amitriptyline hydrochloride

Generic: amitriptyline hydrochloride

Labeler: proficient rx lp
NDC Directory HUMAN PRESCRIPTION DRUG ANDA Inactive Finished

Drug Facts

Product Profile

Brand Name amitriptyline hydrochloride
Generic Name amitriptyline hydrochloride
Labeler proficient rx lp
Dosage Form TABLET, FILM COATED
Routes
ORAL
Active Ingredients

amitriptyline hydrochloride 75 mg/1

Manufacturer
Proficient Rx LP

Identifiers & Regulatory

Product NDC 82804-048
Product ID 82804-048_6dc9d113-1156-43ec-a7eb-253c2ff6bcfa
Product Type HUMAN PRESCRIPTION DRUG
Marketing Category ANDA
Application Number ANDA214548
Listing Expiration 2026-12-31
Marketing Start 2021-05-26

Pharmacologic Class

Classes
tricyclic antidepressant [epc]

Normalized Code Variants

Searchable formats for this product NDC code

Digits Only 82804048
Hyphenated Format 82804-048

Supplemental Identifiers

RxCUI
856853
UPC
0382804048304
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
  • 75 mg/1
source: ndc
Packaging
  • 30 TABLET, FILM COATED in 1 BOTTLE (82804-048-30)
  • 60 TABLET, FILM COATED in 1 BOTTLE (82804-048-60)
  • 90 TABLET, FILM COATED in 1 BOTTLE (82804-048-90)
source: ndc

Packages (3)

82804-048-30 30 TABLET, FILM COATED in 1 BOTTLE (82804-048-30) 82804-048-60 60 TABLET, FILM COATED in 1 BOTTLE (82804-048-60) 82804-048-90 90 TABLET, FILM COATED in 1 BOTTLE (82804-048-90)

Ingredients (1)

amitriptyline hydrochloride (75 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": "6dc9d113-1156-43ec-a7eb-253c2ff6bcfa", "openfda": {"upc": ["0382804048304"], "unii": ["26LUD4JO9K"], "rxcui": ["856853"], "spl_set_id": ["6dc9d113-1156-43ec-a7eb-253c2ff6bcfa"], "manufacturer_name": ["Proficient Rx LP"]}, "finished": true, "packaging": [{"sample": false, "description": "30 TABLET, FILM COATED in 1 BOTTLE (82804-048-30)", "package_ndc": "82804-048-30", "marketing_start_date": "20231221"}, {"sample": false, "description": "60 TABLET, FILM COATED in 1 BOTTLE (82804-048-60)", "package_ndc": "82804-048-60", "marketing_start_date": "20231221"}, {"sample": false, "description": "90 TABLET, FILM COATED in 1 BOTTLE (82804-048-90)", "package_ndc": "82804-048-90", "marketing_start_date": "20231221"}], "brand_name": "Amitriptyline Hydrochloride", "product_id": "82804-048_6dc9d113-1156-43ec-a7eb-253c2ff6bcfa", "dosage_form": "TABLET, FILM COATED", "pharm_class": ["Tricyclic Antidepressant [EPC]"], "product_ndc": "82804-048", "generic_name": "Amitriptyline Hydrochloride", "labeler_name": "Proficient Rx LP", "product_type": "HUMAN PRESCRIPTION DRUG", "brand_name_base": "Amitriptyline Hydrochloride", "active_ingredients": [{"name": "AMITRIPTYLINE HYDROCHLORIDE", "strength": "75 mg/1"}], "application_number": "ANDA214548", "marketing_category": "ANDA", "marketing_start_date": "20210526", "listing_expiration_date": "20261231"}