Perphenazine

Product NDC: 0781-8048
Requested package NDC: 0781-8048-01
11-digit product format: 007818048
Labeler code: 0781
Product ID: 0781-8048_9e348a80-ecb9-409b-91e7-3a48423314ff
Type: HUMAN PRESCRIPTION DRUG
Nonproprietary name: Perphenazine
Dosage form: TABLET, FILM COATED
Route: ORAL
Labeler: Sandoz Inc
Application: ANDA089685
Marketing category: ANDA
Marketing start: 1988-12-08
Marketing end: 2027-03-21
Substance: PERPHENAZINE
Active strength: 8 mg/1
Pharmacologic classes: Phenothiazine [EPC], Phenothiazines [CS]
NDC exclude flag: No
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	RLD / RS	Approval date
A089685-001	PERPHENAZINE	PERPHENAZINE	8MG	TABLET / ORAL	AB		1988-12-08
A089685-002	PERPHENAZINE	PERPHENAZINE	2MG	TABLET / ORAL	AB		1988-12-08
A089685-003	PERPHENAZINE	PERPHENAZINE	4MG	TABLET / ORAL	AB		1988-12-08
A089685-004	PERPHENAZINE	PERPHENAZINE	16MG	TABLET / ORAL	AB	RS	1988-12-08

