amitriptyline hydrochloride

Generic: amitriptyline hydrochloride

Labeler: westminster pharmaceuticals, llc
NDC Directory HUMAN PRESCRIPTION DRUG ANDA Inactive Finished

Drug Facts

Product Profile

Brand Name amitriptyline hydrochloride
Generic Name amitriptyline hydrochloride
Labeler westminster pharmaceuticals, llc
Dosage Form TABLET, COATED
Routes
ORAL
Active Ingredients

amitriptyline hydrochloride 100 mg/1

Manufacturer
Westminster Pharmaceuticals, LLC

Identifiers & Regulatory

Product NDC 69367-392
Product ID 69367-392_3991983c-6f46-46e2-825c-ed9e5d4c1cb4
Product Type HUMAN PRESCRIPTION DRUG
Marketing Category ANDA
Application Number ANDA212654
Listing Expiration 2026-12-31
Marketing Start 2024-05-20

Pharmacologic Class

Classes
tricyclic antidepressant [epc]

Normalized Code Variants

Searchable formats for this product NDC code

Digits Only 69367392
Hyphenated Format 69367-392

Supplemental Identifiers

RxCUI
856762 856773 856783 856834 856845 856853
UPC
0369367391016 0369367393010 0369367392013 0369367388016 0369367390019 0369367389013
UNII
26LUD4JO9K

Packaging Origin

Original Packager
true

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 ANDA212654 (source: ndc)
Routes
ORAL
source: ndc

Resolved Composition

Strengths
  • 100 mg/1
source: ndc
Packaging
  • 100 TABLET, COATED in 1 BOTTLE (69367-392-01)
source: ndc

Packages (1)

69367-392-01 100 TABLET, COATED in 1 BOTTLE (69367-392-01)

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": "3991983c-6f46-46e2-825c-ed9e5d4c1cb4", "openfda": {"upc": ["0369367391016", "0369367393010", "0369367392013", "0369367388016", "0369367390019", "0369367389013"], "unii": ["26LUD4JO9K"], "rxcui": ["856762", "856773", "856783", "856834", "856845", "856853"], "spl_set_id": ["d46ff585-7082-4a7c-a88f-2acf3be0f1d5"], "manufacturer_name": ["Westminster Pharmaceuticals, LLC"], "is_original_packager": [true]}, "finished": true, "packaging": [{"sample": false, "description": "100 TABLET, COATED in 1 BOTTLE (69367-392-01)", "package_ndc": "69367-392-01", "marketing_start_date": "20240520"}], "brand_name": "Amitriptyline Hydrochloride", "product_id": "69367-392_3991983c-6f46-46e2-825c-ed9e5d4c1cb4", "dosage_form": "TABLET, COATED", "pharm_class": ["Tricyclic Antidepressant [EPC]"], "product_ndc": "69367-392", "generic_name": "Amitriptyline Hydrochloride", "labeler_name": "Westminster Pharmaceuticals, LLC", "product_type": "HUMAN PRESCRIPTION DRUG", "brand_name_base": "Amitriptyline Hydrochloride", "active_ingredients": [{"name": "AMITRIPTYLINE HYDROCHLORIDE", "strength": "100 mg/1"}], "application_number": "ANDA212654", "marketing_category": "ANDA", "marketing_start_date": "20240520", "listing_expiration_date": "20261231"}