Fluphenazine Hydrochloride

Product NDC: 0527-1790
11-digit product format: 005271790
Labeler code: 0527
Product ID: 0527-1790_59cf1ea7-b827-4780-bf94-cd3446d6dcc3
Type: HUMAN PRESCRIPTION DRUG
Nonproprietary name: Fluphenazine Hydrochloride
Dosage form: TABLET, FILM COATED
Route: ORAL
Labeler: Lannett Company, Inc.
Application: ANDA089743
Marketing category: ANDA
Marketing start: 1988-08-25
Substance: FLUPHENAZINE HYDROCHLORIDE
Active strength: 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	TE codes	RLD / RS	Approval date
A089743-001	FLUPHENAZINE HYDROCHLORIDE	FLUPHENAZINE HYDROCHLORIDE	10MG	TABLET / ORAL	AB		1988-08-25
A089743-002	FLUPHENAZINE HYDROCHLORIDE	FLUPHENAZINE HYDROCHLORIDE	1MG	TABLET / ORAL	AB		1988-08-25
A089743-003	FLUPHENAZINE HYDROCHLORIDE	FLUPHENAZINE HYDROCHLORIDE	2.5MG	TABLET / ORAL	AB		1988-08-25
A089743-004	FLUPHENAZINE HYDROCHLORIDE	FLUPHENAZINE HYDROCHLORIDE	5MG	TABLET / ORAL	AB	RS	1988-08-25

Therapeutic equivalence codes#

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

Application-product, TE code table
Application-product	TE code
A089743-001	AB
A089743-002	AB
A089743-003	AB
A089743-004	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 5 · 164 observed states.

