Perphenazine

Product NDC
0591-4102
Requested package NDC
0591-4102-77
11-digit product format
005914102
Labeler code
0591
Product ID
0591-4102_ac53b4c3-a05c-4ffc-a9ee-82bc1664fbc2
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Perphenazine
Dosage form
TABLET, FILM COATED
Route
ORAL
Labeler
Actavis Pharma, Inc.
Application
ANDA207582
Marketing category
ANDA
Marketing start
2017-05-30
Substance
PERPHENAZINE
Active strength
4 mg/1
Pharmacologic classes
Phenothiazine [EPC], Phenothiazines [CS]
NDC exclude flag
No
Listing certified through
2026-12-31
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
DatasetScopeProduct NDCPackage NDCCodeStatusReporting periodSource date
unfinished packagepackage0591-41020591-4102-77UNFINISHEDActive or certified unfinished drug listing2026-08-17

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 dateSnapshotSource SHA-256
2025-12-14 21:27 UTC · source 2025-12-05a6255e0c9aa5…a0211a219f2e…
2025-08-26 23:59 UTC · source 2025-08-261d862106b807…00c93037cd84…
2025-05-15 14:59 UTC · source 2025-05-14390b4c401c3f…2c692c2daee3…
2025-04-01 07:37 UTC · source 2025-03-31e30019b0c005…a3f0b14938b7…
2025-03-01 13:19 UTC · source 2025-02-28bbbc9f937eca…946b9c97cf81…
2025-02-27 05:24 UTC · source 2025-02-26f268b84574a6…26285f5ac5df…
2025-02-01 13:13 UTC · source 2025-01-31f764e8902f78…92046438deef…
2025-01-20 13:05 UTC · source 2025-01-1768b1e3bced9e…98a755eb8bc6…
2024-11-29 20:42 UTC · source 2024-11-2905c55d027831…ca05dca9dc4c…
2024-11-09 02:36 UTC · source 2024-11-0848b4f40e6753…c7c7a00d2afa…
2024-10-09 02:27 UTC · source 2024-10-0827f29a85d7e4…1372111e901f…
2024-07-10 04:00 UTC · source 2024-07-098d62ce987f31…9fe9ef23e30d…

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-productTrade nameIngredientStrengthDosage form / routeTE codesRLD / RSApproval date
A207582-001PERPHENAZINEPERPHENAZINE2MGTABLET / ORALAB2016-10-17
A207582-002PERPHENAZINEPERPHENAZINE4MGTABLET / ORALAB2016-10-17
A207582-003PERPHENAZINEPERPHENAZINE8MGTABLET / ORALAB2016-10-17
A207582-004PERPHENAZINEPERPHENAZINE16MGTABLET / ORALAB2016-10-17

Therapeutic equivalence codes#

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

Application-product, TE code table
Application-productTE code
A207582-001AB
A207582-002AB
A207582-003AB
A207582-004AB

