protriptyline hydrochloride

Generic: protriptyline hydrochloride

Labeler: sigmapharm laboratories, llc
NDC Directory HUMAN PRESCRIPTION DRUG ANDA Inactive Finished

Drug Facts

Product Profile

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

protriptyline hydrochloride 5 mg/1

Manufacturer
Sigmapharm Laboratories, LLC

Identifiers & Regulatory

Product NDC 42794-004
Product ID 42794-004_f1f190da-554e-55cb-e053-2a95a90a2871
Product Type HUMAN PRESCRIPTION DRUG
Marketing Category ANDA
Application Number ANDA090462
Listing Expiration 2026-12-31
Marketing Start 2020-03-02

Pharmacologic Class

Classes
tricyclic antidepressant [epc]

Normalized Code Variants

Searchable formats for this product NDC code

Digits Only 42794004
Hyphenated Format 42794-004

Supplemental Identifiers

RxCUI
905168 905172
UPC
0342794007026 0342794004025
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 ANDA090462 (source: ndc)
Routes
ORAL
source: ndc

Resolved Composition

Strengths
  • 5 mg/1
source: ndc
Packaging
  • 100 TABLET, FILM COATED in 1 BOTTLE (42794-004-02)
source: ndc

Packages (1)

42794-004-02 100 TABLET, FILM COATED in 1 BOTTLE (42794-004-02)

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": "f1f190da-554e-55cb-e053-2a95a90a2871", "openfda": {"upc": ["0342794007026", "0342794004025"], "unii": ["44665V00O8"], "rxcui": ["905168", "905172"], "spl_set_id": ["a023e637-bee9-8c86-e053-2a95a90aa488"], "manufacturer_name": ["Sigmapharm Laboratories, LLC"], "is_original_packager": [true]}, "finished": true, "packaging": [{"sample": false, "description": "100 TABLET, FILM COATED in 1 BOTTLE (42794-004-02)", "package_ndc": "42794-004-02", "marketing_start_date": "20200302"}], "brand_name": "Protriptyline Hydrochloride", "product_id": "42794-004_f1f190da-554e-55cb-e053-2a95a90a2871", "dosage_form": "TABLET, FILM COATED", "pharm_class": ["Tricyclic Antidepressant [EPC]"], "product_ndc": "42794-004", "generic_name": "Protriptyline Hydrochloride", "labeler_name": "Sigmapharm Laboratories, LLC", "product_type": "HUMAN PRESCRIPTION DRUG", "brand_name_base": "Protriptyline Hydrochloride", "active_ingredients": [{"name": "PROTRIPTYLINE HYDROCHLORIDE", "strength": "5 mg/1"}], "application_number": "ANDA090462", "marketing_category": "ANDA", "marketing_start_date": "20200302", "listing_expiration_date": "20261231"}