Home NDC 0378-0330 Perphenazine and Amitriptyline Hydrochloride
Product NDC 0378-0330
11-digit product format 003780330
Labeler code 0378
Product ID 0378-0330_a0ce12cc-6720-4bbe-9e86-41feb8e6d4cd
Type HUMAN PRESCRIPTION DRUG
Nonproprietary name perphenazine and amitriptyline hydrochloride
Dosage form TABLET, FILM COATED
Route ORAL
Labeler Mylan Pharmaceuticals Inc.
Application ANDA071443
Marketing category ANDA
Marketing start 1988-11-10
Substance AMITRIPTYLINE HYDROCHLORIDE; PERPHENAZINE
Active strength 10; 2 mg/1; mg/1
Pharmacologic classes Phenothiazine [EPC], Phenothiazines [CS], Tricyclic Antidepressant [EPC]
NDC exclude flag No
Listing certified through 2026-12-31
Current FDA listing Yes Observed NDC auxiliary status history# This history shows the information present in each captured FDA auxiliary file. It is not a continuous regulatory timeline, and a missing record does not establish a status.
Historic NDC status page 1 of 1 · 12 matching rows.
View current auxiliary records. · View the auxiliary file history.
Captured / source date, Snapshot, Source SHA-256 table Captured / source date Snapshot Source SHA-256 2025-12-14 17:58 UTC · source 2025-12-05 d630ba8d3edf…732f749b63fb…2025-08-27 00:01 UTC · source 2025-08-26 f5e01cc5f278…a2eaf40c39c3…2025-04-01 02:39 UTC · source 2025-03-31 2ef7874e63bc…57b86245f4fa…2025-03-28 20:22 UTC · source 2025-03-28 a1b67e2a42f9…c4cf2c586c0d…2025-03-22 03:12 UTC · source 2025-03-21 cfe11265f3b6…090c488252e2…2025-03-10 12:48 UTC · source 2025-03-10 cdf11ea48f46…ba0047e9e063…2025-02-02 03:52 UTC · source 2025-01-31 302b2466d912…e7b80fea0513…2025-01-20 13:05 UTC · source 2025-01-20 ed331223b511…672a5bd82f5f…2025-01-11 03:41 UTC · source 2025-01-10 0efc9e666f02…f202fb6c5f17…2024-11-09 02:27 UTC · source 2024-11-08 ad56d346431e…cc804d4bbf1e…2024-10-04 04:10 UTC · source 2024-10-03 367a005e9d99…383a685ebd0f…2024-07-10 04:00 UTC · source 2024-07-09 557ba5c1ecfa…9c80585c8c6e…
Source provenance: Browse the complete Orange Book source catalog · source snapshot 43 .
Orange Book products# Current product rows page 1 of 1 · 5 matching rows.
Application-product, Trade name, Ingredient table Application-product Trade name Ingredient Strength Dosage form / route TE codes RLD / RS Approval date A071443-001 PERPHENAZINE AND AMITRIPTYLINE HYDROCHLORIDE AMITRIPTYLINE HYDROCHLORIDE; PERPHENAZINE 50MG;4MG TABLET / ORAL RS 1988-11-10 A071443-002 PERPHENAZINE AND AMITRIPTYLINE HYDROCHLORIDE AMITRIPTYLINE HYDROCHLORIDE; PERPHENAZINE 10MG;2MG TABLET / ORAL 1988-11-10 A071443-003 PERPHENAZINE AND AMITRIPTYLINE HYDROCHLORIDE AMITRIPTYLINE HYDROCHLORIDE; PERPHENAZINE 10MG;4MG TABLET / ORAL 1988-11-10 A071443-004 PERPHENAZINE AND AMITRIPTYLINE HYDROCHLORIDE AMITRIPTYLINE HYDROCHLORIDE; PERPHENAZINE 25MG;2MG TABLET / ORAL RS 1988-11-10 A071443-005 PERPHENAZINE AND AMITRIPTYLINE HYDROCHLORIDE AMITRIPTYLINE HYDROCHLORIDE; PERPHENAZINE 25MG;4MG TABLET / ORAL RS 1988-11-10