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
CapturedEditionApplication-productTrade nameStrengthDosage form / routeProduct TE source textRLD / RSApproval dateSource SHA-256
2026-08-18 06:07:402026-07A207582-001PERPHENAZINE2MGTABLET / ORALAB2016-10-17caaa826d4ba7…
2026-08-18 06:07:402026-07A207582-002PERPHENAZINE4MGTABLET / ORALAB2016-10-17caaa826d4ba7…
2026-08-18 06:07:402026-07A207582-003PERPHENAZINE8MGTABLET / ORALAB2016-10-17caaa826d4ba7…
2026-08-18 06:07:402026-07A207582-004PERPHENAZINE16MGTABLET / ORALAB2016-10-17caaa826d4ba7…
2026-02-19 14:30 UTC2026-02A207582-001PERPHENAZINE2MGTABLET / ORALAB2016-10-17011fe1cb6892…
2026-02-19 14:30 UTC2026-02A207582-002PERPHENAZINE4MGTABLET / ORALAB2016-10-17011fe1cb6892…
2026-02-19 14:30 UTC2026-02A207582-003PERPHENAZINE8MGTABLET / ORALAB2016-10-17011fe1cb6892…
2026-02-19 14:30 UTC2026-02A207582-004PERPHENAZINE16MGTABLET / ORALAB2016-10-17011fe1cb6892…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A207582-001PERPHENAZINE2MGTABLET / ORALAB2016-10-1731067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A207582-002PERPHENAZINE4MGTABLET / ORALAB2016-10-1731067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A207582-003PERPHENAZINE8MGTABLET / ORALAB2016-10-1731067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A207582-004PERPHENAZINE16MGTABLET / ORALAB2016-10-1731067a03dcf5…
2025-08-23 18:47 UTC2025-08A207582-001PERPHENAZINE2MGTABLET / ORALAB2016-10-176a471c1ec25d…
2025-08-23 18:47 UTC2025-08A207582-002PERPHENAZINE4MGTABLET / ORALAB2016-10-176a471c1ec25d…
2025-08-23 18:47 UTC2025-08A207582-003PERPHENAZINE8MGTABLET / ORALAB2016-10-176a471c1ec25d…
2025-08-23 18:47 UTC2025-08A207582-004PERPHENAZINE16MGTABLET / ORALAB2016-10-176a471c1ec25d…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A207582-001PERPHENAZINE2MGTABLET / ORALAB2016-10-17fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A207582-002PERPHENAZINE4MGTABLET / ORALAB2016-10-17fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A207582-003PERPHENAZINE8MGTABLET / ORALAB2016-10-17fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A207582-004PERPHENAZINE16MGTABLET / ORALAB2016-10-17fd3edfee7708…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A207582-001PERPHENAZINE2MGTABLET / ORALAB2016-10-17b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A207582-002PERPHENAZINE4MGTABLET / ORALAB2016-10-17b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A207582-003PERPHENAZINE8MGTABLET / ORALAB2016-10-17b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A207582-004PERPHENAZINE16MGTABLET / ORALAB2016-10-17b8a1b40f171c…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A207582-001PERPHENAZINE2MGTABLET / ORALAB2016-10-1703ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A207582-002PERPHENAZINE4MGTABLET / ORALAB2016-10-1703ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A207582-003PERPHENAZINE8MGTABLET / ORALAB2016-10-1703ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A207582-004PERPHENAZINE16MGTABLET / ORALAB2016-10-1703ed91905a0d…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A207582-001PERPHENAZINE2MGTABLET / ORALAB2016-10-172680178bc6a6…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A207582-002PERPHENAZINE4MGTABLET / ORALAB2016-10-172680178bc6a6…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A207582-003PERPHENAZINE8MGTABLET / ORALAB2016-10-172680178bc6a6…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A207582-004PERPHENAZINE16MGTABLET / ORALAB2016-10-172680178bc6a6…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A207582-001PERPHENAZINE2MGTABLET / ORALAB2016-10-175bbf6a4d5a75…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A207582-002PERPHENAZINE4MGTABLET / ORALAB2016-10-175bbf6a4d5a75…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A207582-003PERPHENAZINE8MGTABLET / ORALAB2016-10-175bbf6a4d5a75…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A207582-004PERPHENAZINE16MGTABLET / ORALAB2016-10-175bbf6a4d5a75…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A207582-001PERPHENAZINE2MGTABLET / ORALAB2016-10-17d8e5a09893c0…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A207582-002PERPHENAZINE4MGTABLET / ORALAB2016-10-17d8e5a09893c0…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A207582-003PERPHENAZINE8MGTABLET / ORALAB2016-10-17d8e5a09893c0…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A207582-004PERPHENAZINE16MGTABLET / ORALAB2016-10-17d8e5a09893c0…

