Perphenazine and Amitriptyline Hydrochloride

Product NDC: 0378-0330
Requested package NDC: 0378-0330-05
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

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 · 1 matching rows.

Dataset, Scope, Product NDC table
Dataset	Scope	Product NDC	Package NDC	Code	Status	Reporting period	Source date
excluded package	package	0378-0330	0378-0330-05	D	Discontinued by firm		2026-08-03

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 1.

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	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 · 205 observed states.

Captured, Edition, Application-product table
Captured	Edition	Application-product	Trade name	Strength	Dosage form / route	RLD / RS	Approval date	Source SHA-256
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…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A071443-001	PERPHENAZINE AND AMITRIPTYLINE HYDROCHLORIDE	50MG;4MG	TABLET / ORAL	RS	1988-11-10	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A071443-002	PERPHENAZINE AND AMITRIPTYLINE HYDROCHLORIDE	10MG;2MG	TABLET / ORAL		1988-11-10	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A071443-003	PERPHENAZINE AND AMITRIPTYLINE HYDROCHLORIDE	10MG;4MG	TABLET / ORAL		1988-11-10	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A071443-004	PERPHENAZINE AND AMITRIPTYLINE HYDROCHLORIDE	25MG;2MG	TABLET / ORAL	RS	1988-11-10	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A071443-005	PERPHENAZINE AND AMITRIPTYLINE HYDROCHLORIDE	25MG;4MG	TABLET / ORAL	RS	1988-11-10	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A071443-001	PERPHENAZINE AND AMITRIPTYLINE HYDROCHLORIDE	50MG;4MG	TABLET / ORAL	RS	1988-11-10	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A071443-002	PERPHENAZINE AND AMITRIPTYLINE HYDROCHLORIDE	10MG;2MG	TABLET / ORAL		1988-11-10	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A071443-003	PERPHENAZINE AND AMITRIPTYLINE HYDROCHLORIDE	10MG;4MG	TABLET / ORAL		1988-11-10	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A071443-004	PERPHENAZINE AND AMITRIPTYLINE HYDROCHLORIDE	25MG;2MG	TABLET / ORAL	RS	1988-11-10	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A071443-005	PERPHENAZINE AND AMITRIPTYLINE HYDROCHLORIDE	25MG;4MG	TABLET / ORAL	RS	1988-11-10	`5bbf6a4d5a75…`

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	10 mg/1
AMITRIPTYLINE HYDROCHLORIDE	2 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.

Identifier, FDA.report destination table
Identifier	FDA.report destination
e2937445-c015-c9a5-52f8-a2959da97290	Available on FDA.report

DailyMed Product Concepts#

Product concept, Relation, Version table
Product concept	Relation	Version	Effective
16c7ce1f-d1cb-56cf-bc49-4eaa8b55e0a1	Product name	9	20260106
e5006e90-7f2e-4341-bcdb-f83027a8fc39	Product name	6	20240611
6f1277d7-db3a-63fa-be84-d390d1482706	Product name	1	20140508
aa9828b2-adf8-0dd3-9f6c-b68f39e467c1	Product name	1	20140508

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 Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDC	Billing unit	Product NDC	DailyMed indexing SPL	SPL version	Effective
0378-0330-01	EA - Each	0378-0330	3a281f45-3440-4d47-b54e-3c80d8db8512	1	2012-07-24
0378-0330-05	EA - Each	0378-0330	af991f7b-dc6f-413b-8d28-6446cbab6501	1	2012-07-24

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
Ingredient	Type	UNII	DailyMed label	SPL version
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.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
Perphenazine and Amitriptyline Hydrochloride	PERPHENAZINE AND AMITRIPTYLINE HYDROCHLORIDE	Mylan Pharmaceuticals Inc.	e2937445-c015-c9a5-52f8-a2959da97290	2025-08-30	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 071443 application number: ANDA071443 ndc (package): 0378-0330-05 ndc (product): 0378-0330 ndc11 (package): 00378033005

UNII, Preferred term, Registry number table
UNII	Preferred term	Registry number	Matched term
26LUD4JO9K	AMITRIPTYLINE HYDROCHLORIDE	549-18-8	AMITRIPTYLINE HYDROCHLORIDE
FTA7XXY4EZ	PERPHENAZINE	58-39-9	PERPHENAZINE

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUI	RxNorm string	TTY	DailyMed	SPL version
856706	perphenazine 2 MG / amitriptyline HCl 10 MG Oral Tablet	PSN	e2937445-c015-c9a5-52f8-a2959da97290	21
856797	perphenazine 2 MG / amitriptyline HCl 25 MG Oral Tablet	PSN	e2937445-c015-c9a5-52f8-a2959da97290	21
856720	perphenazine 4 MG / amitriptyline HCl 10 MG Oral Tablet	PSN	e2937445-c015-c9a5-52f8-a2959da97290	21
856825	perphenazine 4 MG / amitriptyline HCl 25 MG Oral Tablet	PSN	e2937445-c015-c9a5-52f8-a2959da97290	21
856840	perphenazine 4 MG / amitriptyline HCl 50 MG Oral Tablet	PSN	e2937445-c015-c9a5-52f8-a2959da97290	21
856706	amitriptyline hydrochloride 10 MG / perphenazine 2 MG Oral Tablet	SCD	e2937445-c015-c9a5-52f8-a2959da97290	21
856720	amitriptyline hydrochloride 10 MG / perphenazine 4 MG Oral Tablet	SCD	e2937445-c015-c9a5-52f8-a2959da97290	21
856797	amitriptyline hydrochloride 25 MG / perphenazine 2 MG Oral Tablet	SCD	e2937445-c015-c9a5-52f8-a2959da97290	21
856825	amitriptyline hydrochloride 25 MG / perphenazine 4 MG Oral Tablet	SCD	e2937445-c015-c9a5-52f8-a2959da97290	21
856840	amitriptyline hydrochloride 50 MG / perphenazine 4 MG Oral Tablet	SCD	e2937445-c015-c9a5-52f8-a2959da97290	21

Packages#

Package NDC, 11-digit format, Description table
Package NDC	11-digit format	Description	Marketing start	Marketing end	Sample	Exclude flag	Status
0378-0330-05	00378033005	500 TABLET, FILM COATED in 1 BOTTLE, PLASTIC (0378-0330-05)	1988-11-10	2022-11-30	No	No	Current

Title, Manufacturer, Effective date table
Title	Manufacturer	Effective date	Type	Version
Perphenazine and Amitriptyline Hydrochloride	Mylan Pharmaceuticals Inc.	2025-08-30	HUMAN PRESCRIPTION DRUG LABEL	21