Fluphenazine Hydrochloride

Product NDC
59651-687
Requested package NDC
59651-687-47
11-digit product format
596510687
Labeler code
59651
Product ID
59651-687_1109b107-f7af-45b7-b8ee-709c59123074
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Fluphenazine Hydrochloride
Dosage form
TABLET
Route
ORAL
Labeler
Aurobindo Pharma Limited
Application
ANDA218055
Marketing category
ANDA
Marketing start
2023-08-18
Substance
FLUPHENAZINE HYDROCHLORIDE
Active strength
2.5 mg/1
Pharmacologic classes
Phenothiazine [EPC], Phenothiazines [CS]
NDC exclude flag
No
Listing certified through
2026-12-31
Current FDA listing
Yes

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
unfinished packagepackage59651-68759651-687-47UNFINISHEDActive or certified unfinished drug listing2026-08-10

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 · 14 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 21:27 UTC · source 2025-12-05a6255e0c9aa5…a0211a219f2e…
2025-08-26 23:59 UTC · source 2025-08-261d862106b807…00c93037cd84…
2025-05-15 14:59 UTC · source 2025-05-14390b4c401c3f…2c692c2daee3…
2025-04-01 07:37 UTC · source 2025-03-31e30019b0c005…a3f0b14938b7…
2025-03-01 13:19 UTC · source 2025-02-28bbbc9f937eca…946b9c97cf81…
2025-02-27 05:24 UTC · source 2025-02-26f268b84574a6…26285f5ac5df…
2025-02-01 13:13 UTC · source 2025-01-31f764e8902f78…92046438deef…
2025-01-20 13:05 UTC · source 2025-01-1768b1e3bced9e…98a755eb8bc6…
2024-11-29 20:42 UTC · source 2024-11-2905c55d027831…ca05dca9dc4c…
2024-11-09 02:36 UTC · source 2024-11-0848b4f40e6753…c7c7a00d2afa…
2024-10-09 02:27 UTC · source 2024-10-0827f29a85d7e4…1372111e901f…
2024-07-10 04:00 UTC · source 2024-07-098d62ce987f31…9fe9ef23e30d…
2024-05-28 21:11 UTC · source 2024-05-28d1e113ab4d42…063ee3eb0a1d…
2024-05-15 03:51 UTC · source 2024-05-1450b4072663b7…eae3003ed65e…

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
A218055-001FLUPHENAZINE HYDROCHLORIDEFLUPHENAZINE HYDROCHLORIDE1MGTABLET / ORALAB2023-08-18
A218055-002FLUPHENAZINE HYDROCHLORIDEFLUPHENAZINE HYDROCHLORIDE2.5MGTABLET / ORALAB2023-08-18
A218055-003FLUPHENAZINE HYDROCHLORIDEFLUPHENAZINE HYDROCHLORIDE5MGTABLET / ORALAB2023-08-18
A218055-004FLUPHENAZINE HYDROCHLORIDEFLUPHENAZINE HYDROCHLORIDE10MGTABLET / ORALAB2023-08-18

Therapeutic equivalence codes#

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

Application-product, TE code table
Application-productTE code
A218055-001AB
A218055-002AB
A218055-003AB
A218055-004AB

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 2 · 80 observed states.

