Fluphenazine Hydrochloride

Product NDC: 68462-338
11-digit product format: 684620338
Labeler code: 68462
Product ID: 68462-338_b5186569-6be5-4ff2-a95e-f162f76254d9
Type: HUMAN PRESCRIPTION DRUG
Nonproprietary name: Fluphenazine Hydrochloride
Dosage form: TABLET, FILM COATED
Route: ORAL
Labeler: Glenmark Pharmaceuticals Inc., USA
Application: ANDA216350
Marketing category: ANDA
Marketing start: 2023-11-06
Substance: FLUPHENAZINE HYDROCHLORIDE
Active strength: 10 mg/1
Pharmacologic classes: Phenothiazine [EPC], Phenothiazines [CS]
NDC exclude flag: No
Listing certified through: 2027-12-31
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
A216350-001	FLUPHENAZINE HYDROCHLORIDE	FLUPHENAZINE HYDROCHLORIDE	1MG	TABLET / ORAL	AB	2023-11-06
A216350-002	FLUPHENAZINE HYDROCHLORIDE	FLUPHENAZINE HYDROCHLORIDE	2.5MG	TABLET / ORAL	AB	2023-11-06
A216350-003	FLUPHENAZINE HYDROCHLORIDE	FLUPHENAZINE HYDROCHLORIDE	5MG	TABLET / ORAL	AB	2023-11-06
A216350-004	FLUPHENAZINE HYDROCHLORIDE	FLUPHENAZINE HYDROCHLORIDE	10MG	TABLET / ORAL	AB	2023-11-06

