perphenazine and amitriptyline hydrochloride (0378-0442)

Drug Facts

Product Profile

Brand Name perphenazine and amitriptyline hydrochloride

Generic Name perphenazine and amitriptyline hydrochloride

Labeler mylan pharmaceuticals inc.

Dosage Form TABLET, FILM COATED

Routes

ORAL

Active Ingredients

amitriptyline hydrochloride 25 mg/1, perphenazine 2 mg/1

Manufacturer

Mylan Pharmaceuticals Inc.

Identifiers & Regulatory

Product NDC 0378-0442

Product ID 0378-0442_a0ce12cc-6720-4bbe-9e86-41feb8e6d4cd

Product Type HUMAN PRESCRIPTION DRUG

Marketing Category ANDA

Application Number ANDA071443

Listing Expiration 2026-12-31

Marketing Start 1988-11-10

Pharmacologic Class

Established (EPC)

phenothiazine [epc]

Chemical Structure

phenothiazines [cs]

Normalized Code Variants

Searchable formats for this product NDC code

Digits Only 03780442

Hyphenated Format 0378-0442

Supplemental Identifiers

RxCUI

856706 856720 856797 856825 856840

UNII

26LUD4JO9K FTA7XXY4EZ

NUI

N0000175746 M0016525

Packaging Origin

Original Packager

true

Resolved Product View

Precedence rule: structured NDC data is preferred, falling back to linked label metadata when unavailable. Source tags show the origin of each value.

Resolved Identity

Brand Name perphenazine and amitriptyline hydrochloride (source: ndc)

Generic Name perphenazine and amitriptyline hydrochloride (source: ndc)

Application Number ANDA071443 (source: ndc)

Routes

ORAL

source: ndc

Resolved Composition

Strengths

25 mg/1
2 mg/1

source: ndc

Packaging

100 TABLET, FILM COATED in 1 BOTTLE, PLASTIC (0378-0442-01)

source: ndc

Packages (1)

0378-0442-01 100 TABLET, FILM COATED in 1 BOTTLE, PLASTIC (0378-0442-01)

Ingredients (2)

amitriptyline hydrochloride (25 mg/1) perphenazine (2 mg/1)

Linked Drug Pages (1)

Perphenazine and Amitriptyline Hydrochloride ndc-match (0.9)

Raw FDA Data

View complete raw FDA NDC JSON payload

{"route": ["ORAL"], "spl_id": "a0ce12cc-6720-4bbe-9e86-41feb8e6d4cd", "openfda": {"nui": ["N0000175746", "M0016525"], "unii": ["26LUD4JO9K", "FTA7XXY4EZ"], "rxcui": ["856706", "856720", "856797", "856825", "856840"], "spl_set_id": ["e2937445-c015-c9a5-52f8-a2959da97290"], "pharm_class_cs": ["Phenothiazines [CS]"], "pharm_class_epc": ["Phenothiazine [EPC]"], "manufacturer_name": ["Mylan Pharmaceuticals Inc."], "is_original_packager": [true]}, "finished": true, "packaging": [{"sample": false, "description": "100 TABLET, FILM COATED in 1 BOTTLE, PLASTIC (0378-0442-01)", "package_ndc": "0378-0442-01", "marketing_start_date": "19881110"}], "brand_name": "Perphenazine and Amitriptyline Hydrochloride", "product_id": "0378-0442_a0ce12cc-6720-4bbe-9e86-41feb8e6d4cd", "dosage_form": "TABLET, FILM COATED", "pharm_class": ["Phenothiazine [EPC]", "Phenothiazines [CS]", "Tricyclic Antidepressant [EPC]"], "product_ndc": "0378-0442", "generic_name": "perphenazine and amitriptyline hydrochloride", "labeler_name": "Mylan Pharmaceuticals Inc.", "product_type": "HUMAN PRESCRIPTION DRUG", "brand_name_base": "Perphenazine and Amitriptyline Hydrochloride", "active_ingredients": [{"name": "AMITRIPTYLINE HYDROCHLORIDE", "strength": "25 mg/1"}, {"name": "PERPHENAZINE", "strength": "2 mg/1"}], "application_number": "ANDA071443", "marketing_category": "ANDA", "marketing_start_date": "19881110", "listing_expiration_date": "20261231"}