FDA.reportPublic FDA data

Perphenazine and Amitriptyline Hydrochloride

Product NDC
0378-0073
11-digit product format
003780073
Labeler code
0378
Product ID
0378-0073_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
50; 4 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

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-productTrade nameIngredientStrengthDosage form / routeTE codesRLD / RSApproval date
A071443-001PERPHENAZINE AND AMITRIPTYLINE HYDROCHLORIDEAMITRIPTYLINE HYDROCHLORIDE; PERPHENAZINE50MG;4MGTABLET / ORALRS1988-11-10
A071443-002PERPHENAZINE AND AMITRIPTYLINE HYDROCHLORIDEAMITRIPTYLINE HYDROCHLORIDE; PERPHENAZINE10MG;2MGTABLET / ORAL1988-11-10
A071443-003PERPHENAZINE AND AMITRIPTYLINE HYDROCHLORIDEAMITRIPTYLINE HYDROCHLORIDE; PERPHENAZINE10MG;4MGTABLET / ORAL1988-11-10
A071443-004PERPHENAZINE AND AMITRIPTYLINE HYDROCHLORIDEAMITRIPTYLINE HYDROCHLORIDE; PERPHENAZINE25MG;2MGTABLET / ORALRS1988-11-10
A071443-005PERPHENAZINE AND AMITRIPTYLINE HYDROCHLORIDEAMITRIPTYLINE HYDROCHLORIDE; PERPHENAZINE25MG;4MGTABLET / ORALRS1988-11-10

