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 10 mg/1

Manufacturer
A-S Medication Solutions

Identifiers & Regulatory

Product NDC 50090-7424
Product ID 50090-7424_37519f6d-7e12-4583-8f65-0a81a5c52bd4
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 500907424
Hyphenated Format 50090-7424

Supplemental Identifiers

RxCUI
856783
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
  • 10 mg/1
source: ndc
Packaging
  • 30 TABLET, COATED in 1 BOTTLE (50090-7424-0)
  • 100 TABLET, COATED in 1 BOTTLE (50090-7424-1)
  • 90 TABLET, COATED in 1 BOTTLE (50090-7424-6)
  • 60 TABLET, COATED in 1 BOTTLE (50090-7424-7)
source: ndc

Packages (4)

50090-7424-0 30 TABLET, COATED in 1 BOTTLE (50090-7424-0) 50090-7424-1 100 TABLET, COATED in 1 BOTTLE (50090-7424-1) 50090-7424-6 90 TABLET, COATED in 1 BOTTLE (50090-7424-6) 50090-7424-7 60 TABLET, COATED in 1 BOTTLE (50090-7424-7)

Ingredients (1)

amitriptyline hydrochloride (10 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": "37519f6d-7e12-4583-8f65-0a81a5c52bd4", "openfda": {"unii": ["26LUD4JO9K"], "rxcui": ["856783"], "spl_set_id": ["9d00b912-69be-4d9a-8c81-42cfc9bf6e09"], "manufacturer_name": ["A-S Medication Solutions"]}, "finished": true, "packaging": [{"sample": false, "description": "30 TABLET, COATED in 1 BOTTLE (50090-7424-0)", "package_ndc": "50090-7424-0", "marketing_start_date": "20241028"}, {"sample": false, "description": "100 TABLET, COATED in 1 BOTTLE (50090-7424-1)", "package_ndc": "50090-7424-1", "marketing_start_date": "20241028"}, {"sample": false, "description": "90 TABLET, COATED in 1 BOTTLE (50090-7424-6)", "package_ndc": "50090-7424-6", "marketing_start_date": "20241028"}, {"sample": false, "description": "60 TABLET, COATED in 1 BOTTLE (50090-7424-7)", "package_ndc": "50090-7424-7", "marketing_start_date": "20241028"}], "brand_name": "Amitriptyline Hydrochloride", "product_id": "50090-7424_37519f6d-7e12-4583-8f65-0a81a5c52bd4", "dosage_form": "TABLET, COATED", "pharm_class": ["Tricyclic Antidepressant [EPC]"], "product_ndc": "50090-7424", "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": "10 mg/1"}], "application_number": "ANDA212654", "marketing_category": "ANDA", "marketing_start_date": "20240520", "listing_expiration_date": "20261231"}