Home NDC 33342-449 Perphenazine
Product NDC 33342-449
11-digit product format 333420449
Labeler code 33342
Product ID 33342-449_921ea109-cb8a-40b9-a290-53a7fee4988d
Type HUMAN PRESCRIPTION DRUG
Nonproprietary name Perphenazine
Dosage form TABLET
Route ORAL
Labeler Macleods Pharmaceuticals Limited
Application ANDA212545
Marketing category ANDA
Marketing start 2024-05-06
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 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-product Trade name Ingredient Strength Dosage form / route TE codes RLD / RS Approval date A212545-001 PERPHENAZINE PERPHENAZINE 2MG TABLET / ORAL AB 2024-05-06 A212545-002 PERPHENAZINE PERPHENAZINE 4MG TABLET / ORAL AB 2024-05-06 A212545-003 PERPHENAZINE PERPHENAZINE 8MG TABLET / ORAL AB 2024-05-06 A212545-004 PERPHENAZINE PERPHENAZINE 16MG TABLET / ORAL AB 2024-05-06
Therapeutic equivalence codes# Current TE-code rows page 1 of 1 · 4 matching rows.
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 Captured Edition Application-product Trade name Strength Dosage form / route Product TE source text RLD / RS Approval date Source SHA-256 2026-08-18 06:07:40 2026-07 A212545-001 PERPHENAZINE 2MG TABLET / ORAL AB 2024-05-06 caaa826d4ba7…2026-08-18 06:07:40 2026-07 A212545-002 PERPHENAZINE 4MG TABLET / ORAL AB 2024-05-06 caaa826d4ba7…2026-08-18 06:07:40 2026-07 A212545-003 PERPHENAZINE 8MG TABLET / ORAL AB 2024-05-06 caaa826d4ba7…2026-08-18 06:07:40 2026-07 A212545-004 PERPHENAZINE 16MG TABLET / ORAL AB 2024-05-06 caaa826d4ba7…2026-02-19 14:30 UTC 2026-02 A212545-001 PERPHENAZINE 2MG TABLET / ORAL AB 2024-05-06 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 A212545-002 PERPHENAZINE 4MG TABLET / ORAL AB 2024-05-06 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 A212545-003 PERPHENAZINE 8MG TABLET / ORAL AB 2024-05-06 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 A212545-004 PERPHENAZINE 16MG TABLET / ORAL AB 2024-05-06 011fe1cb6892…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 A212545-001 PERPHENAZINE 2MG TABLET / ORAL AB 2024-05-06 31067a03dcf5…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 A212545-002 PERPHENAZINE 4MG TABLET / ORAL AB 2024-05-06 31067a03dcf5…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 A212545-003 PERPHENAZINE 8MG TABLET / ORAL AB 2024-05-06 31067a03dcf5…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 A212545-004 PERPHENAZINE 16MG TABLET / ORAL AB 2024-05-06 31067a03dcf5…2025-08-23 18:47 UTC 2025-08 A212545-001 PERPHENAZINE 2MG TABLET / ORAL AB 2024-05-06 6a471c1ec25d…2025-08-23 18:47 UTC 2025-08 A212545-002 PERPHENAZINE 4MG TABLET / ORAL AB 2024-05-06 6a471c1ec25d…2025-08-23 18:47 UTC 2025-08 A212545-003 PERPHENAZINE 8MG TABLET / ORAL AB 2024-05-06 6a471c1ec25d…2025-08-23 18:47 UTC 2025-08 A212545-004 PERPHENAZINE 16MG TABLET / ORAL AB 2024-05-06 6a471c1ec25d…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 A212545-001 PERPHENAZINE 2MG TABLET / ORAL AB 2024-05-06 fd3edfee7708…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 A212545-002 PERPHENAZINE 4MG TABLET / ORAL AB 2024-05-06 fd3edfee7708…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 A212545-003 PERPHENAZINE 8MG TABLET / ORAL AB 2024-05-06 fd3edfee7708…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 A212545-004 PERPHENAZINE 16MG TABLET / ORAL AB 2024-05-06 fd3edfee7708…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 A212545-001 PERPHENAZINE 2MG TABLET / ORAL AB 2024-05-06 b8a1b40f171c…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 A212545-002 PERPHENAZINE 4MG TABLET / ORAL AB 2024-05-06 b8a1b40f171c…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 A212545-003 PERPHENAZINE 8MG TABLET / ORAL AB 2024-05-06 b8a1b40f171c…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 A212545-004 PERPHENAZINE 16MG TABLET / ORAL AB 2024-05-06 