Fluphenazine Hydrochloride

Product NDC: 60687-761
11-digit product format: 606870761
Labeler code: 60687
Product ID: 60687-761_365e2405-914b-bc98-e063-6394a90adf9a
Type: HUMAN PRESCRIPTION DRUG
Nonproprietary name: Fluphenazine Hydrochloride
Dosage form: TABLET, FILM COATED
Route: ORAL
Labeler: American Health Packaging
Application: ANDA214534
Marketing category: ANDA
Marketing start: 2023-11-09
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-product	Trade name	Ingredient	Strength	Dosage form / route	TE codes	Approval date
A214534-001	FLUPHENAZINE HYDROCHLORIDE	FLUPHENAZINE HYDROCHLORIDE	1MG	TABLET / ORAL	AB	2021-01-07
A214534-002	FLUPHENAZINE HYDROCHLORIDE	FLUPHENAZINE HYDROCHLORIDE	2.5MG	TABLET / ORAL	AB	2021-01-07
A214534-003	FLUPHENAZINE HYDROCHLORIDE	FLUPHENAZINE HYDROCHLORIDE	5MG	TABLET / ORAL	AB	2021-01-07
A214534-004	FLUPHENAZINE HYDROCHLORIDE	FLUPHENAZINE HYDROCHLORIDE	10MG	TABLET / ORAL	AB	2021-01-07