Therapeutic equivalence codes#

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

Application-product, TE code table
Application-product	TE code
A089685-001	AB
A089685-002	AB
A089685-003	AB
A089685-004	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	RLD / RS	Approval date	Source SHA-256
2026-09-14 22:38:34	2026-08	A089685-001	PERPHENAZINE	8MG	TABLET / ORAL	AB		1988-12-08	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	A089685-002	PERPHENAZINE	2MG	TABLET / ORAL	AB		1988-12-08	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	A089685-003	PERPHENAZINE	4MG	TABLET / ORAL	AB		1988-12-08	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	A089685-004	PERPHENAZINE	16MG	TABLET / ORAL	AB	RS	1988-12-08	`84e616aacf4f…`
2026-08-18 06:07:40	2026-07	A089685-001	PERPHENAZINE	8MG	TABLET / ORAL	AB		1988-12-08	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	A089685-002	PERPHENAZINE	2MG	TABLET / ORAL	AB		1988-12-08	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	A089685-003	PERPHENAZINE	4MG	TABLET / ORAL	AB		1988-12-08	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	A089685-004	PERPHENAZINE	16MG	TABLET / ORAL	AB	RS	1988-12-08	`caaa826d4ba7…`
2026-02-19 14:30 UTC	2026-02	A089685-001	PERPHENAZINE	8MG	TABLET / ORAL	AB		1988-12-08	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A089685-002	PERPHENAZINE	2MG	TABLET / ORAL	AB		1988-12-08	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A089685-003	PERPHENAZINE	4MG	TABLET / ORAL	AB		1988-12-08	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A089685-004	PERPHENAZINE	16MG	TABLET / ORAL	AB	RS	1988-12-08	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A089685-001	PERPHENAZINE	8MG	TABLET / ORAL	AB		1988-12-08	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A089685-002	PERPHENAZINE	2MG	TABLET / ORAL	AB		1988-12-08	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A089685-003	PERPHENAZINE	4MG	TABLET / ORAL	AB		1988-12-08	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A089685-004	PERPHENAZINE	16MG	TABLET / ORAL	AB	RS	1988-12-08	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A089685-001	PERPHENAZINE	8MG	TABLET / ORAL	AB		1988-12-08	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A089685-002	PERPHENAZINE	2MG	TABLET / ORAL	AB		1988-12-08	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A089685-003	PERPHENAZINE	4MG	TABLET / ORAL	AB		1988-12-08	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A089685-004	PERPHENAZINE	16MG	TABLET / ORAL	AB	RS	1988-12-08	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A089685-001	PERPHENAZINE	8MG	TABLET / ORAL	AB		1988-12-08	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A089685-002	PERPHENAZINE	2MG	TABLET / ORAL	AB		1988-12-08	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A089685-003	PERPHENAZINE	4MG	TABLET / ORAL	AB		1988-12-08	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A089685-004	PERPHENAZINE	16MG	TABLET / ORAL	AB	RS	1988-12-08	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A089685-001	PERPHENAZINE	8MG	TABLET / ORAL	AB		1988-12-08	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A089685-002	PERPHENAZINE	2MG	TABLET / ORAL	AB		1988-12-08	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A089685-003	PERPHENAZINE	4MG	TABLET / ORAL	AB		1988-12-08	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A089685-004	PERPHENAZINE	16MG	TABLET / ORAL	AB	RS	1988-12-08	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A089685-001	PERPHENAZINE	8MG	TABLET / ORAL	AB		1988-12-08	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A089685-002	PERPHENAZINE	2MG	TABLET / ORAL	AB		1988-12-08	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A089685-003	PERPHENAZINE	4MG	TABLET / ORAL	AB		1988-12-08	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A089685-004	PERPHENAZINE	16MG	TABLET / ORAL	AB	RS	1988-12-08	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A089685-001	PERPHENAZINE	8MG	TABLET / ORAL	AB		1988-12-08	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A089685-002	PERPHENAZINE	2MG	TABLET / ORAL	AB		1988-12-08	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A089685-003	PERPHENAZINE	4MG	TABLET / ORAL	AB		1988-12-08	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A089685-004	PERPHENAZINE	16MG	TABLET / ORAL	AB	RS	1988-12-08	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A089685-001	PERPHENAZINE	8MG	TABLET / ORAL	AB		1988-12-08	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A089685-002	PERPHENAZINE	2MG	TABLET / ORAL	AB		1988-12-08	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A089685-003	PERPHENAZINE	4MG	TABLET / ORAL	AB		1988-12-08	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A089685-004	PERPHENAZINE	16MG	TABLET / ORAL	AB	RS	1988-12-08	`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	A089685-001	AB	1	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	A089685-002	AB	1	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	A089685-003	AB	1	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	A089685-004	AB	1	`84e616aacf4f…`
2026-08-18 06:07:40	2026-07	A089685-001	AB	1	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	A089685-002	AB	1	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	A089685-003	AB	1	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	A089685-004	AB	1	`caaa826d4ba7…`
2026-02-19 14:30 UTC	2026-02	A089685-001	AB	1	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A089685-002	AB	1	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A089685-003	AB	1	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A089685-004	AB	1	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A089685-001	AB	1	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A089685-002	AB	1	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A089685-003	AB	1	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A089685-004	AB	1	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A089685-001	AB	1	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A089685-002	AB	1	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A089685-003	AB	1	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A089685-004	AB	1	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A089685-001	AB	1	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A089685-002	AB	1	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A089685-003	AB	1	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A089685-004	AB	1	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A089685-001	AB	1	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A089685-002	AB	1	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A089685-003	AB	1	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A089685-004	AB	1	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A089685-001	AB	1	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A089685-002	AB	1	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A089685-003	AB	1	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A089685-004	AB	1	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A089685-001	AB	1	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A089685-002	AB	1	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A089685-003	AB	1	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A089685-004	AB	1	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A089685-001	AB	1	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A089685-002	AB	1	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A089685-003	AB	1	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A089685-004	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

Active Ingredients#

Ingredient, Strength table
Ingredient	Strength
PERPHENAZINE	8 mg/1

Harmonized UNII identifiers#

UNII identifiers page 1 of 1 · 1 matching rows.

Identifier, FDA.report destination table
Identifier	FDA.report destination
FTA7XXY4EZ	Internal UNII lookup

Harmonized RxCUI identifiers#

RxCUI identifiers page 1 of 1 · 4 matching rows.

