Fluphenazine Hydrochloride

Product NDC: 0121-0654
11-digit product format: 001210654
Labeler code: 0121
Product ID: 0121-0654_be2cdaa4-74b5-4256-90c0-e1410973b3f5
Type: HUMAN PRESCRIPTION DRUG
Nonproprietary name: Fluphenazine Hydrochloride
Dosage form: ELIXIR
Route: ORAL
Labeler: PAI Holdings, LLC dba PAI Pharma
Application: ANDA040146
Marketing category: ANDA
Marketing start: 2010-08-31
Substance: FLUPHENAZINE HYDROCHLORIDE
Active strength: .5 mg/mL
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 42.

Orange Book products#

Current product rows page 1 of 1 · 1 matching rows.

Application-product, Trade name, Ingredient table
Application-product	Trade name	Ingredient	Strength	Dosage form / route	TE codes	RLD / RS	Approval date
A040146-001	FLUPHENAZINE HYDROCHLORIDE	FLUPHENAZINE HYDROCHLORIDE	2.5MG/5ML	ELIXIR / ORAL		RS	1996-08-21

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 · 42 observed states.

Captured, Edition, Application-product table
Captured	Edition	Application-product	Trade name	Strength	Dosage form / route	RLD / RS	Approval date	Source SHA-256
2026-08-18 06:07:40	2026-07	A040146-001	FLUPHENAZINE HYDROCHLORIDE	2.5MG/5ML	ELIXIR / ORAL	RS	1996-08-21	`caaa826d4ba7…`
2026-02-19 14:30 UTC	2026-02	A040146-001	FLUPHENAZINE HYDROCHLORIDE	2.5MG/5ML	ELIXIR / ORAL	RS	1996-08-21	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A040146-001	FLUPHENAZINE HYDROCHLORIDE	2.5MG/5ML	ELIXIR / ORAL	RS	1996-08-21	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A040146-001	FLUPHENAZINE HYDROCHLORIDE	2.5MG/5ML	ELIXIR / ORAL	RS	1996-08-21	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A040146-001	FLUPHENAZINE HYDROCHLORIDE	2.5MG/5ML	ELIXIR / ORAL	RS	1996-08-21	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A040146-001	FLUPHENAZINE HYDROCHLORIDE	2.5MG/5ML	ELIXIR / ORAL	RS	1996-08-21	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A040146-001	FLUPHENAZINE HYDROCHLORIDE	2.5MG/5ML	ELIXIR / ORAL	RS	1996-08-21	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A040146-001	FLUPHENAZINE HYDROCHLORIDE	2.5MG/5ML	ELIXIR / ORAL	RS	1996-08-21	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A040146-001	FLUPHENAZINE HYDROCHLORIDE	2.5MG/5ML	ELIXIR / ORAL	RS	1996-08-21	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A040146-001	FLUPHENAZINE HYDROCHLORIDE	2.5MG/5ML	ELIXIR / ORAL	RS	1996-08-21	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A040146-001	FLUPHENAZINE HYDROCHLORIDE	2.5MG/5ML	ELIXIR / ORAL	RS	1996-08-21	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A040146-001	FLUPHENAZINE HYDROCHLORIDE	2.5MG/5ML	ELIXIR / ORAL	RS	1996-08-21	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A040146-001	FLUPHENAZINE HYDROCHLORIDE	2.5MG/5ML	ELIXIR / ORAL	RS	1996-08-21	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A040146-001	FLUPHENAZINE HYDROCHLORIDE	2.5MG/5ML	ELIXIR / ORAL	RS	1996-08-21	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	A040146-001	FLUPHENAZINE HYDROCHLORIDE	2.5MG/5ML	ELIXIR / ORAL	RS	1996-08-21	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A040146-001	FLUPHENAZINE HYDROCHLORIDE	2.5MG/5ML	ELIXIR / ORAL	RS	1996-08-21	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	A040146-001	FLUPHENAZINE HYDROCHLORIDE	2.5MG/5ML	ELIXIR / ORAL	RS	1996-08-21	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	A040146-001	FLUPHENAZINE HYDROCHLORIDE	2.5MG/5ML	ELIXIR / ORAL	RS	1996-08-21	`4b0b4de00fa7…`
