amitriptyline hydrochloride

Generic: amitriptyline hydrochloride

Labeler: avpak
NDC Directory HUMAN PRESCRIPTION DRUG ANDA Inactive Finished

Drug Facts

Product Profile

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

amitriptyline hydrochloride 100 mg/1

Manufacturer
AvPAK

Identifiers & Regulatory

Product NDC 50268-041
Product ID 50268-041_2b489726-9f79-c6d3-e063-6294a90a1ff3
Product Type HUMAN PRESCRIPTION DRUG
Marketing Category ANDA
Application Number ANDA214548
Listing Expiration 2026-12-31
Marketing Start 2023-02-28

Pharmacologic Class

Classes
tricyclic antidepressant [epc]

Normalized Code Variants

Searchable formats for this product NDC code

Digits Only 50268041
Hyphenated Format 50268-041

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 hydrochloride (source: ndc)
Generic Name amitriptyline hydrochloride (source: ndc)
Application Number ANDA214548 (source: ndc)
Routes
ORAL
source: ndc

Resolved Composition

Strengths
  • 100 mg/1
source: ndc
Packaging
  • 50 BLISTER PACK in 1 BOX (50268-041-15) / 1 TABLET, FILM COATED in 1 BLISTER PACK (50268-041-11)
source: ndc

Packages (1)

50268-041-15 50 BLISTER PACK in 1 BOX (50268-041-15) / 1 TABLET, FILM COATED in 1 BLISTER PACK (50268-041-11)

Ingredients (1)

amitriptyline hydrochloride (100 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": "2b489726-9f79-c6d3-e063-6294a90a1ff3", "openfda": {"unii": ["26LUD4JO9K"], "rxcui": ["856762"], "spl_set_id": ["f5c5f3b6-e92b-1120-e053-2995a90ae8fa"], "manufacturer_name": ["AvPAK"]}, "finished": true, "packaging": [{"sample": false, "description": "50 BLISTER PACK in 1 BOX (50268-041-15)  / 1 TABLET, FILM COATED in 1 BLISTER PACK (50268-041-11)", "package_ndc": "50268-041-15", "marketing_start_date": "20230228"}], "brand_name": "Amitriptyline Hydrochloride", "product_id": "50268-041_2b489726-9f79-c6d3-e063-6294a90a1ff3", "dosage_form": "TABLET, FILM COATED", "pharm_class": ["Tricyclic Antidepressant [EPC]"], "product_ndc": "50268-041", "generic_name": "Amitriptyline Hydrochloride", "labeler_name": "AvPAK", "product_type": "HUMAN PRESCRIPTION DRUG", "brand_name_base": "Amitriptyline Hydrochloride", "active_ingredients": [{"name": "AMITRIPTYLINE HYDROCHLORIDE", "strength": "100 mg/1"}], "application_number": "ANDA214548", "marketing_category": "ANDA", "marketing_start_date": "20230228", "listing_expiration_date": "20261231"}