amitriptyline hydrochloride

Generic: amitriptyline hydrochloride

Labeler: northwind health company, llc
NDC Directory HUMAN PRESCRIPTION DRUG ANDA Inactive Finished

Drug Facts

Product Profile

Brand Name amitriptyline hydrochloride
Generic Name amitriptyline hydrochloride
Labeler northwind health company, llc
Dosage Form TABLET, FILM COATED
Routes
ORAL
Active Ingredients

amitriptyline hydrochloride 10 mg/1

Manufacturer
Northwind Health Company, LLC

Identifiers & Regulatory

Product NDC 51655-632
Product ID 51655-632_494f537b-78b7-4502-e063-6294a90a3092
Product Type HUMAN PRESCRIPTION DRUG
Marketing Category ANDA
Application Number ANDA202446
Listing Expiration 2027-12-31
Marketing Start 2022-06-02

Pharmacologic Class

Classes
tricyclic antidepressant [epc]

Normalized Code Variants

Searchable formats for this product NDC code

Digits Only 51655632
Hyphenated Format 51655-632

Supplemental Identifiers

RxCUI
856783
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 ANDA202446 (source: ndc)
Routes
ORAL
source: ndc

Resolved Composition

Strengths
  • 10 mg/1
source: ndc
Packaging
  • 90 TABLET, FILM COATED in 1 BOTTLE, PLASTIC (51655-632-26)
source: ndc

Packages (1)

51655-632-26 90 TABLET, FILM COATED in 1 BOTTLE, PLASTIC (51655-632-26)

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": "494f537b-78b7-4502-e063-6294a90a3092", "openfda": {"unii": ["26LUD4JO9K"], "rxcui": ["856783"], "spl_set_id": ["e3afe026-7072-0a7d-e053-2995a90a52d4"], "manufacturer_name": ["Northwind Health Company, LLC"]}, "finished": true, "packaging": [{"sample": false, "description": "90 TABLET, FILM COATED in 1 BOTTLE, PLASTIC (51655-632-26)", "package_ndc": "51655-632-26", "marketing_start_date": "20220602"}], "brand_name": "AMITRIPTYLINE HYDROCHLORIDE", "product_id": "51655-632_494f537b-78b7-4502-e063-6294a90a3092", "dosage_form": "TABLET, FILM COATED", "pharm_class": ["Tricyclic Antidepressant [EPC]"], "product_ndc": "51655-632", "generic_name": "AMITRIPTYLINE HYDROCHLORIDE", "labeler_name": "Northwind Health Company, LLC", "product_type": "HUMAN PRESCRIPTION DRUG", "brand_name_base": "AMITRIPTYLINE HYDROCHLORIDE", "active_ingredients": [{"name": "AMITRIPTYLINE HYDROCHLORIDE", "strength": "10 mg/1"}], "application_number": "ANDA202446", "marketing_category": "ANDA", "marketing_start_date": "20220602", "listing_expiration_date": "20271231"}