Fluphenazine Hydrochloride

Product NDC: 24979-137
11-digit product format: 249790137
Labeler code: 24979
Product ID: 24979-137_e2589baf-4d61-4d50-a578-41c51fbb6deb
Type: HUMAN PRESCRIPTION DRUG
Nonproprietary name: Fluphenazine Hydrochloride
Dosage form: TABLET, FILM COATED
Route: ORAL
Labeler: Upsher-Smith Laboratories, LLC
Application: ANDA215848
Marketing category: ANDA
Marketing start: 2022-08-01
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

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	Approval date
A215848-001	FLUPHENAZINE HYDROCHLORIDE	FLUPHENAZINE HYDROCHLORIDE	2.5MG	TABLET / ORAL	2022-04-01
A215848-002	FLUPHENAZINE HYDROCHLORIDE	FLUPHENAZINE HYDROCHLORIDE	5MG	TABLET / ORAL	2022-04-01
A215848-003	FLUPHENAZINE HYDROCHLORIDE	FLUPHENAZINE HYDROCHLORIDE	10MG	TABLET / ORAL	2022-04-01
A215848-004	FLUPHENAZINE HYDROCHLORIDE	FLUPHENAZINE HYDROCHLORIDE	1MG	TABLET / ORAL	2022-12-14

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 · 114 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	A215848-001	FLUPHENAZINE HYDROCHLORIDE	2.5MG	TABLET / ORAL		2022-04-01	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A215848-002	FLUPHENAZINE HYDROCHLORIDE	5MG	TABLET / ORAL		2022-04-01	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A215848-003	FLUPHENAZINE HYDROCHLORIDE	10MG	TABLET / ORAL		2022-04-01	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A215848-004	FLUPHENAZINE HYDROCHLORIDE	1MG	TABLET / ORAL		2022-12-14	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A215848-001	FLUPHENAZINE HYDROCHLORIDE	2.5MG	TABLET / ORAL		2022-04-01	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A215848-002	FLUPHENAZINE HYDROCHLORIDE	5MG	TABLET / ORAL		2022-04-01	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A215848-003	FLUPHENAZINE HYDROCHLORIDE	10MG	TABLET / ORAL		2022-04-01	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A215848-004	FLUPHENAZINE HYDROCHLORIDE	1MG	TABLET / ORAL		2022-12-14	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A215848-001	FLUPHENAZINE HYDROCHLORIDE	2.5MG	TABLET / ORAL		2022-04-01	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A215848-002	FLUPHENAZINE HYDROCHLORIDE	5MG	TABLET / ORAL		2022-04-01	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A215848-003	FLUPHENAZINE HYDROCHLORIDE	10MG	TABLET / ORAL		2022-04-01	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A215848-004	FLUPHENAZINE HYDROCHLORIDE	1MG	TABLET / ORAL		2022-12-14	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A215848-001	FLUPHENAZINE HYDROCHLORIDE	2.5MG	TABLET / ORAL	AB	2022-04-01	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A215848-002	FLUPHENAZINE HYDROCHLORIDE	5MG	TABLET / ORAL	AB	2022-04-01	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A215848-003	FLUPHENAZINE HYDROCHLORIDE	10MG	TABLET / ORAL	AB	2022-04-01	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A215848-004	FLUPHENAZINE HYDROCHLORIDE	1MG	TABLET / ORAL	AB	2022-12-14	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A215848-001	FLUPHENAZINE HYDROCHLORIDE	2.5MG	TABLET / ORAL	AB	2022-04-01	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A215848-002	FLUPHENAZINE HYDROCHLORIDE	5MG	TABLET / ORAL	AB	2022-04-01	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A215848-003	FLUPHENAZINE HYDROCHLORIDE	10MG	TABLET / ORAL	AB	2022-04-01	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A215848-004	FLUPHENAZINE HYDROCHLORIDE	1MG	TABLET / ORAL	AB	2022-12-14	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A215848-001	FLUPHENAZINE HYDROCHLORIDE	2.5MG	TABLET / ORAL	AB	2022-04-01	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A215848-002	FLUPHENAZINE HYDROCHLORIDE	5MG	TABLET / ORAL	AB	2022-04-01	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A215848-003	FLUPHENAZINE HYDROCHLORIDE	10MG	TABLET / ORAL	AB	2022-04-01	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A215848-004	FLUPHENAZINE HYDROCHLORIDE	1MG	TABLET / ORAL	AB	2022-12-14	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A215848-001	FLUPHENAZINE HYDROCHLORIDE	2.5MG	TABLET / ORAL	AB	2022-04-01	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A215848-002	FLUPHENAZINE HYDROCHLORIDE	5MG	TABLET / ORAL	AB	2022-04-01	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A215848-003	FLUPHENAZINE HYDROCHLORIDE	10MG	TABLET / ORAL	AB	2022-04-01	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A215848-004	FLUPHENAZINE HYDROCHLORIDE	1MG	TABLET / ORAL	AB	2022-12-14	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A215848-001	FLUPHENAZINE HYDROCHLORIDE	2.5MG	TABLET / ORAL	AB	2022-04-01	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A215848-002	FLUPHENAZINE HYDROCHLORIDE	5MG	TABLET / ORAL	AB	2022-04-01	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A215848-003	FLUPHENAZINE HYDROCHLORIDE	10MG	TABLET / ORAL	AB	2022-04-01	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A215848-004	FLUPHENAZINE HYDROCHLORIDE	1MG	TABLET / ORAL	AB	2022-12-14	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A215848-001	FLUPHENAZINE HYDROCHLORIDE	2.5MG	TABLET / ORAL	AB	2022-04-01	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A215848-002	FLUPHENAZINE HYDROCHLORIDE	5MG	TABLET / ORAL	AB	2022-04-01	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A215848-003	FLUPHENAZINE HYDROCHLORIDE	10MG	TABLET / ORAL	AB	2022-04-01	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A215848-004	FLUPHENAZINE HYDROCHLORIDE	1MG	TABLET / ORAL	AB	2022-12-14	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A215848-001	FLUPHENAZINE HYDROCHLORIDE	2.5MG	TABLET / ORAL	AB	2022-04-01	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A215848-002	FLUPHENAZINE HYDROCHLORIDE	5MG	TABLET / ORAL	AB	2022-04-01	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A215848-003	FLUPHENAZINE HYDROCHLORIDE	10MG	TABLET / ORAL	AB	2022-04-01	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A215848-004	FLUPHENAZINE HYDROCHLORIDE	1MG	TABLET / ORAL	AB	2022-12-14	`d06236e962d9…`

