Fluphenazine Hydrochloride

Product NDC: 17856-0654
11-digit product format: 178560654
Labeler code: 17856
Product ID: 17856-0654_fc470a09-3e5e-430c-b3fd-fb03a1a26b07
Type: HUMAN PRESCRIPTION DRUG
Nonproprietary name: Fluphenazine Hydrochloride
Dosage form: ELIXIR
Route: ORAL
Labeler: ATLANTIC BIOLOGICALS CORP.
Application: ANDA040146
Marketing category: ANDA
Marketing start: 2019-04-16
Marketing end: 0000-00-00
Substance: FLUPHENAZINE HYDROCHLORIDE
Active strength: 1 mg/mL
Pharmacologic classes: Phenothiazines [CS],Phenothiazine [EPC]
NDC exclude flag: No
Listing certified through: 2022-12-31
Current FDA listing: Historical FDA.report record

NDC auxiliary status#

These records are reproduced from FDA’s unfinished, excluded, and compounder listings. They describe what appeared in the source files; a missing record does not establish a regulatory status. View all current auxiliary records, including entries without an NDC. · View the auxiliary file history.

Current NDC status page 1 of 1 · 2 matching rows.

Dataset, Scope, Product NDC table
Dataset	Scope	Product NDC	Package NDC	Code	Status	Reporting period	Source date
excluded product	product	17856-0654		I	Inactivated by FDA		2026-08-17
excluded package	package	17856-0654	17856-0654-1	I	Inactivated by FDA		2026-08-17

Observed NDC auxiliary status history#

This history shows the information present in each captured FDA auxiliary file. It is not a continuous regulatory timeline, and a missing record does not establish a status.

Historic NDC status page 1 of 1 · 30 matching rows.

View current auxiliary records. · View the auxiliary file history.