Therapeutic equivalence codes#

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

Application-product, TE code table
Application-product	TE code
A214534-001	AB
A214534-002	AB
A214534-003	AB
A214534-004	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 4 · 140 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	A214534-001	FLUPHENAZINE HYDROCHLORIDE	1MG	TABLET / ORAL	AB	2021-01-07	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A214534-002	FLUPHENAZINE HYDROCHLORIDE	2.5MG	TABLET / ORAL	AB	2021-01-07	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A214534-003	FLUPHENAZINE HYDROCHLORIDE	5MG	TABLET / ORAL	AB	2021-01-07	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A214534-004	FLUPHENAZINE HYDROCHLORIDE	10MG	TABLET / ORAL	AB	2021-01-07	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A214534-001	FLUPHENAZINE HYDROCHLORIDE	1MG	TABLET / ORAL	AB	2021-01-07	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A214534-002	FLUPHENAZINE HYDROCHLORIDE	2.5MG	TABLET / ORAL	AB	2021-01-07	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A214534-003	FLUPHENAZINE HYDROCHLORIDE	5MG	TABLET / ORAL	AB	2021-01-07	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A214534-004	FLUPHENAZINE HYDROCHLORIDE	10MG	TABLET / ORAL	AB	2021-01-07	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A214534-001	FLUPHENAZINE HYDROCHLORIDE	1MG	TABLET / ORAL	AB	2021-01-07	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A214534-002	FLUPHENAZINE HYDROCHLORIDE	2.5MG	TABLET / ORAL	AB	2021-01-07	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A214534-003	FLUPHENAZINE HYDROCHLORIDE	5MG	TABLET / ORAL	AB	2021-01-07	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A214534-004	FLUPHENAZINE HYDROCHLORIDE	10MG	TABLET / ORAL	AB	2021-01-07	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A214534-001	FLUPHENAZINE HYDROCHLORIDE	1MG	TABLET / ORAL	AB	2021-01-07	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A214534-002	FLUPHENAZINE HYDROCHLORIDE	2.5MG	TABLET / ORAL	AB	2021-01-07	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A214534-003	FLUPHENAZINE HYDROCHLORIDE	5MG	TABLET / ORAL	AB	2021-01-07	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A214534-004	FLUPHENAZINE HYDROCHLORIDE	10MG	TABLET / ORAL	AB	2021-01-07	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A214534-001	FLUPHENAZINE HYDROCHLORIDE	1MG	TABLET / ORAL	AB	2021-01-07	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A214534-002	FLUPHENAZINE HYDROCHLORIDE	2.5MG	TABLET / ORAL	AB	2021-01-07	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A214534-003	FLUPHENAZINE HYDROCHLORIDE	5MG	TABLET / ORAL	AB	2021-01-07	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A214534-004	FLUPHENAZINE HYDROCHLORIDE	10MG	TABLET / ORAL	AB	2021-01-07	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A214534-001	FLUPHENAZINE HYDROCHLORIDE	1MG	TABLET / ORAL	AB	2021-01-07	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A214534-002	FLUPHENAZINE HYDROCHLORIDE	2.5MG	TABLET / ORAL	AB	2021-01-07	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A214534-003	FLUPHENAZINE HYDROCHLORIDE	5MG	TABLET / ORAL	AB	2021-01-07	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A214534-004	FLUPHENAZINE HYDROCHLORIDE	10MG	TABLET / ORAL	AB	2021-01-07	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A214534-001	FLUPHENAZINE HYDROCHLORIDE	1MG	TABLET / ORAL	AB	2021-01-07	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A214534-002	FLUPHENAZINE HYDROCHLORIDE	2.5MG	TABLET / ORAL	AB	2021-01-07	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A214534-003	FLUPHENAZINE HYDROCHLORIDE	5MG	TABLET / ORAL	AB	2021-01-07	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A214534-004	FLUPHENAZINE HYDROCHLORIDE	10MG	TABLET / ORAL	AB	2021-01-07	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A214534-001	FLUPHENAZINE HYDROCHLORIDE	1MG	TABLET / ORAL	AB	2021-01-07	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A214534-002	FLUPHENAZINE HYDROCHLORIDE	2.5MG	TABLET / ORAL	AB	2021-01-07	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A214534-003	FLUPHENAZINE HYDROCHLORIDE	5MG	TABLET / ORAL	AB	2021-01-07	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A214534-004	FLUPHENAZINE HYDROCHLORIDE	10MG	TABLET / ORAL	AB	2021-01-07	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A214534-001	FLUPHENAZINE HYDROCHLORIDE	1MG	TABLET / ORAL	AB	2021-01-07	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A214534-002	FLUPHENAZINE HYDROCHLORIDE	2.5MG	TABLET / ORAL	AB	2021-01-07	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A214534-003	FLUPHENAZINE HYDROCHLORIDE	5MG	TABLET / ORAL	AB	2021-01-07	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A214534-004	FLUPHENAZINE HYDROCHLORIDE	10MG	TABLET / ORAL	AB	2021-01-07	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A214534-001	FLUPHENAZINE HYDROCHLORIDE	1MG	TABLET / ORAL	AB	2021-01-07	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A214534-002	FLUPHENAZINE HYDROCHLORIDE	2.5MG	TABLET / ORAL	AB	2021-01-07	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A214534-003	FLUPHENAZINE HYDROCHLORIDE	5MG	TABLET / ORAL	AB	2021-01-07	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A214534-004	FLUPHENAZINE HYDROCHLORIDE	10MG	TABLET / ORAL	AB	2021-01-07	`d06236e962d9…`

Observed Orange Book normalized TE history#

Normalized TE history page 1 of 4 · 140 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	A214534-001	AB	1	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A214534-002	AB	1	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A214534-003	AB	1	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A214534-004	AB	1	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A214534-001	AB	1	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A214534-002	AB	1	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A214534-003	AB	1	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A214534-004	AB	1	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A214534-001	AB	1	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A214534-002	AB	1	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A214534-003	AB	1	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A214534-004	AB	1	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A214534-001	AB	1	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A214534-002	AB	1	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A214534-003	AB	1	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A214534-004	AB	1	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A214534-001	AB	1	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A214534-002	AB	1	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A214534-003	AB	1	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A214534-004	AB	1	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A214534-001	AB	1	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A214534-002	AB	1	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A214534-003	AB	1	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A214534-004	AB	1	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A214534-001	AB	1	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A214534-002	AB	1	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A214534-003	AB	1	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A214534-004	AB	1	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A214534-001	AB	1	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A214534-002	AB	1	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A214534-003	AB	1	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A214534-004	AB	1	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A214534-001	AB	1	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A214534-002	AB	1	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A214534-003	AB	1	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A214534-004	AB	1	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A214534-001	AB	1	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A214534-002	AB	1	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A214534-003	AB	1	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A214534-004	AB	1	`d06236e962d9…`

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	10 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 · 2 matching rows.

