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
Routes
ORAL
Active Ingredients

amitriptyline hydrochloride 50 mg/1

Manufacturer
A-S Medication Solutions

Identifiers & Regulatory

Product NDC 50090-7598
Product ID 50090-7598_3cd066c4-eb34-43bc-a6ce-1e9d4a877162
Product Type HUMAN PRESCRIPTION DRUG
Marketing Category ANDA
Application Number ANDA217411
Listing Expiration 2026-12-31
Marketing Start 2023-06-10

Pharmacologic Class

Classes
tricyclic antidepressant [epc]

Normalized Code Variants

Searchable formats for this product NDC code

Digits Only 500907598
Hyphenated Format 50090-7598

Supplemental Identifiers

RxCUI
856845
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 ANDA217411 (source: ndc)
Routes
ORAL
source: ndc

Resolved Composition

Strengths
  • 50 mg/1
source: ndc
Packaging
  • 100 TABLET in 1 BOTTLE (50090-7598-0)
  • 30 TABLET in 1 BOTTLE (50090-7598-1)
  • 60 TABLET in 1 BOTTLE (50090-7598-2)
  • 90 TABLET in 1 BOTTLE (50090-7598-5)
source: ndc

Packages (4)

50090-7598-0 100 TABLET in 1 BOTTLE (50090-7598-0) 50090-7598-1 30 TABLET in 1 BOTTLE (50090-7598-1) 50090-7598-2 60 TABLET in 1 BOTTLE (50090-7598-2) 50090-7598-5 90 TABLET in 1 BOTTLE (50090-7598-5)

Ingredients (1)

amitriptyline hydrochloride (50 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": "3cd066c4-eb34-43bc-a6ce-1e9d4a877162", "openfda": {"unii": ["26LUD4JO9K"], "rxcui": ["856845"], "spl_set_id": ["9110367c-4104-4836-8af3-649f86b0b3ea"], "manufacturer_name": ["A-S Medication Solutions"]}, "finished": true, "packaging": [{"sample": false, "description": "100 TABLET in 1 BOTTLE (50090-7598-0)", "package_ndc": "50090-7598-0", "marketing_start_date": "20250707"}, {"sample": false, "description": "30 TABLET in 1 BOTTLE (50090-7598-1)", "package_ndc": "50090-7598-1", "marketing_start_date": "20250707"}, {"sample": false, "description": "60 TABLET in 1 BOTTLE (50090-7598-2)", "package_ndc": "50090-7598-2", "marketing_start_date": "20250707"}, {"sample": false, "description": "90 TABLET in 1 BOTTLE (50090-7598-5)", "package_ndc": "50090-7598-5", "marketing_start_date": "20250707"}], "brand_name": "Amitriptyline Hydrochloride", "product_id": "50090-7598_3cd066c4-eb34-43bc-a6ce-1e9d4a877162", "dosage_form": "TABLET", "pharm_class": ["Tricyclic Antidepressant [EPC]"], "product_ndc": "50090-7598", "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": "50 mg/1"}], "application_number": "ANDA217411", "marketing_category": "ANDA", "marketing_start_date": "20230610", "listing_expiration_date": "20261231"}