Captured, Edition, Application-product table
Captured	Edition	Application-product	Trade name	Strength	Dosage form / route	Product TE source text	RLD / RS	Approval date	Source SHA-256
2026-02-19 14:30 UTC	2026-02	A089743-001	FLUPHENAZINE HYDROCHLORIDE	10MG	TABLET / ORAL	AB		1988-08-25	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A089743-002	FLUPHENAZINE HYDROCHLORIDE	1MG	TABLET / ORAL	AB		1988-08-25	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A089743-003	FLUPHENAZINE HYDROCHLORIDE	2.5MG	TABLET / ORAL	AB		1988-08-25	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A089743-004	FLUPHENAZINE HYDROCHLORIDE	5MG	TABLET / ORAL	AB	RS	1988-08-25	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A089743-001	FLUPHENAZINE HYDROCHLORIDE	10MG	TABLET / ORAL	AB		1988-08-25	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A089743-002	FLUPHENAZINE HYDROCHLORIDE	1MG	TABLET / ORAL	AB		1988-08-25	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A089743-003	FLUPHENAZINE HYDROCHLORIDE	2.5MG	TABLET / ORAL	AB		1988-08-25	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A089743-004	FLUPHENAZINE HYDROCHLORIDE	5MG	TABLET / ORAL	AB	RS	1988-08-25	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A089743-001	FLUPHENAZINE HYDROCHLORIDE	10MG	TABLET / ORAL	AB		1988-08-25	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A089743-002	FLUPHENAZINE HYDROCHLORIDE	1MG	TABLET / ORAL	AB		1988-08-25	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A089743-003	FLUPHENAZINE HYDROCHLORIDE	2.5MG	TABLET / ORAL	AB		1988-08-25	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A089743-004	FLUPHENAZINE HYDROCHLORIDE	5MG	TABLET / ORAL	AB	RS	1988-08-25	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A089743-001	FLUPHENAZINE HYDROCHLORIDE	10MG	TABLET / ORAL	AB		1988-08-25	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A089743-002	FLUPHENAZINE HYDROCHLORIDE	1MG	TABLET / ORAL	AB		1988-08-25	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A089743-003	FLUPHENAZINE HYDROCHLORIDE	2.5MG	TABLET / ORAL	AB		1988-08-25	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A089743-004	FLUPHENAZINE HYDROCHLORIDE	5MG	TABLET / ORAL	AB	RS	1988-08-25	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A089743-001	FLUPHENAZINE HYDROCHLORIDE	10MG	TABLET / ORAL	AB		1988-08-25	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A089743-002	FLUPHENAZINE HYDROCHLORIDE	1MG	TABLET / ORAL	AB		1988-08-25	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A089743-003	FLUPHENAZINE HYDROCHLORIDE	2.5MG	TABLET / ORAL	AB		1988-08-25	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A089743-004	FLUPHENAZINE HYDROCHLORIDE	5MG	TABLET / ORAL	AB	RS	1988-08-25	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A089743-001	FLUPHENAZINE HYDROCHLORIDE	10MG	TABLET / ORAL	AB		1988-08-25	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A089743-002	FLUPHENAZINE HYDROCHLORIDE	1MG	TABLET / ORAL	AB		1988-08-25	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A089743-003	FLUPHENAZINE HYDROCHLORIDE	2.5MG	TABLET / ORAL	AB		1988-08-25	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A089743-004	FLUPHENAZINE HYDROCHLORIDE	5MG	TABLET / ORAL	AB	RS	1988-08-25	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A089743-001	FLUPHENAZINE HYDROCHLORIDE	10MG	TABLET / ORAL	AB		1988-08-25	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A089743-002	FLUPHENAZINE HYDROCHLORIDE	1MG	TABLET / ORAL	AB		1988-08-25	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A089743-003	FLUPHENAZINE HYDROCHLORIDE	2.5MG	TABLET / ORAL	AB		1988-08-25	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A089743-004	FLUPHENAZINE HYDROCHLORIDE	5MG	TABLET / ORAL	AB	RS	1988-08-25	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A089743-001	FLUPHENAZINE HYDROCHLORIDE	10MG	TABLET / ORAL	AB		1988-08-25	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A089743-002	FLUPHENAZINE HYDROCHLORIDE	1MG	TABLET / ORAL	AB		1988-08-25	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A089743-003	FLUPHENAZINE HYDROCHLORIDE	2.5MG	TABLET / ORAL	AB		1988-08-25	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A089743-004	FLUPHENAZINE HYDROCHLORIDE	5MG	TABLET / ORAL	AB	RS	1988-08-25	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A089743-001	FLUPHENAZINE HYDROCHLORIDE	10MG	TABLET / ORAL	AB		1988-08-25	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A089743-002	FLUPHENAZINE HYDROCHLORIDE	1MG	TABLET / ORAL	AB		1988-08-25	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A089743-003	FLUPHENAZINE HYDROCHLORIDE	2.5MG	TABLET / ORAL	AB		1988-08-25	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A089743-004	FLUPHENAZINE HYDROCHLORIDE	5MG	TABLET / ORAL	AB	RS	1988-08-25	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A089743-001	FLUPHENAZINE HYDROCHLORIDE	10MG	TABLET / ORAL	AB		1988-08-25	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A089743-002	FLUPHENAZINE HYDROCHLORIDE	1MG	TABLET / ORAL	AB		1988-08-25	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A089743-003	FLUPHENAZINE HYDROCHLORIDE	2.5MG	TABLET / ORAL	AB		1988-08-25	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A089743-004	FLUPHENAZINE HYDROCHLORIDE	5MG	TABLET / ORAL	AB	RS	1988-08-25	`d06236e962d9…`

