AMITRIPTYLINE HYDROCHLORIDE

Generic: AMITRIPTYLINE HYDROCHLORIDE

Labeler: Preferred Pharmaceuticals Inc.
NDC Directory HUMAN PRESCRIPTION DRUG ANDA Active

Drug Facts

Product Profile

Brand Name AMITRIPTYLINE HYDROCHLORIDE
Generic Name AMITRIPTYLINE HYDROCHLORIDE
Labeler Preferred Pharmaceuticals Inc.
Dosage Form TABLET, FILM COATED
Routes
ORAL
Active Ingredients

AMITRIPTYLINE HYDROCHLORIDE 25 mg/1

Identifiers & Regulatory

Product NDC 68788-6825
Product ID 68788-6825_864852b9-d01b-45bb-8365-7051d2b324b2
Product Type HUMAN PRESCRIPTION DRUG
Marketing Category ANDA
Application Number ANDA202446
Listing Expiration 2026-12-31
Marketing Start 2016-11-16

Normalized Code Variants

Searchable formats for this product NDC code

Digits Only 687886825
Hyphenated Format 68788-6825

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 ANDA202446 (source: ndc)
Routes
ORAL
source: ndc

Resolved Composition

Strengths
  • 25 mg/1
source: ndc
Packaging
  • 30 TABLET, FILM COATED in 1 BOTTLE (68788-6825-3)
  • 60 TABLET, FILM COATED in 1 BOTTLE (68788-6825-6)
  • 28 TABLET, FILM COATED in 1 BOTTLE (68788-6825-8)
  • 90 TABLET, FILM COATED in 1 BOTTLE (68788-6825-9)
source: ndc

Packages (4)

68788-6825-3 30 TABLET, FILM COATED in 1 BOTTLE (68788-6825-3) 68788-6825-6 60 TABLET, FILM COATED in 1 BOTTLE (68788-6825-6) 68788-6825-8 28 TABLET, FILM COATED in 1 BOTTLE (68788-6825-8) 68788-6825-9 90 TABLET, FILM COATED in 1 BOTTLE (68788-6825-9)

Ingredients (1)

AMITRIPTYLINE HYDROCHLORIDE (25 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": "864852b9-d01b-45bb-8365-7051d2b324b2", "openfda": {"unii": ["26LUD4JO9K"], "rxcui": ["856834"], "spl_set_id": ["e38166fa-0aa1-42fd-8530-9db8399c6962"], "manufacturer_name": ["Preferred Pharmaceuticals Inc."]}, "finished": true, "packaging": [{"sample": false, "description": "30 TABLET, FILM COATED in 1 BOTTLE (68788-6825-3)", "package_ndc": "68788-6825-3", "marketing_start_date": "20161116"}, {"sample": false, "description": "60 TABLET, FILM COATED in 1 BOTTLE (68788-6825-6)", "package_ndc": "68788-6825-6", "marketing_start_date": "20161116"}, {"sample": false, "description": "28 TABLET, FILM COATED in 1 BOTTLE (68788-6825-8)", "package_ndc": "68788-6825-8", "marketing_start_date": "20161116"}, {"sample": false, "description": "90 TABLET, FILM COATED in 1 BOTTLE (68788-6825-9)", "package_ndc": "68788-6825-9", "marketing_start_date": "20161116"}], "brand_name": "AMITRIPTYLINE HYDROCHLORIDE", "product_id": "68788-6825_864852b9-d01b-45bb-8365-7051d2b324b2", "dosage_form": "TABLET, FILM COATED", "pharm_class": ["Tricyclic Antidepressant [EPC]"], "product_ndc": "68788-6825", "generic_name": "AMITRIPTYLINE HYDROCHLORIDE", "labeler_name": "Preferred Pharmaceuticals Inc.", "product_type": "HUMAN PRESCRIPTION DRUG", "brand_name_base": "AMITRIPTYLINE HYDROCHLORIDE", "active_ingredients": [{"name": "AMITRIPTYLINE HYDROCHLORIDE", "strength": "25 mg/1"}], "application_number": "ANDA202446", "marketing_category": "ANDA", "marketing_start_date": "20161116", "listing_expiration_date": "20261231"}