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
Routes
ORAL
Active Ingredients

amitriptyline hydrochloride 100 mg/1

Manufacturer
Direct_rx

Identifiers & Regulatory

Product NDC 72189-581
Product ID 72189-581_227affe9-36ef-2423-e063-6394a90a58f6
Product Type HUMAN PRESCRIPTION DRUG
Marketing Category ANDA
Application Number ANDA217411
Listing Expiration 2026-12-31
Marketing Start 2024-09-19

Pharmacologic Class

Classes
tricyclic antidepressant [epc]

Normalized Code Variants

Searchable formats for this product NDC code

Digits Only 72189581
Hyphenated Format 72189-581

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

Resolved Composition

Strengths
  • 100 mg/1
source: ndc
Packaging
  • 30 TABLET in 1 BOTTLE (72189-581-30)
source: ndc

Packages (1)

72189-581-30 30 TABLET in 1 BOTTLE (72189-581-30)

Ingredients (1)

amitriptyline hydrochloride (100 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": "227affe9-36ef-2423-e063-6394a90a58f6", "openfda": {"unii": ["26LUD4JO9K"], "rxcui": ["856762"], "spl_set_id": ["227affe9-36ee-2423-e063-6394a90a58f6"], "manufacturer_name": ["Direct_rx"]}, "finished": true, "packaging": [{"sample": false, "description": "30 TABLET in 1 BOTTLE (72189-581-30)", "package_ndc": "72189-581-30", "marketing_start_date": "20240919"}], "brand_name": "Amitriptyline HCL", "product_id": "72189-581_227affe9-36ef-2423-e063-6394a90a58f6", "dosage_form": "TABLET", "pharm_class": ["Tricyclic Antidepressant [EPC]"], "product_ndc": "72189-581", "generic_name": "Amitriptyline HCL", "labeler_name": "Direct_rx", "product_type": "HUMAN PRESCRIPTION DRUG", "brand_name_base": "Amitriptyline HCL", "active_ingredients": [{"name": "AMITRIPTYLINE HYDROCHLORIDE", "strength": "100 mg/1"}], "application_number": "ANDA217411", "marketing_category": "ANDA", "marketing_start_date": "20240919", "listing_expiration_date": "20261231"}