Observed Orange Book normalized TE history#

Normalized TE history page 1 of 5 · 164 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	A089743-001	AB	1	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A089743-002	AB	1	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A089743-003	AB	1	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A089743-004	AB	1	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A089743-001	AB	1	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A089743-002	AB	1	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A089743-003	AB	1	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A089743-004	AB	1	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A089743-001	AB	1	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A089743-002	AB	1	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A089743-003	AB	1	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A089743-004	AB	1	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A089743-001	AB	1	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A089743-002	AB	1	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A089743-003	AB	1	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A089743-004	AB	1	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A089743-001	AB	1	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A089743-002	AB	1	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A089743-003	AB	1	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A089743-004	AB	1	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A089743-001	AB	1	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A089743-002	AB	1	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A089743-003	AB	1	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A089743-004	AB	1	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A089743-001	AB	1	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A089743-002	AB	1	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A089743-003	AB	1	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A089743-004	AB	1	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A089743-001	AB	1	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A089743-002	AB	1	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A089743-003	AB	1	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A089743-004	AB	1	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A089743-001	AB	1	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A089743-002	AB	1	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A089743-003	AB	1	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A089743-004	AB	1	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A089743-001	AB	1	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A089743-002	AB	1	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A089743-003	AB	1	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A089743-004	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	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
6cd6ba35-3481-48c1-87db-dc74ce9d7d75	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
3c386306-c48a-413e-bb69-70cb268496f3	Product name	1	20210727
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
0527-1790-01	Fluphenazine Hydrochloride	100 in 1 BOTTLE, PLASTIC	TABLET, FILM COATED	100		18
0527-1790-05	Fluphenazine Hydrochloride	500 in 1 BOTTLE, PLASTIC	TABLET, FILM COATED	500		18

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDC	Billing unit	Product NDC	DailyMed indexing SPL	SPL version	Effective
0527-1790-01	EA - Each	0527-1790	58843e4f-44b2-4c5e-93ef-2cce69e6b965	1	2012-07-24
0527-1790-05	EA - Each	0527-1790	5c9150c5-0e84-4ba1-9106-bcb0b14ff30f	1	2012-07-24

