perphenazine and amitriptyline hydrochloride

Generic: perphenazine and amitriptyline hydrochloride

Labeler: mylan pharmaceuticals inc.
NDC Directory HUMAN PRESCRIPTION DRUG ANDA Inactive Finished

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 4 mg/1

Manufacturer
Mylan Pharmaceuticals Inc.

Identifiers & Regulatory

Product NDC 0378-0574
Product ID 0378-0574_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 03780574
Hyphenated Format 0378-0574

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
  • 4 mg/1
source: ndc
Packaging
  • 100 TABLET, FILM COATED in 1 BOTTLE, PLASTIC (0378-0574-01)
source: ndc

Packages (1)

0378-0574-01 100 TABLET, FILM COATED in 1 BOTTLE, PLASTIC (0378-0574-01)

Ingredients (2)

amitriptyline hydrochloride (25 mg/1) perphenazine (4 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 (0378-0574-01)", "package_ndc": "0378-0574-01", "marketing_start_date": "19881110"}], "brand_name": "Perphenazine and Amitriptyline Hydrochloride", "product_id": "0378-0574_a0ce12cc-6720-4bbe-9e86-41feb8e6d4cd", "dosage_form": "TABLET, FILM COATED", "pharm_class": ["Phenothiazine [EPC]", "Phenothiazines [CS]", "Tricyclic Antidepressant [EPC]"], "product_ndc": "0378-0574", "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": "4 mg/1"}], "application_number": "ANDA071443", "marketing_category": "ANDA", "marketing_start_date": "19881110", "listing_expiration_date": "20261231"}