FDA.reportPublic FDA data

Perphenazine and Amitriptyline Hydrochloride

Product NDC
0378-0042
11-digit product format
003780042
Labeler code
0378
Product ID
0378-0042_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; 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

Additional Listing Data#

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

Active Ingredients#

Ingredient, Strength table
IngredientStrength
AMITRIPTYLINE HYDROCHLORIDE10 mg/1
PERPHENAZINE4 mg/1

Harmonized Identifiers#

Field, Values table
FieldValues
UniiFTA7XXY4EZ, 26LUD4JO9K
Rxcui856706, 856720, 856797, 856825, 856840

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
0378-0042-01Perphenazine 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
0378-0042-01EA - Each0378-0042c628de1b-a788-40f5-818b-5a3d057ac11f12012-07-24

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
0378-0042PERPHENAZINE AND AMITRIPTYLINE HYDROCHLORIDE TABLET, FILM COATED [MYLAN PHARMACEUTICALS INC.]20Current NDC, Legacy NDC, 1 package rows20250411_e2937445-c015-c9a5-52f8-a2959da97290.zip

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
0378-0042-0100378004201100 TABLET, FILM COATED in 1 BOTTLE, PLASTIC (0378-0042-01) 1988-11-100000-00-00NoNoCurrent