Perphenazine

Product NDC
70518-3106
11-digit product format
705183106
Labeler code
70518
Product ID
70518-3106_c34267b2-c553-e704-e053-2a95a90af1db
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
perphenazine
Dosage form
TABLET, FILM COATED
Route
ORAL
Labeler
REMEDYREPACK INC.
Application
ANDA040226
Marketing category
ANDA
Marketing start
2021-05-26
Marketing end
0000-00-00
Substance
PERPHENAZINE
Active strength
4 mg/1
Pharmacologic classes
Phenothiazine [EPC],Phenothiazines [CS]
NDC exclude flag
No
Listing certified through
2022-12-31
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 · 2 matching rows.

Dataset, Scope, Product NDC table
DatasetScopeProduct NDCPackage NDCCodeStatusReporting periodSource date
excluded productproduct70518-3106DDiscontinued by firm2026-08-11
excluded packagepackage70518-310670518-3106-0DDiscontinued by firm2026-08-11

Source provenance: Browse the complete Orange Book source catalog · source snapshot 1.

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
A040226-001PERPHENAZINEPERPHENAZINE2MGTABLET / ORALAB1998-12-31
A040226-002PERPHENAZINEPERPHENAZINE4MGTABLET / ORALAB1998-12-31
A040226-003PERPHENAZINEPERPHENAZINE8MGTABLET / ORALAB1998-12-31
A040226-004PERPHENAZINEPERPHENAZINE16MGTABLET / ORALAB1998-12-31

Therapeutic equivalence codes#

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

Application-product, TE code table
Application-productTE code
A040226-001AB
A040226-002AB
A040226-003AB
A040226-004AB

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 · 164 observed states.

Captured, Edition, Application-product table
CapturedEditionApplication-productTrade nameStrengthDosage form / routeProduct TE source textRLD / RSApproval dateSource SHA-256
2026-02-19 14:30 UTC2026-02A040226-001PERPHENAZINE2MGTABLET / ORALAB1998-12-31011fe1cb6892…
2026-02-19 14:30 UTC2026-02A040226-002PERPHENAZINE4MGTABLET / ORALAB1998-12-31011fe1cb6892…
2026-02-19 14:30 UTC2026-02A040226-003PERPHENAZINE8MGTABLET / ORALAB1998-12-31011fe1cb6892…
2026-02-19 14:30 UTC2026-02A040226-004PERPHENAZINE16MGTABLET / ORALAB1998-12-31011fe1cb6892…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A040226-001PERPHENAZINE2MGTABLET / ORALAB1998-12-3131067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A040226-002PERPHENAZINE4MGTABLET / ORALAB1998-12-3131067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A040226-003PERPHENAZINE8MGTABLET / ORALAB1998-12-3131067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A040226-004PERPHENAZINE16MGTABLET / ORALAB1998-12-3131067a03dcf5…
2025-08-23 18:47 UTC2025-08A040226-001PERPHENAZINE2MGTABLET / ORALAB1998-12-316a471c1ec25d…
2025-08-23 18:47 UTC2025-08A040226-002PERPHENAZINE4MGTABLET / ORALAB1998-12-316a471c1ec25d…
2025-08-23 18:47 UTC2025-08A040226-003PERPHENAZINE8MGTABLET / ORALAB1998-12-316a471c1ec25d…
2025-08-23 18:47 UTC2025-08A040226-004PERPHENAZINE16MGTABLET / ORALAB1998-12-316a471c1ec25d…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A040226-001PERPHENAZINE2MGTABLET / ORALAB1998-12-31fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A040226-002PERPHENAZINE4MGTABLET / ORALAB1998-12-31fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A040226-003PERPHENAZINE8MGTABLET / ORALAB1998-12-31fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A040226-004PERPHENAZINE16MGTABLET / ORALAB1998-12-31fd3edfee7708…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A040226-001PERPHENAZINE2MGTABLET / ORALAB1998-12-31b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A040226-002PERPHENAZINE4MGTABLET / ORALAB1998-12-31b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A040226-003PERPHENAZINE8MGTABLET / ORALAB1998-12-31b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A040226-004PERPHENAZINE16MGTABLET / ORALAB1998-12-31b8a1b40f171c…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A040226-001PERPHENAZINE2MGTABLET / ORALAB1998-12-3103ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A040226-002PERPHENAZINE4MGTABLET / ORALAB1998-12-3103ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A040226-003PERPHENAZINE8MGTABLET / ORALAB1998-12-3103ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A040226-004PERPHENAZINE16MGTABLET / ORALAB1998-12-3103ed91905a0d…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A040226-001PERPHENAZINE2MGTABLET / ORALAB1998-12-312680178bc6a6…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A040226-002PERPHENAZINE4MGTABLET / ORALAB1998-12-312680178bc6a6…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A040226-003PERPHENAZINE8MGTABLET / ORALAB1998-12-312680178bc6a6…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A040226-004PERPHENAZINE16MGTABLET / ORALAB1998-12-312680178bc6a6…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A040226-001PERPHENAZINE2MGTABLET / ORALAB1998-12-315bbf6a4d5a75…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A040226-002PERPHENAZINE4MGTABLET / ORALAB1998-12-315bbf6a4d5a75…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A040226-003PERPHENAZINE8MGTABLET / ORALAB1998-12-315bbf6a4d5a75…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A040226-004PERPHENAZINE16MGTABLET / ORALAB1998-12-315bbf6a4d5a75…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A040226-001PERPHENAZINE2MGTABLET / ORALAB1998-12-31d8e5a09893c0…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A040226-002PERPHENAZINE4MGTABLET / ORALAB1998-12-31d8e5a09893c0…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A040226-003PERPHENAZINE8MGTABLET / ORALAB1998-12-31d8e5a09893c0…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A040226-004PERPHENAZINE16MGTABLET / ORALAB1998-12-31d8e5a09893c0…
2024-10-29 15:01 UTC2024-10A040226-001PERPHENAZINE2MGTABLET / ORALAB1998-12-31d06236e962d9…
2024-10-29 15:01 UTC2024-10A040226-002PERPHENAZINE4MGTABLET / ORALAB1998-12-31d06236e962d9…
2024-10-29 15:01 UTC2024-10A040226-003PERPHENAZINE8MGTABLET / ORALAB1998-12-31d06236e962d9…
2024-10-29 15:01 UTC2024-10A040226-004PERPHENAZINE16MGTABLET / ORALAB1998-12-31d06236e962d9…

