Perphenazine

Product NDC
0781-1049
Requested package NDC
0781-1049-13
11-digit product format
007811049
Labeler code
0781
Product ID
0781-1049_e0965094-dfb3-4724-b04d-17e2b3754788
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
2021-12-31
Substance
PERPHENAZINE
Active strength
16 mg/1
Pharmacologic classes
Phenothiazine [EPC],Phenothiazines [CS]
NDC exclude flag
No
Listing certified through
0000-00-00
Current FDA listing
Historical FDA.report record

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
excluded packagepackage0781-10490781-1049-13DDiscontinued by firm2026-08-17

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 17:58 UTC · source 2025-12-05d630ba8d3edf…732f749b63fb…
2025-08-27 00:01 UTC · source 2025-08-26f5e01cc5f278…a2eaf40c39c3…
2025-04-01 02:39 UTC · source 2025-03-312ef7874e63bc…57b86245f4fa…
2025-03-28 20:22 UTC · source 2025-03-28a1b67e2a42f9…c4cf2c586c0d…
2025-03-22 03:12 UTC · source 2025-03-21cfe11265f3b6…090c488252e2…
2025-03-10 12:48 UTC · source 2025-03-10cdf11ea48f46…ba0047e9e063…
2025-02-02 03:52 UTC · source 2025-01-31302b2466d912…e7b80fea0513…
2025-01-20 13:05 UTC · source 2025-01-20ed331223b511…672a5bd82f5f…
2025-01-11 03:41 UTC · source 2025-01-100efc9e666f02…f202fb6c5f17…
2024-11-09 02:27 UTC · source 2024-11-08ad56d346431e…cc804d4bbf1e…
2024-10-04 04:10 UTC · source 2024-10-03367a005e9d99…383a685ebd0f…
2024-07-10 04:00 UTC · source 2024-07-09557ba5c1ecfa…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-productTrade nameIngredientStrengthDosage form / routeTE codesRLD / RSApproval date
A089685-001PERPHENAZINEPERPHENAZINE8MGTABLET / ORALAB1988-12-08
A089685-002PERPHENAZINEPERPHENAZINE2MGTABLET / ORALAB1988-12-08
A089685-003PERPHENAZINEPERPHENAZINE4MGTABLET / ORALAB1988-12-08
A089685-004PERPHENAZINEPERPHENAZINE16MGTABLET / ORALABRS1988-12-08

Therapeutic equivalence codes#

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

Application-product, TE code table
Application-productTE code
A089685-001AB
A089685-002AB
A089685-003AB
A089685-004AB

