amitriptyline hydrochloride

Generic: amitriptyline hydrochloride

Labeler: asclemed usa, inc.
NDC Directory HUMAN PRESCRIPTION DRUG ANDA Inactive Finished

Drug Facts

Product Profile

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

amitriptyline hydrochloride 10 mg/1

Manufacturer
Asclemed USA, Inc.

Identifiers & Regulatory

Product NDC 76420-693
Product ID 76420-693_12a7cd78-b13d-91e0-e063-6294a90a339b
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 76420693
Hyphenated Format 76420-693

Supplemental Identifiers

RxCUI
856762 856773 856783 856834 856845 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
  • 10 mg/1
source: ndc
Packaging
  • 100 TABLET, FILM COATED in 1 BOTTLE (76420-693-01)
  • 30 TABLET, FILM COATED in 1 BOTTLE (76420-693-30)
  • 60 TABLET, FILM COATED in 1 BOTTLE (76420-693-60)
  • 90 TABLET, FILM COATED in 1 BOTTLE (76420-693-90)
source: ndc

Packages (4)

76420-693-01 100 TABLET, FILM COATED in 1 BOTTLE (76420-693-01) 76420-693-30 30 TABLET, FILM COATED in 1 BOTTLE (76420-693-30) 76420-693-60 60 TABLET, FILM COATED in 1 BOTTLE (76420-693-60) 76420-693-90 90 TABLET, FILM COATED in 1 BOTTLE (76420-693-90)

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": "12a7cd78-b13d-91e0-e063-6294a90a339b", "openfda": {"unii": ["26LUD4JO9K"], "rxcui": ["856762", "856773", "856783", "856834", "856845", "856853"], "spl_set_id": ["776d2c2c-d897-4da1-a99a-b4324e1f864f"], "manufacturer_name": ["Asclemed USA, Inc."]}, "finished": true, "packaging": [{"sample": false, "description": "100 TABLET, FILM COATED in 1 BOTTLE (76420-693-01)", "package_ndc": "76420-693-01", "marketing_start_date": "20240302"}, {"sample": false, "description": "30 TABLET, FILM COATED in 1 BOTTLE (76420-693-30)", "package_ndc": "76420-693-30", "marketing_start_date": "20240302"}, {"sample": false, "description": "60 TABLET, FILM COATED in 1 BOTTLE (76420-693-60)", "package_ndc": "76420-693-60", "marketing_start_date": "20240302"}, {"sample": false, "description": "90 TABLET, FILM COATED in 1 BOTTLE (76420-693-90)", "package_ndc": "76420-693-90", "marketing_start_date": "20240302"}], "brand_name": "Amitriptyline Hydrochloride", "product_id": "76420-693_12a7cd78-b13d-91e0-e063-6294a90a339b", "dosage_form": "TABLET, FILM COATED", "pharm_class": ["Tricyclic Antidepressant [EPC]"], "product_ndc": "76420-693", "generic_name": "Amitriptyline Hydrochloride", "labeler_name": "Asclemed USA, Inc.", "product_type": "HUMAN PRESCRIPTION DRUG", "brand_name_base": "Amitriptyline Hydrochloride", "active_ingredients": [{"name": "AMITRIPTYLINE HYDROCHLORIDE", "strength": "10 mg/1"}], "application_number": "ANDA214548", "marketing_category": "ANDA", "marketing_start_date": "20210526", "listing_expiration_date": "20261231"}