Observed Orange Book normalized TE history#

Normalized TE history page 1 of 3 · 98 observed states.

Captured, Edition, Application-product table
Captured	Edition	Application-product	TE code	Order	Source SHA-256
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A215848-001	AB	1	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A215848-002	AB	1	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A215848-003	AB	1	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A215848-004	AB	1	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A215848-001	AB	1	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A215848-002	AB	1	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A215848-003	AB	1	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A215848-004	AB	1	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A215848-001	AB	1	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A215848-002	AB	1	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A215848-003	AB	1	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A215848-004	AB	1	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A215848-001	AB	1	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A215848-002	AB	1	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A215848-003	AB	1	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A215848-004	AB	1	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A215848-001	AB	1	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A215848-002	AB	1	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A215848-003	AB	1	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A215848-004	AB	1	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A215848-001	AB	1	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A215848-002	AB	1	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A215848-003	AB	1	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A215848-004	AB	1	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A215848-001	AB	1	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A215848-002	AB	1	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A215848-003	AB	1	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A215848-004	AB	1	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A215848-001	AB	1	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A215848-002	AB	1	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A215848-003	AB	1	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A215848-004	AB	1	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A215848-001	AB	1	`301d65b070ca…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A215848-002	AB	1	`301d65b070ca…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A215848-003	AB	1	`301d65b070ca…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A215848-004	AB	1	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A215848-001	AB	1	`1e350fbaab3a…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A215848-002	AB	1	`1e350fbaab3a…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A215848-003	AB	1	`1e350fbaab3a…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A215848-004	AB	1	`1e350fbaab3a…`

Additional Listing Data#

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

Active Ingredients#

Ingredient, Strength table
Ingredient	Strength
FLUPHENAZINE HYDROCHLORIDE	2.5 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
d0a090fa-f7c9-4f6d-a9a3-9838870c7049	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
362d7abb-94e6-4c60-9a58-266894157713	Product name	1	20231023
816b97af-edc5-4060-aff1-b814bdbcad50	Product name	1	20190415
817a13b7-685c-6d80-08bc-347c9a7530c4	Product name	3	20171211
419aab54-5d5a-4146-9453-026d4a9991be	Product name	2	20170525
89dac932-b90a-4410-9ab1-84c53e57de25	Product name	1	20150316
adfcae9b-bddd-ca49-dfd9-a2e8267a7d37	Product name	1	20140508
d723478e-ad4a-ec23-6bd7-cfe33e1e3840	Product name	1	20140508

