protriptyline hydrochloride

Generic: protriptyline hydrochloride

Labeler: epic pharma, llc
NDC Directory HUMAN PRESCRIPTION DRUG ANDA Inactive Finished

Drug Facts

Product Profile

Brand Name protriptyline hydrochloride
Generic Name protriptyline hydrochloride
Labeler epic pharma, llc
Dosage Form TABLET, FILM COATED
Routes
ORAL
Active Ingredients

protriptyline hydrochloride 5 mg/1

Manufacturer
Epic Pharma, LLC

Identifiers & Regulatory

Product NDC 42806-096
Product ID 42806-096_e68d74c7-1d6a-4453-bb46-0047047b7527
Product Type HUMAN PRESCRIPTION DRUG
Marketing Category ANDA
Application Number ANDA202220
Listing Expiration 2026-12-31
Marketing Start 2013-01-09

Pharmacologic Class

Classes
tricyclic antidepressant [epc]

Normalized Code Variants

Searchable formats for this product NDC code

Digits Only 42806096
Hyphenated Format 42806-096

Supplemental Identifiers

RxCUI
905168 905172
UPC
0342806097014 0342806096307
UNII
44665V00O8

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 protriptyline hydrochloride (source: ndc)
Generic Name protriptyline hydrochloride (source: ndc)
Application Number ANDA202220 (source: ndc)
Routes
ORAL
source: ndc

Resolved Composition

Strengths
  • 5 mg/1
source: ndc
Packaging
  • 100 TABLET, FILM COATED in 1 BOTTLE (42806-096-01)
  • 1000 TABLET, FILM COATED in 1 BOTTLE (42806-096-10)
  • 30 TABLET, FILM COATED in 1 BOTTLE (42806-096-30)
source: ndc

Packages (3)

42806-096-01 100 TABLET, FILM COATED in 1 BOTTLE (42806-096-01) 42806-096-10 1000 TABLET, FILM COATED in 1 BOTTLE (42806-096-10) 42806-096-30 30 TABLET, FILM COATED in 1 BOTTLE (42806-096-30)

Ingredients (1)

protriptyline hydrochloride (5 mg/1)

Linked Drug Pages (1)

Protriptyline Hydrochloride ndc-match (0.9)

Raw FDA Data

View complete raw FDA NDC JSON payload 
{"route": ["ORAL"], "spl_id": "e68d74c7-1d6a-4453-bb46-0047047b7527", "openfda": {"upc": ["0342806097014", "0342806096307"], "unii": ["44665V00O8"], "rxcui": ["905168", "905172"], "spl_set_id": ["c6c7c39e-e510-4f4a-bf7a-926f0e075d3a"], "manufacturer_name": ["Epic Pharma, LLC"], "is_original_packager": [true]}, "finished": true, "packaging": [{"sample": false, "description": "100 TABLET, FILM COATED in 1 BOTTLE (42806-096-01)", "package_ndc": "42806-096-01", "marketing_start_date": "20130109"}, {"sample": false, "description": "1000 TABLET, FILM COATED in 1 BOTTLE (42806-096-10)", "package_ndc": "42806-096-10", "marketing_start_date": "20130109"}, {"sample": false, "description": "30 TABLET, FILM COATED in 1 BOTTLE (42806-096-30)", "package_ndc": "42806-096-30", "marketing_start_date": "20200710"}], "brand_name": "Protriptyline Hydrochloride", "product_id": "42806-096_e68d74c7-1d6a-4453-bb46-0047047b7527", "dosage_form": "TABLET, FILM COATED", "pharm_class": ["Tricyclic Antidepressant [EPC]"], "product_ndc": "42806-096", "generic_name": "Protriptyline Hydrochloride", "labeler_name": "Epic Pharma, LLC", "product_type": "HUMAN PRESCRIPTION DRUG", "brand_name_base": "Protriptyline Hydrochloride", "active_ingredients": [{"name": "PROTRIPTYLINE HYDROCHLORIDE", "strength": "5 mg/1"}], "application_number": "ANDA202220", "marketing_category": "ANDA", "marketing_start_date": "20130109", "listing_expiration_date": "20261231"}