Perphenazine

Product NDC: 68084-607
11-digit product format: 680840607
Labeler code: 68084
Product ID: 68084-607_5c8bc13b-5022-7560-e063-6394a90ab85d
Type: HUMAN PRESCRIPTION DRUG
Nonproprietary name: perphenazine
Dosage form: TABLET, FILM COATED
Route: ORAL
Labeler: American Health Packaging
Application: ANDA040226
Marketing category: ANDA
Marketing start: 2012-08-09
Substance: PERPHENAZINE
Active strength: 8 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
A040226-001	PERPHENAZINE	PERPHENAZINE	2MG	TABLET / ORAL	AB	1998-12-31
A040226-002	PERPHENAZINE	PERPHENAZINE	4MG	TABLET / ORAL	AB	1998-12-31
A040226-003	PERPHENAZINE	PERPHENAZINE	8MG	TABLET / ORAL	AB	1998-12-31
A040226-004	PERPHENAZINE	PERPHENAZINE	16MG	TABLET / ORAL	AB	1998-12-31

Therapeutic equivalence codes#

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

Application-product, TE code table
Application-product	TE code
A040226-001	AB
A040226-002	AB
A040226-003	AB
A040226-004	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 · 172 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	A040226-001	PERPHENAZINE	2MG	TABLET / ORAL	AB	1998-12-31	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	A040226-002	PERPHENAZINE	4MG	TABLET / ORAL	AB	1998-12-31	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	A040226-003	PERPHENAZINE	8MG	TABLET / ORAL	AB	1998-12-31	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	A040226-004	PERPHENAZINE	16MG	TABLET / ORAL	AB	1998-12-31	`84e616aacf4f…`
2026-08-18 06:07:40	2026-07	A040226-001	PERPHENAZINE	2MG	TABLET / ORAL	AB	1998-12-31	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	A040226-002	PERPHENAZINE	4MG	TABLET / ORAL	AB	1998-12-31	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	A040226-003	PERPHENAZINE	8MG	TABLET / ORAL	AB	1998-12-31	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	A040226-004	PERPHENAZINE	16MG	TABLET / ORAL	AB	1998-12-31	`caaa826d4ba7…`
2026-02-19 14:30 UTC	2026-02	A040226-001	PERPHENAZINE	2MG	TABLET / ORAL	AB	1998-12-31	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A040226-002	PERPHENAZINE	4MG	TABLET / ORAL	AB	1998-12-31	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A040226-003	PERPHENAZINE	8MG	TABLET / ORAL	AB	1998-12-31	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A040226-004	PERPHENAZINE	16MG	TABLET / ORAL	AB	1998-12-31	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A040226-001	PERPHENAZINE	2MG	TABLET / ORAL	AB	1998-12-31	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A040226-002	PERPHENAZINE	4MG	TABLET / ORAL	AB	1998-12-31	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A040226-003	PERPHENAZINE	8MG	TABLET / ORAL	AB	1998-12-31	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A040226-004	PERPHENAZINE	16MG	TABLET / ORAL	AB	1998-12-31	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A040226-001	PERPHENAZINE	2MG	TABLET / ORAL	AB	1998-12-31	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A040226-002	PERPHENAZINE	4MG	TABLET / ORAL	AB	1998-12-31	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A040226-003	PERPHENAZINE	8MG	TABLET / ORAL	AB	1998-12-31	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A040226-004	PERPHENAZINE	16MG	TABLET / ORAL	AB	1998-12-31	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A040226-001	PERPHENAZINE	2MG	TABLET / ORAL	AB	1998-12-31	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A040226-002	PERPHENAZINE	4MG	TABLET / ORAL	AB	1998-12-31	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A040226-003	PERPHENAZINE	8MG	TABLET / ORAL	AB	1998-12-31	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A040226-004	PERPHENAZINE	16MG	TABLET / ORAL	AB	1998-12-31	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A040226-001	PERPHENAZINE	2MG	TABLET / ORAL	AB	1998-12-31	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A040226-002	PERPHENAZINE	4MG	TABLET / ORAL	AB	1998-12-31	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A040226-003	PERPHENAZINE	8MG	TABLET / ORAL	AB	1998-12-31	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A040226-004	PERPHENAZINE	16MG	TABLET / ORAL	AB	1998-12-31	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A040226-001	PERPHENAZINE	2MG	TABLET / ORAL	AB	1998-12-31	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A040226-002	PERPHENAZINE	4MG	TABLET / ORAL	AB	1998-12-31	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A040226-003	PERPHENAZINE	8MG	TABLET / ORAL	AB	1998-12-31	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A040226-004	PERPHENAZINE	16MG	TABLET / ORAL	AB	1998-12-31	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A040226-001	PERPHENAZINE	2MG	TABLET / ORAL	AB	1998-12-31	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A040226-002	PERPHENAZINE	4MG	TABLET / ORAL	AB	1998-12-31	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A040226-003	PERPHENAZINE	8MG	TABLET / ORAL	AB	1998-12-31	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A040226-004	PERPHENAZINE	16MG	TABLET / ORAL	AB	1998-12-31	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A040226-001	PERPHENAZINE	2MG	TABLET / ORAL	AB	1998-12-31	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A040226-002	PERPHENAZINE	4MG	TABLET / ORAL	AB	1998-12-31	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A040226-003	PERPHENAZINE	8MG	TABLET / ORAL	AB	1998-12-31	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A040226-004	PERPHENAZINE	16MG	TABLET / ORAL	AB	1998-12-31	`5bbf6a4d5a75…`

