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 50 mg/1

Manufacturer
A-S Medication Solutions

Identifiers & Regulatory

Product NDC 50090-7183
Product ID 50090-7183_b8f0f192-6383-4b21-ac0a-30ff64acd54f
Product Type HUMAN PRESCRIPTION DRUG
Marketing Category ANDA
Application Number ANDA210086
Listing Expiration 2026-12-31
Marketing Start 2021-08-25

Pharmacologic Class

Classes
tricyclic antidepressant [epc]

Normalized Code Variants

Searchable formats for this product NDC code

Digits Only 500907183
Hyphenated Format 50090-7183

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 ANDA210086 (source: ndc)
Routes
ORAL
source: ndc

Resolved Composition

Strengths
  • 50 mg/1
source: ndc
Packaging
  • 100 TABLET, FILM COATED in 1 BOTTLE (50090-7183-0)
  • 30 TABLET, FILM COATED in 1 BOTTLE (50090-7183-1)
  • 60 TABLET, FILM COATED in 1 BOTTLE (50090-7183-2)
  • 90 TABLET, FILM COATED in 1 BOTTLE (50090-7183-5)
source: ndc

Packages (4)

50090-7183-0 100 TABLET, FILM COATED in 1 BOTTLE (50090-7183-0) 50090-7183-1 30 TABLET, FILM COATED in 1 BOTTLE (50090-7183-1) 50090-7183-2 60 TABLET, FILM COATED in 1 BOTTLE (50090-7183-2) 50090-7183-5 90 TABLET, FILM COATED in 1 BOTTLE (50090-7183-5)

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": "b8f0f192-6383-4b21-ac0a-30ff64acd54f", "openfda": {"unii": ["26LUD4JO9K"], "rxcui": ["856845"], "spl_set_id": ["b793f1f8-c1f9-46f0-8156-1a4957db3a1f"], "manufacturer_name": ["A-S Medication Solutions"]}, "finished": true, "packaging": [{"sample": false, "description": "100 TABLET, FILM COATED in 1 BOTTLE (50090-7183-0)", "package_ndc": "50090-7183-0", "marketing_start_date": "20240618"}, {"sample": false, "description": "30 TABLET, FILM COATED in 1 BOTTLE (50090-7183-1)", "package_ndc": "50090-7183-1", "marketing_start_date": "20240618"}, {"sample": false, "description": "60 TABLET, FILM COATED in 1 BOTTLE (50090-7183-2)", "package_ndc": "50090-7183-2", "marketing_start_date": "20240618"}, {"sample": false, "description": "90 TABLET, FILM COATED in 1 BOTTLE (50090-7183-5)", "package_ndc": "50090-7183-5", "marketing_start_date": "20240618"}], "brand_name": "Amitriptyline Hydrochloride", "product_id": "50090-7183_b8f0f192-6383-4b21-ac0a-30ff64acd54f", "dosage_form": "TABLET, FILM COATED", "pharm_class": ["Tricyclic Antidepressant [EPC]"], "product_ndc": "50090-7183", "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": "ANDA210086", "marketing_category": "ANDA", "marketing_start_date": "20210825", "listing_expiration_date": "20261231"}