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
Ingredient	Type	UNII	DailyMed label	SPL version
FLUPHENAZINE HYDROCHLORIDE	ACTIVE INGREDIENT	ZOU145W1XL	FLUPHENAZINE HYDROCHLORIDE TABLET, FILM COATED [LANNETT COMPANY, INC.]	7
FLUPHENAZINE	ACTIVE MOIETY	S79426A41Z	FLUPHENAZINE HYDROCHLORIDE TABLET, FILM COATED [LANNETT COMPANY, INC.]	7
D&C RED NO. 27	INACTIVE INGREDIENT	2LRS185U6K	FLUPHENAZINE HYDROCHLORIDE TABLET, FILM COATED [LANNETT COMPANY, INC.]	7
D&C RED NO. 30	INACTIVE INGREDIENT	2S42T2808B	FLUPHENAZINE HYDROCHLORIDE TABLET, FILM COATED [LANNETT COMPANY, INC.]	7
D&C YELLOW NO. 10	INACTIVE INGREDIENT	35SW5USQ3G	FLUPHENAZINE HYDROCHLORIDE TABLET, FILM COATED [LANNETT COMPANY, INC.]	7
DIBASIC CALCIUM PHOSPHATE DIHYDRATE	INACTIVE INGREDIENT	O7TSZ97GEP	FLUPHENAZINE HYDROCHLORIDE TABLET, FILM COATED [LANNETT COMPANY, INC.]	7
FD&C BLUE NO. 1	INACTIVE INGREDIENT	H3R47K3TBD	FLUPHENAZINE HYDROCHLORIDE TABLET, FILM COATED [LANNETT COMPANY, INC.]	7
FD&C BLUE NO. 2	INACTIVE INGREDIENT	L06K8R7DQK	FLUPHENAZINE HYDROCHLORIDE TABLET, FILM COATED [LANNETT COMPANY, INC.]	7
FD&C RED NO. 40	INACTIVE INGREDIENT	WZB9127XOA	FLUPHENAZINE HYDROCHLORIDE TABLET, FILM COATED [LANNETT COMPANY, INC.]	7
FD&C YELLOW NO. 6	INACTIVE INGREDIENT	H77VEI93A8	FLUPHENAZINE HYDROCHLORIDE TABLET, FILM COATED [LANNETT COMPANY, INC.]	7
HYPROMELLOSES	INACTIVE INGREDIENT	3NXW29V3WO	FLUPHENAZINE HYDROCHLORIDE TABLET, FILM COATED [LANNETT COMPANY, INC.]	7
LACTOSE MONOHYDRATE	INACTIVE INGREDIENT	EWQ57Q8I5X	FLUPHENAZINE HYDROCHLORIDE TABLET, FILM COATED [LANNETT COMPANY, INC.]	7
MAGNESIUM STEARATE	INACTIVE INGREDIENT	70097M6I30	FLUPHENAZINE HYDROCHLORIDE TABLET, FILM COATED [LANNETT COMPANY, INC.]	7
POLYETHYLENE GLYCOL	INACTIVE INGREDIENT	3WJQ0SDW1A	FLUPHENAZINE HYDROCHLORIDE TABLET, FILM COATED [LANNETT COMPANY, INC.]	7
POLYSORBATE 80	INACTIVE INGREDIENT	6OZP39ZG8H	FLUPHENAZINE HYDROCHLORIDE TABLET, FILM COATED [LANNETT COMPANY, INC.]	7
STARCH, CORN	INACTIVE INGREDIENT	O8232NY3SJ	FLUPHENAZINE HYDROCHLORIDE TABLET, FILM COATED [LANNETT COMPANY, INC.]	7
TITANIUM DIOXIDE	INACTIVE INGREDIENT	15FIX9V2JP	FLUPHENAZINE HYDROCHLORIDE TABLET, FILM COATED [LANNETT COMPANY, INC.]	7