Observed Orange Book normalized TE history#

Normalized TE history page 1 of 5 · 172 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	A040226-001	AB	1	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	A040226-002	AB	1	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	A040226-003	AB	1	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	A040226-004	AB	1	`84e616aacf4f…`
2026-08-18 06:07:40	2026-07	A040226-001	AB	1	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	A040226-002	AB	1	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	A040226-003	AB	1	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	A040226-004	AB	1	`caaa826d4ba7…`
2026-02-19 14:30 UTC	2026-02	A040226-001	AB	1	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A040226-002	AB	1	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A040226-003	AB	1	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A040226-004	AB	1	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A040226-001	AB	1	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A040226-002	AB	1	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A040226-003	AB	1	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A040226-004	AB	1	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A040226-001	AB	1	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A040226-002	AB	1	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A040226-003	AB	1	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A040226-004	AB	1	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A040226-001	AB	1	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A040226-002	AB	1	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A040226-003	AB	1	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A040226-004	AB	1	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A040226-001	AB	1	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A040226-002	AB	1	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A040226-003	AB	1	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A040226-004	AB	1	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A040226-001	AB	1	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A040226-002	AB	1	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A040226-003	AB	1	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A040226-004	AB	1	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A040226-001	AB	1	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A040226-002	AB	1	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A040226-003	AB	1	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A040226-004	AB	1	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A040226-001	AB	1	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A040226-002	AB	1	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A040226-003	AB	1	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A040226-004	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: Perphenazine
Listing expiration: 2027-12-31

Active Ingredients#

Ingredient, Strength table
Ingredient	Strength
PERPHENAZINE	8 mg/1

DailyMed Product Concepts#

Product concept, Relation, Version table
Product concept	Relation	Version	Effective
16c7ce1f-d1cb-56cf-bc49-4eaa8b55e0a1	Product name	9	20260106
aa9828b2-adf8-0dd3-9f6c-b68f39e467c1	Product name	1	20140508

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDC	Product	Description	Form	Quantity	Strength	SPL version
68084-607-01	Perphenazine	100 in 1 BOX, UNIT-DOSE	TABLET, FILM COATED	100		14
68084-607-11	Perphenazine	1 in 1 BLISTER PACK	TABLET, FILM COATED	1		14

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDC	Billing unit	Product NDC	DailyMed indexing SPL	SPL version	Effective
68084-607-01	EA - Each	68084-607	c06bc50c-95fa-4c57-9919-8dc717331b4e	1	2012-07-24
68084-607-11	EA - Each	68084-607	10190841-adc9-4b92-a033-9af83879c33c	1	2012-07-24

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
Ingredient	Type	UNII	DailyMed label	SPL version
PERPHENAZINE	ACTIVE INGREDIENT	FTA7XXY4EZ	PERPHENAZINE TABLET, FILM COATED [AMERICAN HEALTH PACKAGING]	5
PERPHENAZINE	ACTIVE MOIETY	FTA7XXY4EZ	PERPHENAZINE TABLET, FILM COATED [AMERICAN HEALTH PACKAGING]	5
CELLULOSE, MICROCRYSTALLINE	INACTIVE INGREDIENT	OP1R32D61U	PERPHENAZINE TABLET, FILM COATED [AMERICAN HEALTH PACKAGING]	5
FERRIC OXIDE YELLOW	INACTIVE INGREDIENT	EX438O2MRT	PERPHENAZINE TABLET, FILM COATED [AMERICAN HEALTH PACKAGING]	5
FERROSOFERRIC OXIDE	INACTIVE INGREDIENT	XM0M87F357	PERPHENAZINE TABLET, FILM COATED [AMERICAN HEALTH PACKAGING]	5
LACTOSE MONOHYDRATE	INACTIVE INGREDIENT	EWQ57Q8I5X	PERPHENAZINE TABLET, FILM COATED [AMERICAN HEALTH PACKAGING]	5
MAGNESIUM STEARATE	INACTIVE INGREDIENT	70097M6I30	PERPHENAZINE TABLET, FILM COATED [AMERICAN HEALTH PACKAGING]	5
POLYETHYLENE GLYCOLS	INACTIVE INGREDIENT	3WJQ0SDW1A	PERPHENAZINE TABLET, FILM COATED [AMERICAN HEALTH PACKAGING]	5
POLYVINYL ALCOHOL	INACTIVE INGREDIENT	532B59J990	PERPHENAZINE TABLET, FILM COATED [AMERICAN HEALTH PACKAGING]	5
SODIUM STARCH GLYCOLATE TYPE A POTATO	INACTIVE INGREDIENT	5856J3G2A2	PERPHENAZINE TABLET, FILM COATED [AMERICAN HEALTH PACKAGING]	5
TALC	INACTIVE INGREDIENT	7SEV7J4R1U	PERPHENAZINE TABLET, FILM COATED [AMERICAN HEALTH PACKAGING]	5
TITANIUM DIOXIDE	INACTIVE INGREDIENT	15FIX9V2JP	PERPHENAZINE TABLET, FILM COATED [AMERICAN HEALTH PACKAGING]	5

