Fluphenazine Hydrochloride

Product NDC: 0832-6003
11-digit product format: 008326003
Labeler code: 0832
Product ID: 0832-6003_3bb74f82-8872-9829-e063-6294a90aeace
Type: HUMAN PRESCRIPTION DRUG
Nonproprietary name: Fluphenazine Hydrochloride
Dosage form: TABLET, FILM COATED
Route: ORAL
Labeler: Upsher-Smith Laboratories,LLC
Application: ANDA213784
Marketing category: ANDA
Marketing start: 2022-11-22
Marketing end: 2027-07-31
Substance: FLUPHENAZINE HYDROCHLORIDE
Active strength: 1 mg/1
Pharmacologic classes: Phenothiazine [EPC], Phenothiazines [CS]
NDC exclude flag: No
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
Dataset	Scope	Product NDC	Package NDC	Code	Status	Reporting period	Source date
excluded package	package	0832-6003	0832-6003-11	D	Discontinued by firm		2026-08-10

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-product	Trade name	Ingredient	Strength	Dosage form / route	TE codes	Approval date
A213784-001	FLUPHENAZINE HYDROCHLORIDE	FLUPHENAZINE HYDROCHLORIDE	1MG	TABLET / ORAL	AB	2022-10-24
A213784-002	FLUPHENAZINE HYDROCHLORIDE	FLUPHENAZINE HYDROCHLORIDE	2.5MG	TABLET / ORAL	AB	2022-10-24
A213784-003	FLUPHENAZINE HYDROCHLORIDE	FLUPHENAZINE HYDROCHLORIDE	5MG	TABLET / ORAL	AB	2022-10-24
A213784-004	FLUPHENAZINE HYDROCHLORIDE	FLUPHENAZINE HYDROCHLORIDE	10MG	TABLET / ORAL	AB	2022-10-24

Therapeutic equivalence codes#

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

Application-product, TE code table
Application-product	TE code
A213784-001	AB
A213784-002	AB
A213784-003	AB
A213784-004	AB

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 3 · 100 observed states.

