Fluphenazine Hydrochloride

Product NDC
43598-037
11-digit product format
435980037
Labeler code
43598
Product ID
43598-037_95c5a977-cf1e-488a-8eff-c5fabc4b73c3
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Fluphenazine Hydrochloride
Dosage form
TABLET, FILM COATED
Route
ORAL
Labeler
Dr. Reddy�s Laboratories Inc.
Application
ANDA214534
Marketing category
ANDA
Marketing start
2021-02-15
Substance
FLUPHENAZINE HYDROCHLORIDE
Active strength
10 mg/1
Pharmacologic classes
Phenothiazine [EPC], Phenothiazines [CS]
NDC exclude flag
No
Listing certified through
2026-12-31
Current FDA listing
Yes

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
A214534-001FLUPHENAZINE HYDROCHLORIDEFLUPHENAZINE HYDROCHLORIDE1MGTABLET / ORALAB2021-01-07
A214534-002FLUPHENAZINE HYDROCHLORIDEFLUPHENAZINE HYDROCHLORIDE2.5MGTABLET / ORALAB2021-01-07
A214534-003FLUPHENAZINE HYDROCHLORIDEFLUPHENAZINE HYDROCHLORIDE5MGTABLET / ORALAB2021-01-07
A214534-004FLUPHENAZINE HYDROCHLORIDEFLUPHENAZINE HYDROCHLORIDE10MGTABLET / ORALAB2021-01-07

Therapeutic equivalence codes#

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

Application-product, TE code table
Application-productTE code
A214534-001AB
A214534-002AB
A214534-003AB
A214534-004AB

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 · 140 observed states.

