PERPHENAZINE

Product NDC
70518-4144
11-digit product format
705184144
Labeler code
70518
Product ID
70518-4144_3fb4d137-66ff-36ee-e063-6394a90a6872
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
PERPHENAZINE
Dosage form
TABLET
Route
ORAL
Labeler
REMEDYREPACK INC.
Application
ANDA210163
Marketing category
ANDA
Marketing start
2024-07-17
Substance
PERPHENAZINE
Active strength
16 mg/1
Pharmacologic classes
Phenothiazine [EPC], Phenothiazines [CS]
NDC exclude flag
No
Listing certified through
2026-12-31
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
A210163-001PERPHENAZINEPERPHENAZINE2MGTABLET / ORALAB2022-05-18
A210163-002PERPHENAZINEPERPHENAZINE4MGTABLET / ORALAB2022-05-18
A210163-003PERPHENAZINEPERPHENAZINE8MGTABLET / ORALAB2022-05-18
A210163-004PERPHENAZINEPERPHENAZINE16MGTABLET / ORALAB2022-05-18

Therapeutic equivalence codes#

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

Application-product, TE code table
Application-productTE code
A210163-001AB
A210163-002AB
A210163-003AB
A210163-004AB

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 3 · 120 observed states.

Captured, Edition, Application-product table
CapturedEditionApplication-productTrade nameStrengthDosage form / routeProduct TE source textRLD / RSApproval dateSource SHA-256
2026-08-18 06:07:402026-07A210163-001PERPHENAZINE2MGTABLET / ORALAB2022-05-18caaa826d4ba7…
2026-08-18 06:07:402026-07A210163-002PERPHENAZINE4MGTABLET / ORALAB2022-05-18caaa826d4ba7…
2026-08-18 06:07:402026-07A210163-003PERPHENAZINE8MGTABLET / ORALAB2022-05-18caaa826d4ba7…
2026-08-18 06:07:402026-07A210163-004PERPHENAZINE16MGTABLET / ORALAB2022-05-18caaa826d4ba7…
2026-02-19 14:30 UTC2026-02A210163-001PERPHENAZINE2MGTABLET / ORALAB2022-05-18011fe1cb6892…
2026-02-19 14:30 UTC2026-02A210163-002PERPHENAZINE4MGTABLET / ORALAB2022-05-18011fe1cb6892…
2026-02-19 14:30 UTC2026-02A210163-003PERPHENAZINE8MGTABLET / ORALAB2022-05-18011fe1cb6892…
2026-02-19 14:30 UTC2026-02A210163-004PERPHENAZINE16MGTABLET / ORALAB2022-05-18011fe1cb6892…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A210163-001PERPHENAZINE2MGTABLET / ORALAB2022-05-1831067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A210163-002PERPHENAZINE4MGTABLET / ORALAB2022-05-1831067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A210163-003PERPHENAZINE8MGTABLET / ORALAB2022-05-1831067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A210163-004PERPHENAZINE16MGTABLET / ORALAB2022-05-1831067a03dcf5…
2025-08-23 18:47 UTC2025-08A210163-001PERPHENAZINE2MGTABLET / ORALAB2022-05-186a471c1ec25d…
2025-08-23 18:47 UTC2025-08A210163-002PERPHENAZINE4MGTABLET / ORALAB2022-05-186a471c1ec25d…
2025-08-23 18:47 UTC2025-08A210163-003PERPHENAZINE8MGTABLET / ORALAB2022-05-186a471c1ec25d…
2025-08-23 18:47 UTC2025-08A210163-004PERPHENAZINE16MGTABLET / ORALAB2022-05-186a471c1ec25d…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A210163-001PERPHENAZINE2MGTABLET / ORALAB2022-05-18fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A210163-002PERPHENAZINE4MGTABLET / ORALAB2022-05-18fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A210163-003PERPHENAZINE8MGTABLET / ORALAB2022-05-18fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A210163-004PERPHENAZINE16MGTABLET / ORALAB2022-05-18fd3edfee7708…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A210163-001PERPHENAZINE2MGTABLET / ORALAB2022-05-18b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A210163-002PERPHENAZINE4MGTABLET / ORALAB2022-05-18b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A210163-003PERPHENAZINE8MGTABLET / ORALAB2022-05-18b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A210163-004PERPHENAZINE16MGTABLET / ORALAB2022-05-18b8a1b40f171c…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A210163-001PERPHENAZINE2MGTABLET / ORALAB2022-05-1803ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A210163-002PERPHENAZINE4MGTABLET / ORALAB2022-05-1803ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A210163-003PERPHENAZINE8MGTABLET / ORALAB2022-05-1803ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A210163-004PERPHENAZINE16MGTABLET / ORALAB2022-05-1803ed91905a0d…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A210163-001PERPHENAZINE2MGTABLET / ORALAB2022-05-182680178bc6a6…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A210163-002PERPHENAZINE4MGTABLET / ORALAB2022-05-182680178bc6a6…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A210163-003PERPHENAZINE8MGTABLET / ORALAB2022-05-182680178bc6a6…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A210163-004PERPHENAZINE16MGTABLET / ORALAB2022-05-182680178bc6a6…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A210163-001PERPHENAZINE2MGTABLET / ORALAB2022-05-185bbf6a4d5a75…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A210163-002PERPHENAZINE4MGTABLET / ORALAB2022-05-185bbf6a4d5a75…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A210163-003PERPHENAZINE8MGTABLET / ORALAB2022-05-185bbf6a4d5a75…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A210163-004PERPHENAZINE16MGTABLET / ORALAB2022-05-185bbf6a4d5a75…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A210163-001PERPHENAZINE2MGTABLET / ORALAB2022-05-18d8e5a09893c0…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A210163-002PERPHENAZINE4MGTABLET / ORALAB2022-05-18d8e5a09893c0…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A210163-003PERPHENAZINE8MGTABLET / ORALAB2022-05-18d8e5a09893c0…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A210163-004PERPHENAZINE16MGTABLET / ORALAB2022-05-18d8e5a09893c0…