b8a1b40f171c…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 A212545-001 PERPHENAZINE 2MG TABLET / ORAL AB 2024-05-06 03ed91905a0d…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 A212545-002 PERPHENAZINE 4MG TABLET / ORAL AB 2024-05-06 03ed91905a0d…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 A212545-003 PERPHENAZINE 8MG TABLET / ORAL AB 2024-05-06 03ed91905a0d…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 A212545-004 PERPHENAZINE 16MG TABLET / ORAL AB 2024-05-06 03ed91905a0d…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 A212545-001 PERPHENAZINE 2MG TABLET / ORAL AB 2024-05-06 2680178bc6a6…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 A212545-002 PERPHENAZINE 4MG TABLET / ORAL AB 2024-05-06 2680178bc6a6…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 A212545-003 PERPHENAZINE 8MG TABLET / ORAL AB 2024-05-06 2680178bc6a6…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 A212545-004 PERPHENAZINE 16MG TABLET / ORAL AB 2024-05-06 2680178bc6a6…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 A212545-001 PERPHENAZINE 2MG TABLET / ORAL AB 2024-05-06 5bbf6a4d5a75…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 A212545-002 PERPHENAZINE 4MG TABLET / ORAL AB 2024-05-06 5bbf6a4d5a75…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 A212545-003 PERPHENAZINE 8MG TABLET / ORAL AB 2024-05-06 5bbf6a4d5a75…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 A212545-004 PERPHENAZINE 16MG TABLET / ORAL AB 2024-05-06 5bbf6a4d5a75…2024-11-08 22:44 UTC · 3 captures of this ZIP 2024-11 A212545-001 PERPHENAZINE 2MG TABLET / ORAL AB 2024-05-06 d8e5a09893c0…2024-11-08 22:44 UTC · 3 captures of this ZIP 2024-11 A212545-002 PERPHENAZINE 4MG TABLET / ORAL AB 2024-05-06 d8e5a09893c0…2024-11-08 22:44 UTC · 3 captures of this ZIP 2024-11 A212545-003 PERPHENAZINE 8MG TABLET / ORAL AB 2024-05-06 d8e5a09893c0…2024-11-08 22:44 UTC · 3 captures of this ZIP 2024-11 A212545-004 PERPHENAZINE 16MG TABLET / ORAL AB 2024-05-06 d8e5a09893c0…
Observed Orange Book normalized TE history# Normalized TE history page 1 of 2 · 64 observed states.
Additional Listing Data#
Finished product Yes
Brand name base Perphenazine
Listing expiration 2026-12-31 Active Ingredients# Ingredient, Strength table Ingredient Strength PERPHENAZINE 4 mg/1
Harmonized UNII identifiers# UNII identifiers page 1 of 1 · 1 matching rows.
Identifier, FDA.report destination table Identifier FDA.report destination FTA7XXY4EZ Internal UNII lookup
Harmonized RxCUI identifiers# RxCUI identifiers page 1 of 1 · 4 matching rows.
Identifier, FDA.report destination table Identifier FDA.report destination 198075 Internal RxNorm lookup 198076 Internal RxNorm lookup 198077 Internal RxNorm lookup 198078 Internal RxNorm lookup
Harmonized SPL set identifiers# SPL set identifiers page 1 of 1 · 1 matching rows.
DailyMed Product Concepts# DailyMed Package Descriptions# Package NDC, Product, Description table Package NDC Product Description Form Quantity Strength SPL version 33342-449-11 Perphenazine 100 in 1 BOTTLE TABLET 100 2 33342-449-15 Perphenazine 500 in 1 BOTTLE TABLET 500 2
DailyMed Dashboard NDC Coverage# NDC, Dashboard title, SPL version table NDC Dashboard title SPL version Validation Dashboard ZIP 33342-449 PERPHENAZINE TABLET [MACLEODS PHARMACEUTICALS LIMITED] 2 Current NDC, 2 package rows 20241019_28f0cc81-538c-4a4b-be8d-509428fcbb9c.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 · 2 matching rows.
DailyMed RxNorm Mappings# Packages# Package NDC, 11-digit format, Description table Package NDC 11-digit format Description Units Marketing start Sample Exclude flag Status 33342-449-11 33342044911 100 TABLET in 1 BOTTLE (33342-449-11) 100 tablet 2024-05-06 No No Current 33342-449-15 33342044915 500 TABLET in 1 BOTTLE (33342-449-15) 500 tablet 2024-05-06 No No Current