Captured, Edition, Application-product table
CapturedEditionApplication-productTrade nameStrengthDosage form / routeProduct TE source textRLD / RSApproval dateSource SHA-256
2026-02-19 14:30 UTC2026-02A214534-001FLUPHENAZINE HYDROCHLORIDE1MGTABLET / ORALAB2021-01-07011fe1cb6892…
2026-02-19 14:30 UTC2026-02A214534-002FLUPHENAZINE HYDROCHLORIDE2.5MGTABLET / ORALAB2021-01-07011fe1cb6892…
2026-02-19 14:30 UTC2026-02A214534-003FLUPHENAZINE HYDROCHLORIDE5MGTABLET / ORALAB2021-01-07011fe1cb6892…
2026-02-19 14:30 UTC2026-02A214534-004FLUPHENAZINE HYDROCHLORIDE10MGTABLET / ORALAB2021-01-07011fe1cb6892…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A214534-001FLUPHENAZINE HYDROCHLORIDE1MGTABLET / ORALAB2021-01-0731067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A214534-002FLUPHENAZINE HYDROCHLORIDE2.5MGTABLET / ORALAB2021-01-0731067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A214534-003FLUPHENAZINE HYDROCHLORIDE5MGTABLET / ORALAB2021-01-0731067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A214534-004FLUPHENAZINE HYDROCHLORIDE10MGTABLET / ORALAB2021-01-0731067a03dcf5…
2025-08-23 18:47 UTC2025-08A214534-001FLUPHENAZINE HYDROCHLORIDE1MGTABLET / ORALAB2021-01-076a471c1ec25d…
2025-08-23 18:47 UTC2025-08A214534-002FLUPHENAZINE HYDROCHLORIDE2.5MGTABLET / ORALAB2021-01-076a471c1ec25d…
2025-08-23 18:47 UTC2025-08A214534-003FLUPHENAZINE HYDROCHLORIDE5MGTABLET / ORALAB2021-01-076a471c1ec25d…
2025-08-23 18:47 UTC2025-08A214534-004FLUPHENAZINE HYDROCHLORIDE10MGTABLET / ORALAB2021-01-076a471c1ec25d…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A214534-001FLUPHENAZINE HYDROCHLORIDE1MGTABLET / ORALAB2021-01-07fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A214534-002FLUPHENAZINE HYDROCHLORIDE2.5MGTABLET / ORALAB2021-01-07fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A214534-003FLUPHENAZINE HYDROCHLORIDE5MGTABLET / ORALAB2021-01-07fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A214534-004FLUPHENAZINE HYDROCHLORIDE10MGTABLET / ORALAB2021-01-07fd3edfee7708…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A214534-001FLUPHENAZINE HYDROCHLORIDE1MGTABLET / ORALAB2021-01-07b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A214534-002FLUPHENAZINE HYDROCHLORIDE2.5MGTABLET / ORALAB2021-01-07b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A214534-003FLUPHENAZINE HYDROCHLORIDE5MGTABLET / ORALAB2021-01-07b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A214534-004FLUPHENAZINE HYDROCHLORIDE10MGTABLET / ORALAB2021-01-07b8a1b40f171c…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A214534-001FLUPHENAZINE HYDROCHLORIDE1MGTABLET / ORALAB2021-01-0703ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A214534-002FLUPHENAZINE HYDROCHLORIDE2.5MGTABLET / ORALAB2021-01-0703ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A214534-003FLUPHENAZINE HYDROCHLORIDE5MGTABLET / ORALAB2021-01-0703ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A214534-004FLUPHENAZINE HYDROCHLORIDE10MGTABLET / ORALAB2021-01-0703ed91905a0d…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A214534-001FLUPHENAZINE HYDROCHLORIDE1MGTABLET / ORALAB2021-01-072680178bc6a6…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A214534-002FLUPHENAZINE HYDROCHLORIDE2.5MGTABLET / ORALAB2021-01-072680178bc6a6…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A214534-003FLUPHENAZINE HYDROCHLORIDE5MGTABLET / ORALAB2021-01-072680178bc6a6…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A214534-004FLUPHENAZINE HYDROCHLORIDE10MGTABLET / ORALAB2021-01-072680178bc6a6…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A214534-001FLUPHENAZINE HYDROCHLORIDE1MGTABLET / ORALAB2021-01-075bbf6a4d5a75…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A214534-002FLUPHENAZINE HYDROCHLORIDE2.5MGTABLET / ORALAB2021-01-075bbf6a4d5a75…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A214534-003FLUPHENAZINE HYDROCHLORIDE5MGTABLET / ORALAB2021-01-075bbf6a4d5a75…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A214534-004FLUPHENAZINE HYDROCHLORIDE10MGTABLET / ORALAB2021-01-075bbf6a4d5a75…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A214534-001FLUPHENAZINE HYDROCHLORIDE1MGTABLET / ORALAB2021-01-07d8e5a09893c0…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A214534-002FLUPHENAZINE HYDROCHLORIDE2.5MGTABLET / ORALAB2021-01-07d8e5a09893c0…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A214534-003FLUPHENAZINE HYDROCHLORIDE5MGTABLET / ORALAB2021-01-07d8e5a09893c0…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A214534-004FLUPHENAZINE HYDROCHLORIDE10MGTABLET / ORALAB2021-01-07d8e5a09893c0…
2024-10-29 15:01 UTC2024-10A214534-001FLUPHENAZINE HYDROCHLORIDE1MGTABLET / ORALAB2021-01-07d06236e962d9…
2024-10-29 15:01 UTC2024-10A214534-002FLUPHENAZINE HYDROCHLORIDE2.5MGTABLET / ORALAB2021-01-07d06236e962d9…
2024-10-29 15:01 UTC2024-10A214534-003FLUPHENAZINE HYDROCHLORIDE5MGTABLET / ORALAB2021-01-07d06236e962d9…
2024-10-29 15:01 UTC2024-10A214534-004FLUPHENAZINE HYDROCHLORIDE10MGTABLET / ORALAB2021-01-07d06236e962d9…

Observed Orange Book normalized TE history#

Normalized TE history page 1 of 4 · 140 observed states.