Captured, Edition, Application-product table
CapturedEditionApplication-productTrade nameStrengthDosage form / routeProduct TE source textRLD / RSApproval dateSource SHA-256
2026-02-19 14:30 UTC2026-02A218055-001FLUPHENAZINE HYDROCHLORIDE1MGTABLET / ORALAB2023-08-18011fe1cb6892…
2026-02-19 14:30 UTC2026-02A218055-002FLUPHENAZINE HYDROCHLORIDE2.5MGTABLET / ORALAB2023-08-18011fe1cb6892…
2026-02-19 14:30 UTC2026-02A218055-003FLUPHENAZINE HYDROCHLORIDE5MGTABLET / ORALAB2023-08-18011fe1cb6892…
2026-02-19 14:30 UTC2026-02A218055-004FLUPHENAZINE HYDROCHLORIDE10MGTABLET / ORALAB2023-08-18011fe1cb6892…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A218055-001FLUPHENAZINE HYDROCHLORIDE1MGTABLET / ORALAB2023-08-1831067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A218055-002FLUPHENAZINE HYDROCHLORIDE2.5MGTABLET / ORALAB2023-08-1831067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A218055-003FLUPHENAZINE HYDROCHLORIDE5MGTABLET / ORALAB2023-08-1831067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A218055-004FLUPHENAZINE HYDROCHLORIDE10MGTABLET / ORALAB2023-08-1831067a03dcf5…
2025-08-23 18:47 UTC2025-08A218055-001FLUPHENAZINE HYDROCHLORIDE1MGTABLET / ORALAB2023-08-186a471c1ec25d…
2025-08-23 18:47 UTC2025-08A218055-002FLUPHENAZINE HYDROCHLORIDE2.5MGTABLET / ORALAB2023-08-186a471c1ec25d…
2025-08-23 18:47 UTC2025-08A218055-003FLUPHENAZINE HYDROCHLORIDE5MGTABLET / ORALAB2023-08-186a471c1ec25d…
2025-08-23 18:47 UTC2025-08A218055-004FLUPHENAZINE HYDROCHLORIDE10MGTABLET / ORALAB2023-08-186a471c1ec25d…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A218055-001FLUPHENAZINE HYDROCHLORIDE1MGTABLET / ORALAB2023-08-18fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A218055-002FLUPHENAZINE HYDROCHLORIDE2.5MGTABLET / ORALAB2023-08-18fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A218055-003FLUPHENAZINE HYDROCHLORIDE5MGTABLET / ORALAB2023-08-18fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A218055-004FLUPHENAZINE HYDROCHLORIDE10MGTABLET / ORALAB2023-08-18fd3edfee7708…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A218055-001FLUPHENAZINE HYDROCHLORIDE1MGTABLET / ORALAB2023-08-18b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A218055-002FLUPHENAZINE HYDROCHLORIDE2.5MGTABLET / ORALAB2023-08-18b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A218055-003FLUPHENAZINE HYDROCHLORIDE5MGTABLET / ORALAB2023-08-18b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A218055-004FLUPHENAZINE HYDROCHLORIDE10MGTABLET / ORALAB2023-08-18b8a1b40f171c…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A218055-001FLUPHENAZINE HYDROCHLORIDE1MGTABLET / ORALAB2023-08-1803ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A218055-002FLUPHENAZINE HYDROCHLORIDE2.5MGTABLET / ORALAB2023-08-1803ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A218055-003FLUPHENAZINE HYDROCHLORIDE5MGTABLET / ORALAB2023-08-1803ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A218055-004FLUPHENAZINE HYDROCHLORIDE10MGTABLET / ORALAB2023-08-1803ed91905a0d…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A218055-001FLUPHENAZINE HYDROCHLORIDE1MGTABLET / ORALAB2023-08-182680178bc6a6…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A218055-002FLUPHENAZINE HYDROCHLORIDE2.5MGTABLET / ORALAB2023-08-182680178bc6a6…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A218055-003FLUPHENAZINE HYDROCHLORIDE5MGTABLET / ORALAB2023-08-182680178bc6a6…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A218055-004FLUPHENAZINE HYDROCHLORIDE10MGTABLET / ORALAB2023-08-182680178bc6a6…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A218055-001FLUPHENAZINE HYDROCHLORIDE1MGTABLET / ORALAB2023-08-185bbf6a4d5a75…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A218055-002FLUPHENAZINE HYDROCHLORIDE2.5MGTABLET / ORALAB2023-08-185bbf6a4d5a75…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A218055-003FLUPHENAZINE HYDROCHLORIDE5MGTABLET / ORALAB2023-08-185bbf6a4d5a75…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A218055-004FLUPHENAZINE HYDROCHLORIDE10MGTABLET / ORALAB2023-08-185bbf6a4d5a75…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A218055-001FLUPHENAZINE HYDROCHLORIDE1MGTABLET / ORALAB2023-08-18d8e5a09893c0…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A218055-002FLUPHENAZINE HYDROCHLORIDE2.5MGTABLET / ORALAB2023-08-18d8e5a09893c0…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A218055-003FLUPHENAZINE HYDROCHLORIDE5MGTABLET / ORALAB2023-08-18d8e5a09893c0…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A218055-004FLUPHENAZINE HYDROCHLORIDE10MGTABLET / ORALAB2023-08-18d8e5a09893c0…
2024-10-29 15:01 UTC2024-10A218055-001FLUPHENAZINE HYDROCHLORIDE1MGTABLET / ORALAB2023-08-18d06236e962d9…
2024-10-29 15:01 UTC2024-10A218055-002FLUPHENAZINE HYDROCHLORIDE2.5MGTABLET / ORALAB2023-08-18d06236e962d9…
2024-10-29 15:01 UTC2024-10A218055-003FLUPHENAZINE HYDROCHLORIDE5MGTABLET / ORALAB2023-08-18d06236e962d9…
2024-10-29 15:01 UTC2024-10A218055-004FLUPHENAZINE HYDROCHLORIDE10MGTABLET / ORALAB2023-08-18d06236e962d9…

Observed Orange Book normalized TE history#

Normalized TE history page 1 of 2 · 80 observed states.