Observed Orange Book normalized TE history#

Normalized TE history page 1 of 5 · 164 observed states.

Captured, Edition, Application-product table
CapturedEditionApplication-productTE codeOrderSource SHA-256
2026-02-19 14:30 UTC2026-02A040226-001AB1011fe1cb6892…
2026-02-19 14:30 UTC2026-02A040226-002AB1011fe1cb6892…
2026-02-19 14:30 UTC2026-02A040226-003AB1011fe1cb6892…
2026-02-19 14:30 UTC2026-02A040226-004AB1011fe1cb6892…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A040226-001AB131067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A040226-002AB131067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A040226-003AB131067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A040226-004AB131067a03dcf5…
2025-08-23 18:47 UTC2025-08A040226-001AB16a471c1ec25d…
2025-08-23 18:47 UTC2025-08A040226-002AB16a471c1ec25d…
2025-08-23 18:47 UTC2025-08A040226-003AB16a471c1ec25d…
2025-08-23 18:47 UTC2025-08A040226-004AB16a471c1ec25d…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A040226-001AB1fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A040226-002AB1fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A040226-003AB1fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A040226-004AB1fd3edfee7708…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A040226-001AB1b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A040226-002AB1b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A040226-003AB1b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A040226-004AB1b8a1b40f171c…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A040226-001AB103ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A040226-002AB103ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A040226-003AB103ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A040226-004AB103ed91905a0d…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A040226-001AB12680178bc6a6…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A040226-002AB12680178bc6a6…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A040226-003AB12680178bc6a6…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A040226-004AB12680178bc6a6…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A040226-001AB15bbf6a4d5a75…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A040226-002AB15bbf6a4d5a75…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A040226-003AB15bbf6a4d5a75…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A040226-004AB15bbf6a4d5a75…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A040226-001AB1d8e5a09893c0…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A040226-002AB1d8e5a09893c0…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A040226-003AB1d8e5a09893c0…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A040226-004AB1d8e5a09893c0…
2024-10-29 15:01 UTC2024-10A040226-001AB1d06236e962d9…
2024-10-29 15:01 UTC2024-10A040226-002AB1d06236e962d9…
2024-10-29 15:01 UTC2024-10A040226-003AB1d06236e962d9…
2024-10-29 15:01 UTC2024-10A040226-004AB1d06236e962d9…