Captured, Edition, Application-product table
CapturedEditionApplication-productTE codeOrderSource SHA-256
2026-02-19 14:30 UTC2026-02A214534-001AB1011fe1cb6892…
2026-02-19 14:30 UTC2026-02A214534-002AB1011fe1cb6892…
2026-02-19 14:30 UTC2026-02A214534-003AB1011fe1cb6892…
2026-02-19 14:30 UTC2026-02A214534-004AB1011fe1cb6892…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A214534-001AB131067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A214534-002AB131067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A214534-003AB131067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A214534-004AB131067a03dcf5…
2025-08-23 18:47 UTC2025-08A214534-001AB16a471c1ec25d…
2025-08-23 18:47 UTC2025-08A214534-002AB16a471c1ec25d…
2025-08-23 18:47 UTC2025-08A214534-003AB16a471c1ec25d…
2025-08-23 18:47 UTC2025-08A214534-004AB16a471c1ec25d…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A214534-001AB1fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A214534-002AB1fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A214534-003AB1fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A214534-004AB1fd3edfee7708…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A214534-001AB1b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A214534-002AB1b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A214534-003AB1b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A214534-004AB1b8a1b40f171c…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A214534-001AB103ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A214534-002AB103ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A214534-003AB103ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A214534-004AB103ed91905a0d…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A214534-001AB12680178bc6a6…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A214534-002AB12680178bc6a6…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A214534-003AB12680178bc6a6…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A214534-004AB12680178bc6a6…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A214534-001AB15bbf6a4d5a75…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A214534-002AB15bbf6a4d5a75…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A214534-003AB15bbf6a4d5a75…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A214534-004AB15bbf6a4d5a75…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A214534-001AB1d8e5a09893c0…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A214534-002AB1d8e5a09893c0…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A214534-003AB1d8e5a09893c0…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A214534-004AB1d8e5a09893c0…
2024-10-29 15:01 UTC2024-10A214534-001AB1d06236e962d9…
2024-10-29 15:01 UTC2024-10A214534-002AB1d06236e962d9…
2024-10-29 15:01 UTC2024-10A214534-003AB1d06236e962d9…
2024-10-29 15:01 UTC2024-10A214534-004AB1d06236e962d9…

Additional Listing Data#

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

Active Ingredients#

Ingredient, Strength table
IngredientStrength
FLUPHENAZINE HYDROCHLORIDE10 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
98aeddfd-4f24-4d1a-820d-d0abc1733794Available 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
43598-037-01Fluphenazine Hydrochloride100 in 1 BOTTLE, PLASTICTABLET, FILM COATED1004

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
43598-037-01EA - Each43598-03784656129-beab-4579-b549-0ade87fcc38912021-03-02

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
43598-037FLUPHENAZINE HYDROCHLORIDE TABLET, FILM COATED [DR. REDDY’S LABORATORIES INC.]4Current NDC, Legacy NDC, 1 package rows20241123_98aeddfd-4f24-4d1a-820d-d0abc1733794.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 · 5 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
Fluphenazine HydrochlorideFLUPHENAZINE HYDROCHLORIDEAmerican Health Packagingb6eadd59-a7d0-400e-ba1d-795b9243f77d2025-05-30Boxed warning, Warnings, Adverse reactionsExact identifier
application applno (ANDA): 214534
application number: ANDA214534
Fluphenazine HydrochlorideFLUPHENAZINE HYDROCHLORIDEGolden State Medical Supply, Inc.c2c6d6a1-b4b9-506d-e053-2995a90aac232025-01-14Boxed warning, Warnings, Adverse reactionsExact identifier
application applno (ANDA): 214534
application number: ANDA214534
Fluphenazine HydrochlorideFLUPHENAZINE HYDROCHLORIDEAvPAKe3277017-1d58-7105-e053-2995a90a92552025-01-09Boxed warning, Warnings, Adverse reactionsExact identifier
application applno (ANDA): 214534
application number: ANDA214534
Fluphenazine HydrochlorideFLUPHENAZINE HYDROCHLORIDEAvPAKdbfd138a-e107-3f78-e053-2995a90a6d8c2025-01-09Boxed warning, Warnings, Adverse reactionsExact identifier
application applno (ANDA): 214534
application number: ANDA214534
Fluphenazine HydrochlorideFLUPHENAZINE HYDROCHLORIDEDr. Reddys Laboratories Inc.98aeddfd-4f24-4d1a-820d-d0abc17337942024-11-21Boxed warning, Warnings, Adverse reactionsExact identifier
application applno (ANDA): 214534
application number: ANDA214534
ndc (product): 43598-037