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDC	Dashboard title	SPL version	Validation	Dashboard ZIP
68084-607	PERPHENAZINE TABLET, FILM COATED [AMERICAN HEALTH PACKAGING]	13	Current NDC, Legacy NDC, 2 package rows	20241122_a17c90f9-3d5d-4503-ba2c-754b45decbf8.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 · 11 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
Perphenazine	PERPHENAZINE	Par Health USA, LLC	5fbfe9da-26e8-4705-98f3-42acd3d7b439	2026-08-25	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 040226 application number: ANDA040226
Perphenazine	PERPHENAZINE	American Health Packaging	a17c90f9-3d5d-4503-ba2c-754b45decbf8	2025-11-18	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 040226 application number: ANDA040226 ndc (product): 68084-607
Perphenazine	PERPHENAZINE	Bryant Ranch Prepack	c644628a-76c2-40d9-b7d8-0077743713b9	2023-12-07	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 040226 application number: ANDA040226
Perphenazine	PERPHENAZINE	Bryant Ranch Prepack	0e87e78e-d39c-44fc-95a0-70cdb2a91941	2023-12-07	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 040226 application number: ANDA040226
Perphenazine	PERPHENAZINE	Bryant Ranch Prepack	e2f9903c-cbac-4f14-b684-f12cc7e5aa85	2023-12-07	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 040226 application number: ANDA040226
Perphenazine	PERPHENAZINE	Bryant Ranch Prepack	18c20201-ad92-40ac-8f99-6048c2d32c68	2023-09-12	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 040226 application number: ANDA040226
Perphenazine	PERPHENAZINE	Bryant Ranch Prepack	9ad131c1-0620-4d3c-9734-bcffd98430e2	2023-09-12	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 040226 application number: ANDA040226
Perphenazine	PERPHENAZINE	Bryant Ranch Prepack	63e3a25b-a9e2-449d-8631-41f700f4cdeb	2023-09-12	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 040226 application number: ANDA040226
Perphenazine	PERPHENAZINE	Bryant Ranch Prepack	4882ec28-f516-4dc8-ab15-76cf455af709	2023-03-02	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 040226 application number: ANDA040226
Perphenazine	PERPHENAZINE	Bryant Ranch Prepack	59b1a63e-6cba-4102-a5e8-83dca540341d	2023-03-02	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 040226 application number: ANDA040226
Perphenazine	PERPHENAZINE	Bryant Ranch Prepack	b5f08bc9-79b5-4c6f-8fe4-ec2ef022ebe0	2023-03-02	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 040226 application number: ANDA040226

UNII, Preferred term, Registry number table
UNII	Preferred term	Registry number	Matched term
FTA7XXY4EZ	PERPHENAZINE	58-39-9	PERPHENAZINE

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUI	RxNorm string	TTY	DailyMed	SPL version
198077	perphenazine 4 MG Oral Tablet	PSN	a17c90f9-3d5d-4503-ba2c-754b45decbf8	14
198078	perphenazine 8 MG Oral Tablet	PSN	a17c90f9-3d5d-4503-ba2c-754b45decbf8	14
198077	perphenazine 4 MG Oral Tablet	SCD	a17c90f9-3d5d-4503-ba2c-754b45decbf8	14
198078	perphenazine 8 MG Oral Tablet	SCD	a17c90f9-3d5d-4503-ba2c-754b45decbf8	14

Packages#

Package NDC, 11-digit format, Description table
Package NDC	11-digit format	Description	Units	Marketing start	Marketing end	Sample	Exclude flag	Status
68084-607-01	68084060701	100 BLISTER PACK in 1 BOX, UNIT-DOSE (68084-607-01) / 1 TABLET, FILM COATED in 1 BLISTER PACK (68084-607-11)	100 blister pack	2012-08-09	0000-00-00	No	No	Current
68084-607-11	68084060711	1 in 1 BLISTER PACK						Historical

Title, Manufacturer, Effective date table
Title	Manufacturer	Effective date	Type	Version
Perphenazine Tablets, USP 8260201/1025 Rx only	American Health Packaging	2026-09-28	HUMAN PRESCRIPTION DRUG LABEL	15