2019-12-13 00:20 UTC	2019-12	A040146-001	FLUPHENAZINE HYDROCHLORIDE	2.5MG/5ML	ELIXIR / ORAL	RS	1996-08-21	`74a2ff9319b5…`
2022-03-09 01:35 UTC	2022-03	A040146-001	FLUPHENAZINE HYDROCHLORIDE	2.5MG/5ML	ELIXIR / ORAL	RS	1996-08-21	`bb7c543d1eb4…`
2021-12-28 21:50 UTC	2021-12	A040146-001	FLUPHENAZINE HYDROCHLORIDE	2.5MG/5ML	ELIXIR / ORAL	RS	1996-08-21	`782e0a99824c…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	A040146-001	FLUPHENAZINE HYDROCHLORIDE	2.5MG/5ML	ELIXIR / ORAL	RS	1996-08-21	`87673890dc5c…`
2021-03-12 10:30 UTC	2021-03	A040146-001	FLUPHENAZINE HYDROCHLORIDE	2.5MG/5ML	ELIXIR / ORAL	RS	1996-08-21	`5aa47cf7b7d7…`
2020-12-22 03:56 UTC	2020-12	A040146-001	FLUPHENAZINE HYDROCHLORIDE	2.5MG/5ML	ELIXIR / ORAL	RS	1996-08-21	`8869cabd3fbd…`
2020-11-12 02:37 UTC	2020-11	A040146-001	FLUPHENAZINE HYDROCHLORIDE	2.5MG/5ML	ELIXIR / ORAL	RS	1996-08-21	`c0c555d07b60…`
2019-12-14 00:12 UTC	2019-12	A040146-001	FLUPHENAZINE HYDROCHLORIDE	2.5MG/5ML	ELIXIR / ORAL	RS	1996-08-21	`3f01610625f2…`
2019-09-15 20:21 UTC	2019-09	A040146-001	FLUPHENAZINE HYDROCHLORIDE	2.5MG/5ML	ELIXIR / ORAL	RS	1996-08-21	`b00525d2431f…`
2019-07-19 19:46 UTC	2019-07	A040146-001	FLUPHENAZINE HYDROCHLORIDE	2.5MG/5ML	ELIXIR / ORAL	RS	1996-08-21	`ea99ee380514…`
2024-03-16 18:09 UTC · 4 captures of this ZIP	2024-03	A040146-001	FLUPHENAZINE HYDROCHLORIDE	2.5MG/5ML	ELIXIR / ORAL	RS	1996-08-21	`6a51e52b5d6a…`
2024-02-18 07:12 UTC	2024-02	A040146-001	FLUPHENAZINE HYDROCHLORIDE	2.5MG/5ML	ELIXIR / ORAL	RS	1996-08-21	`1c564ffb4f44…`
2023-12-20 04:57 UTC	2023-12	A040146-001	FLUPHENAZINE HYDROCHLORIDE	2.5MG/5ML	ELIXIR / ORAL	RS	1996-08-21	`ea1830bbd6c7…`
2023-11-28 05:40 UTC · 2 captures of this ZIP	2023-11	A040146-001	FLUPHENAZINE HYDROCHLORIDE	2.5MG/5ML	ELIXIR / ORAL	RS	1996-08-21	`a72a2bbeb626…`
2023-10-25 00:34 UTC · 2 captures of this ZIP	2023-10	A040146-001	FLUPHENAZINE HYDROCHLORIDE	2.5MG/5ML	ELIXIR / ORAL	RS	1996-08-21	`9b2671bbb829…`
2023-07-15 15:27 UTC · 2 captures of this ZIP	2023-07	A040146-001	FLUPHENAZINE HYDROCHLORIDE	2.5MG/5ML	ELIXIR / ORAL	RS	1996-08-21	`a67488948f0b…`
2023-06-13 01:57 UTC · 3 captures of this ZIP	2023-06	A040146-001	FLUPHENAZINE HYDROCHLORIDE	2.5MG/5ML	ELIXIR / ORAL	RS	1996-08-21	`3f0d92c62455…`
2023-05-13 08:27 UTC	2023-05	A040146-001	FLUPHENAZINE HYDROCHLORIDE	2.5MG/5ML	ELIXIR / ORAL	RS	1996-08-21	`053a50430f4f…`
2023-01-26 05:58 UTC	2023-01	A040146-001	FLUPHENAZINE HYDROCHLORIDE	2.5MG/5ML	ELIXIR / ORAL	RS	1996-08-21	`3bdfa0b2c4d7…`
2022-11-12 20:34 UTC · 5 captures of this ZIP	2022-11	A040146-001	FLUPHENAZINE HYDROCHLORIDE	2.5MG/5ML	ELIXIR / ORAL	RS	1996-08-21	`3a93d1ddd44b…`
2022-10-28 04:53 UTC	2022-10	A040146-001	FLUPHENAZINE HYDROCHLORIDE	2.5MG/5ML	ELIXIR / ORAL	RS	1996-08-21	`f41ea6bd6efb…`
2022-09-29 23:25 UTC	2022-09	A040146-001	FLUPHENAZINE HYDROCHLORIDE	2.5MG/5ML	ELIXIR / ORAL	RS	1996-08-21	`e64feba35796…`

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/mL

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 · 1 matching rows.