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
865117fluPHENAZine HCl 1 MG Oral TabletPSNc2c6d6a1-b4b9-506d-e053-2995a90aac236
859841fluPHENAZine HCl 10 MG Oral TabletPSNc2c6d6a1-b4b9-506d-e053-2995a90aac236
865123fluPHENAZine HCl 2.5 MG Oral TabletPSNc2c6d6a1-b4b9-506d-e053-2995a90aac236
860918fluPHENAZine HCl 5 MG Oral TabletPSNc2c6d6a1-b4b9-506d-e053-2995a90aac236
865117fluphenazine hydrochloride 1 MG Oral TabletSCDc2c6d6a1-b4b9-506d-e053-2995a90aac236
859841fluphenazine hydrochloride 10 MG Oral TabletSCDc2c6d6a1-b4b9-506d-e053-2995a90aac236
865123fluphenazine hydrochloride 2.5 MG Oral TabletSCDc2c6d6a1-b4b9-506d-e053-2995a90aac236
860918fluphenazine hydrochloride 5 MG Oral TabletSCDc2c6d6a1-b4b9-506d-e053-2995a90aac236
865117fluPHENAZine HCl 1 MG Oral TabletPSN98aeddfd-4f24-4d1a-820d-d0abc17337944
859841fluPHENAZine HCl 10 MG Oral TabletPSN98aeddfd-4f24-4d1a-820d-d0abc17337944
865123fluPHENAZine HCl 2.5 MG Oral TabletPSN98aeddfd-4f24-4d1a-820d-d0abc17337944
860918fluPHENAZine HCl 5 MG Oral TabletPSN98aeddfd-4f24-4d1a-820d-d0abc17337944
865117fluphenazine hydrochloride 1 MG Oral TabletSCD98aeddfd-4f24-4d1a-820d-d0abc17337944
859841fluphenazine hydrochloride 10 MG Oral TabletSCD98aeddfd-4f24-4d1a-820d-d0abc17337944
865123fluphenazine hydrochloride 2.5 MG Oral TabletSCD98aeddfd-4f24-4d1a-820d-d0abc17337944
860918fluphenazine hydrochloride 5 MG Oral TabletSCD98aeddfd-4f24-4d1a-820d-d0abc17337944
859841fluPHENAZine HCl 10 MG Oral TabletPSNdbfd138a-e107-3f78-e053-2995a90a6d8c3
859841fluPHENAZine HCl 10 MG Oral TabletPSNb6eadd59-a7d0-400e-ba1d-795b9243f77d3
860918fluPHENAZine HCl 5 MG Oral TabletPSNb6eadd59-a7d0-400e-ba1d-795b9243f77d3
859841fluphenazine hydrochloride 10 MG Oral TabletSCDb6eadd59-a7d0-400e-ba1d-795b9243f77d3
859841fluphenazine hydrochloride 10 MG Oral TabletSCDdbfd138a-e107-3f78-e053-2995a90a6d8c3
860918fluphenazine hydrochloride 5 MG Oral TabletSCDb6eadd59-a7d0-400e-ba1d-795b9243f77d3

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionMarketing startMarketing endSampleExclude flagStatus
43598-037-0143598003701100 TABLET, FILM COATED in 1 BOTTLE, PLASTIC (43598-037-01) 2021-02-150000-00-00NoNoCurrent