Perphenazine

Product NDC
70518-4484
11-digit product format
705184484
Labeler code
70518
Product ID
70518-4484_5139b72c-036a-351d-e063-6394a90a7d40
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Perphenazine
Dosage form
TABLET
Route
ORAL
Labeler
REMEDYREPACK INC.
Application
ANDA212545
Marketing category
ANDA
Marketing start
2025-09-24
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

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
A212545-001PERPHENAZINEPERPHENAZINE2MGTABLET / ORALAB2024-05-06
A212545-002PERPHENAZINEPERPHENAZINE4MGTABLET / ORALAB2024-05-06
A212545-003PERPHENAZINEPERPHENAZINE8MGTABLET / ORALAB2024-05-06
A212545-004PERPHENAZINEPERPHENAZINE16MGTABLET / ORALAB2024-05-06

Therapeutic equivalence codes#

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

Application-product, TE code table
Application-productTE code
A212545-001AB
A212545-002AB
A212545-003AB
A212545-004AB

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 2 · 64 observed states.

Captured, Edition, Application-product table
CapturedEditionApplication-productTrade nameStrengthDosage form / routeProduct TE source textRLD / RSApproval dateSource SHA-256
2026-08-18 06:07:402026-07A212545-001PERPHENAZINE2MGTABLET / ORALAB2024-05-06caaa826d4ba7…
2026-08-18 06:07:402026-07A212545-002PERPHENAZINE4MGTABLET / ORALAB2024-05-06caaa826d4ba7…
2026-08-18 06:07:402026-07A212545-003PERPHENAZINE8MGTABLET / ORALAB2024-05-06caaa826d4ba7…
2026-08-18 06:07:402026-07A212545-004PERPHENAZINE16MGTABLET / ORALAB2024-05-06caaa826d4ba7…
2026-02-19 14:30 UTC2026-02A212545-001PERPHENAZINE2MGTABLET / ORALAB2024-05-06011fe1cb6892…
2026-02-19 14:30 UTC2026-02A212545-002PERPHENAZINE4MGTABLET / ORALAB2024-05-06011fe1cb6892…
2026-02-19 14:30 UTC2026-02A212545-003PERPHENAZINE8MGTABLET / ORALAB2024-05-06011fe1cb6892…
2026-02-19 14:30 UTC2026-02A212545-004PERPHENAZINE16MGTABLET / ORALAB2024-05-06011fe1cb6892…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A212545-001PERPHENAZINE2MGTABLET / ORALAB2024-05-0631067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A212545-002PERPHENAZINE4MGTABLET / ORALAB2024-05-0631067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A212545-003PERPHENAZINE8MGTABLET / ORALAB2024-05-0631067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A212545-004PERPHENAZINE16MGTABLET / ORALAB2024-05-0631067a03dcf5…
2025-08-23 18:47 UTC2025-08A212545-001PERPHENAZINE2MGTABLET / ORALAB2024-05-066a471c1ec25d…
2025-08-23 18:47 UTC2025-08A212545-002PERPHENAZINE4MGTABLET / ORALAB2024-05-066a471c1ec25d…
2025-08-23 18:47 UTC2025-08A212545-003PERPHENAZINE8MGTABLET / ORALAB2024-05-066a471c1ec25d…
2025-08-23 18:47 UTC2025-08A212545-004PERPHENAZINE16MGTABLET / ORALAB2024-05-066a471c1ec25d…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A212545-001PERPHENAZINE2MGTABLET / ORALAB2024-05-06fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A212545-002PERPHENAZINE4MGTABLET / ORALAB2024-05-06fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A212545-003PERPHENAZINE8MGTABLET / ORALAB2024-05-06fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A212545-004PERPHENAZINE16MGTABLET / ORALAB2024-05-06fd3edfee7708…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A212545-001PERPHENAZINE2MGTABLET / ORALAB2024-05-06b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A212545-002PERPHENAZINE4MGTABLET / ORALAB2024-05-06b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A212545-003PERPHENAZINE8MGTABLET / ORALAB2024-05-06b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A212545-004PERPHENAZINE16MGTABLET / ORALAB2024-05-06b8a1b40f171c…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A212545-001PERPHENAZINE2MGTABLET / ORALAB2024-05-0603ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A212545-002PERPHENAZINE4MGTABLET / ORALAB2024-05-0603ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A212545-003PERPHENAZINE8MGTABLET / ORALAB2024-05-0603ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A212545-004PERPHENAZINE16MGTABLET / ORALAB2024-05-0603ed91905a0d…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A212545-001PERPHENAZINE2MGTABLET / ORALAB2024-05-062680178bc6a6…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A212545-002PERPHENAZINE4MGTABLET / ORALAB2024-05-062680178bc6a6…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A212545-003PERPHENAZINE8MGTABLET / ORALAB2024-05-062680178bc6a6…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A212545-004PERPHENAZINE16MGTABLET / ORALAB2024-05-062680178bc6a6…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A212545-001PERPHENAZINE2MGTABLET / ORALAB2024-05-065bbf6a4d5a75…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A212545-002PERPHENAZINE4MGTABLET / ORALAB2024-05-065bbf6a4d5a75…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A212545-003PERPHENAZINE8MGTABLET / ORALAB2024-05-065bbf6a4d5a75…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A212545-004PERPHENAZINE16MGTABLET / ORALAB2024-05-065bbf6a4d5a75…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A212545-001PERPHENAZINE2MGTABLET / ORALAB2024-05-06d8e5a09893c0…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A212545-002PERPHENAZINE4MGTABLET / ORALAB2024-05-06d8e5a09893c0…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A212545-003PERPHENAZINE8MGTABLET / ORALAB2024-05-06d8e5a09893c0…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A212545-004PERPHENAZINE16MGTABLET / ORALAB2024-05-06d8e5a09893c0…