Observed Orange Book normalized TE history#

Normalized TE history page 1 of 3 · 120 observed states.

Captured, Edition, Application-product table
CapturedEditionApplication-productTE codeOrderSource SHA-256
2026-08-18 06:07:402026-07A210163-001AB1caaa826d4ba7…
2026-08-18 06:07:402026-07A210163-002AB1caaa826d4ba7…
2026-08-18 06:07:402026-07A210163-003AB1caaa826d4ba7…
2026-08-18 06:07:402026-07A210163-004AB1caaa826d4ba7…
2026-02-19 14:30 UTC2026-02A210163-001AB1011fe1cb6892…
2026-02-19 14:30 UTC2026-02A210163-002AB1011fe1cb6892…
2026-02-19 14:30 UTC2026-02A210163-003AB1011fe1cb6892…
2026-02-19 14:30 UTC2026-02A210163-004AB1011fe1cb6892…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A210163-001AB131067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A210163-002AB131067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A210163-003AB131067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A210163-004AB131067a03dcf5…
2025-08-23 18:47 UTC2025-08A210163-001AB16a471c1ec25d…
2025-08-23 18:47 UTC2025-08A210163-002AB16a471c1ec25d…
2025-08-23 18:47 UTC2025-08A210163-003AB16a471c1ec25d…
2025-08-23 18:47 UTC2025-08A210163-004AB16a471c1ec25d…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A210163-001AB1fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A210163-002AB1fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A210163-003AB1fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A210163-004AB1fd3edfee7708…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A210163-001AB1b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A210163-002AB1b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A210163-003AB1b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A210163-004AB1b8a1b40f171c…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A210163-001AB103ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A210163-002AB103ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A210163-003AB103ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A210163-004AB103ed91905a0d…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A210163-001AB12680178bc6a6…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A210163-002AB12680178bc6a6…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A210163-003AB12680178bc6a6…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A210163-004AB12680178bc6a6…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A210163-001AB15bbf6a4d5a75…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A210163-002AB15bbf6a4d5a75…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A210163-003AB15bbf6a4d5a75…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A210163-004AB15bbf6a4d5a75…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A210163-001AB1d8e5a09893c0…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A210163-002AB1d8e5a09893c0…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A210163-003AB1d8e5a09893c0…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A210163-004AB1d8e5a09893c0…

Additional Listing Data#

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

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
c4150683-0772-4344-bb1c-f050b84175d6Available 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
70518-4144-0PERPHENAZINE100 in 1 BOXTABLET1004
70518-4144-1PERPHENAZINE1 in 1 POUCHTABLET14

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
70518-4144PERPHENAZINE TABLET [REMEDYREPACK INC.]3Current NDC, 2 package rows20241212_c4150683-0772-4344-bb1c-f050b84175d6.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 · 3 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
PerphenazinePERPHENAZINEChartwell RX, LLCba5f3963-3080-48bc-806a-0aed72e2c25b2025-12-10Boxed warning, Warnings, Adverse reactionsExact identifier
application applno (ANDA): 210163
application number: ANDA210163
PERPHENAZINEPERPHENAZINEREMEDYREPACK INC.c4150683-0772-4344-bb1c-f050b84175d62025-09-26Boxed warning, Warnings, Adverse reactionsExact identifier
application applno (ANDA): 210163
application number: ANDA210163
ndc (product): 70518-4144
PERPHENAZINEPERPHENAZINEHeritage Pharmaceuticals Inc. d/b/a Avet Pharmaceuticals Inc.935a7567-0395-4901-960c-79587fa14c8d2024-11-14Boxed warning, Warnings, Adverse reactionsExact identifier
application applno (ANDA): 210163
application number: ANDA210163

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
198075perphenazine 16 MG Oral TabletPSNc4150683-0772-4344-bb1c-f050b84175d64
198075perphenazine 16 MG Oral TabletSCDc4150683-0772-4344-bb1c-f050b84175d64

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startSampleExclude flagStatus
70518-4144-070518414400100 POUCH in 1 BOX (70518-4144-0) / 1 TABLET in 1 POUCH (70518-4144-1) 100 pouch2024-07-17NoNoCurrent
70518-4144-1705184144011 in 1 POUCHHistorical