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 06:07:402026-07A089685-001PERPHENAZINE8MGTABLET / ORALAB1988-12-08caaa826d4ba7…
2026-08-18 06:07:402026-07A089685-002PERPHENAZINE2MGTABLET / ORALAB1988-12-08caaa826d4ba7…
2026-08-18 06:07:402026-07A089685-003PERPHENAZINE4MGTABLET / ORALAB1988-12-08caaa826d4ba7…
2026-08-18 06:07:402026-07A089685-004PERPHENAZINE16MGTABLET / ORALABRS1988-12-08caaa826d4ba7…
2026-02-19 14:30 UTC2026-02A089685-001PERPHENAZINE8MGTABLET / ORALAB1988-12-08011fe1cb6892…
2026-02-19 14:30 UTC2026-02A089685-002PERPHENAZINE2MGTABLET / ORALAB1988-12-08011fe1cb6892…
2026-02-19 14:30 UTC2026-02A089685-003PERPHENAZINE4MGTABLET / ORALAB1988-12-08011fe1cb6892…
2026-02-19 14:30 UTC2026-02A089685-004PERPHENAZINE16MGTABLET / ORALABRS1988-12-08011fe1cb6892…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A089685-001PERPHENAZINE8MGTABLET / ORALAB1988-12-0831067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A089685-002PERPHENAZINE2MGTABLET / ORALAB1988-12-0831067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A089685-003PERPHENAZINE4MGTABLET / ORALAB1988-12-0831067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A089685-004PERPHENAZINE16MGTABLET / ORALABRS1988-12-0831067a03dcf5…
2025-08-23 18:47 UTC2025-08A089685-001PERPHENAZINE8MGTABLET / ORALAB1988-12-086a471c1ec25d…
2025-08-23 18:47 UTC2025-08A089685-002PERPHENAZINE2MGTABLET / ORALAB1988-12-086a471c1ec25d…
2025-08-23 18:47 UTC2025-08A089685-003PERPHENAZINE4MGTABLET / ORALAB1988-12-086a471c1ec25d…
2025-08-23 18:47 UTC2025-08A089685-004PERPHENAZINE16MGTABLET / ORALABRS1988-12-086a471c1ec25d…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A089685-001PERPHENAZINE8MGTABLET / ORALAB1988-12-08fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A089685-002PERPHENAZINE2MGTABLET / ORALAB1988-12-08fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A089685-003PERPHENAZINE4MGTABLET / ORALAB1988-12-08fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A089685-004PERPHENAZINE16MGTABLET / ORALABRS1988-12-08fd3edfee7708…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A089685-001PERPHENAZINE8MGTABLET / ORALAB1988-12-08b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A089685-002PERPHENAZINE2MGTABLET / ORALAB1988-12-08b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A089685-003PERPHENAZINE4MGTABLET / ORALAB1988-12-08b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A089685-004PERPHENAZINE16MGTABLET / ORALABRS1988-12-08b8a1b40f171c…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A089685-001PERPHENAZINE8MGTABLET / ORALAB1988-12-0803ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A089685-002PERPHENAZINE2MGTABLET / ORALAB1988-12-0803ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A089685-003PERPHENAZINE4MGTABLET / ORALAB1988-12-0803ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A089685-004PERPHENAZINE16MGTABLET / ORALABRS1988-12-0803ed91905a0d…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A089685-001PERPHENAZINE8MGTABLET / ORALAB1988-12-082680178bc6a6…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A089685-002PERPHENAZINE2MGTABLET / ORALAB1988-12-082680178bc6a6…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A089685-003PERPHENAZINE4MGTABLET / ORALAB1988-12-082680178bc6a6…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A089685-004PERPHENAZINE16MGTABLET / ORALABRS1988-12-082680178bc6a6…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A089685-001PERPHENAZINE8MGTABLET / ORALAB1988-12-085bbf6a4d5a75…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A089685-002PERPHENAZINE2MGTABLET / ORALAB1988-12-085bbf6a4d5a75…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A089685-003PERPHENAZINE4MGTABLET / ORALAB1988-12-085bbf6a4d5a75…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A089685-004PERPHENAZINE16MGTABLET / ORALABRS1988-12-085bbf6a4d5a75…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A089685-001PERPHENAZINE8MGTABLET / ORALAB1988-12-08d8e5a09893c0…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A089685-002PERPHENAZINE2MGTABLET / ORALAB1988-12-08d8e5a09893c0…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A089685-003PERPHENAZINE4MGTABLET / ORALAB1988-12-08d8e5a09893c0…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A089685-004PERPHENAZINE16MGTABLET / ORALABRS1988-12-08d8e5a09893c0…

