amitriptyline hcl

Generic: amitriptyline hcl

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

Drug Facts

Product Profile

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

amitriptyline hydrochloride 25 mg/1

Manufacturer
Advanced Rx of Tennessee, LLC

Identifiers & Regulatory

Product NDC 80425-0212
Product ID 80425-0212_2a9a3145-4892-cc47-e063-6394a90ac830
Product Type HUMAN PRESCRIPTION DRUG
Marketing Category ANDA
Application Number ANDA202446
Marketing Start 2023-03-22
Marketing End 2026-03-31

Pharmacologic Class

Classes
tricyclic antidepressant [epc]

Normalized Code Variants

Searchable formats for this product NDC code

Digits Only 804250212
Hyphenated Format 80425-0212

Supplemental Identifiers

RxCUI
856834
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 hcl (source: ndc)
Generic Name amitriptyline hcl (source: ndc)
Application Number ANDA202446 (source: ndc)
Routes
ORAL
source: ndc

Resolved Composition

Strengths
  • 25 mg/1
source: ndc
Packaging
  • 30 TABLET, FILM COATED in 1 BOTTLE (80425-0212-1)
  • 60 TABLET, FILM COATED in 1 BOTTLE (80425-0212-2)
  • 90 TABLET, FILM COATED in 1 BOTTLE (80425-0212-3)
source: ndc

Packages (3)

80425-0212-1 30 TABLET, FILM COATED in 1 BOTTLE (80425-0212-1) 80425-0212-2 60 TABLET, FILM COATED in 1 BOTTLE (80425-0212-2) 80425-0212-3 90 TABLET, FILM COATED in 1 BOTTLE (80425-0212-3)

Ingredients (1)

amitriptyline hydrochloride (25 mg/1)

Linked Drug Pages (1)

Amitriptyline HCL ndc-match (0.9)

Raw FDA Data

View complete raw FDA NDC JSON payload 
{"route": ["ORAL"], "spl_id": "2a9a3145-4892-cc47-e063-6394a90ac830", "openfda": {"unii": ["26LUD4JO9K"], "rxcui": ["856834"], "spl_set_id": ["f780d3c0-1247-5ad2-e053-6394a90a4454"], "manufacturer_name": ["Advanced Rx of Tennessee, LLC"]}, "finished": true, "packaging": [{"sample": false, "description": "30 TABLET, FILM COATED in 1 BOTTLE (80425-0212-1)", "package_ndc": "80425-0212-1", "marketing_end_date": "20260331", "marketing_start_date": "20230322"}, {"sample": false, "description": "60 TABLET, FILM COATED in 1 BOTTLE (80425-0212-2)", "package_ndc": "80425-0212-2", "marketing_end_date": "20260331", "marketing_start_date": "20230322"}, {"sample": false, "description": "90 TABLET, FILM COATED in 1 BOTTLE (80425-0212-3)", "package_ndc": "80425-0212-3", "marketing_end_date": "20260331", "marketing_start_date": "20230322"}], "brand_name": "Amitriptyline HCL", "product_id": "80425-0212_2a9a3145-4892-cc47-e063-6394a90ac830", "dosage_form": "TABLET, FILM COATED", "pharm_class": ["Tricyclic Antidepressant [EPC]"], "product_ndc": "80425-0212", "generic_name": "Amitriptyline HCL", "labeler_name": "Advanced Rx of Tennessee, LLC", "product_type": "HUMAN PRESCRIPTION DRUG", "brand_name_base": "Amitriptyline HCL", "active_ingredients": [{"name": "AMITRIPTYLINE HYDROCHLORIDE", "strength": "25 mg/1"}], "application_number": "ANDA202446", "marketing_category": "ANDA", "marketing_end_date": "20260331", "marketing_start_date": "20230322"}