Captured / source date, Dataset, Scope table
Captured / source date	Dataset	Scope	Package NDC	Snapshot	Source SHA-256
2025-12-14 17:58 UTC · source 2025-12-05	excluded product	product		`d630ba8d3edf…`	`732f749b63fb…`
2025-12-14 17:58 UTC · source 2025-12-05	excluded package	package	17856-0654-1	`d630ba8d3edf…`	`732f749b63fb…`
2025-08-27 00:01 UTC · source 2025-08-26	excluded product	product		`f5e01cc5f278…`	`a2eaf40c39c3…`
2025-08-27 00:01 UTC · source 2025-08-26	excluded package	package	17856-0654-1	`f5e01cc5f278…`	`a2eaf40c39c3…`
2025-04-01 02:39 UTC · source 2025-03-31	excluded product	product		`2ef7874e63bc…`	`57b86245f4fa…`
2025-04-01 02:39 UTC · source 2025-03-31	excluded package	package	17856-0654-1	`2ef7874e63bc…`	`57b86245f4fa…`
2025-03-28 20:22 UTC · source 2025-03-28	excluded product	product		`a1b67e2a42f9…`	`c4cf2c586c0d…`
2025-03-28 20:22 UTC · source 2025-03-28	excluded package	package	17856-0654-1	`a1b67e2a42f9…`	`c4cf2c586c0d…`
2025-03-22 03:12 UTC · source 2025-03-21	excluded product	product		`cfe11265f3b6…`	`090c488252e2…`
2025-03-22 03:12 UTC · source 2025-03-21	excluded package	package	17856-0654-1	`cfe11265f3b6…`	`090c488252e2…`
2025-03-10 12:48 UTC · source 2025-03-10	excluded product	product		`cdf11ea48f46…`	`ba0047e9e063…`
2025-03-10 12:48 UTC · source 2025-03-10	excluded package	package	17856-0654-1	`cdf11ea48f46…`	`ba0047e9e063…`
2025-02-02 03:52 UTC · source 2025-01-31	excluded product	product		`302b2466d912…`	`e7b80fea0513…`
2025-02-02 03:52 UTC · source 2025-01-31	excluded package	package	17856-0654-1	`302b2466d912…`	`e7b80fea0513…`
2025-01-20 13:05 UTC · source 2025-01-20	excluded product	product		`ed331223b511…`	`672a5bd82f5f…`
2025-01-20 13:05 UTC · source 2025-01-20	excluded package	package	17856-0654-1	`ed331223b511…`	`672a5bd82f5f…`
2025-01-11 03:41 UTC · source 2025-01-10	excluded product	product		`0efc9e666f02…`	`f202fb6c5f17…`
2025-01-11 03:41 UTC · source 2025-01-10	excluded package	package	17856-0654-1	`0efc9e666f02…`	`f202fb6c5f17…`
2024-11-09 02:27 UTC · source 2024-11-08	excluded product	product		`ad56d346431e…`	`cc804d4bbf1e…`
2024-11-09 02:27 UTC · source 2024-11-08	excluded package	package	17856-0654-1	`ad56d346431e…`	`cc804d4bbf1e…`
2024-10-04 04:10 UTC · source 2024-10-03	excluded product	product		`367a005e9d99…`	`383a685ebd0f…`
2024-10-04 04:10 UTC · source 2024-10-03	excluded package	package	17856-0654-1	`367a005e9d99…`	`383a685ebd0f…`
2024-07-10 04:00 UTC · source 2024-07-09	excluded product	product		`557ba5c1ecfa…`	`9c80585c8c6e…`
2024-07-10 04:00 UTC · source 2024-07-09	excluded package	package	17856-0654-1	`557ba5c1ecfa…`	`9c80585c8c6e…`
2024-05-28 21:12 UTC · source 2024-05-28	excluded product	product		`8af77b9d5b6f…`	`d9bbb34c5368…`
2024-05-28 21:12 UTC · source 2024-05-28	excluded package	package	17856-0654-1	`8af77b9d5b6f…`	`d9bbb34c5368…`
2024-05-15 03:39 UTC · source 2024-05-14	excluded product	product		`834df4deac94…`	`adcc014656a3…`
2024-05-15 03:39 UTC · source 2024-05-14	excluded package	package	17856-0654-1	`834df4deac94…`	`adcc014656a3…`
2024-03-11 06:39 UTC · source 2024-03-08	excluded product	product		`1332a3947898…`	`d4bfe170f9cd…`
2024-03-11 06:39 UTC · source 2024-03-08	excluded package	package	17856-0654-1	`1332a3947898…`	`d4bfe170f9cd…`

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…`

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

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDC	Effective	Action	Document	Indexing SPL	Related label
17856-0654-1	2023-01-30	C162847	48780-1	f386c64a-1319-0266-e053-dadaa90a7c1a	Fluphenazine Hydrochloride Elixir USP

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDC	Product	Description	Form	Quantity	Strength	SPL version
17856-0654-1	Fluphenazine Hydrochloride	72 in 1 BOX, UNIT-DOSE	ELIXIR	72		2
17856-0654-1	Fluphenazine Hydrochloride	5 mL in 1 CUP, UNIT-DOSE	ELIXIR	5		2

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDC	Dashboard title	SPL version	Validation	Dashboard ZIP
17856-0654	FLUPHENAZINE HYDROCHLORIDE ELIXIR [ATLANTIC BIOLOGICALS CORP.]	2	Legacy NDC, 2 package rows	20210128_006045b9-c22a-430a-b202-eb5cddc908ea.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

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	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	Marketing start	Marketing end	Sample	Exclude flag	Status
17856-0654-1	17856065401	72 CUP, UNIT-DOSE in 1 BOX, UNIT-DOSE (17856-0654-1) > 5 mL in 1 CUP, UNIT-DOSE	2021-01-26	0000-00-00	No	No	Current

Title, Manufacturer, Effective date table
Title	Manufacturer	Effective date	Type	Version
Fluphenazine Hydrochloride Elixir USP	ATLANTIC BIOLOGICALS CORP.	2021-01-26	HUMAN PRESCRIPTION DRUG LABEL	2