Observed Orange Book normalized TE history#

Normalized TE history page 1 of 2 · 64 observed states.

Captured, Edition, Application-product table
CapturedEditionApplication-productTE codeOrderSource SHA-256
2026-08-18 06:07:402026-07A212545-001AB1caaa826d4ba7…
2026-08-18 06:07:402026-07A212545-002AB1caaa826d4ba7…
2026-08-18 06:07:402026-07A212545-003AB1caaa826d4ba7…
2026-08-18 06:07:402026-07A212545-004AB1caaa826d4ba7…
2026-02-19 14:30 UTC2026-02A212545-001AB1011fe1cb6892…
2026-02-19 14:30 UTC2026-02A212545-002AB1011fe1cb6892…
2026-02-19 14:30 UTC2026-02A212545-003AB1011fe1cb6892…
2026-02-19 14:30 UTC2026-02A212545-004AB1011fe1cb6892…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A212545-001AB131067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A212545-002AB131067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A212545-003AB131067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A212545-004AB131067a03dcf5…
2025-08-23 18:47 UTC2025-08A212545-001AB16a471c1ec25d…
2025-08-23 18:47 UTC2025-08A212545-002AB16a471c1ec25d…
2025-08-23 18:47 UTC2025-08A212545-003AB16a471c1ec25d…
2025-08-23 18:47 UTC2025-08A212545-004AB16a471c1ec25d…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A212545-001AB1fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A212545-002AB1fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A212545-003AB1fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A212545-004AB1fd3edfee7708…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A212545-001AB1b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A212545-002AB1b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A212545-003AB1b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A212545-004AB1b8a1b40f171c…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A212545-001AB103ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A212545-002AB103ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A212545-003AB103ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A212545-004AB103ed91905a0d…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A212545-001AB12680178bc6a6…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A212545-002AB12680178bc6a6…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A212545-003AB12680178bc6a6…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A212545-004AB12680178bc6a6…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A212545-001AB15bbf6a4d5a75…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A212545-002AB15bbf6a4d5a75…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A212545-003AB15bbf6a4d5a75…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A212545-004AB15bbf6a4d5a75…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A212545-001AB1d8e5a09893c0…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A212545-002AB1d8e5a09893c0…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A212545-003AB1d8e5a09893c0…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A212545-004AB1d8e5a09893c0…

Additional Listing Data#

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

Active Ingredients#

Ingredient, Strength table
IngredientStrength
PERPHENAZINE16 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 · 1 matching rows.

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

Harmonized SPL set identifiers#

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

Identifier, FDA.report destination table
IdentifierFDA.report destination
bb08cedf-18ab-4341-a84e-c092ff7a5c98Available 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
70518-4484-0Perphenazine100 in 1 BOXTABLET1003
70518-4484-1Perphenazine1 in 1 POUCHTABLET13
70518-4484-2Perphenazine30 in 1 BLISTER PACKTABLET303

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 · 2 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
PerphenazinePERPHENAZINEREMEDYREPACK INC.bb08cedf-18ab-4341-a84e-c092ff7a5c982026-05-07Boxed warning, Warnings, Adverse reactionsExact identifier
application applno (ANDA): 212545
application number: ANDA212545
ndc (product): 70518-4484
PerphenazinePERPHENAZINEMacleods Pharmaceuticals Limited28f0cc81-538c-4a4b-be8d-509428fcbb9c2024-10-11Boxed warning, Warnings, Adverse reactionsExact identifier
application applno (ANDA): 212545
application number: ANDA212545

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
198075perphenazine 16 MG Oral TabletPSNbb08cedf-18ab-4341-a84e-c092ff7a5c983
198075perphenazine 16 MG Oral TabletSCDbb08cedf-18ab-4341-a84e-c092ff7a5c983

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startSampleExclude flagStatus
70518-4484-070518448400100 POUCH in 1 BOX (70518-4484-0) / 1 TABLET in 1 POUCH (70518-4484-1) 100 pouch2025-09-24NoNoCurrent
70518-4484-1705184484011 in 1 POUCHHistorical
70518-4484-27051844840230 TABLET in 1 BLISTER PACK (70518-4484-2) 30 tablet2026-01-20NoNoCurrent