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 6 · 215 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 2026-09-14 22:38:34 2026-08 A071443-001 PERPHENAZINE AND AMITRIPTYLINE HYDROCHLORIDE 50MG;4MG TABLET / ORAL RS 1988-11-10 84e616aacf4f…2026-09-14 22:38:34 2026-08 A071443-002 PERPHENAZINE AND AMITRIPTYLINE HYDROCHLORIDE 10MG;2MG TABLET / ORAL 1988-11-10 84e616aacf4f…2026-09-14 22:38:34 2026-08 A071443-003 PERPHENAZINE AND AMITRIPTYLINE HYDROCHLORIDE 10MG;4MG TABLET / ORAL 1988-11-10 84e616aacf4f…2026-09-14 22:38:34 2026-08 A071443-004 PERPHENAZINE AND AMITRIPTYLINE HYDROCHLORIDE 25MG;2MG TABLET / ORAL RS 1988-11-10 84e616aacf4f…2026-09-14 22:38:34 2026-08 A071443-005 PERPHENAZINE AND AMITRIPTYLINE HYDROCHLORIDE 25MG;4MG TABLET / ORAL RS 1988-11-10 84e616aacf4f…2026-08-18 06:07:40 2026-07 A071443-001 PERPHENAZINE AND AMITRIPTYLINE HYDROCHLORIDE 50MG;4MG TABLET / ORAL RS 1988-11-10 caaa826d4ba7…2026-08-18 06:07:40 2026-07 A071443-002 PERPHENAZINE AND AMITRIPTYLINE HYDROCHLORIDE 10MG;2MG TABLET / ORAL 1988-11-10 caaa826d4ba7…2026-08-18 06:07:40 2026-07 A071443-003 PERPHENAZINE AND AMITRIPTYLINE HYDROCHLORIDE 10MG;4MG TABLET / ORAL 1988-11-10 caaa826d4ba7…2026-08-18 06:07:40 2026-07 A071443-004 PERPHENAZINE AND AMITRIPTYLINE HYDROCHLORIDE 25MG;2MG TABLET / ORAL RS 1988-11-10 caaa826d4ba7…2026-08-18 06:07:40 2026-07 A071443-005 PERPHENAZINE AND AMITRIPTYLINE HYDROCHLORIDE 25MG;4MG TABLET / ORAL RS 1988-11-10 caaa826d4ba7…2026-02-19 14:30 UTC 2026-02 A071443-001 PERPHENAZINE AND AMITRIPTYLINE HYDROCHLORIDE 50MG;4MG TABLET / ORAL RS 1988-11-10 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 A071443-002 PERPHENAZINE AND AMITRIPTYLINE HYDROCHLORIDE 10MG;2MG TABLET / ORAL 1988-11-10 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 A071443-003 PERPHENAZINE AND AMITRIPTYLINE HYDROCHLORIDE 10MG;4MG TABLET / ORAL 1988-11-10 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 A071443-004 PERPHENAZINE AND AMITRIPTYLINE HYDROCHLORIDE 25MG;2MG TABLET / ORAL RS 1988-11-10 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 A071443-005 PERPHENAZINE AND AMITRIPTYLINE HYDROCHLORIDE 25MG;4MG TABLET / ORAL RS 1988-11-10 011fe1cb6892…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 A071443-001 PERPHENAZINE AND AMITRIPTYLINE HYDROCHLORIDE 50MG;4MG TABLET / ORAL RS 1988-11-10 31067a03dcf5…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 A071443-002 PERPHENAZINE AND AMITRIPTYLINE HYDROCHLORIDE 10MG;2MG TABLET / ORAL 1988-11-10 31067a03dcf5…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 A071443-003 PERPHENAZINE AND AMITRIPTYLINE HYDROCHLORIDE 10MG;4MG TABLET / ORAL 1988-11-10 31067a03dcf5…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 A071443-004 PERPHENAZINE AND AMITRIPTYLINE HYDROCHLORIDE 25MG;2MG TABLET / ORAL RS 1988-11-10 31067a03dcf5…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 A071443-005 PERPHENAZINE AND AMITRIPTYLINE HYDROCHLORIDE 25MG;4MG TABLET / ORAL RS 1988-11-10 31067a03dcf5…2025-08-23 18:47 UTC 2025-08 A071443-001 PERPHENAZINE AND AMITRIPTYLINE HYDROCHLORIDE 50MG;4MG TABLET / ORAL RS 1988-11-10 6a471c1ec25d…2025-08-23 18:47 UTC 2025-08 A071443-002 PERPHENAZINE AND AMITRIPTYLINE HYDROCHLORIDE 10MG;2MG TABLET / ORAL 1988-11-10 6a471c1ec25d…2025-08-23 18:47 UTC 2025-08 