Observed Orange Book normalized TE history#

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

Captured, Edition, Application-product table
CapturedEditionApplication-productTE codeOrderSource SHA-256
2026-08-18 06:07:402026-07A207582-001AB1caaa826d4ba7…
2026-08-18 06:07:402026-07A207582-002AB1caaa826d4ba7…
2026-08-18 06:07:402026-07A207582-003AB1caaa826d4ba7…
2026-08-18 06:07:402026-07A207582-004AB1caaa826d4ba7…
2026-02-19 14:30 UTC2026-02A207582-001AB1011fe1cb6892…
2026-02-19 14:30 UTC2026-02A207582-002AB1011fe1cb6892…
2026-02-19 14:30 UTC2026-02A207582-003AB1011fe1cb6892…
2026-02-19 14:30 UTC2026-02A207582-004AB1011fe1cb6892…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A207582-001AB131067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A207582-002AB131067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A207582-003AB131067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A207582-004AB131067a03dcf5…
2025-08-23 18:47 UTC2025-08A207582-001AB16a471c1ec25d…
2025-08-23 18:47 UTC2025-08A207582-002AB16a471c1ec25d…
2025-08-23 18:47 UTC2025-08A207582-003AB16a471c1ec25d…
2025-08-23 18:47 UTC2025-08A207582-004AB16a471c1ec25d…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A207582-001AB1fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A207582-002AB1fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A207582-003AB1fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A207582-004AB1fd3edfee7708…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A207582-001AB1b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A207582-002AB1b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A207582-003AB1b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A207582-004AB1b8a1b40f171c…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A207582-001AB103ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A207582-002AB103ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A207582-003AB103ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A207582-004AB103ed91905a0d…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A207582-001AB12680178bc6a6…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A207582-002AB12680178bc6a6…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A207582-003AB12680178bc6a6…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A207582-004AB12680178bc6a6…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A207582-001AB15bbf6a4d5a75…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A207582-002AB15bbf6a4d5a75…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A207582-003AB15bbf6a4d5a75…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A207582-004AB15bbf6a4d5a75…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A207582-001AB1d8e5a09893c0…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A207582-002AB1d8e5a09893c0…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A207582-003AB1d8e5a09893c0…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A207582-004AB1d8e5a09893c0…

Additional Listing Data#

Finished product
Yes
Brand name base
Perphenazine
Listing expiration
2026-12-31

Active Ingredients#

Ingredient, Strength table
IngredientStrength
PERPHENAZINE4 mg/1

Harmonized UNII identifiers#

UNII identifiers page 1 of 1 · 1 matching rows.

Identifier, FDA.report destination table
IdentifierFDA.report destination
FTA7XXY4EZInternal UNII lookup

Harmonized RxCUI identifiers#

RxCUI identifiers page 1 of 1 · 4 matching rows.

Identifier, FDA.report destination table
IdentifierFDA.report destination
198075Internal RxNorm lookup
198076Internal RxNorm lookup
198077Internal RxNorm lookup
198078Internal RxNorm lookup

Harmonized SPL set identifiers#

SPL set identifiers page 1 of 1 · 1 matching rows.

Identifier, FDA.report destination table
IdentifierFDA.report destination
bb1a3d20-1f93-48a1-9e27-4712a8561757Available on FDA.report

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
16c7ce1f-d1cb-56cf-bc49-4eaa8b55e0a1Product name920260106
aa9828b2-adf8-0dd3-9f6c-b68f39e467c1Product name120140508

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
0591-4102-01Perphenazine100 in 1 BOTTLETABLET, FILM COATED10013

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
0591-4102-01EA - Each0591-41027c0c8131-855e-4a5c-a5c9-5ca88af3872e12017-07-07

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
0591-4102PERPHENAZINE TABLET, FILM COATED [ACTAVIS PHARMA, INC.]13Current NDC, Legacy NDC, 1 package rows20250507_bb1a3d20-1f93-48a1-9e27-4712a8561757.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
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
PerphenazinePERPHENAZINEActavis Pharma, Inc.bb1a3d20-1f93-48a1-9e27-4712a85617572025-03-31Boxed warning, Warnings, Adverse reactionsExact identifier
application applno (ANDA): 207582
application number: ANDA207582
ndc (product): 0591-4102

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
198075perphenazine 16 MG Oral TabletPSNbb1a3d20-1f93-48a1-9e27-4712a856175713
198076perphenazine 2 MG Oral TabletPSNbb1a3d20-1f93-48a1-9e27-4712a856175713
198077perphenazine 4 MG Oral TabletPSNbb1a3d20-1f93-48a1-9e27-4712a856175713
198078perphenazine 8 MG Oral TabletPSNbb1a3d20-1f93-48a1-9e27-4712a856175713
198075perphenazine 16 MG Oral TabletSCDbb1a3d20-1f93-48a1-9e27-4712a856175713
198076perphenazine 2 MG Oral TabletSCDbb1a3d20-1f93-48a1-9e27-4712a856175713
198077perphenazine 4 MG Oral TabletSCDbb1a3d20-1f93-48a1-9e27-4712a856175713
198078perphenazine 8 MG Oral TabletSCDbb1a3d20-1f93-48a1-9e27-4712a856175713

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionMarketing startStatus
0591-4102-770059141027772816 TABLET, FILM COATED in 1 CONTAINER (0591-4102-77)04-JUL-24Current