Captured, Edition, Application-product table
Captured	Edition	Application-product	Trade name	Strength	Dosage form / route	Product TE source text	Approval date	Source SHA-256
2026-02-19 14:30 UTC	2026-02	A213784-001	FLUPHENAZINE HYDROCHLORIDE	1MG	TABLET / ORAL	AB	2022-10-24	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A213784-002	FLUPHENAZINE HYDROCHLORIDE	2.5MG	TABLET / ORAL	AB	2022-10-24	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A213784-003	FLUPHENAZINE HYDROCHLORIDE	5MG	TABLET / ORAL	AB	2022-10-24	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A213784-004	FLUPHENAZINE HYDROCHLORIDE	10MG	TABLET / ORAL	AB	2022-10-24	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A213784-001	FLUPHENAZINE HYDROCHLORIDE	1MG	TABLET / ORAL	AB	2022-10-24	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A213784-002	FLUPHENAZINE HYDROCHLORIDE	2.5MG	TABLET / ORAL	AB	2022-10-24	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A213784-003	FLUPHENAZINE HYDROCHLORIDE	5MG	TABLET / ORAL	AB	2022-10-24	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A213784-004	FLUPHENAZINE HYDROCHLORIDE	10MG	TABLET / ORAL	AB	2022-10-24	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A213784-001	FLUPHENAZINE HYDROCHLORIDE	1MG	TABLET / ORAL	AB	2022-10-24	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A213784-002	FLUPHENAZINE HYDROCHLORIDE	2.5MG	TABLET / ORAL	AB	2022-10-24	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A213784-003	FLUPHENAZINE HYDROCHLORIDE	5MG	TABLET / ORAL	AB	2022-10-24	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A213784-004	FLUPHENAZINE HYDROCHLORIDE	10MG	TABLET / ORAL	AB	2022-10-24	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A213784-001	FLUPHENAZINE HYDROCHLORIDE	1MG	TABLET / ORAL	AB	2022-10-24	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A213784-002	FLUPHENAZINE HYDROCHLORIDE	2.5MG	TABLET / ORAL	AB	2022-10-24	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A213784-003	FLUPHENAZINE HYDROCHLORIDE	5MG	TABLET / ORAL	AB	2022-10-24	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A213784-004	FLUPHENAZINE HYDROCHLORIDE	10MG	TABLET / ORAL	AB	2022-10-24	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A213784-001	FLUPHENAZINE HYDROCHLORIDE	1MG	TABLET / ORAL	AB	2022-10-24	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A213784-002	FLUPHENAZINE HYDROCHLORIDE	2.5MG	TABLET / ORAL	AB	2022-10-24	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A213784-003	FLUPHENAZINE HYDROCHLORIDE	5MG	TABLET / ORAL	AB	2022-10-24	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A213784-004	FLUPHENAZINE HYDROCHLORIDE	10MG	TABLET / ORAL	AB	2022-10-24	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A213784-001	FLUPHENAZINE HYDROCHLORIDE	1MG	TABLET / ORAL	AB	2022-10-24	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A213784-002	FLUPHENAZINE HYDROCHLORIDE	2.5MG	TABLET / ORAL	AB	2022-10-24	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A213784-003	FLUPHENAZINE HYDROCHLORIDE	5MG	TABLET / ORAL	AB	2022-10-24	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A213784-004	FLUPHENAZINE HYDROCHLORIDE	10MG	TABLET / ORAL	AB	2022-10-24	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A213784-001	FLUPHENAZINE HYDROCHLORIDE	1MG	TABLET / ORAL	AB	2022-10-24	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A213784-002	FLUPHENAZINE HYDROCHLORIDE	2.5MG	TABLET / ORAL	AB	2022-10-24	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A213784-003	FLUPHENAZINE HYDROCHLORIDE	5MG	TABLET / ORAL	AB	2022-10-24	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A213784-004	FLUPHENAZINE HYDROCHLORIDE	10MG	TABLET / ORAL	AB	2022-10-24	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A213784-001	FLUPHENAZINE HYDROCHLORIDE	1MG	TABLET / ORAL	AB	2022-10-24	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A213784-002	FLUPHENAZINE HYDROCHLORIDE	2.5MG	TABLET / ORAL	AB	2022-10-24	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A213784-003	FLUPHENAZINE HYDROCHLORIDE	5MG	TABLET / ORAL	AB	2022-10-24	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A213784-004	FLUPHENAZINE HYDROCHLORIDE	10MG	TABLET / ORAL	AB	2022-10-24	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A213784-001	FLUPHENAZINE HYDROCHLORIDE	1MG	TABLET / ORAL	AB	2022-10-24	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A213784-002	FLUPHENAZINE HYDROCHLORIDE	2.5MG	TABLET / ORAL	AB	2022-10-24	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A213784-003	FLUPHENAZINE HYDROCHLORIDE	5MG	TABLET / ORAL	AB	2022-10-24	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A213784-004	FLUPHENAZINE HYDROCHLORIDE	10MG	TABLET / ORAL	AB	2022-10-24	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A213784-001	FLUPHENAZINE HYDROCHLORIDE	1MG	TABLET / ORAL	AB	2022-10-24	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A213784-002	FLUPHENAZINE HYDROCHLORIDE	2.5MG	TABLET / ORAL	AB	2022-10-24	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A213784-003	FLUPHENAZINE HYDROCHLORIDE	5MG	TABLET / ORAL	AB	2022-10-24	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A213784-004	FLUPHENAZINE HYDROCHLORIDE	10MG	TABLET / ORAL	AB	2022-10-24	`d06236e962d9…`

Observed Orange Book normalized TE history#

Normalized TE history page 1 of 3 · 100 observed states.

Captured, Edition, Application-product table
Captured	Edition	Application-product	TE code	Order	Source SHA-256
2026-02-19 14:30 UTC	2026-02	A213784-001	AB	1	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A213784-002	AB	1	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A213784-003	AB	1	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A213784-004	AB	1	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A213784-001	AB	1	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A213784-002	AB	1	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A213784-003	AB	1	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A213784-004	AB	1	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A213784-001	AB	1	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A213784-002	AB	1	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A213784-003	AB	1	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A213784-004	AB	1	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A213784-001	AB	1	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A213784-002	AB	1	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A213784-003	AB	1	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A213784-004	AB	1	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A213784-001	AB	1	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A213784-002	AB	1	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A213784-003	AB	1	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A213784-004	AB	1	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A213784-001	AB	1	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A213784-002	AB	1	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A213784-003	AB	1	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A213784-004	AB	1	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A213784-001	AB	1	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A213784-002	AB	1	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A213784-003	AB	1	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A213784-004	AB	1	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A213784-001	AB	1	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A213784-002	AB	1	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A213784-003	AB	1	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A213784-004	AB	1	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A213784-001	AB	1	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A213784-002	AB	1	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A213784-003	AB	1	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A213784-004	AB	1	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A213784-001	AB	1	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A213784-002	AB	1	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A213784-003	AB	1	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A213784-004	AB	1	`d06236e962d9…`

Additional Listing Data#

Finished product: Yes
Brand name base: Fluphenazine Hydrochloride

Active Ingredients#

Ingredient, Strength table
Ingredient	Strength
FLUPHENAZINE HYDROCHLORIDE	1 mg/1

Harmonized UNII identifiers#

UNII identifiers page 1 of 1 · 1 matching rows.