Therapeutic equivalence codes#

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

Application-product, TE code table
Application-product	TE code
A216350-001	AB
A216350-002	AB
A216350-003	AB
A216350-004	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 2 · 76 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	A216350-001	FLUPHENAZINE HYDROCHLORIDE	1MG	TABLET / ORAL	AB	2023-11-06	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A216350-002	FLUPHENAZINE HYDROCHLORIDE	2.5MG	TABLET / ORAL	AB	2023-11-06	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A216350-003	FLUPHENAZINE HYDROCHLORIDE	5MG	TABLET / ORAL	AB	2023-11-06	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A216350-004	FLUPHENAZINE HYDROCHLORIDE	10MG	TABLET / ORAL	AB	2023-11-06	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A216350-001	FLUPHENAZINE HYDROCHLORIDE	1MG	TABLET / ORAL	AB	2023-11-06	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A216350-002	FLUPHENAZINE HYDROCHLORIDE	2.5MG	TABLET / ORAL	AB	2023-11-06	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A216350-003	FLUPHENAZINE HYDROCHLORIDE	5MG	TABLET / ORAL	AB	2023-11-06	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A216350-004	FLUPHENAZINE HYDROCHLORIDE	10MG	TABLET / ORAL	AB	2023-11-06	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A216350-001	FLUPHENAZINE HYDROCHLORIDE	1MG	TABLET / ORAL	AB	2023-11-06	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A216350-002	FLUPHENAZINE HYDROCHLORIDE	2.5MG	TABLET / ORAL	AB	2023-11-06	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A216350-003	FLUPHENAZINE HYDROCHLORIDE	5MG	TABLET / ORAL	AB	2023-11-06	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A216350-004	FLUPHENAZINE HYDROCHLORIDE	10MG	TABLET / ORAL	AB	2023-11-06	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A216350-001	FLUPHENAZINE HYDROCHLORIDE	1MG	TABLET / ORAL	AB	2023-11-06	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A216350-002	FLUPHENAZINE HYDROCHLORIDE	2.5MG	TABLET / ORAL	AB	2023-11-06	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A216350-003	FLUPHENAZINE HYDROCHLORIDE	5MG	TABLET / ORAL	AB	2023-11-06	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A216350-004	FLUPHENAZINE HYDROCHLORIDE	10MG	TABLET / ORAL	AB	2023-11-06	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A216350-001	FLUPHENAZINE HYDROCHLORIDE	1MG	TABLET / ORAL	AB	2023-11-06	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A216350-002	FLUPHENAZINE HYDROCHLORIDE	2.5MG	TABLET / ORAL	AB	2023-11-06	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A216350-003	FLUPHENAZINE HYDROCHLORIDE	5MG	TABLET / ORAL	AB	2023-11-06	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A216350-004	FLUPHENAZINE HYDROCHLORIDE	10MG	TABLET / ORAL	AB	2023-11-06	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A216350-001	FLUPHENAZINE HYDROCHLORIDE	1MG	TABLET / ORAL	AB	2023-11-06	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A216350-002	FLUPHENAZINE HYDROCHLORIDE	2.5MG	TABLET / ORAL	AB	2023-11-06	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A216350-003	FLUPHENAZINE HYDROCHLORIDE	5MG	TABLET / ORAL	AB	2023-11-06	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A216350-004	FLUPHENAZINE HYDROCHLORIDE	10MG	TABLET / ORAL	AB	2023-11-06	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A216350-001	FLUPHENAZINE HYDROCHLORIDE	1MG	TABLET / ORAL	AB	2023-11-06	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A216350-002	FLUPHENAZINE HYDROCHLORIDE	2.5MG	TABLET / ORAL	AB	2023-11-06	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A216350-003	FLUPHENAZINE HYDROCHLORIDE	5MG	TABLET / ORAL	AB	2023-11-06	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A216350-004	FLUPHENAZINE HYDROCHLORIDE	10MG	TABLET / ORAL	AB	2023-11-06	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A216350-001	FLUPHENAZINE HYDROCHLORIDE	1MG	TABLET / ORAL	AB	2023-11-06	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A216350-002	FLUPHENAZINE HYDROCHLORIDE	2.5MG	TABLET / ORAL	AB	2023-11-06	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A216350-003	FLUPHENAZINE HYDROCHLORIDE	5MG	TABLET / ORAL	AB	2023-11-06	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A216350-004	FLUPHENAZINE HYDROCHLORIDE	10MG	TABLET / ORAL	AB	2023-11-06	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A216350-001	FLUPHENAZINE HYDROCHLORIDE	1MG	TABLET / ORAL	AB	2023-11-06	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A216350-002	FLUPHENAZINE HYDROCHLORIDE	2.5MG	TABLET / ORAL	AB	2023-11-06	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A216350-003	FLUPHENAZINE HYDROCHLORIDE	5MG	TABLET / ORAL	AB	2023-11-06	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A216350-004	FLUPHENAZINE HYDROCHLORIDE	10MG	TABLET / ORAL	AB	2023-11-06	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A216350-001	FLUPHENAZINE HYDROCHLORIDE	1MG	TABLET / ORAL	AB	2023-11-06	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A216350-002	FLUPHENAZINE HYDROCHLORIDE	2.5MG	TABLET / ORAL	AB	2023-11-06	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A216350-003	FLUPHENAZINE HYDROCHLORIDE	5MG	TABLET / ORAL	AB	2023-11-06	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A216350-004	FLUPHENAZINE HYDROCHLORIDE	10MG	TABLET / ORAL	AB	2023-11-06	`d06236e962d9…`

Observed Orange Book normalized TE history#

Normalized TE history page 1 of 2 · 76 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	A216350-001	AB	1	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A216350-002	AB	1	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A216350-003	AB	1	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A216350-004	AB	1	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A216350-001	AB	1	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A216350-002	AB	1	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A216350-003	AB	1	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A216350-004	AB	1	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A216350-001	AB	1	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A216350-002	AB	1	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A216350-003	AB	1	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A216350-004	AB	1	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A216350-001	AB	1	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A216350-002	AB	1	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A216350-003	AB	1	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A216350-004	AB	1	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A216350-001	AB	1	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A216350-002	AB	1	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A216350-003	AB	1	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A216350-004	AB	1	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A216350-001	AB	1	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A216350-002	AB	1	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A216350-003	AB	1	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A216350-004	AB	1	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A216350-001	AB	1	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A216350-002	AB	1	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A216350-003	AB	1	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A216350-004	AB	1	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A216350-001	AB	1	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A216350-002	AB	1	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A216350-003	AB	1	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A216350-004	AB	1	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A216350-001	AB	1	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A216350-002	AB	1	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A216350-003	AB	1	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A216350-004	AB	1	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A216350-001	AB	1	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A216350-002	AB	1	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A216350-003	AB	1	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A216350-004	AB	1	`d06236e962d9…`

