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 50 mg/1

Manufacturer
A-S Medication Solutions

Identifiers & Regulatory

Product NDC 50090-7599
Product ID 50090-7599_2f5fe8de-9178-4691-8678-2b20ff8d8d27
Product Type HUMAN PRESCRIPTION DRUG
Marketing Category ANDA
Application Number ANDA212654
Listing Expiration 2027-12-31
Marketing Start 2024-05-20

Pharmacologic Class

Classes
tricyclic antidepressant [epc]

Normalized Code Variants

Searchable formats for this product NDC code

Digits Only 500907599
Hyphenated Format 50090-7599

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 ANDA212654 (source: ndc)
Routes
ORAL
source: ndc

Resolved Composition

Strengths
  • 50 mg/1
source: ndc
Packaging
  • 100 TABLET, COATED in 1 BOTTLE (50090-7599-0)
  • 30 TABLET, COATED in 1 BOTTLE (50090-7599-1)
  • 60 TABLET, COATED in 1 BOTTLE (50090-7599-2)
  • 90 TABLET, COATED in 1 BOTTLE (50090-7599-5)
source: ndc

Packages (4)

Ingredients (1)

amitriptyline hydrochloride (50 mg/1)

Linked Drug Pages (1)

Raw FDA Data

View complete raw FDA NDC JSON payload
{"route": ["ORAL"], "spl_id": "2f5fe8de-9178-4691-8678-2b20ff8d8d27", "openfda": {"unii": ["26LUD4JO9K"], "rxcui": ["856845"], "spl_set_id": ["5fe84552-9650-42e4-9870-add97b46dfe1"], "manufacturer_name": ["A-S Medication Solutions"]}, "finished": true, "packaging": [{"sample": false, "description": "100 TABLET, COATED in 1 BOTTLE (50090-7599-0)", "package_ndc": "50090-7599-0", "marketing_start_date": "20250709"}, {"sample": false, "description": "30 TABLET, COATED in 1 BOTTLE (50090-7599-1)", "package_ndc": "50090-7599-1", "marketing_start_date": "20250709"}, {"sample": false, "description": "60 TABLET, COATED in 1 BOTTLE (50090-7599-2)", "package_ndc": "50090-7599-2", "marketing_start_date": "20250709"}, {"sample": false, "description": "90 TABLET, COATED in 1 BOTTLE (50090-7599-5)", "package_ndc": "50090-7599-5", "marketing_start_date": "20250709"}], "brand_name": "Amitriptyline Hydrochloride", "product_id": "50090-7599_2f5fe8de-9178-4691-8678-2b20ff8d8d27", "dosage_form": "TABLET, COATED", "pharm_class": ["Tricyclic Antidepressant [EPC]"], "product_ndc": "50090-7599", "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": "ANDA212654", "marketing_category": "ANDA", "marketing_start_date": "20240520", "listing_expiration_date": "20271231"}