amitriptyline hydrochloride

Generic: amitriptyline hydrochloride

Labeler: coupler llc
NDC Directory HUMAN PRESCRIPTION DRUG ANDA Inactive Finished

Drug Facts

Product Profile

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

amitriptyline hydrochloride 150 mg/1

Manufacturer
Coupler LLC

Identifiers & Regulatory

Product NDC 67046-1625
Product ID 67046-1625_4616c30a-f8a2-6a3b-e063-6394a90a476e
Product Type HUMAN PRESCRIPTION DRUG
Marketing Category ANDA
Application Number ANDA214548
Listing Expiration 2026-12-31
Marketing Start 2025-12-16

Pharmacologic Class

Classes
tricyclic antidepressant [epc]

Normalized Code Variants

Searchable formats for this product NDC code

Digits Only 670461625
Hyphenated Format 67046-1625

Supplemental Identifiers

RxCUI
856773
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
  • 150 mg/1
source: ndc
Packaging
  • 30 TABLET, FILM COATED in 1 BLISTER PACK (67046-1625-3)
source: ndc

Packages (1)

67046-1625-3 30 TABLET, FILM COATED in 1 BLISTER PACK (67046-1625-3)

Ingredients (1)

amitriptyline hydrochloride (150 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": "4616c30a-f8a2-6a3b-e063-6394a90a476e", "openfda": {"unii": ["26LUD4JO9K"], "rxcui": ["856773"], "spl_set_id": ["4616c2be-03a5-4279-e063-6294a90ac052"], "manufacturer_name": ["Coupler LLC"]}, "finished": true, "packaging": [{"sample": false, "description": "30 TABLET, FILM COATED in 1 BLISTER PACK (67046-1625-3)", "package_ndc": "67046-1625-3", "marketing_start_date": "20251216"}], "brand_name": "Amitriptyline Hydrochloride", "product_id": "67046-1625_4616c30a-f8a2-6a3b-e063-6394a90a476e", "dosage_form": "TABLET, FILM COATED", "pharm_class": ["Tricyclic Antidepressant [EPC]"], "product_ndc": "67046-1625", "generic_name": "Amitriptyline Hydrochloride", "labeler_name": "Coupler LLC", "product_type": "HUMAN PRESCRIPTION DRUG", "brand_name_base": "Amitriptyline Hydrochloride", "active_ingredients": [{"name": "AMITRIPTYLINE HYDROCHLORIDE", "strength": "150 mg/1"}], "application_number": "ANDA214548", "marketing_category": "ANDA", "marketing_start_date": "20251216", "listing_expiration_date": "20261231"}