amitriptyline hydrochloride

Generic: amitriptyline hydrochloride

Labeler: northstar rx llc.
NDC Directory HUMAN PRESCRIPTION DRUG ANDA Inactive Finished

Drug Facts

Product Profile

Brand Name amitriptyline hydrochloride
Generic Name amitriptyline hydrochloride
Labeler northstar rx llc.
Dosage Form TABLET, FILM COATED
Routes
ORAL
Active Ingredients

amitriptyline hydrochloride 100 mg/1

Manufacturer
Northstar Rx LLC.

Identifiers & Regulatory

Product NDC 16714-261
Product ID 16714-261_f089e8f9-aed0-4f80-812d-35a969447345
Product Type HUMAN PRESCRIPTION DRUG
Marketing Category ANDA
Application Number ANDA210086
Listing Expiration 2026-12-31
Marketing Start 2021-08-25

Pharmacologic Class

Classes
tricyclic antidepressant [epc]

Normalized Code Variants

Searchable formats for this product NDC code

Digits Only 16714261
Hyphenated Format 16714-261

Supplemental Identifiers

RxCUI
856762 856773 856783 856834 856845 856853
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 ANDA210086 (source: ndc)
Routes
ORAL
source: ndc

Resolved Composition

Strengths
  • 100 mg/1
source: ndc
Packaging
  • 100 TABLET, FILM COATED in 1 BOTTLE (16714-261-01)
source: ndc

Packages (1)

16714-261-01 100 TABLET, FILM COATED in 1 BOTTLE (16714-261-01)

Ingredients (1)

amitriptyline hydrochloride (100 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": "f089e8f9-aed0-4f80-812d-35a969447345", "openfda": {"unii": ["26LUD4JO9K"], "rxcui": ["856762", "856773", "856783", "856834", "856845", "856853"], "spl_set_id": ["8ed28f42-e41a-45ca-a86f-849ebeb6ab80"], "manufacturer_name": ["Northstar Rx LLC."], "is_original_packager": [true]}, "finished": true, "packaging": [{"sample": false, "description": "100 TABLET, FILM COATED in 1 BOTTLE (16714-261-01)", "package_ndc": "16714-261-01", "marketing_start_date": "20210825"}], "brand_name": "Amitriptyline Hydrochloride", "product_id": "16714-261_f089e8f9-aed0-4f80-812d-35a969447345", "dosage_form": "TABLET, FILM COATED", "pharm_class": ["Tricyclic Antidepressant [EPC]"], "product_ndc": "16714-261", "generic_name": "Amitriptyline Hydrochloride", "labeler_name": "Northstar Rx LLC.", "product_type": "HUMAN PRESCRIPTION DRUG", "brand_name_base": "Amitriptyline Hydrochloride", "active_ingredients": [{"name": "AMITRIPTYLINE HYDROCHLORIDE", "strength": "100 mg/1"}], "application_number": "ANDA210086", "marketing_category": "ANDA", "marketing_start_date": "20210825", "listing_expiration_date": "20261231"}