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDCEffectiveActionDocumentIndexing SPLRelated label
70518-3106-02023-03-16C16284748780-1f386c649-fff2-0266-e053-dadaa90a7c1aPerphenazine Tablets, USP
70518-3106-02023-01-30C16284748780-1f386c649-fff2-0266-e053-dadaa90a7c1aPerphenazine Tablets, USP

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
70518-3106PERPHENAZINE TABLET, FILM COATED [REMEDYREPACK INC.]4Legacy NDC20240124_4ee52e79-6e3a-4b97-8c27-4f1b5dedd4a4.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 · 12 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
PerphenazinePERPHENAZINEAmerican Health Packaginga17c90f9-3d5d-4503-ba2c-754b45decbf82025-11-18Boxed warning, Warnings, Adverse reactionsExact identifier
application applno (ANDA): 040226
application number: ANDA040226
PerphenazinePERPHENAZINEMajor Pharmaceuticals0dc77ea9-32ee-4b6d-b69d-8c712bcf5fe42025-04-15Boxed warning, Warnings, Adverse reactionsExact identifier
application applno (ANDA): 040226
application number: ANDA040226
PerphenazinePERPHENAZINEEndo USA, Inc.5fbfe9da-26e8-4705-98f3-42acd3d7b4392024-11-18Boxed warning, Warnings, Adverse reactionsExact identifier
application applno (ANDA): 040226
application number: ANDA040226
PerphenazinePERPHENAZINEBryant Ranch Prepackc644628a-76c2-40d9-b7d8-0077743713b92023-12-07Boxed warning, Warnings, Adverse reactionsExact identifier
application applno (ANDA): 040226
application number: ANDA040226
PerphenazinePERPHENAZINEBryant Ranch Prepack0e87e78e-d39c-44fc-95a0-70cdb2a919412023-12-07Boxed warning, Warnings, Adverse reactionsExact identifier
application applno (ANDA): 040226
application number: ANDA040226
PerphenazinePERPHENAZINEBryant Ranch Prepacke2f9903c-cbac-4f14-b684-f12cc7e5aa852023-12-07Boxed warning, Warnings, Adverse reactionsExact identifier
application applno (ANDA): 040226
application number: ANDA040226
PerphenazinePERPHENAZINEBryant Ranch Prepack18c20201-ad92-40ac-8f99-6048c2d32c682023-09-12Boxed warning, Warnings, Adverse reactionsExact identifier
application applno (ANDA): 040226
application number: ANDA040226
PerphenazinePERPHENAZINEBryant Ranch Prepack9ad131c1-0620-4d3c-9734-bcffd98430e22023-09-12Boxed warning, Warnings, Adverse reactionsExact identifier
application applno (ANDA): 040226
application number: ANDA040226
PerphenazinePERPHENAZINEBryant Ranch Prepack63e3a25b-a9e2-449d-8631-41f700f4cdeb2023-09-12Boxed warning, Warnings, Adverse reactionsExact identifier
application applno (ANDA): 040226
application number: ANDA040226
PerphenazinePERPHENAZINEBryant Ranch Prepack4882ec28-f516-4dc8-ab15-76cf455af7092023-03-02Boxed warning, Warnings, Adverse reactionsExact identifier
application applno (ANDA): 040226
application number: ANDA040226
PerphenazinePERPHENAZINEBryant Ranch Prepack59b1a63e-6cba-4102-a5e8-83dca540341d2023-03-02Boxed warning, Warnings, Adverse reactionsExact identifier
application applno (ANDA): 040226
application number: ANDA040226
PerphenazinePERPHENAZINEBryant Ranch Prepackb5f08bc9-79b5-4c6f-8fe4-ec2ef022ebe02023-03-02Boxed warning, Warnings, Adverse reactionsExact identifier
application applno (ANDA): 040226
application number: ANDA040226

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionMarketing startMarketing endSampleExclude flagStatus
70518-3106-07051831060030 TABLET, FILM COATED in 1 BLISTER PACK (70518-3106-0) 2021-05-260000-00-00NoNoCurrent