WATER	INACTIVE INGREDIENT	059QF0KO0R	FLUPHENAZINE HYDROCHLORIDE TABLET, FILM COATED [LANNETT COMPANY, INC.]	7
FLUPHENAZINE HYDROCHLORIDE	ACTIVE INGREDIENT	ZOU145W1XL	FLUPHENAZINE HYDROCHLORIDE TABLET, FILM COATED [AMERICAN HEALTH PACKAGING]	3
FLUPHENAZINE	ACTIVE MOIETY	S79426A41Z	FLUPHENAZINE HYDROCHLORIDE TABLET, FILM COATED [AMERICAN HEALTH PACKAGING]	3
CALCIUM PHOSPHATE, DIBASIC, DIHYDRATE	INACTIVE INGREDIENT	O7TSZ97GEP	FLUPHENAZINE HYDROCHLORIDE TABLET, FILM COATED [AMERICAN HEALTH PACKAGING]	3
D&C RED NO. 27	INACTIVE INGREDIENT	2LRS185U6K	FLUPHENAZINE HYDROCHLORIDE TABLET, FILM COATED [AMERICAN HEALTH PACKAGING]	3
D&C RED NO. 30	INACTIVE INGREDIENT	2S42T2808B	FLUPHENAZINE HYDROCHLORIDE TABLET, FILM COATED [AMERICAN HEALTH PACKAGING]	3
D&C YELLOW NO. 10	INACTIVE INGREDIENT	35SW5USQ3G	FLUPHENAZINE HYDROCHLORIDE TABLET, FILM COATED [AMERICAN HEALTH PACKAGING]	3
FD&C BLUE NO. 1	INACTIVE INGREDIENT	H3R47K3TBD	FLUPHENAZINE HYDROCHLORIDE TABLET, FILM COATED [AMERICAN HEALTH PACKAGING]	3
FD&C RED NO. 40	INACTIVE INGREDIENT	WZB9127XOA	FLUPHENAZINE HYDROCHLORIDE TABLET, FILM COATED [AMERICAN HEALTH PACKAGING]	3
FD&C YELLOW NO. 6	INACTIVE INGREDIENT	H77VEI93A8	FLUPHENAZINE HYDROCHLORIDE TABLET, FILM COATED [AMERICAN HEALTH PACKAGING]	3
HYPROMELLOSES	INACTIVE INGREDIENT	3NXW29V3WO	FLUPHENAZINE HYDROCHLORIDE TABLET, FILM COATED [AMERICAN HEALTH PACKAGING]	3
LACTOSE MONOHYDRATE	INACTIVE INGREDIENT	EWQ57Q8I5X	FLUPHENAZINE HYDROCHLORIDE TABLET, FILM COATED [AMERICAN HEALTH PACKAGING]	3
MAGNESIUM STEARATE	INACTIVE INGREDIENT	70097M6I30	FLUPHENAZINE HYDROCHLORIDE TABLET, FILM COATED [AMERICAN HEALTH PACKAGING]	3
POLYETHYLENE GLYCOLS	INACTIVE INGREDIENT	3WJQ0SDW1A	FLUPHENAZINE HYDROCHLORIDE TABLET, FILM COATED [AMERICAN HEALTH PACKAGING]	3
POLYSORBATE 80	INACTIVE INGREDIENT	6OZP39ZG8H	FLUPHENAZINE HYDROCHLORIDE TABLET, FILM COATED [AMERICAN HEALTH PACKAGING]	3
STARCH, CORN	INACTIVE INGREDIENT	O8232NY3SJ	FLUPHENAZINE HYDROCHLORIDE TABLET, FILM COATED [AMERICAN HEALTH PACKAGING]	3
TITANIUM DIOXIDE	INACTIVE INGREDIENT	15FIX9V2JP	FLUPHENAZINE HYDROCHLORIDE TABLET, FILM COATED [AMERICAN HEALTH PACKAGING]	3
WATER	INACTIVE INGREDIENT	059QF0KO0R	FLUPHENAZINE HYDROCHLORIDE TABLET, FILM COATED [AMERICAN HEALTH PACKAGING]	3