A071443-003 PERPHENAZINE AND AMITRIPTYLINE HYDROCHLORIDE 10MG;4MG TABLET / ORAL 1988-11-10 6a471c1ec25d…2025-08-23 18:47 UTC 2025-08 A071443-004 PERPHENAZINE AND AMITRIPTYLINE HYDROCHLORIDE 25MG;2MG TABLET / ORAL RS 1988-11-10 6a471c1ec25d…2025-08-23 18:47 UTC 2025-08 A071443-005 PERPHENAZINE AND AMITRIPTYLINE HYDROCHLORIDE 25MG;4MG TABLET / ORAL RS 1988-11-10 6a471c1ec25d…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 A071443-001 PERPHENAZINE AND AMITRIPTYLINE HYDROCHLORIDE 50MG;4MG TABLET / ORAL RS 1988-11-10 fd3edfee7708…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 A071443-002 PERPHENAZINE AND AMITRIPTYLINE HYDROCHLORIDE 10MG;2MG TABLET / ORAL 1988-11-10 fd3edfee7708…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 A071443-003 PERPHENAZINE AND AMITRIPTYLINE HYDROCHLORIDE 10MG;4MG TABLET / ORAL 1988-11-10 fd3edfee7708…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 A071443-004 PERPHENAZINE AND AMITRIPTYLINE HYDROCHLORIDE 25MG;2MG TABLET / ORAL RS 1988-11-10 fd3edfee7708…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 A071443-005 PERPHENAZINE AND AMITRIPTYLINE HYDROCHLORIDE 25MG;4MG TABLET / ORAL RS 1988-11-10 fd3edfee7708…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 A071443-001 PERPHENAZINE AND AMITRIPTYLINE HYDROCHLORIDE 50MG;4MG TABLET / ORAL RS 1988-11-10 b8a1b40f171c…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 A071443-002 PERPHENAZINE AND AMITRIPTYLINE HYDROCHLORIDE 10MG;2MG TABLET / ORAL 1988-11-10 b8a1b40f171c…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 A071443-003 PERPHENAZINE AND AMITRIPTYLINE HYDROCHLORIDE 10MG;4MG TABLET / ORAL 1988-11-10 b8a1b40f171c…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 A071443-004 PERPHENAZINE AND AMITRIPTYLINE HYDROCHLORIDE 25MG;2MG TABLET / ORAL RS 1988-11-10 b8a1b40f171c…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 A071443-005 PERPHENAZINE AND AMITRIPTYLINE HYDROCHLORIDE 25MG;4MG TABLET / ORAL RS 1988-11-10 b8a1b40f171c…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 A071443-001 PERPHENAZINE AND AMITRIPTYLINE HYDROCHLORIDE 50MG;4MG TABLET / ORAL RS 1988-11-10 03ed91905a0d…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 A071443-002 PERPHENAZINE AND AMITRIPTYLINE HYDROCHLORIDE 10MG;2MG TABLET / ORAL 1988-11-10 03ed91905a0d…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 A071443-003 PERPHENAZINE AND AMITRIPTYLINE HYDROCHLORIDE 10MG;4MG TABLET / ORAL 1988-11-10 03ed91905a0d…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 A071443-004 PERPHENAZINE AND AMITRIPTYLINE HYDROCHLORIDE 25MG;2MG TABLET / ORAL RS 1988-11-10 03ed91905a0d…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 A071443-005 PERPHENAZINE AND AMITRIPTYLINE HYDROCHLORIDE 25MG;4MG TABLET / ORAL RS 1988-11-10 03ed91905a0d…
Additional Listing Data#
Finished product Yes
Brand name base Perphenazine and Amitriptyline Hydrochloride
Listing expiration 2026-12-31 Active Ingredients# Ingredient, Strength table Ingredient Strength PERPHENAZINE 2 mg/1 AMITRIPTYLINE HYDROCHLORIDE 10 mg/1
Harmonized UNII identifiers# UNII identifiers page 1 of 1 · 2 matching rows.
