amitriptyline hydrochloride

Generic: amitriptyline hydrochloride

Labeler: aphena pharma solutions - tennessee, llc
NDC Directory HUMAN PRESCRIPTION DRUG ANDA Inactive Finished

Drug Facts

Product Profile

Brand Name amitriptyline hydrochloride
Generic Name amitriptyline hydrochloride
Labeler aphena pharma solutions - tennessee, llc
Dosage Form TABLET, FILM COATED
Routes
ORAL
Active Ingredients

amitriptyline hydrochloride 25 mg/1

Manufacturer
Aphena Pharma Solutions - Tennessee, LLC

Identifiers & Regulatory

Product NDC 71610-695
Product ID 71610-695_9b34dd5c-22e5-440d-a552-070aaeeefd55
Product Type HUMAN PRESCRIPTION DRUG
Marketing Category ANDA
Application Number ANDA214548
Listing Expiration 2026-12-31
Marketing Start 2021-05-26

Pharmacologic Class

Classes
tricyclic antidepressant [epc]

Normalized Code Variants

Searchable formats for this product NDC code

Digits Only 71610695
Hyphenated Format 71610-695

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 ANDA214548 (source: ndc)
Routes
ORAL
source: ndc

Resolved Composition

Strengths
  • 25 mg/1
source: ndc
Packaging
  • 30 TABLET, FILM COATED in 1 BOTTLE (71610-695-30)
  • 60 TABLET, FILM COATED in 1 BOTTLE (71610-695-53)
  • 90 TABLET, FILM COATED in 1 BOTTLE (71610-695-60)
source: ndc

Packages (3)

71610-695-30 30 TABLET, FILM COATED in 1 BOTTLE (71610-695-30) 71610-695-53 60 TABLET, FILM COATED in 1 BOTTLE (71610-695-53) 71610-695-60 90 TABLET, FILM COATED in 1 BOTTLE (71610-695-60)

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": "9b34dd5c-22e5-440d-a552-070aaeeefd55", "openfda": {"unii": ["26LUD4JO9K"], "rxcui": ["856834"], "spl_set_id": ["8746c047-51b9-4040-aeec-cd1f5b6eb3d4"], "manufacturer_name": ["Aphena Pharma Solutions - Tennessee, LLC"]}, "finished": true, "packaging": [{"sample": false, "description": "30 TABLET, FILM COATED in 1 BOTTLE (71610-695-30)", "package_ndc": "71610-695-30", "marketing_start_date": "20230320"}, {"sample": false, "description": "60 TABLET, FILM COATED in 1 BOTTLE (71610-695-53)", "package_ndc": "71610-695-53", "marketing_start_date": "20230320"}, {"sample": false, "description": "90 TABLET, FILM COATED in 1 BOTTLE (71610-695-60)", "package_ndc": "71610-695-60", "marketing_start_date": "20230320"}], "brand_name": "Amitriptyline Hydrochloride", "product_id": "71610-695_9b34dd5c-22e5-440d-a552-070aaeeefd55", "dosage_form": "TABLET, FILM COATED", "pharm_class": ["Tricyclic Antidepressant [EPC]"], "product_ndc": "71610-695", "generic_name": "Amitriptyline Hydrochloride", "labeler_name": "Aphena Pharma Solutions - Tennessee, LLC", "product_type": "HUMAN PRESCRIPTION DRUG", "brand_name_base": "Amitriptyline Hydrochloride", "active_ingredients": [{"name": "AMITRIPTYLINE HYDROCHLORIDE", "strength": "25 mg/1"}], "application_number": "ANDA214548", "marketing_category": "ANDA", "marketing_start_date": "20210526", "listing_expiration_date": "20261231"}