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 25 mg/1

Manufacturer
Direct_Rx

Identifiers & Regulatory

Product NDC 72189-420
Product ID 72189-420_2c4d06ff-9f7a-48ac-e063-6394a90a6b9d
Product Type HUMAN PRESCRIPTION DRUG
Marketing Category ANDA
Application Number ANDA214548
Listing Expiration 2026-12-31
Marketing Start 2023-02-07

Pharmacologic Class

Classes
tricyclic antidepressant [epc]

Normalized Code Variants

Searchable formats for this product NDC code

Digits Only 72189420
Hyphenated Format 72189-420

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 ANDA214548 (source: ndc)
Routes
ORAL
source: ndc

Resolved Composition

Strengths
  • 25 mg/1
source: ndc
Packaging
  • 30 TABLET, FILM COATED in 1 BOTTLE (72189-420-30)
  • 60 TABLET, FILM COATED in 1 BOTTLE (72189-420-60)
  • 90 TABLET, FILM COATED in 1 BOTTLE (72189-420-90)
source: ndc

Packages (3)

72189-420-30 30 TABLET, FILM COATED in 1 BOTTLE (72189-420-30) 72189-420-60 60 TABLET, FILM COATED in 1 BOTTLE (72189-420-60) 72189-420-90 90 TABLET, FILM COATED in 1 BOTTLE (72189-420-90)

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": "2c4d06ff-9f7a-48ac-e063-6394a90a6b9d", "openfda": {"unii": ["26LUD4JO9K"], "rxcui": ["856834"], "spl_set_id": ["f420498a-bfcc-4549-e053-2995a90a7b09"], "manufacturer_name": ["Direct_Rx"]}, "finished": true, "packaging": [{"sample": false, "description": "30 TABLET, FILM COATED in 1 BOTTLE (72189-420-30)", "package_ndc": "72189-420-30", "marketing_start_date": "20230207"}, {"sample": false, "description": "60 TABLET, FILM COATED in 1 BOTTLE (72189-420-60)", "package_ndc": "72189-420-60", "marketing_start_date": "20230207"}, {"sample": false, "description": "90 TABLET, FILM COATED in 1 BOTTLE (72189-420-90)", "package_ndc": "72189-420-90", "marketing_start_date": "20230207"}], "brand_name": "AMITRIPTYLINE HCL", "product_id": "72189-420_2c4d06ff-9f7a-48ac-e063-6394a90a6b9d", "dosage_form": "TABLET, FILM COATED", "pharm_class": ["Tricyclic Antidepressant [EPC]"], "product_ndc": "72189-420", "generic_name": "AMITRIPTYLINE HCL", "labeler_name": "Direct_Rx", "product_type": "HUMAN PRESCRIPTION DRUG", "brand_name_base": "AMITRIPTYLINE HCL", "active_ingredients": [{"name": "AMITRIPTYLINE HYDROCHLORIDE", "strength": "25 mg/1"}], "application_number": "ANDA214548", "marketing_category": "ANDA", "marketing_start_date": "20230207", "listing_expiration_date": "20261231"}