Identifier, FDA.report destination table Identifier FDA.report destination 26LUD4JO9K Internal UNII lookup FTA7XXY4EZ Internal UNII lookup
Harmonized RxCUI identifiers# RxCUI identifiers page 1 of 1 · 5 matching rows.
Identifier, FDA.report destination table Identifier FDA.report destination 856706 Internal RxNorm lookup 856720 Internal RxNorm lookup 856797 Internal RxNorm lookup 856825 Internal RxNorm lookup 856840 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 0378-0330-01 Perphenazine and Amitriptyline Hydrochloride 100 in 1 BOTTLE, PLASTIC TABLET, FILM COATED 100 21 0378-0330-05 Perphenazine and Amitriptyline Hydrochloride 500 in 1 BOTTLE, PLASTIC TABLET, FILM COATED 500 21
DailyMed Socrata Ingredients# Ingredient, Type, UNII table Ingredient Type UNII DailyMed label SPL version Uploaded AMITRIPTYLINE HYDROCHLORIDE ACTIVE INGREDIENT 26LUD4JO9K PERPHENAZINE AND AMITRIPTYLINE HYDROCHLORIDE TABLET, FILM COATED [MYLAN PHARMACEUTICALS INC.] 7 PERPHENAZINE ACTIVE INGREDIENT FTA7XXY4EZ PERPHENAZINE AND AMITRIPTYLINE HYDROCHLORIDE TABLET, FILM COATED [MYLAN PHARMACEUTICALS INC.] 7 AMITRIPTYLINE ACTIVE MOIETY 1806D8D52K PERPHENAZINE AND AMITRIPTYLINE HYDROCHLORIDE TABLET, FILM COATED [MYLAN PHARMACEUTICALS INC.] 7 PERPHENAZINE ACTIVE MOIETY FTA7XXY4EZ PERPHENAZINE AND AMITRIPTYLINE HYDROCHLORIDE TABLET, FILM COATED [MYLAN PHARMACEUTICALS INC.] 7 CALCIUM SULFATE INACTIVE INGREDIENT WAT0DDB505 PERPHENAZINE AND AMITRIPTYLINE HYDROCHLORIDE TABLET, FILM COATED [MYLAN PHARMACEUTICALS INC.] 7 CELLULOSE, MICROCRYSTALLINE INACTIVE INGREDIENT OP1R32D61U PERPHENAZINE AND AMITRIPTYLINE HYDROCHLORIDE TABLET, FILM COATED [MYLAN PHARMACEUTICALS INC.] 7 CROSCARMELLOSE SODIUM INACTIVE INGREDIENT M28OL1HH48 PERPHENAZINE AND AMITRIPTYLINE HYDROCHLORIDE TABLET, FILM COATED [MYLAN PHARMACEUTICALS INC.] 7 D&C RED NO. 7 INACTIVE INGREDIENT ECW0LZ41X8 PERPHENAZINE AND AMITRIPTYLINE HYDROCHLORIDE TABLET, FILM COATED [MYLAN PHARMACEUTICALS INC.] 7 FD&C BLUE NO. 1 INACTIVE INGREDIENT H3R47K3TBD PERPHENAZINE AND AMITRIPTYLINE HYDROCHLORIDE TABLET, FILM COATED [MYLAN PHARMACEUTICALS INC.] 7 FD&C YELLOW NO. 6 INACTIVE INGREDIENT H77VEI93A8 PERPHENAZINE AND AMITRIPTYLINE HYDROCHLORIDE