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
CapturedEditionApplication-productTrade nameStrengthDosage form / routeProduct TE source textRLD / RSApproval dateSource SHA-256
2026-02-19 14:30 UTC2026-02A071443-001PERPHENAZINE AND AMITRIPTYLINE HYDROCHLORIDE50MG;4MGTABLET / ORALRS1988-11-10011fe1cb6892…
2026-02-19 14:30 UTC2026-02A071443-002PERPHENAZINE AND AMITRIPTYLINE HYDROCHLORIDE10MG;2MGTABLET / ORAL1988-11-10011fe1cb6892…
2026-02-19 14:30 UTC2026-02A071443-003PERPHENAZINE AND AMITRIPTYLINE HYDROCHLORIDE10MG;4MGTABLET / ORAL1988-11-10011fe1cb6892…
2026-02-19 14:30 UTC2026-02A071443-004PERPHENAZINE AND AMITRIPTYLINE HYDROCHLORIDE25MG;2MGTABLET / ORALRS1988-11-10011fe1cb6892…
2026-02-19 14:30 UTC2026-02A071443-005PERPHENAZINE AND AMITRIPTYLINE HYDROCHLORIDE25MG;4MGTABLET / ORALRS1988-11-10011fe1cb6892…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A071443-001PERPHENAZINE AND AMITRIPTYLINE HYDROCHLORIDE50MG;4MGTABLET / ORALRS1988-11-1031067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A071443-002PERPHENAZINE AND AMITRIPTYLINE HYDROCHLORIDE10MG;2MGTABLET / ORAL1988-11-1031067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A071443-003PERPHENAZINE AND AMITRIPTYLINE HYDROCHLORIDE10MG;4MGTABLET / ORAL1988-11-1031067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A071443-004PERPHENAZINE AND AMITRIPTYLINE HYDROCHLORIDE25MG;2MGTABLET / ORALRS1988-11-1031067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A071443-005PERPHENAZINE AND AMITRIPTYLINE HYDROCHLORIDE25MG;4MGTABLET / ORALRS1988-11-1031067a03dcf5…
2025-08-23 18:47 UTC2025-08A071443-001PERPHENAZINE AND AMITRIPTYLINE HYDROCHLORIDE50MG;4MGTABLET / ORALRS1988-11-106a471c1ec25d…
2025-08-23 18:47 UTC2025-08A071443-002PERPHENAZINE AND AMITRIPTYLINE HYDROCHLORIDE10MG;2MGTABLET / ORAL1988-11-106a471c1ec25d…
2025-08-23 18:47 UTC2025-08A071443-003PERPHENAZINE AND AMITRIPTYLINE HYDROCHLORIDE10MG;4MGTABLET / ORAL1988-11-106a471c1ec25d…
2025-08-23 18:47 UTC2025-08A071443-004PERPHENAZINE AND AMITRIPTYLINE HYDROCHLORIDE25MG;2MGTABLET / ORALRS1988-11-106a471c1ec25d…
2025-08-23 18:47 UTC2025-08A071443-005PERPHENAZINE AND AMITRIPTYLINE HYDROCHLORIDE25MG;4MGTABLET / ORALRS1988-11-106a471c1ec25d…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A071443-001PERPHENAZINE AND AMITRIPTYLINE HYDROCHLORIDE50MG;4MGTABLET / ORALRS1988-11-10fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A071443-002PERPHENAZINE AND AMITRIPTYLINE HYDROCHLORIDE10MG;2MGTABLET / ORAL1988-11-10fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A071443-003PERPHENAZINE AND AMITRIPTYLINE HYDROCHLORIDE10MG;4MGTABLET / ORAL1988-11-10fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A071443-004PERPHENAZINE AND AMITRIPTYLINE HYDROCHLORIDE25MG;2MGTABLET / ORALRS1988-11-10fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A071443-005PERPHENAZINE AND AMITRIPTYLINE HYDROCHLORIDE25MG;4MGTABLET / ORALRS1988-11-10fd3edfee7708…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A071443-001PERPHENAZINE AND AMITRIPTYLINE HYDROCHLORIDE50MG;4MGTABLET / ORALRS1988-11-10b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A071443-002PERPHENAZINE AND AMITRIPTYLINE HYDROCHLORIDE10MG;2MGTABLET / ORAL1988-11-10b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A071443-003PERPHENAZINE AND AMITRIPTYLINE HYDROCHLORIDE10MG;4MGTABLET / ORAL1988-11-10b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A071443-004PERPHENAZINE AND AMITRIPTYLINE HYDROCHLORIDE25MG;2MGTABLET / ORALRS1988-11-10b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A071443-005PERPHENAZINE AND AMITRIPTYLINE HYDROCHLORIDE25MG;4MGTABLET / ORALRS1988-11-10b8a1b40f171c…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A071443-001PERPHENAZINE AND AMITRIPTYLINE HYDROCHLORIDE50MG;4MGTABLET / ORALRS1988-11-1003ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A071443-002PERPHENAZINE AND AMITRIPTYLINE HYDROCHLORIDE10MG;2MGTABLET / ORAL1988-11-1003ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A071443-003PERPHENAZINE AND AMITRIPTYLINE HYDROCHLORIDE10MG;4MGTABLET / ORAL1988-11-1003ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A071443-004PERPHENAZINE AND AMITRIPTYLINE HYDROCHLORIDE25MG;2MGTABLET / ORALRS1988-11-1003ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A071443-005PERPHENAZINE AND AMITRIPTYLINE HYDROCHLORIDE25MG;4MGTABLET / ORALRS1988-11-1003ed91905a0d…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A071443-001PERPHENAZINE AND AMITRIPTYLINE HYDROCHLORIDE50MG;4MGTABLET / ORALRS1988-11-102680178bc6a6…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A071443-002PERPHENAZINE AND AMITRIPTYLINE HYDROCHLORIDE10MG;2MGTABLET / ORAL1988-11-102680178bc6a6…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A071443-003PERPHENAZINE AND AMITRIPTYLINE HYDROCHLORIDE10MG;4MGTABLET / ORAL1988-11-102680178bc6a6…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A071443-004PERPHENAZINE AND AMITRIPTYLINE HYDROCHLORIDE25MG;2MGTABLET / ORALRS1988-11-102680178bc6a6…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A071443-005PERPHENAZINE AND AMITRIPTYLINE HYDROCHLORIDE25MG;4MGTABLET / ORALRS1988-11-102680178bc6a6…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A071443-001PERPHENAZINE AND AMITRIPTYLINE HYDROCHLORIDE50MG;4MGTABLET / ORALRS1988-11-105bbf6a4d5a75…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A071443-002PERPHENAZINE AND AMITRIPTYLINE HYDROCHLORIDE10MG;2MGTABLET / ORAL1988-11-105bbf6a4d5a75…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A071443-003PERPHENAZINE AND AMITRIPTYLINE HYDROCHLORIDE10MG;4MGTABLET / ORAL1988-11-105bbf6a4d5a75…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A071443-004PERPHENAZINE AND AMITRIPTYLINE HYDROCHLORIDE25MG;2MGTABLET / ORALRS1988-11-105bbf6a4d5a75…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A071443-005PERPHENAZINE AND AMITRIPTYLINE HYDROCHLORIDE25MG;4MGTABLET / ORALRS1988-11-105bbf6a4d5a75…

Additional Listing Data#

Finished product
Yes
Brand name base
Perphenazine and Amitriptyline Hydrochloride
Listing expiration
2026-12-31

Active Ingredients#

Ingredient, Strength table
IngredientStrength
PERPHENAZINE50 mg/1
AMITRIPTYLINE HYDROCHLORIDE4 mg/1

Harmonized UNII identifiers#

UNII identifiers page 1 of 1 · 2 matching rows.