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 06:07:402026-07A089685-001AB1caaa826d4ba7…
2026-08-18 06:07:402026-07A089685-002AB1caaa826d4ba7…
2026-08-18 06:07:402026-07A089685-003AB1caaa826d4ba7…
2026-08-18 06:07:402026-07A089685-004AB1caaa826d4ba7…
2026-02-19 14:30 UTC2026-02A089685-001AB1011fe1cb6892…
2026-02-19 14:30 UTC2026-02A089685-002AB1011fe1cb6892…
2026-02-19 14:30 UTC2026-02A089685-003AB1011fe1cb6892…
2026-02-19 14:30 UTC2026-02A089685-004AB1011fe1cb6892…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A089685-001AB131067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A089685-002AB131067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A089685-003AB131067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A089685-004AB131067a03dcf5…
2025-08-23 18:47 UTC2025-08A089685-001AB16a471c1ec25d…
2025-08-23 18:47 UTC2025-08A089685-002AB16a471c1ec25d…
2025-08-23 18:47 UTC2025-08A089685-003AB16a471c1ec25d…
2025-08-23 18:47 UTC2025-08A089685-004AB16a471c1ec25d…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A089685-001AB1fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A089685-002AB1fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A089685-003AB1fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A089685-004AB1fd3edfee7708…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A089685-001AB1b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A089685-002AB1b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A089685-003AB1b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A089685-004AB1b8a1b40f171c…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A089685-001AB103ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A089685-002AB103ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A089685-003AB103ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A089685-004AB103ed91905a0d…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A089685-001AB12680178bc6a6…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A089685-002AB12680178bc6a6…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A089685-003AB12680178bc6a6…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A089685-004AB12680178bc6a6…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A089685-001AB15bbf6a4d5a75…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A089685-002AB15bbf6a4d5a75…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A089685-003AB15bbf6a4d5a75…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A089685-004AB15bbf6a4d5a75…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A089685-001AB1d8e5a09893c0…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A089685-002AB1d8e5a09893c0…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A089685-003AB1d8e5a09893c0…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A089685-004AB1d8e5a09893c0…

DailyMed Product Concepts#

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

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
0781-1049-01EA - Each0781-10495e76d3f2-eaff-45d3-b532-3dae88843dfa12012-07-24

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIIDailyMed labelSPL versionUploaded
PERPHENAZINEACTIVE INGREDIENTFTA7XXY4EZPERPHENAZINE TABLET, FILM COATED [SANDOZ INC]12
PERPHENAZINEACTIVE MOIETYFTA7XXY4EZPERPHENAZINE TABLET, FILM COATED [SANDOZ INC]12
CELLULOSE, MICROCRYSTALLINEINACTIVE INGREDIENTOP1R32D61UPERPHENAZINE TABLET, FILM COATED [SANDOZ INC]12
HYDROXYPROPYL CELLULOSE (TYPE H)INACTIVE INGREDIENTRFW2ET671PPERPHENAZINE TABLET, FILM COATED [SANDOZ INC]12
HYPROMELLOSE 2910 (3 MPA.S)INACTIVE INGREDIENT0VUT3PMY82PERPHENAZINE TABLET, FILM COATED [SANDOZ INC]12
HYPROMELLOSESINACTIVE INGREDIENT3NXW29V3WOPERPHENAZINE TABLET, FILM COATED [SANDOZ INC]12
LACTOSE MONOHYDRATEINACTIVE INGREDIENTEWQ57Q8I5XPERPHENAZINE TABLET, FILM COATED [SANDOZ INC]12
MAGNESIUM STEARATEINACTIVE INGREDIENT70097M6I30PERPHENAZINE TABLET, FILM COATED [SANDOZ INC]12
POLYETHYLENE GLYCOLSINACTIVE INGREDIENT3WJQ0SDW1APERPHENAZINE TABLET, FILM COATED [SANDOZ INC]12
POLYSORBATE 80INACTIVE INGREDIENT6OZP39ZG8HPERPHENAZINE TABLET, FILM COATED [SANDOZ INC]12
STARCH, CORNINACTIVE INGREDIENTO8232NY3SJPERPHENAZINE TABLET, FILM COATED [SANDOZ INC]12
TITANIUM DIOXIDEINACTIVE INGREDIENT15FIX9V2JPPERPHENAZINE TABLET, FILM COATED [SANDOZ INC]12
PERPHENAZINEACTIVE INGREDIENTFTA7XXY4EZPERPHENAZINE TABLET, FILM COATED [STATE OF FLORIDA DOH CENTRAL PHARMACY]2
PERPHENAZINEACTIVE MOIETYFTA7XXY4EZPERPHENAZINE TABLET, FILM COATED [STATE OF FLORIDA DOH CENTRAL PHARMACY]2
CELLULOSE, MICROCRYSTALLINEINACTIVE INGREDIENTOP1R32D61UPERPHENAZINE TABLET, FILM COATED [STATE OF FLORIDA DOH CENTRAL PHARMACY]2
HYDROXYPROPYL CELLULOSEINACTIVE INGREDIENTRFW2ET671PPERPHENAZINE TABLET, FILM COATED [STATE OF FLORIDA DOH CENTRAL PHARMACY]2
HYPROMELLOSEINACTIVE INGREDIENT3NXW29V3WOPERPHENAZINE TABLET, FILM COATED [STATE OF FLORIDA DOH CENTRAL PHARMACY]2
LACTOSE MONOHYDRATEINACTIVE INGREDIENTEWQ57Q8I5XPERPHENAZINE TABLET, FILM COATED [STATE OF FLORIDA DOH CENTRAL PHARMACY]2
MAGNESIUM STEARATEINACTIVE INGREDIENT70097M6I30PERPHENAZINE TABLET, FILM COATED [STATE OF FLORIDA DOH CENTRAL PHARMACY]2
POLYETHYLENE GLYCOLINACTIVE INGREDIENT3WJQ0SDW1APERPHENAZINE TABLET, FILM COATED [STATE OF FLORIDA DOH CENTRAL PHARMACY]2
POLYSORBATE 80INACTIVE INGREDIENT6OZP39ZG8HPERPHENAZINE TABLET, FILM COATED [STATE OF FLORIDA DOH CENTRAL PHARMACY]2
STARCH, CORNINACTIVE INGREDIENTO8232NY3SJPERPHENAZINE TABLET, FILM COATED [STATE OF FLORIDA DOH CENTRAL PHARMACY]2
TITANIUM DIOXIDEINACTIVE INGREDIENT15FIX9V2JPPERPHENAZINE TABLET, FILM COATED [STATE OF FLORIDA DOH CENTRAL PHARMACY]2

