Home NDC 0781-8049 Perphenazine
Product NDC 0781-8049
11-digit product format 007818049
Labeler code 0781
Product ID 0781-8049_9e348a80-ecb9-409b-91e7-3a48423314ff
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 2027-03-21
Substance PERPHENAZINE
Active strength 16 mg/1
Pharmacologic classes Phenothiazine [EPC], Phenothiazines [CS]
NDC exclude flag No
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 A089685-001 PERPHENAZINE PERPHENAZINE 8MG TABLET / ORAL AB 1988-12-08 A089685-002 PERPHENAZINE PERPHENAZINE 2MG TABLET / ORAL AB 1988-12-08 A089685-003 PERPHENAZINE PERPHENAZINE 4MG TABLET / ORAL AB 1988-12-08 A089685-004 PERPHENAZINE PERPHENAZINE 16MG TABLET / ORAL AB RS 1988-12-08
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 5 · 168 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 A089685-001 PERPHENAZINE 8MG TABLET / ORAL AB 1988-12-08 caaa826d4ba7…2026-08-18 06:07:40 2026-07 A089685-002 PERPHENAZINE 2MG TABLET / ORAL AB 1988-12-08 caaa826d4ba7…2026-08-18 06:07:40 2026-07 A089685-003 PERPHENAZINE 4MG TABLET / ORAL AB 1988-12-08 caaa826d4ba7…2026-08-18 06:07:40 2026-07 A089685-004 PERPHENAZINE 16MG TABLET / ORAL AB RS 1988-12-08 caaa826d4ba7…2026-02-19 14:30 UTC 2026-02 A089685-001 PERPHENAZINE 8MG TABLET / ORAL AB 1988-12-08 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 A089685-002 PERPHENAZINE 2MG TABLET / ORAL AB 1988-12-08 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 A089685-003 PERPHENAZINE 4MG TABLET / ORAL AB 1988-12-08 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 A089685-004 PERPHENAZINE 16MG TABLET / ORAL AB RS 1988-12-08 011fe1cb6892…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 A089685-001 PERPHENAZINE 8MG TABLET / ORAL AB 1988-12-08 31067a03dcf5…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 A089685-002 PERPHENAZINE 2MG TABLET / ORAL AB 1988-12-08 31067a03dcf5…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 A089685-003 PERPHENAZINE 4MG TABLET / ORAL AB 1988-12-08 31067a03dcf5…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 A089685-004 PERPHENAZINE 16MG TABLET / ORAL AB RS 1988-12-08 31067a03dcf5…2025-08-23 18:47 UTC 2025-08 A089685-001 PERPHENAZINE 8MG TABLET / ORAL AB 1988-12-08 6a471c1ec25d…2025-08-23 18:47 UTC 2025-08 A089685-002 PERPHENAZINE 2MG TABLET / ORAL AB 1988-12-08 6a471c1ec25d…2025-08-23 18:47 UTC 2025-08 A089685-003 PERPHENAZINE 4MG TABLET / ORAL AB 1988-12-08 6a471c1ec25d…2025-08-23 18:47 UTC 2025-08 A089685-004 PERPHENAZINE 16MG TABLET / ORAL AB RS 1988-12-08 6a471c1ec25d…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 A089685-001 PERPHENAZINE 8MG TABLET / ORAL AB 1988-12-08 fd3edfee7708…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 A089685-002 PERPHENAZINE 2MG TABLET / ORAL AB 1988-12-08 fd3edfee7708…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 A089685-003 PERPHENAZINE 4MG TABLET / ORAL AB 1988-12-08 fd3edfee7708…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 A089685-004 PERPHENAZINE 16MG TABLET / ORAL AB RS 1988-12-08 fd3edfee7708…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 A089685-001 PERPHENAZINE 8MG TABLET / ORAL AB 1988-12-08 b8a1b40f171c…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 A089685-002 PERPHENAZINE 2MG TABLET / ORAL AB 1988-12-08 b8a1b40f171c…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 A089685-003 PERPHENAZINE 4MG TABLET / ORAL AB 1988-12-08 b8a1b40f171c…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 A089685-004 PERPHENAZINE 16MG TABLET / ORAL AB RS 1988-12-08 b8a1b40f171c…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 A089685-001 PERPHENAZINE 8MG TABLET / ORAL AB 1988-12-08 03ed91905a0d…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 A089685-002 PERPHENAZINE 2MG TABLET / ORAL AB 1988-12-08 03ed91905a0d…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 A089685-003 PERPHENAZINE 4MG TABLET / ORAL AB 1988-12-08 03ed91905a0d…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 A089685-004 PERPHENAZINE 16MG TABLET / ORAL AB RS 1988-12-08 03ed91905a0d…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 A089685-001 PERPHENAZINE 8MG TABLET / ORAL AB 1988-12-08 2680178bc6a6…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 A089685-002 PERPHENAZINE 2MG TABLET / ORAL AB 1988-12-08 2680178bc6a6…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 A089685-003 PERPHENAZINE 4MG TABLET / ORAL AB 1988-12-08 2680178bc6a6…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 A089685-004 PERPHENAZINE 16MG TABLET / ORAL AB RS 1988-12-08 2680178bc6a6…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 A089685-001 PERPHENAZINE 8MG TABLET / ORAL AB 1988-12-08 5bbf6a4d5a75…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 A089685-002 PERPHENAZINE 2MG TABLET / ORAL AB 1988-12-08 5bbf6a4d5a75…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 A089685-003 PERPHENAZINE 4MG TABLET / ORAL AB 1988-12-08 5bbf6a4d5a75…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 A089685-004 PERPHENAZINE 16MG TABLET / ORAL AB RS 1988-12-08 5bbf6a4d5a75…2024-11-08 22:44 UTC · 3 captures of this ZIP 2024-11 A089685-001 PERPHENAZINE 8MG TABLET / ORAL AB 1988-12-08 d8e5a09893c0…2024-11-08 22:44 UTC · 3 captures of this ZIP 2024-11 A089685-002 PERPHENAZINE 2MG TABLET / ORAL AB 1988-12-08 d8e5a09893c0…2024-11-08 22:44 UTC · 3 captures of this ZIP 2024-11 A089685-003 PERPHENAZINE 4MG TABLET / ORAL AB 1988-12-08 d8e5a09893c0…2024-11-08 22:44 UTC · 3 captures of this ZIP 2024-11 A089685-004 PERPHENAZINE 16MG TABLET / ORAL AB RS 1988-12-08 d8e5a09893c0…
Observed Orange Book normalized TE history# Normalized TE history page 1 of 5 · 168 observed states.
Additional Listing Data#
Finished product Yes
Brand name base Perphenazine Active Ingredients# Ingredient, Strength table Ingredient Strength PERPHENAZINE 16 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# FDA-Initiated Inactive NDC Indexing# DailyMed Package Descriptions# Package NDC, Product, Description table Package NDC Product Description Form Quantity Strength SPL version 0781-8049-01 Perphenazine 100 in 1 BOTTLE TABLET, FILM COATED 100 4
DailyMed Dashboard NDC Coverage# NDC, Dashboard title, SPL version table NDC Dashboard title SPL version Validation Dashboard ZIP 0781-8049 PERPHENAZINE TABLET, FILM COATED [SANDOZ INC] 4 Current NDC, Legacy NDC, 1 package rows 20240322_fc32500c-cc42-4f85-9cee-88f983fcbc16.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 · 4 matching rows.
Brand, Generic, Manufacturer table Brand Generic Manufacturer SPL set ID Effective date Available safety fields Join Perphenazine PERPHENAZINE REMEDYREPACK INC. 9588d223-41e4-4bb2-9306-f082498404c5 2026-07-21 Boxed warning, Warnings, Adverse reactions Exact identifier application applno (ANDA): 089685 application number: ANDA089685 Perphenazine PERPHENAZINE REMEDYREPACK INC. da5519cd-7b96-4468-910c-87dffdb1888e 2026-07-01 Boxed warning, Warnings, Adverse reactions Exact identifier application applno (ANDA): 089685 application number: ANDA089685 Perphenazine PERPHENAZINE REMEDYREPACK INC. fc903628-248c-4d12-88b4-a551aeadb4d2 2026-06-17 Boxed warning, Warnings, Adverse reactions Exact identifier application applno (ANDA): 089685 application number: ANDA089685 Perphenazine PERPHENAZINE Sandoz Inc fc32500c-cc42-4f85-9cee-88f983fcbc16 2024-03-25 Boxed warning, Warnings, Adverse reactions Exact identifier application applno (ANDA): 089685 application number: ANDA089685 ndc (product): 0781-8049
DailyMed RxNorm Mappings# Packages# Package NDC, 11-digit format, Description table Package NDC 11-digit format Description Marketing start Marketing end Sample Exclude flag Status 0781-8049-01 00781804901 100 TABLET, FILM COATED in 1 BOTTLE (0781-8049-01) 2018-08-28 2027-03-21 No No Current