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, COATED
Routes
ORAL
Active Ingredients

amitriptyline hydrochloride 25 mg/1

Manufacturer
A-S Medication Solutions

Identifiers & Regulatory

Product NDC 50090-7271
Product ID 50090-7271_af087e8d-4224-4c41-af4a-fde2d04bec70
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 500907271
Hyphenated Format 50090-7271

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 ANDA212654 (source: ndc)
Routes
ORAL
source: ndc

Resolved Composition

Strengths
  • 25 mg/1
source: ndc
Packaging
  • 30 TABLET, COATED in 1 BOTTLE (50090-7271-0)
  • 100 TABLET, COATED in 1 BOTTLE (50090-7271-1)
  • 60 TABLET, COATED in 1 BOTTLE (50090-7271-4)
  • 90 TABLET, COATED in 1 BOTTLE (50090-7271-8)
source: ndc

Packages (4)

50090-7271-0 30 TABLET, COATED in 1 BOTTLE (50090-7271-0) 50090-7271-1 100 TABLET, COATED in 1 BOTTLE (50090-7271-1) 50090-7271-4 60 TABLET, COATED in 1 BOTTLE (50090-7271-4) 50090-7271-8 90 TABLET, COATED in 1 BOTTLE (50090-7271-8)

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": "af087e8d-4224-4c41-af4a-fde2d04bec70", "openfda": {"unii": ["26LUD4JO9K"], "rxcui": ["856834"], "spl_set_id": ["ace6748d-735c-4e6e-b327-a20101fd23d4"], "manufacturer_name": ["A-S Medication Solutions"]}, "finished": true, "packaging": [{"sample": false, "description": "30 TABLET, COATED in 1 BOTTLE (50090-7271-0)", "package_ndc": "50090-7271-0", "marketing_start_date": "20241008"}, {"sample": false, "description": "100 TABLET, COATED in 1 BOTTLE (50090-7271-1)", "package_ndc": "50090-7271-1", "marketing_start_date": "20241008"}, {"sample": false, "description": "60 TABLET, COATED in 1 BOTTLE (50090-7271-4)", "package_ndc": "50090-7271-4", "marketing_start_date": "20241008"}, {"sample": false, "description": "90 TABLET, COATED in 1 BOTTLE (50090-7271-8)", "package_ndc": "50090-7271-8", "marketing_start_date": "20241008"}], "brand_name": "Amitriptyline Hydrochloride", "product_id": "50090-7271_af087e8d-4224-4c41-af4a-fde2d04bec70", "dosage_form": "TABLET, COATED", "pharm_class": ["Tricyclic Antidepressant [EPC]"], "product_ndc": "50090-7271", "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": "ANDA212654", "marketing_category": "ANDA", "marketing_start_date": "20240520", "listing_expiration_date": "20261231"}