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
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
PerphenazinePERPHENAZINEREMEDYREPACK INC.9588d223-41e4-4bb2-9306-f082498404c52026-07-21Boxed warning, Warnings, Adverse reactionsExact identifier
application applno (ANDA): 089685
application number: ANDA089685
PerphenazinePERPHENAZINEREMEDYREPACK INC.da5519cd-7b96-4468-910c-87dffdb1888e2026-07-01Boxed warning, Warnings, Adverse reactionsExact identifier
application applno (ANDA): 089685
application number: ANDA089685
PerphenazinePERPHENAZINEREMEDYREPACK INC.fc903628-248c-4d12-88b4-a551aeadb4d22026-06-17Boxed warning, Warnings, Adverse reactionsExact identifier
application applno (ANDA): 089685
application number: ANDA089685
PerphenazinePERPHENAZINESandoz Incfc32500c-cc42-4f85-9cee-88f983fcbc162024-03-25Boxed warning, Warnings, Adverse reactionsExact identifier
application applno (ANDA): 089685
application number: ANDA089685

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
198075perphenazine 16 MG Oral TabletPSNca1b6a78-739b-4e2a-9332-145c887fb2ff2
198076perphenazine 2 MG Oral TabletPSNca1b6a78-739b-4e2a-9332-145c887fb2ff2
198077perphenazine 4 MG Oral TabletPSNca1b6a78-739b-4e2a-9332-145c887fb2ff2
198078perphenazine 8 MG Oral TabletPSNca1b6a78-739b-4e2a-9332-145c887fb2ff2
198075perphenazine 16 MG Oral TabletSCDca1b6a78-739b-4e2a-9332-145c887fb2ff2
198076perphenazine 2 MG Oral TabletSCDca1b6a78-739b-4e2a-9332-145c887fb2ff2
198077perphenazine 4 MG Oral TabletSCDca1b6a78-739b-4e2a-9332-145c887fb2ff2
198078perphenazine 8 MG Oral TabletSCDca1b6a78-739b-4e2a-9332-145c887fb2ff2

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
0781-1049-130078110491310 BLISTER PACK in 1 CARTON (0781-1049-13) > 10 TABLET, FILM COATED in 1 BLISTER PACK10 blister pack1988-12-082021-12-31NoNoCurrent