride Tablets, USP Rx only

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 HYDROCHLORIDEMarlex Pharmaceuticals, Inc.c69f07b1-660c-db03-e053-2995a90a54642025-11-13Boxed warning, Warnings, Adverse reactionsExact identifier
application applno (ANDA): 214674
application number: ANDA214674
Fluphenazine HydrochlorideFLUPHENAZINE HYDROCHLORIDEANI Pharmaceuticals, Inc.6218cbd2-1f7f-40fa-92d2-5d5b0d7fa60b2025-01-24Boxed warning, Warnings, Adverse reactionsExact identifier
application applno (ANDA): 214674
application number: ANDA214674

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
70518-3095-07051830950030 TABLET in 1 BLISTER PACK (70518-3095-0) 30 tablet2021-05-170000-00-00NoNoCurrent