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDC	Product	Description	Form	Quantity	Strength	SPL version
24979-137-01	Fluphenazine Hydrochloride	100 in 1 BOTTLE, PLASTIC	TABLET, FILM COATED	100		5

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDC	Billing unit	Product NDC	DailyMed indexing SPL	SPL version	Effective
24979-137-01	EA - Each	24979-137	5ab38780-ada6-4e74-bf64-b8cbca322958	1	2022-12-07

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDC	Dashboard title	SPL version	Validation	Dashboard ZIP
24979-137	FLUPHENAZINE HYDROCHLORIDE TABLET, FILM COATED [UPSHER-SMITH LABORATORIES, LLC]	5	Current NDC, Legacy NDC, 1 package rows	20241219_d0a090fa-f7c9-4f6d-a9a3-9838870c7049.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 · 2 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	d0a090fa-f7c9-4f6d-a9a3-9838870c7049	2024-12-17	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 215848 application number: ANDA215848 ndc (product): 24979-137
Fluphenazine Hydrochloride	FLUPHENAZINE HYDROCHLORIDE	Proficient Rx LP	bc22941e-d2e7-4165-91ea-7239c8b9882d	2023-02-01	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 215848 application number: ANDA215848

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	d0a090fa-f7c9-4f6d-a9a3-9838870c7049	5
859841	fluPHENAZine HCl 10 MG Oral Tablet	PSN	d0a090fa-f7c9-4f6d-a9a3-9838870c7049	5
865123	fluPHENAZine HCl 2.5 MG Oral Tablet	PSN	d0a090fa-f7c9-4f6d-a9a3-9838870c7049	5
860918	fluPHENAZine HCl 5 MG Oral Tablet	PSN	d0a090fa-f7c9-4f6d-a9a3-9838870c7049	5
865117	fluphenazine hydrochloride 1 MG Oral Tablet	SCD	d0a090fa-f7c9-4f6d-a9a3-9838870c7049	5
859841	fluphenazine hydrochloride 10 MG Oral Tablet	SCD	d0a090fa-f7c9-4f6d-a9a3-9838870c7049	5
865123	fluphenazine hydrochloride 2.5 MG Oral Tablet	SCD	d0a090fa-f7c9-4f6d-a9a3-9838870c7049	5
860918	fluphenazine hydrochloride 5 MG Oral Tablet	SCD	d0a090fa-f7c9-4f6d-a9a3-9838870c7049	5
865117	fluPHENAZine HCl 1 MG Oral Tablet	PSN	bc22941e-d2e7-4165-91ea-7239c8b9882d	1
859841	fluPHENAZine HCl 10 MG Oral Tablet	PSN	bc22941e-d2e7-4165-91ea-7239c8b9882d	1
865123	fluPHENAZine HCl 2.5 MG Oral Tablet	PSN	bc22941e-d2e7-4165-91ea-7239c8b9882d	1
860918	fluPHENAZine HCl 5 MG Oral Tablet	PSN	bc22941e-d2e7-4165-91ea-7239c8b9882d	1
865117	fluphenazine hydrochloride 1 MG Oral Tablet	SCD	bc22941e-d2e7-4165-91ea-7239c8b9882d	1
859841	fluphenazine hydrochloride 10 MG Oral Tablet	SCD	bc22941e-d2e7-4165-91ea-7239c8b9882d	1
865123	fluphenazine hydrochloride 2.5 MG Oral Tablet	SCD	bc22941e-d2e7-4165-91ea-7239c8b9882d	1
860918	fluphenazine hydrochloride 5 MG Oral Tablet	SCD	bc22941e-d2e7-4165-91ea-7239c8b9882d	1

Packages#

Package NDC, 11-digit format, Description table
Package NDC	11-digit format	Description	Marketing start	Marketing end	Sample	Exclude flag	Status
24979-137-01	24979013701	100 TABLET, FILM COATED in 1 BOTTLE, PLASTIC (24979-137-01)	2022-08-01	0000-00-00	No	No	Current

Title, Manufacturer, Effective date table
Title	Manufacturer	Effective date	Type	Version
Fluphenazine Hydrochloride Tablets, USP	Upsher-Smith Laboratories, LLC \| TWi Pharmaceuticals, Inc. \| TWi Pharmaceuticals, Inc. Zhongli Plant \| Apace Packaging LLC \| BORA PHARMACEUTICAL LABORATORIES INC.	2024-12-17	HUMAN PRESCRIPTION DRUG LABEL	5
Fluphenazine Hydrochloride Tablets, USP	Proficient Rx LP	2023-02-01	HUMAN PRESCRIPTION DRUG LABEL	1