amitriptyline hcl

Generic: amitriptyline hcl

Labeler: direct_rx
NDC Directory HUMAN PRESCRIPTION DRUG ANDA Inactive Finished

Drug Facts

Product Profile

Brand Name amitriptyline hcl
Generic Name amitriptyline hcl
Labeler direct_rx
Dosage Form TABLET, FILM COATED
Routes
ORAL
Active Ingredients

amitriptyline hydrochloride 10 mg/1

Manufacturer
Direct_Rx

Identifiers & Regulatory

Product NDC 72189-431
Product ID 72189-431_4c4bca55-969f-d933-e063-6394a90ab8df
Product Type HUMAN PRESCRIPTION DRUG
Marketing Category ANDA
Application Number ANDA214548
Listing Expiration 2027-12-31
Marketing Start 2023-03-13

Pharmacologic Class

Classes
tricyclic antidepressant [epc]

Normalized Code Variants

Searchable formats for this product NDC code

Digits Only 72189431
Hyphenated Format 72189-431

Supplemental Identifiers

RxCUI
856783
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 ANDA214548 (source: ndc)
Routes
ORAL
source: ndc

Resolved Composition

Strengths
  • 10 mg/1
source: ndc
Packaging
  • 30 TABLET, FILM COATED in 1 BOTTLE (72189-431-30)
  • 60 TABLET, FILM COATED in 1 BOTTLE (72189-431-60)
  • 90 TABLET, FILM COATED in 1 BOTTLE (72189-431-90)
source: ndc

Packages (3)

72189-431-30 30 TABLET, FILM COATED in 1 BOTTLE (72189-431-30) 72189-431-60 60 TABLET, FILM COATED in 1 BOTTLE (72189-431-60) 72189-431-90 90 TABLET, FILM COATED in 1 BOTTLE (72189-431-90)

Ingredients (1)

amitriptyline hydrochloride (10 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": "4c4bca55-969f-d933-e063-6394a90ab8df", "openfda": {"unii": ["26LUD4JO9K"], "rxcui": ["856783"], "spl_set_id": ["f6c88d87-66bb-2962-e053-6294a90acfbe"], "manufacturer_name": ["Direct_Rx"]}, "finished": true, "packaging": [{"sample": false, "description": "30 TABLET, FILM COATED in 1 BOTTLE (72189-431-30)", "package_ndc": "72189-431-30", "marketing_start_date": "20230313"}, {"sample": false, "description": "60 TABLET, FILM COATED in 1 BOTTLE (72189-431-60)", "package_ndc": "72189-431-60", "marketing_start_date": "20230313"}, {"sample": false, "description": "90 TABLET, FILM COATED in 1 BOTTLE (72189-431-90)", "package_ndc": "72189-431-90", "marketing_start_date": "20230313"}], "brand_name": "Amitriptyline HCL", "product_id": "72189-431_4c4bca55-969f-d933-e063-6394a90ab8df", "dosage_form": "TABLET, FILM COATED", "pharm_class": ["Tricyclic Antidepressant [EPC]"], "product_ndc": "72189-431", "generic_name": "Amitriptyline HCL", "labeler_name": "Direct_Rx", "product_type": "HUMAN PRESCRIPTION DRUG", "brand_name_base": "Amitriptyline HCL", "active_ingredients": [{"name": "AMITRIPTYLINE HYDROCHLORIDE", "strength": "10 mg/1"}], "application_number": "ANDA214548", "marketing_category": "ANDA", "marketing_start_date": "20230313", "listing_expiration_date": "20271231"}