TABLET, FILM COATED [MYLAN PHARMACEUTICALS INC.] 7 HYDROXYPROPYL CELLULOSE (TYPE H) INACTIVE INGREDIENT RFW2ET671P PERPHENAZINE AND AMITRIPTYLINE HYDROCHLORIDE TABLET, FILM COATED [MYLAN PHARMACEUTICALS INC.] 7 HYPROMELLOSES INACTIVE INGREDIENT 3NXW29V3WO PERPHENAZINE AND AMITRIPTYLINE HYDROCHLORIDE TABLET, FILM COATED [MYLAN PHARMACEUTICALS INC.] 7 MAGNESIUM STEARATE INACTIVE INGREDIENT 70097M6I30 PERPHENAZINE AND AMITRIPTYLINE HYDROCHLORIDE TABLET, FILM COATED [MYLAN PHARMACEUTICALS INC.] 7 POLYETHYLENE GLYCOLS INACTIVE INGREDIENT 3WJQ0SDW1A PERPHENAZINE AND AMITRIPTYLINE HYDROCHLORIDE TABLET, FILM COATED [MYLAN PHARMACEUTICALS INC.] 7 POLYSORBATE 80 INACTIVE INGREDIENT 6OZP39ZG8H PERPHENAZINE AND AMITRIPTYLINE HYDROCHLORIDE TABLET, FILM COATED [MYLAN PHARMACEUTICALS INC.] 7 SILICON DIOXIDE INACTIVE INGREDIENT ETJ7Z6XBU4 PERPHENAZINE AND AMITRIPTYLINE HYDROCHLORIDE TABLET, FILM COATED [MYLAN PHARMACEUTICALS INC.] 7 SODIUM LAURYL SULFATE INACTIVE INGREDIENT 368GB5141J PERPHENAZINE AND AMITRIPTYLINE HYDROCHLORIDE TABLET, FILM COATED [MYLAN PHARMACEUTICALS INC.] 7 STARCH, CORN INACTIVE INGREDIENT O8232NY3SJ PERPHENAZINE AND AMITRIPTYLINE HYDROCHLORIDE TABLET, FILM COATED [MYLAN PHARMACEUTICALS INC.] 7 TALC INACTIVE INGREDIENT 7SEV7J4R1U PERPHENAZINE AND AMITRIPTYLINE HYDROCHLORIDE TABLET, FILM COATED [MYLAN PHARMACEUTICALS INC.] 7 TITANIUM DIOXIDE INACTIVE INGREDIENT 15FIX9V2JP PERPHENAZINE AND AMITRIPTYLINE HYDROCHLORIDE TABLET, FILM COATED [MYLAN PHARMACEUTICALS INC.] 7
DailyMed Dashboard NDC Coverage# NDC, Dashboard title, SPL version table NDC Dashboard title SPL version Validation Dashboard ZIP 0378-0330 PERPHENAZINE AND AMITRIPTYLINE HYDROCHLORIDE TABLET, FILM COATED [MYLAN PHARMACEUTICALS INC.] 20 Current NDC, Legacy NDC, 2 package rows 20250411_e2937445-c015-c9a5-52f8-a2959da97290.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 · 1 matching rows.
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 0378-0330-01 00378033001 100 TABLET, FILM COATED in 1 BOTTLE, PLASTIC (0378-0330-01) 1988-11-10 0000-00-00 No No Current 0378-0330-05 00378033005 500 TABLET, FILM COATED in 1 BOTTLE, PLASTIC (0378-0330-05) 1988-11-10 2022-11-30 No No Current