Identifier, FDA.report destination table
Identifier	FDA.report destination
859835	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
f0a89d5d-01db-47f3-a873-33ab49c6e4f8	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
0121-0654-02	Fluphenazine Hydrochloride	60 mL in 1 BOTTLE	ELIXIR	60		14
0121-0654-16	Fluphenazine Hydrochloride	473 mL in 1 BOTTLE	ELIXIR	473		14

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDC	Billing unit	Product NDC	DailyMed indexing SPL	SPL version	Effective
0121-0654-02	ML - Milliliter	0121-0654	64dd3a3e-ae28-44b8-ad21-edca38a4a86d	1	2012-07-24
0121-0654-16	ML - Milliliter	0121-0654	2ebd35da-dfdb-4658-b2bd-0947fd48de2b	1	2012-07-24

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
Ingredient	Type	UNII	DailyMed label	SPL version	Uploaded
Fluphenazine Hydrochloride	ACTIVE INGREDIENT	ZOU145W1XL	FLUPHENAZINE HYDROCHLORIDE ELIXIR [PHARMACEUTICAL ASSOCIATES, INC.]	3
Fluphenazine	ACTIVE MOIETY	S79426A41Z	FLUPHENAZINE HYDROCHLORIDE ELIXIR [PHARMACEUTICAL ASSOCIATES, INC.]	3

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDC	Dashboard title	SPL version	Validation	Dashboard ZIP
0121-0654	FLUPHENAZINE HYDROCHLORIDE ELIXIR [PAI HOLDINGS, LLC DBA PAI PHARMA]	14	Current NDC, Legacy NDC, 2 package rows	20250210_f0a89d5d-01db-47f3-a873-33ab49c6e4f8.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	PAI Holdings, LLC dba PAI Pharma	f0a89d5d-01db-47f3-a873-33ab49c6e4f8	2025-02-07	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 040146 application number: ANDA040146 ndc (product): 0121-0654

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
859835	fluPHENAZine HCl 2.5 MG in 5 mL Oral Solution	PSN	f0a89d5d-01db-47f3-a873-33ab49c6e4f8	14
859835	fluphenazine hydrochloride 0.5 MG/ML Oral Solution	SCD	f0a89d5d-01db-47f3-a873-33ab49c6e4f8	14
859835	fluphenazine HCl 2.5 MG per 5 ML Oral Solution	SY	f0a89d5d-01db-47f3-a873-33ab49c6e4f8	14
859835	fluPHENAZine HCl 2.5 MG in 5 mL Oral Solution	PSN	006045b9-c22a-430a-b202-eb5cddc908ea	2
859835	fluphenazine hydrochloride 0.5 MG/ML Oral Solution	SCD	006045b9-c22a-430a-b202-eb5cddc908ea	2
859835	fluphenazine HCl 2.5 MG per 5 ML Oral Solution	SY	006045b9-c22a-430a-b202-eb5cddc908ea	2

Packages#

Package NDC, 11-digit format, Description table
Package NDC	11-digit format	Description	Units	Marketing start	Marketing end	Sample	Exclude flag	Status
0121-0654-02	00121065402	60 mL in 1 BOTTLE (0121-0654-02)	60 ml	2010-08-31	0000-00-00	No	No	Current
0121-0654-16	00121065416	473 mL in 1 BOTTLE (0121-0654-16)	473 ml	2010-08-31	0000-00-00	No	No	Current

Title, Manufacturer, Effective date table
Title	Manufacturer	Effective date	Type	Version
Fluphenazine Hydrochloride Elixir USP	PAI Holdings, LLC dba PAI Pharma	2025-02-07	HUMAN PRESCRIPTION DRUG LABEL	14
Fluphenazine Hydrochloride Elixir USP	ATLANTIC BIOLOGICALS CORP.	2021-01-26	HUMAN PRESCRIPTION DRUG LABEL	2
Fluphenazine Hydrochloride Elixir USP	A-S Medication Solutions	2018-08-14	HUMAN PRESCRIPTION DRUG LABEL	3