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDC	Dashboard title	SPL version	Validation	Dashboard ZIP
0527-1790	FLUPHENAZINE HYDROCHLORIDE TABLET, FILM COATED [LANNETT COMPANY, INC.]	18	Current NDC, Legacy NDC, 2 package rows	20241121_6cd6ba35-3481-48c1-87db-dc74ce9d7d75.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	Major Pharmaceuticals	e8d4065a-45fc-4adf-9406-2122ca131d99	2025-09-11	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 089743 application number: ANDA089743
Fluphenazine Hydrochloride	FLUPHENAZINE HYDROCHLORIDE	Lannett Company, Inc.	6cd6ba35-3481-48c1-87db-dc74ce9d7d75	2024-11-13	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 089743 application number: ANDA089743 ndc (product): 0527-1790

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	6cd6ba35-3481-48c1-87db-dc74ce9d7d75	18
859841	fluPHENAZine HCl 10 MG Oral Tablet	PSN	6cd6ba35-3481-48c1-87db-dc74ce9d7d75	18
865123	fluPHENAZine HCl 2.5 MG Oral Tablet	PSN	6cd6ba35-3481-48c1-87db-dc74ce9d7d75	18
860918	fluPHENAZine HCl 5 MG Oral Tablet	PSN	6cd6ba35-3481-48c1-87db-dc74ce9d7d75	18
865117	fluphenazine hydrochloride 1 MG Oral Tablet	SCD	6cd6ba35-3481-48c1-87db-dc74ce9d7d75	18
859841	fluphenazine hydrochloride 10 MG Oral Tablet	SCD	6cd6ba35-3481-48c1-87db-dc74ce9d7d75	18
865123	fluphenazine hydrochloride 2.5 MG Oral Tablet	SCD	6cd6ba35-3481-48c1-87db-dc74ce9d7d75	18
860918	fluphenazine hydrochloride 5 MG Oral Tablet	SCD	6cd6ba35-3481-48c1-87db-dc74ce9d7d75	18
865117	fluPHENAZine HCl 1 MG Oral Tablet	PSN	e8d4065a-45fc-4adf-9406-2122ca131d99	4
859841	fluPHENAZine HCl 10 MG Oral Tablet	PSN	e8d4065a-45fc-4adf-9406-2122ca131d99	4
865123	fluPHENAZine HCl 2.5 MG Oral Tablet	PSN	e8d4065a-45fc-4adf-9406-2122ca131d99	4
860918	fluPHENAZine HCl 5 MG Oral Tablet	PSN	e8d4065a-45fc-4adf-9406-2122ca131d99	4
865117	fluphenazine hydrochloride 1 MG Oral Tablet	SCD	e8d4065a-45fc-4adf-9406-2122ca131d99	4
859841	fluphenazine hydrochloride 10 MG Oral Tablet	SCD	e8d4065a-45fc-4adf-9406-2122ca131d99	4
865123	fluphenazine hydrochloride 2.5 MG Oral Tablet	SCD	e8d4065a-45fc-4adf-9406-2122ca131d99	4
860918	fluphenazine hydrochloride 5 MG Oral Tablet	SCD	e8d4065a-45fc-4adf-9406-2122ca131d99	4
860918	fluPHENAZine HCl 5 MG Oral Tablet	PSN	a8360aca-5f69-4ad0-b2ed-99a66b601198	3
860918	fluphenazine hydrochloride 5 MG Oral Tablet	SCD	a8360aca-5f69-4ad0-b2ed-99a66b601198	3
860918	fluPHENAZine HCl 5 MG Oral Tablet	PSN	76e6a260-7e3b-45f9-b28b-a547c9b809e9	2
860918	fluphenazine hydrochloride 5 MG Oral Tablet	SCD	76e6a260-7e3b-45f9-b28b-a547c9b809e9	2
860918	fluPHENAZine HCl 5 MG Oral Tablet	PSN	05c0ee73-9b77-4f47-a20b-c5e87735fee6	1
860918	fluphenazine hydrochloride 5 MG Oral Tablet	SCD	05c0ee73-9b77-4f47-a20b-c5e87735fee6	1

Packages#

Package NDC, 11-digit format, Description table
Package NDC	11-digit format	Description	Marketing start	Marketing end	Sample	Exclude flag	Status
0527-1790-01	00527179001	100 TABLET, FILM COATED in 1 BOTTLE, PLASTIC (0527-1790-01)	1988-08-25	0000-00-00	No	No	Current
0527-1790-05	00527179005	500 TABLET, FILM COATED in 1 BOTTLE, PLASTIC (0527-1790-05)	1988-08-25	0000-00-00	No	No	Current

Title, Manufacturer, Effective date table
Title	Manufacturer	Effective date	Type	Version
Fluphenazine Hydrochloride Tablets, USP	Major Pharmaceuticals	2025-09-11	HUMAN PRESCRIPTION DRUG LABEL	4
Fluphenazine Hydrochloride Tablets, USP	REMEDYREPACK INC.	2025-02-21	HUMAN PRESCRIPTION DRUG LABEL	12
Fluphenazine Hydrochloride Tablets, USP	Lannett Company, Inc.	2024-11-13	HUMAN PRESCRIPTION DRUG LABEL	18
Fluphenazine Hydrochloride Tablets, USP 8284601/0820 Rx only	American Health Packaging	2024-01-26	HUMAN PRESCRIPTION DRUG LABEL	11
Fluphenazine Hydrochloride Tablets, USP Rx Only	AvKARE	2022-01-13	HUMAN PRESCRIPTION DRUG LABEL	2
Fluphenazine Hydrochloride Tablets, USP	A-S Medication Solutions	2021-10-06	HUMAN PRESCRIPTION DRUG LABEL	1
Fluphenazine Hydrochloride Tablets, USP	A-S Medication Solutions	2021-04-15	HUMAN PRESCRIPTION DRUG LABEL	3
Fluphenazine Hydrochloride Tablets, USP	Carilion Materials Management	2017-12-26	HUMAN PRESCRIPTION DRUG LABEL	2