amitriptyline hydrochloride

Generic: amitriptyline hydrochloride

Labeler: advagen pharma ltd
NDC Directory HUMAN PRESCRIPTION DRUG ANDA Inactive Finished

Drug Facts

Product Profile

Brand Name amitriptyline hydrochloride
Generic Name amitriptyline hydrochloride
Labeler advagen pharma ltd
Dosage Form TABLET, FILM COATED
Routes
ORAL
Active Ingredients

amitriptyline hydrochloride 25 mg/1

Manufacturer
Advagen Pharma Ltd

Identifiers & Regulatory

Product NDC 72888-068
Product ID 72888-068_451e8ad6-a78e-429b-e063-6394a90a2bdb
Product Type HUMAN PRESCRIPTION DRUG
Marketing Category ANDA
Application Number ANDA215376
Listing Expiration 2026-12-31
Marketing Start 2023-05-01

Pharmacologic Class

Classes
tricyclic antidepressant [epc]

Normalized Code Variants

Searchable formats for this product NDC code

Digits Only 72888068
Hyphenated Format 72888-068

Supplemental Identifiers

RxCUI
856762 856773 856783 856834 856845 856853
UPC
0372888067001 0372888072012 0372888071015 0372888070018 0372888067018 0372888069012 0372888071039 0372888069005 0372888068008
UNII
26LUD4JO9K

Packaging Origin

Original Packager
true

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 ANDA215376 (source: ndc)
Routes
ORAL
source: ndc

Resolved Composition

Strengths
  • 25 mg/1
source: ndc
Packaging
  • 1000 TABLET, FILM COATED in 1 BOTTLE (72888-068-00)
  • 100 TABLET, FILM COATED in 1 BOTTLE (72888-068-01)
source: ndc

Packages (2)

72888-068-00 1000 TABLET, FILM COATED in 1 BOTTLE (72888-068-00) 72888-068-01 100 TABLET, FILM COATED in 1 BOTTLE (72888-068-01)

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": "451e8ad6-a78e-429b-e063-6394a90a2bdb", "openfda": {"upc": ["0372888067001", "0372888072012", "0372888071015", "0372888070018", "0372888067018", "0372888069012", "0372888071039", "0372888069005", "0372888068008"], "unii": ["26LUD4JO9K"], "rxcui": ["856762", "856773", "856783", "856834", "856845", "856853"], "spl_set_id": ["651bd090-a420-4dd8-89b0-4cb766c144c2"], "manufacturer_name": ["Advagen Pharma Ltd"], "is_original_packager": [true]}, "finished": true, "packaging": [{"sample": false, "description": "1000 TABLET, FILM COATED in 1 BOTTLE (72888-068-00)", "package_ndc": "72888-068-00", "marketing_start_date": "20230501"}, {"sample": false, "description": "100 TABLET, FILM COATED in 1 BOTTLE (72888-068-01)", "package_ndc": "72888-068-01", "marketing_start_date": "20230501"}], "brand_name": "Amitriptyline Hydrochloride", "product_id": "72888-068_451e8ad6-a78e-429b-e063-6394a90a2bdb", "dosage_form": "TABLET, FILM COATED", "pharm_class": ["Tricyclic Antidepressant [EPC]"], "product_ndc": "72888-068", "generic_name": "Amitriptyline Hydrochloride", "labeler_name": "Advagen Pharma Ltd", "product_type": "HUMAN PRESCRIPTION DRUG", "brand_name_base": "Amitriptyline Hydrochloride", "active_ingredients": [{"name": "AMITRIPTYLINE HYDROCHLORIDE", "strength": "25 mg/1"}], "application_number": "ANDA215376", "marketing_category": "ANDA", "marketing_start_date": "20230501", "listing_expiration_date": "20261231"}