amitriptyline hydrochloride

Generic: amitriptyline hydrochloride

Labeler: a-s medication solutions
NDC Directory HUMAN PRESCRIPTION DRUG ANDA Inactive Finished

Drug Facts

Product Profile

Brand Name amitriptyline hydrochloride
Generic Name amitriptyline hydrochloride
Labeler a-s medication solutions
Dosage Form TABLET, FILM COATED
Routes
ORAL
Active Ingredients

amitriptyline hydrochloride 25 mg/1

Manufacturer
A-S Medication Solutions

Identifiers & Regulatory

Product NDC 50090-6313
Product ID 50090-6313_dd76eba0-6e9a-4fb2-8185-87290c800d76
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 500906313
Hyphenated Format 50090-6313

Supplemental Identifiers

RxCUI
856834
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
  • 25 mg/1
source: ndc
Packaging
  • 30 TABLET, FILM COATED in 1 BOTTLE (50090-6313-0)
  • 100 TABLET, FILM COATED in 1 BOTTLE (50090-6313-1)
  • 60 TABLET, FILM COATED in 1 BOTTLE (50090-6313-4)
  • 90 TABLET, FILM COATED in 1 BOTTLE (50090-6313-8)
source: ndc

Packages (4)

50090-6313-0 30 TABLET, FILM COATED in 1 BOTTLE (50090-6313-0) 50090-6313-1 100 TABLET, FILM COATED in 1 BOTTLE (50090-6313-1) 50090-6313-4 60 TABLET, FILM COATED in 1 BOTTLE (50090-6313-4) 50090-6313-8 90 TABLET, FILM COATED in 1 BOTTLE (50090-6313-8)

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": "dd76eba0-6e9a-4fb2-8185-87290c800d76", "openfda": {"unii": ["26LUD4JO9K"], "rxcui": ["856834"], "spl_set_id": ["69c7a0bd-93d0-40fe-a6d3-f41986b802b4"], "manufacturer_name": ["A-S Medication Solutions"]}, "finished": true, "packaging": [{"sample": false, "description": "30 TABLET, FILM COATED in 1 BOTTLE (50090-6313-0)", "package_ndc": "50090-6313-0", "marketing_start_date": "20230106"}, {"sample": false, "description": "100 TABLET, FILM COATED in 1 BOTTLE (50090-6313-1)", "package_ndc": "50090-6313-1", "marketing_start_date": "20230106"}, {"sample": false, "description": "60 TABLET, FILM COATED in 1 BOTTLE (50090-6313-4)", "package_ndc": "50090-6313-4", "marketing_start_date": "20230106"}, {"sample": false, "description": "90 TABLET, FILM COATED in 1 BOTTLE (50090-6313-8)", "package_ndc": "50090-6313-8", "marketing_start_date": "20230106"}], "brand_name": "Amitriptyline Hydrochloride", "product_id": "50090-6313_dd76eba0-6e9a-4fb2-8185-87290c800d76", "dosage_form": "TABLET, FILM COATED", "pharm_class": ["Tricyclic Antidepressant [EPC]"], "product_ndc": "50090-6313", "generic_name": "Amitriptyline Hydrochloride", "labeler_name": "A-S Medication Solutions", "product_type": "HUMAN PRESCRIPTION DRUG", "brand_name_base": "Amitriptyline Hydrochloride", "active_ingredients": [{"name": "AMITRIPTYLINE HYDROCHLORIDE", "strength": "25 mg/1"}], "application_number": "ANDA214548", "marketing_category": "ANDA", "marketing_start_date": "20210526", "listing_expiration_date": "20261231"}