Captured, Edition, Application-product table
CapturedEditionApplication-productTE codeOrderSource SHA-256
2026-02-19 14:30 UTC2026-02A218055-001AB1011fe1cb6892…
2026-02-19 14:30 UTC2026-02A218055-002AB1011fe1cb6892…
2026-02-19 14:30 UTC2026-02A218055-003AB1011fe1cb6892…
2026-02-19 14:30 UTC2026-02A218055-004AB1011fe1cb6892…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A218055-001AB131067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A218055-002AB131067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A218055-003AB131067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A218055-004AB131067a03dcf5…
2025-08-23 18:47 UTC2025-08A218055-001AB16a471c1ec25d…
2025-08-23 18:47 UTC2025-08A218055-002AB16a471c1ec25d…
2025-08-23 18:47 UTC2025-08A218055-003AB16a471c1ec25d…
2025-08-23 18:47 UTC2025-08A218055-004AB16a471c1ec25d…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A218055-001AB1fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A218055-002AB1fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A218055-003AB1fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A218055-004AB1fd3edfee7708…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A218055-001AB1b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A218055-002AB1b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A218055-003AB1b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A218055-004AB1b8a1b40f171c…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A218055-001AB103ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A218055-002AB103ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A218055-003AB103ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A218055-004AB103ed91905a0d…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A218055-001AB12680178bc6a6…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A218055-002AB12680178bc6a6…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A218055-003AB12680178bc6a6…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A218055-004AB12680178bc6a6…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A218055-001AB15bbf6a4d5a75…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A218055-002AB15bbf6a4d5a75…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A218055-003AB15bbf6a4d5a75…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A218055-004AB15bbf6a4d5a75…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A218055-001AB1d8e5a09893c0…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A218055-002AB1d8e5a09893c0…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A218055-003AB1d8e5a09893c0…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A218055-004AB1d8e5a09893c0…
2024-10-29 15:01 UTC2024-10A218055-001AB1d06236e962d9…
2024-10-29 15:01 UTC2024-10A218055-002AB1d06236e962d9…
2024-10-29 15:01 UTC2024-10A218055-003AB1d06236e962d9…
2024-10-29 15:01 UTC2024-10A218055-004AB1d06236e962d9…

Additional Listing Data#

Finished product
Yes
Brand name base
Fluphenazine Hydrochloride
Listing expiration
2026-12-31

Active Ingredients#

Ingredient, Strength table
IngredientStrength
FLUPHENAZINE HYDROCHLORIDE2.5 mg/1

Harmonized UNII identifiers#

UNII identifiers page 1 of 1 · 1 matching rows.

Identifier, FDA.report destination table
IdentifierFDA.report destination
ZOU145W1XLInternal UNII lookup

Harmonized RxCUI identifiers#

RxCUI identifiers page 1 of 1 · 4 matching rows.

Identifier, FDA.report destination table
IdentifierFDA.report destination
859841Internal RxNorm lookup
860918Internal RxNorm lookup
865117Internal RxNorm lookup
865123Internal RxNorm lookup

Harmonized SPL set identifiers#

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

Identifier, FDA.report destination table
IdentifierFDA.report destination
e73764e7-e666-4ad3-a029-04a528dc1c9eAvailable on FDA.report

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

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
59651-687-01Fluphenazine Hydrochloride100 in 1 BOTTLETABLET1003

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
59651-687-01EA - Each59651-687e25c17ee-92c1-43bf-897b-3a724b45976a12024-02-14

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
59651-687FLUPHENAZINE HYDROCHLORIDE TABLET [AUROBINDO PHARMA LIMITED]3Current NDC, 1 package rows20241121_e73764e7-e666-4ad3-a029-04a528dc1c9e.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 · 1 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
Fluphenazine HydrochlorideFLUPHENAZINE HYDROCHLORIDEAurobindo Pharma Limitede73764e7-e666-4ad3-a029-04a528dc1c9e2024-11-14Boxed warning, Warnings, Adverse reactionsExact identifier
application applno (ANDA): 218055
application number: ANDA218055
ndc (product): 59651-687

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
865117fluPHENAZine HCl 1 MG Oral TabletPSNe73764e7-e666-4ad3-a029-04a528dc1c9e3
859841fluPHENAZine HCl 10 MG Oral TabletPSNe73764e7-e666-4ad3-a029-04a528dc1c9e3
865123fluPHENAZine HCl 2.5 MG Oral TabletPSNe73764e7-e666-4ad3-a029-04a528dc1c9e3
860918fluPHENAZine HCl 5 MG Oral TabletPSNe73764e7-e666-4ad3-a029-04a528dc1c9e3
865117fluphenazine hydrochloride 1 MG Oral TabletSCDe73764e7-e666-4ad3-a029-04a528dc1c9e3
859841fluphenazine hydrochloride 10 MG Oral TabletSCDe73764e7-e666-4ad3-a029-04a528dc1c9e3
865123fluphenazine hydrochloride 2.5 MG Oral TabletSCDe73764e7-e666-4ad3-a029-04a528dc1c9e3
860918fluphenazine hydrochloride 5 MG Oral TabletSCDe73764e7-e666-4ad3-a029-04a528dc1c9e3

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startStatus
59651-687-4759651068747115000 TABLET in 1 BAG (59651-687-47)115000 tablet18-AUG-23Current