Identifier, FDA.report destination table
Identifier	FDA.report destination
859841	Internal RxNorm lookup
860918	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
b6eadd59-a7d0-400e-ba1d-795b9243f77d	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
60687-761-01	Fluphenazine Hydrochloride	100 in 1 CARTON	TABLET, FILM COATED	100		3
60687-761-11	Fluphenazine Hydrochloride	1 in 1 BLISTER PACK	TABLET, FILM COATED	1		3

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDC	Billing unit	Product NDC	DailyMed indexing SPL	SPL version	Effective
60687-761-01	EA - Each	60687-761	fa7e199a-e418-45ad-baf6-c2812dbd8f5d	1	2023-10-16
60687-761-11	EA - Each	60687-761	bf288fe5-28c4-4ec2-880a-165f4f4b7d54	1	2023-10-16

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDC	Dashboard title	SPL version	Validation	Dashboard ZIP
60687-761	FLUPHENAZINE HYDROCHLORIDE TABLET, FILM COATED [AMERICAN HEALTH PACKAGING]	2	Current NDC, 2 package rows	20241030_b6eadd59-a7d0-400e-ba1d-795b9243f77d.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
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
Fluphenazine Hydrochloride	FLUPHENAZINE HYDROCHLORIDE	American Health Packaging	b6eadd59-a7d0-400e-ba1d-795b9243f77d	2025-05-30	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 214534 application number: ANDA214534 ndc (product): 60687-761
Fluphenazine Hydrochloride	FLUPHENAZINE HYDROCHLORIDE	Golden State Medical Supply, Inc.	c2c6d6a1-b4b9-506d-e053-2995a90aac23	2025-01-14	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 214534 application number: ANDA214534
Fluphenazine Hydrochloride	FLUPHENAZINE HYDROCHLORIDE	AvPAK	e3277017-1d58-7105-e053-2995a90a9255	2025-01-09	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 214534 application number: ANDA214534
Fluphenazine Hydrochloride	FLUPHENAZINE HYDROCHLORIDE	AvPAK	dbfd138a-e107-3f78-e053-2995a90a6d8c	2025-01-09	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 214534 application number: ANDA214534
Fluphenazine Hydrochloride	FLUPHENAZINE HYDROCHLORIDE	Dr. Reddys Laboratories Inc.	98aeddfd-4f24-4d1a-820d-d0abc1733794	2024-11-21	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 214534 application number: ANDA214534

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
859841	fluPHENAZine HCl 10 MG Oral Tablet	PSN	b6eadd59-a7d0-400e-ba1d-795b9243f77d	3
860918	fluPHENAZine HCl 5 MG Oral Tablet	PSN	b6eadd59-a7d0-400e-ba1d-795b9243f77d	3
859841	fluphenazine hydrochloride 10 MG Oral Tablet	SCD	b6eadd59-a7d0-400e-ba1d-795b9243f77d	3
860918	fluphenazine hydrochloride 5 MG Oral Tablet	SCD	b6eadd59-a7d0-400e-ba1d-795b9243f77d	3

Packages#

Package NDC, 11-digit format, Description table
Package NDC	11-digit format	Description	Units	Marketing start	Sample	Exclude flag	Status
60687-761-01	60687076101	100 BLISTER PACK in 1 CARTON (60687-761-01) / 1 TABLET, FILM COATED in 1 BLISTER PACK (60687-761-11)	100 blister pack	2023-11-09	No	No	Current
60687-761-11	60687076111	1 in 1 BLISTER PACK					Historical

Title, Manufacturer, Effective date table
Title	Manufacturer	Effective date	Type	Version
Fluphenazine Hydrochloride Tablets, USP 8474901/0425F Rx Only	American Health Packaging	2025-05-30	HUMAN PRESCRIPTION DRUG LABEL	3