amitriptyline hydrochloride

Generic: amitriptyline hydrochloride

Labeler: advanced rx of tennessee, llc
NDC Directory HUMAN PRESCRIPTION DRUG ANDA Inactive Finished

Drug Facts

Product Profile

Brand Name amitriptyline hydrochloride
Generic Name amitriptyline hydrochloride
Labeler advanced rx of tennessee, llc
Dosage Form TABLET
Routes
ORAL
Active Ingredients

amitriptyline hydrochloride 50 mg/1

Manufacturer
Advanced Rx of Tennessee, LLC

Identifiers & Regulatory

Product NDC 80425-0434
Product ID 80425-0434_20b0177a-a97a-8703-e063-6294a90a433c
Product Type HUMAN PRESCRIPTION DRUG
Marketing Category ANDA
Application Number ANDA217411
Listing Expiration 2026-12-31
Marketing Start 2024-08-27

Pharmacologic Class

Classes
tricyclic antidepressant [epc]

Normalized Code Variants

Searchable formats for this product NDC code

Digits Only 804250434
Hyphenated Format 80425-0434

Supplemental Identifiers

RxCUI
856845
UNII
26LUD4JO9K

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 amitriptyline hydrochloride (source: ndc)
Generic Name amitriptyline hydrochloride (source: ndc)
Application Number ANDA217411 (source: ndc)
Routes
ORAL
source: ndc

Resolved Composition

Strengths
  • 50 mg/1
source: ndc
Packaging
  • 30 TABLET in 1 BOTTLE (80425-0434-1)
  • 60 TABLET in 1 BOTTLE (80425-0434-2)
  • 90 TABLET in 1 BOTTLE (80425-0434-3)
source: ndc

Packages (3)

80425-0434-1 30 TABLET in 1 BOTTLE (80425-0434-1) 80425-0434-2 60 TABLET in 1 BOTTLE (80425-0434-2) 80425-0434-3 90 TABLET in 1 BOTTLE (80425-0434-3)

Ingredients (1)

amitriptyline hydrochloride (50 mg/1)

Linked Drug Pages (1)

Amitriptyline Hydrochloride ndc-match (0.9)

Raw FDA Data

View complete raw FDA NDC JSON payload 
{"route": ["ORAL"], "spl_id": "20b0177a-a97a-8703-e063-6294a90a433c", "openfda": {"unii": ["26LUD4JO9K"], "rxcui": ["856845"], "spl_set_id": ["20aff9dc-98a7-6061-e063-6394a90a2aab"], "manufacturer_name": ["Advanced Rx of Tennessee, LLC"]}, "finished": true, "packaging": [{"sample": false, "description": "30 TABLET in 1 BOTTLE (80425-0434-1)", "package_ndc": "80425-0434-1", "marketing_start_date": "20240827"}, {"sample": false, "description": "60 TABLET in 1 BOTTLE (80425-0434-2)", "package_ndc": "80425-0434-2", "marketing_start_date": "20240827"}, {"sample": false, "description": "90 TABLET in 1 BOTTLE (80425-0434-3)", "package_ndc": "80425-0434-3", "marketing_start_date": "20240827"}], "brand_name": "Amitriptyline Hydrochloride", "product_id": "80425-0434_20b0177a-a97a-8703-e063-6294a90a433c", "dosage_form": "TABLET", "pharm_class": ["Tricyclic Antidepressant [EPC]"], "product_ndc": "80425-0434", "generic_name": "Amitriptyline Hydrochloride", "labeler_name": "Advanced Rx of Tennessee, LLC", "product_type": "HUMAN PRESCRIPTION DRUG", "brand_name_base": "Amitriptyline Hydrochloride", "active_ingredients": [{"name": "AMITRIPTYLINE HYDROCHLORIDE", "strength": "50 mg/1"}], "application_number": "ANDA217411", "marketing_category": "ANDA", "marketing_start_date": "20240827", "listing_expiration_date": "20261231"}