Identifier, FDA.report destination table
IdentifierFDA.report destination
26LUD4JO9KInternal UNII lookup
FTA7XXY4EZInternal UNII lookup

Harmonized RxCUI identifiers#

RxCUI identifiers page 1 of 1 · 5 matching rows.

Identifier, FDA.report destination table
IdentifierFDA.report destination
856706Internal RxNorm lookup
856720Internal RxNorm lookup
856797Internal RxNorm lookup
856825Internal RxNorm lookup
856840Internal RxNorm lookup

Harmonized SPL set identifiers#

SPL set identifiers page 1 of 1 · 1 matching rows.

Identifier, FDA.report destination table
IdentifierFDA.report destination
e2937445-c015-c9a5-52f8-a2959da97290Available on FDA.report

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
16c7ce1f-d1cb-56cf-bc49-4eaa8b55e0a1Product name920260106
e5006e90-7f2e-4341-bcdb-f83027a8fc39Product name620240611
6f1277d7-db3a-63fa-be84-d390d1482706Product name120140508
aa9828b2-adf8-0dd3-9f6c-b68f39e467c1Product name120140508

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
0378-0073-01Perphenazine and Amitriptyline Hydrochloride100 in 1 BOTTLE, PLASTICTABLET, FILM COATED10021

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
0378-0073-01EA - Each0378-0073ba96ced1-83c1-43d2-871e-85a9dba9c5bd12012-07-24

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIIDailyMed labelSPL versionUploaded
AMITRIPTYLINE HYDROCHLORIDEACTIVE INGREDIENT26LUD4JO9KPERPHENAZINE AND AMITRIPTYLINE HYDROCHLORIDE TABLET, FILM COATED [MYLAN PHARMACEUTICALS INC.]7
PERPHENAZINEACTIVE INGREDIENTFTA7XXY4EZPERPHENAZINE AND AMITRIPTYLINE HYDROCHLORIDE TABLET, FILM COATED [MYLAN PHARMACEUTICALS INC.]7
AMITRIPTYLINEACTIVE MOIETY1806D8D52KPERPHENAZINE AND AMITRIPTYLINE HYDROCHLORIDE TABLET, FILM COATED [MYLAN PHARMACEUTICALS INC.]7
PERPHENAZINEACTIVE MOIETYFTA7XXY4EZPERPHENAZINE AND AMITRIPTYLINE HYDROCHLORIDE TABLET, FILM COATED [MYLAN PHARMACEUTICALS INC.]7
CALCIUM SULFATEINACTIVE INGREDIENTWAT0DDB505PERPHENAZINE AND AMITRIPTYLINE HYDROCHLORIDE TABLET, FILM COATED [MYLAN PHARMACEUTICALS INC.]7
CELLULOSE, MICROCRYSTALLINEINACTIVE INGREDIENTOP1R32D61UPERPHENAZINE AND AMITRIPTYLINE HYDROCHLORIDE TABLET, FILM COATED [MYLAN PHARMACEUTICALS INC.]7
CROSCARMELLOSE SODIUMINACTIVE INGREDIENTM28OL1HH48PERPHENAZINE AND AMITRIPTYLINE HYDROCHLORIDE TABLET, FILM COATED [MYLAN PHARMACEUTICALS INC.]7
D&C RED NO. 7INACTIVE INGREDIENTECW0LZ41X8PERPHENAZINE AND AMITRIPTYLINE HYDROCHLORIDE TABLET, FILM COATED [MYLAN PHARMACEUTICALS INC.]7
FD&C BLUE NO. 1INACTIVE INGREDIENTH3R47K3TBDPERPHENAZINE AND AMITRIPTYLINE HYDROCHLORIDE TABLET, FILM COATED [MYLAN PHARMACEUTICALS INC.]7
FD&C YELLOW NO. 6INACTIVE INGREDIENTH77VEI93A8PERPHENAZINE AND AMITRIPTYLINE HYDROCHLORIDE TABLET, FILM COATED [MYLAN PHARMACEUTICALS INC.]7
HYDROXYPROPYL CELLULOSE (TYPE H)INACTIVE INGREDIENTRFW2ET671PPERPHENAZINE AND AMITRIPTYLINE HYDROCHLORIDE TABLET, FILM COATED [MYLAN PHARMACEUTICALS INC.]7
HYPROMELLOSESINACTIVE INGREDIENT3NXW29V3WOPERPHENAZINE AND AMITRIPTYLINE HYDROCHLORIDE TABLET, FILM COATED [MYLAN PHARMACEUTICALS INC.]7
MAGNESIUM STEARATEINACTIVE INGREDIENT70097M6I30PERPHENAZINE AND AMITRIPTYLINE HYDROCHLORIDE TABLET, FILM COATED [MYLAN PHARMACEUTICALS INC.]7
POLYETHYLENE GLYCOLSINACTIVE INGREDIENT3WJQ0SDW1APERPHENAZINE AND AMITRIPTYLINE HYDROCHLORIDE TABLET, FILM COATED [MYLAN PHARMACEUTICALS INC.]7
POLYSORBATE 80INACTIVE INGREDIENT6OZP39ZG8HPERPHENAZINE AND AMITRIPTYLINE HYDROCHLORIDE TABLET, FILM COATED [MYLAN PHARMACEUTICALS INC.]7
SILICON DIOXIDEINACTIVE INGREDIENTETJ7Z6XBU4PERPHENAZINE AND AMITRIPTYLINE HYDROCHLORIDE TABLET, FILM COATED [MYLAN PHARMACEUTICALS INC.]7
SODIUM LAURYL SULFATEINACTIVE INGREDIENT368GB5141JPERPHENAZINE AND AMITRIPTYLINE HYDROCHLORIDE TABLET, FILM COATED [MYLAN PHARMACEUTICALS INC.]7
STARCH, CORNINACTIVE INGREDIENTO8232NY3SJPERPHENAZINE AND AMITRIPTYLINE HYDROCHLORIDE TABLET, FILM COATED [MYLAN PHARMACEUTICALS INC.]7
TALCINACTIVE INGREDIENT7SEV7J4R1UPERPHENAZINE AND AMITRIPTYLINE HYDROCHLORIDE TABLET, FILM COATED [MYLAN PHARMACEUTICALS INC.]7
TITANIUM DIOXIDEINACTIVE INGREDIENT15FIX9V2JPPERPHENAZINE AND AMITRIPTYLINE HYDROCHLORIDE TABLET, FILM COATED [MYLAN PHARMACEUTICALS INC.]7

