nortriptyline hydrochloride

Generic: nortriptyline hydrochloride

Labeler: aphena pharma solutions - tennessee, llc
NDC Directory HUMAN PRESCRIPTION DRUG ANDA Inactive Finished

Drug Facts

Product Profile

Brand Name nortriptyline hydrochloride
Generic Name nortriptyline hydrochloride
Labeler aphena pharma solutions - tennessee, llc
Dosage Form CAPSULE
Routes
ORAL
Active Ingredients

nortriptyline hydrochloride 25 mg/1

Manufacturer
Aphena Pharma Solutions - Tennessee, LLC

Identifiers & Regulatory

Product NDC 71610-785
Product ID 71610-785_694842c0-33b2-4cd4-adf7-2dd8999b38ac
Product Type HUMAN PRESCRIPTION DRUG
Marketing Category ANDA
Application Number ANDA074132
Listing Expiration 2026-12-31
Marketing Start 1995-04-06

Pharmacologic Class

Classes
tricyclic antidepressant [epc]

Normalized Code Variants

Searchable formats for this product NDC code

Digits Only 71610785
Hyphenated Format 71610-785

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 ANDA074132 (source: ndc)
Routes
ORAL
source: ndc

Resolved Composition

Strengths
  • 25 mg/1
source: ndc
Packaging
  • 30 CAPSULE in 1 BOTTLE (71610-785-30)
  • 90 CAPSULE in 1 BOTTLE (71610-785-60)
source: ndc

Packages (2)

71610-785-30 30 CAPSULE in 1 BOTTLE (71610-785-30) 71610-785-60 90 CAPSULE in 1 BOTTLE (71610-785-60)

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": "694842c0-33b2-4cd4-adf7-2dd8999b38ac", "openfda": {"unii": ["00FN6IH15D"], "rxcui": ["317136"], "spl_set_id": ["f1868790-c70b-4979-974d-3ce0ffe99e36"], "manufacturer_name": ["Aphena Pharma Solutions - Tennessee, LLC"]}, "finished": true, "packaging": [{"sample": false, "description": "30 CAPSULE in 1 BOTTLE (71610-785-30)", "package_ndc": "71610-785-30", "marketing_start_date": "20240126"}, {"sample": false, "description": "90 CAPSULE in 1 BOTTLE (71610-785-60)", "package_ndc": "71610-785-60", "marketing_start_date": "20240126"}], "brand_name": "Nortriptyline Hydrochloride", "product_id": "71610-785_694842c0-33b2-4cd4-adf7-2dd8999b38ac", "dosage_form": "CAPSULE", "pharm_class": ["Tricyclic Antidepressant [EPC]"], "product_ndc": "71610-785", "generic_name": "Nortriptyline Hydrochloride", "labeler_name": "Aphena Pharma Solutions - Tennessee, LLC", "product_type": "HUMAN PRESCRIPTION DRUG", "brand_name_base": "Nortriptyline Hydrochloride", "active_ingredients": [{"name": "NORTRIPTYLINE HYDROCHLORIDE", "strength": "25 mg/1"}], "application_number": "ANDA074132", "marketing_category": "ANDA", "marketing_start_date": "19950406", "listing_expiration_date": "20261231"}