Identifier, FDA.report destination table
Identifier	FDA.report destination
198075	Internal RxNorm lookup
198076	Internal RxNorm lookup
198077	Internal RxNorm lookup
198078	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
fc32500c-cc42-4f85-9cee-88f983fcbc16	Available on FDA.report

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

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDC	Effective	Action	Document	Indexing SPL	Related label
0781-8048-01	2020-08-18	C162847	48780-1	ab0e2407-32f8-f274-e053-dbdaa90a6471	Perphenazine Tablets, USP
0781-8048-01	2020-07-22	C162847	48780-1	ab0e2407-32f8-f274-e053-dbdaa90a6471	Perphenazine Tablets, USP

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDC	Product	Description	Form	Quantity	Strength	SPL version
0781-8048-01	Perphenazine	100 in 1 BOTTLE	TABLET, FILM COATED	100		4

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDC	Billing unit	Product NDC	DailyMed indexing SPL	SPL version	Effective
0781-8048-01	EA - Each	0781-8048	8214bf7a-eb9e-4b5c-8c09-4d2172b9befd	1	2020-04-20

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDC	Dashboard title	SPL version	Validation	Dashboard ZIP
0781-8048	PERPHENAZINE TABLET, FILM COATED [SANDOZ INC]	4	Current NDC, Legacy NDC, 1 package rows	20240322_fc32500c-cc42-4f85-9cee-88f983fcbc16.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 · 4 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
Perphenazine	PERPHENAZINE	REMEDYREPACK INC.	9588d223-41e4-4bb2-9306-f082498404c5	2026-07-21	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 089685 application number: ANDA089685
Perphenazine	PERPHENAZINE	REMEDYREPACK INC.	da5519cd-7b96-4468-910c-87dffdb1888e	2026-07-01	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 089685 application number: ANDA089685
Perphenazine	PERPHENAZINE	REMEDYREPACK INC.	fc903628-248c-4d12-88b4-a551aeadb4d2	2026-06-17	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 089685 application number: ANDA089685
Perphenazine	PERPHENAZINE	Sandoz Inc	fc32500c-cc42-4f85-9cee-88f983fcbc16	2024-03-25	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 089685 application number: ANDA089685 ndc (package): 0781-8048-01 ndc (product): 0781-8048 ndc11 (package): 00781804801

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
198075	perphenazine 16 MG Oral Tablet	PSN	fc32500c-cc42-4f85-9cee-88f983fcbc16	4
198076	perphenazine 2 MG Oral Tablet	PSN	fc32500c-cc42-4f85-9cee-88f983fcbc16	4
198077	perphenazine 4 MG Oral Tablet	PSN	fc32500c-cc42-4f85-9cee-88f983fcbc16	4
198078	perphenazine 8 MG Oral Tablet	PSN	fc32500c-cc42-4f85-9cee-88f983fcbc16	4
198075	perphenazine 16 MG Oral Tablet	SCD	fc32500c-cc42-4f85-9cee-88f983fcbc16	4
198076	perphenazine 2 MG Oral Tablet	SCD	fc32500c-cc42-4f85-9cee-88f983fcbc16	4
198077	perphenazine 4 MG Oral Tablet	SCD	fc32500c-cc42-4f85-9cee-88f983fcbc16	4
198078	perphenazine 8 MG Oral Tablet	SCD	fc32500c-cc42-4f85-9cee-88f983fcbc16	4

Packages#

Package NDC, 11-digit format, Description table
Package NDC	11-digit format	Description	Marketing start	Marketing end	Sample	Exclude flag	Status
0781-8048-01	00781804801	100 TABLET, FILM COATED in 1 BOTTLE (0781-8048-01)	2018-08-28	2027-03-21	No	No	Current

Title, Manufacturer, Effective date table
Title	Manufacturer	Effective date	Type	Version
Perphenazine Tablets, USP	REMEDYREPACK INC.	2026-06-17	HUMAN PRESCRIPTION DRUG LABEL	7
Perphenazine Tablets, USP	Sandoz Inc	2024-03-25	HUMAN PRESCRIPTION DRUG LABEL	4