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
0378-0073PERPHENAZINE AND AMITRIPTYLINE HYDROCHLORIDE TABLET, FILM COATED [MYLAN PHARMACEUTICALS INC.]20Current NDC, Legacy NDC, 1 package rows20250411_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
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
Perphenazine and Amitriptyline HydrochloridePERPHENAZINE AND AMITRIPTYLINE HYDROCHLORIDEMylan Pharmaceuticals Inc.e2937445-c015-c9a5-52f8-a2959da972902025-08-30Boxed warning, Warnings, Adverse reactionsExact identifier
application applno (ANDA): 071443
application number: ANDA071443
ndc (product): 0378-0073

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
856706perphenazine 2 MG / amitriptyline HCl 10 MG Oral TabletPSNe2937445-c015-c9a5-52f8-a2959da9729021
856797perphenazine 2 MG / amitriptyline HCl 25 MG Oral TabletPSNe2937445-c015-c9a5-52f8-a2959da9729021
856720perphenazine 4 MG / amitriptyline HCl 10 MG Oral TabletPSNe2937445-c015-c9a5-52f8-a2959da9729021
856825perphenazine 4 MG / amitriptyline HCl 25 MG Oral TabletPSNe2937445-c015-c9a5-52f8-a2959da9729021
856840perphenazine 4 MG / amitriptyline HCl 50 MG Oral TabletPSNe2937445-c015-c9a5-52f8-a2959da9729021
856706amitriptyline hydrochloride 10 MG / perphenazine 2 MG Oral TabletSCDe2937445-c015-c9a5-52f8-a2959da9729021
856720amitriptyline hydrochloride 10 MG / perphenazine 4 MG Oral TabletSCDe2937445-c015-c9a5-52f8-a2959da9729021
856797amitriptyline hydrochloride 25 MG / perphenazine 2 MG Oral TabletSCDe2937445-c015-c9a5-52f8-a2959da9729021
856825amitriptyline hydrochloride 25 MG / perphenazine 4 MG Oral TabletSCDe2937445-c015-c9a5-52f8-a2959da9729021
856840amitriptyline hydrochloride 50 MG / perphenazine 4 MG Oral TabletSCDe2937445-c015-c9a5-52f8-a2959da9729021

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionMarketing startMarketing endSampleExclude flagStatus
0378-0073-0100378007301100 TABLET, FILM COATED in 1 BOTTLE, PLASTIC (0378-0073-01) 1988-11-100000-00-00NoNoCurrent