Perphenazine

Product NDC: 70518-1109
11-digit product format: 705181109
Labeler code: 70518
Product ID: 70518-1109_485a1434-53e1-abcf-e063-6294a90a9a74
Type: HUMAN PRESCRIPTION DRUG
Nonproprietary name: Perphenazine
Dosage form: TABLET, FILM COATED
Route: ORAL
Labeler: REMEDYREPACK INC.
Application: ANDA205973
Marketing category: ANDA
Marketing start: 2018-04-11
Substance: PERPHENAZINE
Active strength: 16 mg/1
Pharmacologic classes: Phenothiazine [EPC], Phenothiazines [CS]
NDC exclude flag: No
Listing certified through: 2027-12-31
Current FDA listing: Yes

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 · 1 matching rows.

Dataset, Scope, Product NDC table
Dataset	Scope	Product NDC	Package NDC	Code	Status	Reporting period	Source date
excluded package	package	70518-1109	70518-1109-1	D	Discontinued by firm		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 · 12 matching rows.

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

Captured / source date, Snapshot, Source SHA-256 table
Captured / source date	Snapshot	Source SHA-256
2025-12-14 17:58 UTC · source 2025-12-05	`d630ba8d3edf…`	`732f749b63fb…`
2025-08-27 00:01 UTC · source 2025-08-26	`f5e01cc5f278…`	`a2eaf40c39c3…`
2025-04-01 02:39 UTC · source 2025-03-31	`2ef7874e63bc…`	`57b86245f4fa…`
2025-03-28 20:22 UTC · source 2025-03-28	`a1b67e2a42f9…`	`c4cf2c586c0d…`
2025-03-22 03:12 UTC · source 2025-03-21	`cfe11265f3b6…`	`090c488252e2…`
2025-03-10 12:48 UTC · source 2025-03-10	`cdf11ea48f46…`	`ba0047e9e063…`
2025-02-02 03:52 UTC · source 2025-01-31	`302b2466d912…`	`e7b80fea0513…`
2025-01-20 13:05 UTC · source 2025-01-20	`ed331223b511…`	`672a5bd82f5f…`
2025-01-11 03:41 UTC · source 2025-01-10	`0efc9e666f02…`	`f202fb6c5f17…`
2024-11-09 02:27 UTC · source 2024-11-08	`ad56d346431e…`	`cc804d4bbf1e…`
2024-10-04 04:10 UTC · source 2024-10-03	`367a005e9d99…`	`383a685ebd0f…`
2024-07-10 04:00 UTC · source 2024-07-09	`557ba5c1ecfa…`	`9c80585c8c6e…`

Source provenance: Browse the complete Orange Book source catalog · source snapshot 42.

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
A205973-001	PERPHENAZINE	PERPHENAZINE	2MG	TABLET / ORAL	AB	2015-12-17
A205973-002	PERPHENAZINE	PERPHENAZINE	4MG	TABLET / ORAL	AB	2015-12-17
A205973-003	PERPHENAZINE	PERPHENAZINE	8MG	TABLET / ORAL	AB	2015-12-17
A205973-004	PERPHENAZINE	PERPHENAZINE	16MG	TABLET / ORAL	AB	2015-12-17

