amitriptyline hydrochloride

Generic: amitriptyline hydrochloride

Labeler: advanced rx pharmacy 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 pharmacy of tennessee, llc
Dosage Form TABLET, FILM COATED
Routes
ORAL
Active Ingredients

amitriptyline hydrochloride 100 mg/1

Manufacturer
Advanced Rx Pharmacy of Tennessee, LLC

Identifiers & Regulatory

Product NDC 80425-0287
Product ID 80425-0287_2a9b9724-0257-e829-e063-6394a90a1c07
Product Type HUMAN PRESCRIPTION DRUG
Marketing Category ANDA
Application Number ANDA214548
Listing Expiration 2026-12-31
Marketing Start 2023-03-22

Pharmacologic Class

Classes
tricyclic antidepressant [epc]

Normalized Code Variants

Searchable formats for this product NDC code

Digits Only 804250287
Hyphenated Format 80425-0287

Supplemental Identifiers

RxCUI
856762
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 ANDA214548 (source: ndc)
Routes
ORAL
source: ndc

Resolved Composition

Strengths
  • 100 mg/1
source: ndc
Packaging
  • 30 TABLET, FILM COATED in 1 BOTTLE (80425-0287-1)
  • 60 TABLET, FILM COATED in 1 BOTTLE (80425-0287-2)
  • 90 TABLET, FILM COATED in 1 BOTTLE (80425-0287-3)
source: ndc

Packages (3)

80425-0287-1 30 TABLET, FILM COATED in 1 BOTTLE (80425-0287-1) 80425-0287-2 60 TABLET, FILM COATED in 1 BOTTLE (80425-0287-2) 80425-0287-3 90 TABLET, FILM COATED in 1 BOTTLE (80425-0287-3)

Ingredients (1)

amitriptyline hydrochloride (100 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": "2a9b9724-0257-e829-e063-6394a90a1c07", "openfda": {"unii": ["26LUD4JO9K"], "rxcui": ["856762"], "spl_set_id": ["f78102eb-cbeb-801a-e053-6294a90ab880"], "manufacturer_name": ["Advanced Rx Pharmacy of Tennessee, LLC"]}, "finished": true, "packaging": [{"sample": false, "description": "30 TABLET, FILM COATED in 1 BOTTLE (80425-0287-1)", "package_ndc": "80425-0287-1", "marketing_start_date": "20230322"}, {"sample": false, "description": "60 TABLET, FILM COATED in 1 BOTTLE (80425-0287-2)", "package_ndc": "80425-0287-2", "marketing_start_date": "20230322"}, {"sample": false, "description": "90 TABLET, FILM COATED in 1 BOTTLE (80425-0287-3)", "package_ndc": "80425-0287-3", "marketing_start_date": "20230322"}], "brand_name": "Amitriptyline Hydrochloride", "product_id": "80425-0287_2a9b9724-0257-e829-e063-6394a90a1c07", "dosage_form": "TABLET, FILM COATED", "pharm_class": ["Tricyclic Antidepressant [EPC]"], "product_ndc": "80425-0287", "generic_name": "Amitriptyline Hydrochloride", "labeler_name": "Advanced Rx Pharmacy of Tennessee, LLC", "product_type": "HUMAN PRESCRIPTION DRUG", "brand_name_base": "Amitriptyline Hydrochloride", "active_ingredients": [{"name": "AMITRIPTYLINE HYDROCHLORIDE", "strength": "100 mg/1"}], "application_number": "ANDA214548", "marketing_category": "ANDA", "marketing_start_date": "20230322", "listing_expiration_date": "20261231"}