fluphenazine hydrochloride

Product NDC: 67046-0975
Requested package NDC: 67046-0975-3
11-digit product format: 670460975
Labeler code: 67046
Product ID: 67046-0975_5386524e-546d-324a-e063-6394a90a1f01
Type: HUMAN PRESCRIPTION DRUG
Nonproprietary name: fluphenazine hydrochloride
Dosage form: TABLET, FILM COATED
Route: ORAL
Labeler: Coupler LLC
Application: ANDA213647
Marketing category: ANDA
Marketing start: 2026-06-05
Substance: FLUPHENAZINE HYDROCHLORIDE
Active strength: 1 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 43.

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
A213647-001	FLUPHENAZINE HYDROCHLORIDE	FLUPHENAZINE HYDROCHLORIDE	1MG	TABLET / ORAL	AB	2020-07-09
A213647-002	FLUPHENAZINE HYDROCHLORIDE	FLUPHENAZINE HYDROCHLORIDE	2.5MG	TABLET / ORAL	AB	2020-07-09
A213647-003	FLUPHENAZINE HYDROCHLORIDE	FLUPHENAZINE HYDROCHLORIDE	5MG	TABLET / ORAL	AB	2020-07-09
A213647-004	FLUPHENAZINE HYDROCHLORIDE	FLUPHENAZINE HYDROCHLORIDE	10MG	TABLET / ORAL	AB	2020-07-09

Therapeutic equivalence codes#

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

Application-product, TE code table
Application-product	TE code
A213647-001	AB
A213647-002	AB
A213647-003	AB
A213647-004	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 · 156 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
2026-09-14 22:38:34	2026-08	A213647-001	FLUPHENAZINE HYDROCHLORIDE	1MG	TABLET / ORAL	AB	2020-07-09	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	A213647-002	FLUPHENAZINE HYDROCHLORIDE	2.5MG	TABLET / ORAL	AB	2020-07-09	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	A213647-003	FLUPHENAZINE HYDROCHLORIDE	5MG	TABLET / ORAL	AB	2020-07-09	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	A213647-004	FLUPHENAZINE HYDROCHLORIDE	10MG	TABLET / ORAL	AB	2020-07-09	`84e616aacf4f…`
2026-08-18 06:07:40	2026-07	A213647-001	FLUPHENAZINE HYDROCHLORIDE	1MG	TABLET / ORAL	AB	2020-07-09	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	A213647-002	FLUPHENAZINE HYDROCHLORIDE	2.5MG	TABLET / ORAL	AB	2020-07-09	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	A213647-003	FLUPHENAZINE HYDROCHLORIDE	5MG	TABLET / ORAL	AB	2020-07-09	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	A213647-004	FLUPHENAZINE HYDROCHLORIDE	10MG	TABLET / ORAL	AB	2020-07-09	`caaa826d4ba7…`
2026-02-19 14:30 UTC	2026-02	A213647-001	FLUPHENAZINE HYDROCHLORIDE	1MG	TABLET / ORAL	AB	2020-07-09	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A213647-002	FLUPHENAZINE HYDROCHLORIDE	2.5MG	TABLET / ORAL	AB	2020-07-09	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A213647-003	FLUPHENAZINE HYDROCHLORIDE	5MG	TABLET / ORAL	AB	2020-07-09	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A213647-004	FLUPHENAZINE HYDROCHLORIDE	10MG	TABLET / ORAL	AB	2020-07-09	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A213647-001	FLUPHENAZINE HYDROCHLORIDE	1MG	TABLET / ORAL	AB	2020-07-09	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A213647-002	FLUPHENAZINE HYDROCHLORIDE	2.5MG	TABLET / ORAL	AB	2020-07-09	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A213647-003	FLUPHENAZINE HYDROCHLORIDE	5MG	TABLET / ORAL	AB	2020-07-09	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A213647-004	FLUPHENAZINE HYDROCHLORIDE	10MG	TABLET / ORAL	AB	2020-07-09	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A213647-001	FLUPHENAZINE HYDROCHLORIDE	1MG	TABLET / ORAL	AB	2020-07-09	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A213647-002	FLUPHENAZINE HYDROCHLORIDE	2.5MG	TABLET / ORAL	AB	2020-07-09	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A213647-003	FLUPHENAZINE HYDROCHLORIDE	5MG	TABLET / ORAL	AB	2020-07-09	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A213647-004	FLUPHENAZINE HYDROCHLORIDE	10MG	TABLET / ORAL	AB	2020-07-09	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A213647-001	FLUPHENAZINE HYDROCHLORIDE	1MG	TABLET / ORAL	AB	2020-07-09	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A213647-002	FLUPHENAZINE HYDROCHLORIDE	2.5MG	TABLET / ORAL	AB	2020-07-09	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A213647-003	FLUPHENAZINE HYDROCHLORIDE	5MG	TABLET / ORAL	AB	2020-07-09	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A213647-004	FLUPHENAZINE HYDROCHLORIDE	10MG	TABLET / ORAL	AB	2020-07-09	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A213647-001	FLUPHENAZINE HYDROCHLORIDE	1MG	TABLET / ORAL	AB	2020-07-09	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A213647-002	FLUPHENAZINE HYDROCHLORIDE	2.5MG	TABLET / ORAL	AB	2020-07-09	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A213647-003	FLUPHENAZINE HYDROCHLORIDE	5MG	TABLET / ORAL	AB	2020-07-09	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A213647-004	FLUPHENAZINE HYDROCHLORIDE	10MG	TABLET / ORAL	AB	2020-07-09	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A213647-001	FLUPHENAZINE HYDROCHLORIDE	1MG	TABLET / ORAL	AB	2020-07-09	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A213647-002	FLUPHENAZINE HYDROCHLORIDE	2.5MG	TABLET / ORAL	AB	2020-07-09	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A213647-003	FLUPHENAZINE HYDROCHLORIDE	5MG	TABLET / ORAL	AB	2020-07-09	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A213647-004	FLUPHENAZINE HYDROCHLORIDE	10MG	TABLET / ORAL	AB	2020-07-09	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A213647-001	FLUPHENAZINE HYDROCHLORIDE	1MG	TABLET / ORAL	AB	2020-07-09	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A213647-002	FLUPHENAZINE HYDROCHLORIDE	2.5MG	TABLET / ORAL	AB	2020-07-09	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A213647-003	FLUPHENAZINE HYDROCHLORIDE	5MG	TABLET / ORAL	AB	2020-07-09	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A213647-004	FLUPHENAZINE HYDROCHLORIDE	10MG	TABLET / ORAL	AB	2020-07-09	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A213647-001	FLUPHENAZINE HYDROCHLORIDE	1MG	TABLET / ORAL	AB	2020-07-09	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A213647-002	FLUPHENAZINE HYDROCHLORIDE	2.5MG	TABLET / ORAL	AB	2020-07-09	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A213647-003	FLUPHENAZINE HYDROCHLORIDE	5MG	TABLET / ORAL	AB	2020-07-09	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A213647-004	FLUPHENAZINE HYDROCHLORIDE	10MG	TABLET / ORAL	AB	2020-07-09	`5bbf6a4d5a75…`