Therapeutic equivalence codes#

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

Application-product, TE code table
Application-product	TE code
A205973-001	AB
A205973-002	AB
A205973-003	AB
A205973-004	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 · 168 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
2026-08-18 06:07:40	2026-07	A205973-001	PERPHENAZINE	2MG	TABLET / ORAL	AB	2015-12-17	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	A205973-002	PERPHENAZINE	4MG	TABLET / ORAL	AB	2015-12-17	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	A205973-003	PERPHENAZINE	8MG	TABLET / ORAL	AB	2015-12-17	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	A205973-004	PERPHENAZINE	16MG	TABLET / ORAL	AB	2015-12-17	`caaa826d4ba7…`
2026-02-19 14:30 UTC	2026-02	A205973-001	PERPHENAZINE	2MG	TABLET / ORAL	AB	2015-12-17	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A205973-002	PERPHENAZINE	4MG	TABLET / ORAL	AB	2015-12-17	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A205973-003	PERPHENAZINE	8MG	TABLET / ORAL	AB	2015-12-17	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A205973-004	PERPHENAZINE	16MG	TABLET / ORAL	AB	2015-12-17	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A205973-001	PERPHENAZINE	2MG	TABLET / ORAL	AB	2015-12-17	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A205973-002	PERPHENAZINE	4MG	TABLET / ORAL	AB	2015-12-17	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A205973-003	PERPHENAZINE	8MG	TABLET / ORAL	AB	2015-12-17	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A205973-004	PERPHENAZINE	16MG	TABLET / ORAL	AB	2015-12-17	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A205973-001	PERPHENAZINE	2MG	TABLET / ORAL	AB	2015-12-17	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A205973-002	PERPHENAZINE	4MG	TABLET / ORAL	AB	2015-12-17	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A205973-003	PERPHENAZINE	8MG	TABLET / ORAL	AB	2015-12-17	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A205973-004	PERPHENAZINE	16MG	TABLET / ORAL	AB	2015-12-17	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A205973-001	PERPHENAZINE	2MG	TABLET / ORAL	AB	2015-12-17	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A205973-002	PERPHENAZINE	4MG	TABLET / ORAL	AB	2015-12-17	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A205973-003	PERPHENAZINE	8MG	TABLET / ORAL	AB	2015-12-17	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A205973-004	PERPHENAZINE	16MG	TABLET / ORAL	AB	2015-12-17	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A205973-001	PERPHENAZINE	2MG	TABLET / ORAL	AB	2015-12-17	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A205973-002	PERPHENAZINE	4MG	TABLET / ORAL	AB	2015-12-17	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A205973-003	PERPHENAZINE	8MG	TABLET / ORAL	AB	2015-12-17	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A205973-004	PERPHENAZINE	16MG	TABLET / ORAL	AB	2015-12-17	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A205973-001	PERPHENAZINE	2MG	TABLET / ORAL	AB	2015-12-17	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A205973-002	PERPHENAZINE	4MG	TABLET / ORAL	AB	2015-12-17	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A205973-003	PERPHENAZINE	8MG	TABLET / ORAL	AB	2015-12-17	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A205973-004	PERPHENAZINE	16MG	TABLET / ORAL	AB	2015-12-17	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A205973-001	PERPHENAZINE	2MG	TABLET / ORAL	AB	2015-12-17	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A205973-002	PERPHENAZINE	4MG	TABLET / ORAL	AB	2015-12-17	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A205973-003	PERPHENAZINE	8MG	TABLET / ORAL	AB	2015-12-17	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A205973-004	PERPHENAZINE	16MG	TABLET / ORAL	AB	2015-12-17	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A205973-001	PERPHENAZINE	2MG	TABLET / ORAL	AB	2015-12-17	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A205973-002	PERPHENAZINE	4MG	TABLET / ORAL	AB	2015-12-17	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A205973-003	PERPHENAZINE	8MG	TABLET / ORAL	AB	2015-12-17	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A205973-004	PERPHENAZINE	16MG	TABLET / ORAL	AB	2015-12-17	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A205973-001	PERPHENAZINE	2MG	TABLET / ORAL	AB	2015-12-17	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A205973-002	PERPHENAZINE	4MG	TABLET / ORAL	AB	2015-12-17	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A205973-003	PERPHENAZINE	8MG	TABLET / ORAL	AB	2015-12-17	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A205973-004	PERPHENAZINE	16MG	TABLET / ORAL	AB	2015-12-17	`d8e5a09893c0…`

Observed Orange Book normalized TE history#

Normalized TE history page 1 of 5 · 168 observed states.

Captured, Edition, Application-product table
Captured	Edition	Application-product	TE code	Order	Source SHA-256
2026-08-18 06:07:40	2026-07	A205973-001	AB	1	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	A205973-002	AB	1	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	A205973-003	AB	1	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	A205973-004	AB	1	`caaa826d4ba7…`
2026-02-19 14:30 UTC	2026-02	A205973-001	AB	1	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A205973-002	AB	1	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A205973-003	AB	1	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A205973-004	AB	1	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A205973-001	AB	1	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A205973-002	AB	1	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A205973-003	AB	1	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A205973-004	AB	1	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A205973-001	AB	1	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A205973-002	AB	1	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A205973-003	AB	1	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A205973-004	AB	1	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A205973-001	AB	1	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A205973-002	AB	1	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A205973-003	AB	1	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A205973-004	AB	1	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A205973-001	AB	1	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A205973-002	AB	1	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A205973-003	AB	1	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A205973-004	AB	1	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A205973-001	AB	1	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A205973-002	AB	1	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A205973-003	AB	1	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A205973-004	AB	1	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A205973-001	AB	1	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A205973-002	AB	1	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A205973-003	AB	1	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A205973-004	AB	1	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A205973-001	AB	1	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A205973-002	AB	1	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A205973-003	AB	1	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A205973-004	AB	1	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A205973-001	AB	1	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A205973-002	AB	1	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A205973-003	AB	1	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A205973-004	AB	1	`d8e5a09893c0…`