Identifier, FDA.report destination table
Identifier	FDA.report destination
ZOU145W1XL	Internal UNII lookup

Harmonized RxCUI identifiers#

RxCUI identifiers page 1 of 1 · 4 matching rows.

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

Harmonized SPL set identifiers#

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

Identifier, FDA.report destination table
Identifier	FDA.report destination
f07bb3f1-c68c-441b-9de4-99a219f2500a	Available on FDA.report

DailyMed Product Concepts#

Product concept, Relation, Version table
Product concept	Relation	Version	Effective
4255c821-309e-3e59-d8e2-48974bad3552	Product name	8	20250626
817a13b7-685c-6d80-08bc-347c9a7530c4	Product name	4	20240419
817a13b7-685c-6d80-08bc-347c9a7530c4	Product name	3	20171211
adfcae9b-bddd-ca49-dfd9-a2e8267a7d37	Product name	1	20140508

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDC	Product	Description	Form	Quantity	Strength	SPL version
0832-6003-11	Fluphenazine Hydrochloride	100 in 1 BOTTLE	TABLET, FILM COATED	100		4

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDC	Billing unit	Product NDC	DailyMed indexing SPL	SPL version	Effective
0832-6003-11	EA - Each	0832-6003	e110e228-4b33-4470-ac1d-20e61879eccc	1	2023-04-07

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDC	Dashboard title	SPL version	Validation	Dashboard ZIP
0832-6003	FLUPHENAZINE HYDROCHLORIDE TABLET, FILM COATED [UPSHER-SMITH LABORATORIES,LLC]	3	Current NDC, 1 package rows	20240716_f07bb3f1-c68c-441b-9de4-99a219f2500a.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
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
Fluphenazine Hydrochloride	FLUPHENAZINE HYDROCHLORIDE	Upsher-Smith Laboratories,LLC	f07bb3f1-c68c-441b-9de4-99a219f2500a	2025-08-06	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 213784 application number: ANDA213784 ndc (product): 0832-6003

UNII, Preferred term, Registry number table
UNII	Preferred term	Registry number	Matched term
ZOU145W1XL	FLUPHENAZINE HYDROCHLORIDE	146-56-5	FLUPHENAZINE HYDROCHLORIDE

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUI	RxNorm string	TTY	DailyMed	SPL version
865117	fluPHENAZine HCl 1 MG Oral Tablet	PSN	f07bb3f1-c68c-441b-9de4-99a219f2500a	4
859841	fluPHENAZine HCl 10 MG Oral Tablet	PSN	f07bb3f1-c68c-441b-9de4-99a219f2500a	4
865123	fluPHENAZine HCl 2.5 MG Oral Tablet	PSN	f07bb3f1-c68c-441b-9de4-99a219f2500a	4
860918	fluPHENAZine HCl 5 MG Oral Tablet	PSN	f07bb3f1-c68c-441b-9de4-99a219f2500a	4
865117	fluphenazine hydrochloride 1 MG Oral Tablet	SCD	f07bb3f1-c68c-441b-9de4-99a219f2500a	4
859841	fluphenazine hydrochloride 10 MG Oral Tablet	SCD	f07bb3f1-c68c-441b-9de4-99a219f2500a	4
865123	fluphenazine hydrochloride 2.5 MG Oral Tablet	SCD	f07bb3f1-c68c-441b-9de4-99a219f2500a	4
860918	fluphenazine hydrochloride 5 MG Oral Tablet	SCD	f07bb3f1-c68c-441b-9de4-99a219f2500a	4

Packages#

Package NDC, 11-digit format, Description table
Package NDC	11-digit format	Description	Status
0832-6003-11	00832600311	100 in 1 BOTTLE	Historical

Title, Manufacturer, Effective date table
Title	Manufacturer	Effective date	Type	Version
Fluphenazine Hydrochloride Tablets, USP	Upsher-Smith Laboratories,LLC	2025-08-06	HUMAN PRESCRIPTION DRUG LABEL	4