amitriptyline hydrochloride

Generic: amitriptyline hydrochloride

Labeler: preferred pharmaceuticals inc.
NDC Directory HUMAN PRESCRIPTION DRUG ANDA Inactive Finished

Drug Facts

Product Profile

Brand Name amitriptyline hydrochloride
Generic Name amitriptyline hydrochloride
Labeler preferred pharmaceuticals inc.
Dosage Form TABLET, FILM COATED
Routes
ORAL
Active Ingredients

amitriptyline hydrochloride 75 mg/1

Manufacturer
Preferred Pharmaceuticals Inc.

Identifiers & Regulatory

Product NDC 68788-8339
Product ID 68788-8339_6ffa5d5b-7bf9-4615-a08d-854c700f6980
Product Type HUMAN PRESCRIPTION DRUG
Marketing Category ANDA
Application Number ANDA214548
Listing Expiration 2027-12-31
Marketing Start 2023-02-02

Pharmacologic Class

Classes
tricyclic antidepressant [epc]

Normalized Code Variants

Searchable formats for this product NDC code

Digits Only 687888339
Hyphenated Format 68788-8339

Supplemental Identifiers

RxCUI
856853
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
  • 75 mg/1
source: ndc
Packaging
  • 100 TABLET, FILM COATED in 1 BOTTLE (68788-8339-1)
  • 30 TABLET, FILM COATED in 1 BOTTLE (68788-8339-3)
  • 60 TABLET, FILM COATED in 1 BOTTLE (68788-8339-6)
  • 28 TABLET, FILM COATED in 1 BOTTLE (68788-8339-8)
  • 90 TABLET, FILM COATED in 1 BOTTLE (68788-8339-9)
source: ndc

Packages (5)

68788-8339-1 100 TABLET, FILM COATED in 1 BOTTLE (68788-8339-1) 68788-8339-3 30 TABLET, FILM COATED in 1 BOTTLE (68788-8339-3) 68788-8339-6 60 TABLET, FILM COATED in 1 BOTTLE (68788-8339-6) 68788-8339-8 28 TABLET, FILM COATED in 1 BOTTLE (68788-8339-8) 68788-8339-9 90 TABLET, FILM COATED in 1 BOTTLE (68788-8339-9)

Ingredients (1)

amitriptyline hydrochloride (75 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": "6ffa5d5b-7bf9-4615-a08d-854c700f6980", "openfda": {"unii": ["26LUD4JO9K"], "rxcui": ["856853"], "spl_set_id": ["8b10ac1a-cf66-4efa-9abc-498b2f8a1613"], "manufacturer_name": ["Preferred Pharmaceuticals Inc."]}, "finished": true, "packaging": [{"sample": false, "description": "100 TABLET, FILM COATED in 1 BOTTLE (68788-8339-1)", "package_ndc": "68788-8339-1", "marketing_start_date": "20230202"}, {"sample": false, "description": "30 TABLET, FILM COATED in 1 BOTTLE (68788-8339-3)", "package_ndc": "68788-8339-3", "marketing_start_date": "20230202"}, {"sample": false, "description": "60 TABLET, FILM COATED in 1 BOTTLE (68788-8339-6)", "package_ndc": "68788-8339-6", "marketing_start_date": "20230202"}, {"sample": false, "description": "28 TABLET, FILM COATED in 1 BOTTLE (68788-8339-8)", "package_ndc": "68788-8339-8", "marketing_start_date": "20230202"}, {"sample": false, "description": "90 TABLET, FILM COATED in 1 BOTTLE (68788-8339-9)", "package_ndc": "68788-8339-9", "marketing_start_date": "20230202"}], "brand_name": "Amitriptyline Hydrochloride", "product_id": "68788-8339_6ffa5d5b-7bf9-4615-a08d-854c700f6980", "dosage_form": "TABLET, FILM COATED", "pharm_class": ["Tricyclic Antidepressant [EPC]"], "product_ndc": "68788-8339", "generic_name": "Amitriptyline Hydrochloride", "labeler_name": "Preferred Pharmaceuticals Inc.", "product_type": "HUMAN PRESCRIPTION DRUG", "brand_name_base": "Amitriptyline Hydrochloride", "active_ingredients": [{"name": "AMITRIPTYLINE HYDROCHLORIDE", "strength": "75 mg/1"}], "application_number": "ANDA214548", "marketing_category": "ANDA", "marketing_start_date": "20230202", "listing_expiration_date": "20271231"}