Additional Listing Data#

Finished product: Yes
Brand name base: Perphenazine
Listing expiration: 2027-12-31

Active Ingredients#

Ingredient, Strength table
Ingredient	Strength
PERPHENAZINE	16 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 · 1 matching rows.

Identifier, FDA.report destination table
Identifier	FDA.report destination
198075	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
cf41a02d-c881-4b40-b99c-d5b79dbd645b	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

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDC	Product	Description	Form	Quantity	SPL version
70518-1109-0	Perphenazine	30 in 1 BLISTER PACK	TABLET, FILM COATED	30	13
70518-1109-1	Perphenazine	100 in 1 BOX	TABLET, FILM COATED	100	13
70518-1109-2	Perphenazine	1 in 1 POUCH	TABLET, FILM COATED	1	13

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDC	Dashboard title	SPL version	Validation	Dashboard ZIP
70518-1109	PERPHENAZINE TABLET, FILM COATED [REMEDYREPACK INC.]	11	Current NDC, Legacy NDC, 3 package rows	20250507_cf41a02d-c881-4b40-b99c-d5b79dbd645b.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 · 9 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
Perphenazine	PERPHENAZINE	REMEDYREPACK INC.	cf41a02d-c881-4b40-b99c-d5b79dbd645b	2026-07-02	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 205973 application number: ANDA205973 ndc (product): 70518-1109
Perphenazine	PERPHENAZINE	REMEDYREPACK INC.	1a216d3f-12b0-44c2-b7d3-109fee45978d	2026-01-14	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 205973 application number: ANDA205973
Perphenazine	PERPHENAZINE	REMEDYREPACK INC.	8028ab47-a6de-4924-a4cd-9336fa90dd90	2026-01-14	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 205973 application number: ANDA205973
Perphenazine	PERPHENAZINE	Bryant Ranch Prepack	aaa1127a-393d-454a-b68a-b1f206117f3b	2025-10-28	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 205973 application number: ANDA205973
Perphenazine	PERPHENAZINE	Bryant Ranch Prepack	f6af1fc3-868d-46f3-8bbe-828375fb0fae	2025-04-30	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 205973 application number: ANDA205973
Perphenazine	PERPHENAZINE	Bryant Ranch Prepack	e2e52bd9-b9c2-4f04-af03-bdb54b48c16c	2025-04-30	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 205973 application number: ANDA205973
Perphenazine	PERPHENAZINE	Bryant Ranch Prepack	afaea32d-0dc1-4dcb-9ee2-dd2937ec030e	2025-04-30	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 205973 application number: ANDA205973
Perphenazine	PERPHENAZINE	Bryant Ranch Prepack	41758282-6848-4a47-bbf3-89edc270f7b3	2025-04-30	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 205973 application number: ANDA205973
Perphenazine	PERPHENAZINE	Wilshire Pharmaceuticals, Inc.	5e455842-4892-4795-8c9b-4109a8f30783	2024-11-01	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 205973 application number: ANDA205973

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	cf41a02d-c881-4b40-b99c-d5b79dbd645b	13
198075	perphenazine 16 MG Oral Tablet	SCD	cf41a02d-c881-4b40-b99c-d5b79dbd645b	13

Packages#

Package NDC, 11-digit format, Description table
Package NDC	11-digit format	Description	Units	Marketing start	Marketing end	Sample	Exclude flag	Status
70518-1109-0	70518110900	30 TABLET, FILM COATED in 1 BLISTER PACK (70518-1109-0)		2018-04-11	0000-00-00	No	No	Current
70518-1109-1	70518110901	100 POUCH in 1 BOX (70518-1109-1) > 1 TABLET, FILM COATED in 1 POUCH (70518-1109-2)	100 pouch	2020-03-08	0000-00-00	No	No	Current
70518-1109-2	70518110902	1 in 1 POUCH						Historical