Observed Orange Book normalized TE history#

Normalized TE history page 1 of 4 · 156 observed states.

Captured, Edition, Application-product table
Captured	Edition	Application-product	TE code	Order	Source SHA-256
2026-09-14 22:38:34	2026-08	A213647-001	AB	1	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	A213647-002	AB	1	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	A213647-003	AB	1	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	A213647-004	AB	1	`84e616aacf4f…`
2026-08-18 06:07:40	2026-07	A213647-001	AB	1	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	A213647-002	AB	1	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	A213647-003	AB	1	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	A213647-004	AB	1	`caaa826d4ba7…`
2026-02-19 14:30 UTC	2026-02	A213647-001	AB	1	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A213647-002	AB	1	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A213647-003	AB	1	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A213647-004	AB	1	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A213647-001	AB	1	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A213647-002	AB	1	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A213647-003	AB	1	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A213647-004	AB	1	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A213647-001	AB	1	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A213647-002	AB	1	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A213647-003	AB	1	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A213647-004	AB	1	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A213647-001	AB	1	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A213647-002	AB	1	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A213647-003	AB	1	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A213647-004	AB	1	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A213647-001	AB	1	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A213647-002	AB	1	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A213647-003	AB	1	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A213647-004	AB	1	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A213647-001	AB	1	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A213647-002	AB	1	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A213647-003	AB	1	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A213647-004	AB	1	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A213647-001	AB	1	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A213647-002	AB	1	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A213647-003	AB	1	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A213647-004	AB	1	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A213647-001	AB	1	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A213647-002	AB	1	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A213647-003	AB	1	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A213647-004	AB	1	`5bbf6a4d5a75…`

Reported adverse events (FAERS/openFDA)#

Adverse event summaries are temporarily unavailable. Other product information remains available.

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	1 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 · 1 matching rows.

Identifier, FDA.report destination table
Identifier	FDA.report destination
865117	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
53864ae1-046e-f6de-e063-6294a90a13af	Available on FDA.report

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	Coupler LLC	53864ae1-046e-f6de-e063-6294a90a13af	2026-06-05	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 213647 application number: ANDA213647 ndc (package): 67046-0975-3 ndc (product): 67046-0975 ndc11 (package): 67046097503
fluphenazine hydrochloride	FLUPHENAZINE HYDROCHLORIDE	Amneal Pharmaceuticals NY LLC	5b443b30-5682-4cf3-9ed0-716efddbc865	2026-04-14	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 213647 application number: ANDA213647

UNII, Preferred term, Registry number table
UNII	Preferred term	Registry number	Matched term
ZOU145W1XL	FLUPHENAZINE HYDROCHLORIDE	146-56-5	FLUPHENAZINE HYDROCHLORIDE

Packages#

Package NDC, 11-digit format, Description table
Package NDC	11-digit format	Description	Marketing start	Sample	Exclude flag	Status
67046-0975-3	67046097503	30 TABLET, FILM COATED in 1 BLISTER PACK (67046-0975-3)	2026-06-05	No	No	Current

Title, Manufacturer, Effective date table
Title	Manufacturer	Effective date	Type	Version
Fluphenazine Hydrochloride Tablets, USP (1 mg, 2.5 mg, 5 mg and 10 mg) Rx only	Coupler LLC \| Amneal Pharmaceuticals of New York, LLC	2026-06-05	HUMAN PRESCRIPTION DRUG LABEL	1