nortriptyline hydrochloride

Generic: nortriptyline hydrochloride

Labeler: advanced rx pharmacy of tennessee, llc
NDC Directory HUMAN PRESCRIPTION DRUG ANDA Inactive Finished

Drug Facts

Product Profile

Brand Name nortriptyline hydrochloride
Generic Name nortriptyline hydrochloride
Labeler advanced rx pharmacy of tennessee, llc
Dosage Form CAPSULE
Routes
ORAL
Active Ingredients

nortriptyline hydrochloride 25 mg/1

Manufacturer
Advanced Rx Pharmacy of Tennessee, LLC

Identifiers & Regulatory

Product NDC 80425-0401
Product ID 80425-0401_1a904cd8-5c80-8a0e-e063-6394a90a26d5
Product Type HUMAN PRESCRIPTION DRUG
Marketing Category ANDA
Application Number ANDA073556
Listing Expiration 2026-12-31
Marketing Start 2024-06-07

Pharmacologic Class

Classes
tricyclic antidepressant [epc]

Normalized Code Variants

Searchable formats for this product NDC code

Digits Only 804250401
Hyphenated Format 80425-0401

Supplemental Identifiers

RxCUI
317136
UNII
00FN6IH15D

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 nortriptyline hydrochloride (source: ndc)
Generic Name nortriptyline hydrochloride (source: ndc)
Application Number ANDA073556 (source: ndc)
Routes
ORAL
source: ndc

Resolved Composition

Strengths
  • 25 mg/1
source: ndc
Packaging
  • 30 CAPSULE in 1 BOTTLE, PLASTIC (80425-0401-1)
  • 60 CAPSULE in 1 BOTTLE, PLASTIC (80425-0401-2)
  • 90 CAPSULE in 1 BOTTLE, PLASTIC (80425-0401-3)
source: ndc

Packages (3)

80425-0401-1 30 CAPSULE in 1 BOTTLE, PLASTIC (80425-0401-1) 80425-0401-2 60 CAPSULE in 1 BOTTLE, PLASTIC (80425-0401-2) 80425-0401-3 90 CAPSULE in 1 BOTTLE, PLASTIC (80425-0401-3)

Ingredients (1)

nortriptyline hydrochloride (25 mg/1)

Linked Drug Pages (1)

Nortriptyline Hydrochloride ndc-match (0.9)

Raw FDA Data

View complete raw FDA NDC JSON payload 
{"route": ["ORAL"], "spl_id": "1a904cd8-5c80-8a0e-e063-6394a90a26d5", "openfda": {"unii": ["00FN6IH15D"], "rxcui": ["317136"], "spl_set_id": ["1a904ddf-574a-8a24-e063-6394a90aba3b"], "manufacturer_name": ["Advanced Rx Pharmacy of Tennessee, LLC"]}, "finished": true, "packaging": [{"sample": false, "description": "30 CAPSULE in 1 BOTTLE, PLASTIC (80425-0401-1)", "package_ndc": "80425-0401-1", "marketing_start_date": "20240607"}, {"sample": false, "description": "60 CAPSULE in 1 BOTTLE, PLASTIC (80425-0401-2)", "package_ndc": "80425-0401-2", "marketing_start_date": "20240607"}, {"sample": false, "description": "90 CAPSULE in 1 BOTTLE, PLASTIC (80425-0401-3)", "package_ndc": "80425-0401-3", "marketing_start_date": "20240607"}], "brand_name": "Nortriptyline Hydrochloride", "product_id": "80425-0401_1a904cd8-5c80-8a0e-e063-6394a90a26d5", "dosage_form": "CAPSULE", "pharm_class": ["Tricyclic Antidepressant [EPC]"], "product_ndc": "80425-0401", "generic_name": "Nortriptyline Hydrochloride", "labeler_name": "Advanced Rx Pharmacy of Tennessee, LLC", "product_type": "HUMAN PRESCRIPTION DRUG", "brand_name_base": "Nortriptyline Hydrochloride", "active_ingredients": [{"name": "NORTRIPTYLINE HYDROCHLORIDE", "strength": "25 mg/1"}], "application_number": "ANDA073556", "marketing_category": "ANDA", "marketing_start_date": "20240607", "listing_expiration_date": "20261231"}