Additional Listing Data#

Finished product: Yes
Brand name base: Fluphenazine Hydrochloride
Listing expiration: 2027-12-31

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 · 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
4c3eea71-a7a1-4eda-9871-034ddeb83ed6	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	SPL version
68462-338-01	Fluphenazine Hydrochloride	100 in 1 BOTTLE, PLASTIC	TABLET, FILM COATED	100	5
68462-338-05	Fluphenazine Hydrochloride	500 in 1 BOTTLE, PLASTIC	TABLET, FILM COATED	500	5
68462-338-14	Fluphenazine Hydrochloride	100 in 1 CARTON	TABLET, FILM COATED	100	5
68462-338-14	Fluphenazine Hydrochloride	1 in 1 BLISTER PACK	TABLET, FILM COATED	1	5

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDC	Billing unit	Product NDC	DailyMed indexing SPL	SPL version	Effective
68462-338-01	EA - Each	68462-338	97588447-0881-493c-9324-aeb18afd23ce	1	2024-01-04

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDC	Dashboard title	SPL version	Validation	Dashboard ZIP
68462-338	FLUPHENAZINE HYDROCHLORIDE TABLET, FILM COATED [GLENMARK PHARMACEUTICALS INC., USA]	4	Current NDC, 4 package rows	20250215_4c3eea71-a7a1-4eda-9871-034ddeb83ed6.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	Glenmark Pharmaceuticals Inc., USA	4c3eea71-a7a1-4eda-9871-034ddeb83ed6	2026-01-29	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 216350 application number: ANDA216350 ndc (product): 68462-338

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	4c3eea71-a7a1-4eda-9871-034ddeb83ed6	5
859841	fluPHENAZine HCl 10 MG Oral Tablet	PSN	4c3eea71-a7a1-4eda-9871-034ddeb83ed6	5
865123	fluPHENAZine HCl 2.5 MG Oral Tablet	PSN	4c3eea71-a7a1-4eda-9871-034ddeb83ed6	5
860918	fluPHENAZine HCl 5 MG Oral Tablet	PSN	4c3eea71-a7a1-4eda-9871-034ddeb83ed6	5
865117	fluphenazine hydrochloride 1 MG Oral Tablet	SCD	4c3eea71-a7a1-4eda-9871-034ddeb83ed6	5
859841	fluphenazine hydrochloride 10 MG Oral Tablet	SCD	4c3eea71-a7a1-4eda-9871-034ddeb83ed6	5
865123	fluphenazine hydrochloride 2.5 MG Oral Tablet	SCD	4c3eea71-a7a1-4eda-9871-034ddeb83ed6	5
860918	fluphenazine hydrochloride 5 MG Oral Tablet	SCD	4c3eea71-a7a1-4eda-9871-034ddeb83ed6	5

Packages#

Package NDC, 11-digit format, Description table
Package NDC	11-digit format	Description	Units	Marketing start	Sample	Exclude flag	Status
68462-338-01	68462033801	100 TABLET, FILM COATED in 1 BOTTLE, PLASTIC (68462-338-01)		2023-11-06	No	No	Current
68462-338-05	68462033805	500 TABLET, FILM COATED in 1 BOTTLE, PLASTIC (68462-338-05)		2023-11-06	No	No	Current
68462-338-14	68462033814	100 BLISTER PACK in 1 CARTON (68462-338-14) / 1 TABLET, FILM COATED in 1 BLISTER PACK	100 blister pack	2023-11-06	No	No	Current

Title, Manufacturer, Effective date table
Title	Manufacturer	Effective date	Type	Version
Fluphenazine Hydrochloride Tablets, USP	Glenmark Pharmaceuticals Inc., USA \| Glenmark Pharmaceuticals Limited	2026-01-29	HUMAN PRESCRIPTION DRUG LABEL	5