nortriptyline hydrochloride

Generic: nortriptyline hydrochloride

Labeler: pai holdings, llc dba pai pharma
NDC Directory HUMAN PRESCRIPTION DRUG ANDA Inactive Finished

Drug Facts

Product Profile

Brand Name nortriptyline hydrochloride
Generic Name nortriptyline hydrochloride
Labeler pai holdings, llc dba pai pharma
Dosage Form SOLUTION
Routes
ORAL
Active Ingredients

nortriptyline hydrochloride 10 mg/5mL

Manufacturer
PAI Holdings, LLC dba PAI Pharma

Identifiers & Regulatory

Product NDC 0121-0678
Product ID 0121-0678_49445e55-d381-44c5-9e91-392f530d6dfc
Product Type HUMAN PRESCRIPTION DRUG
Marketing Category ANDA
Application Number ANDA075606
Listing Expiration 2027-12-31
Marketing Start 2000-08-23

Pharmacologic Class

Classes
tricyclic antidepressant [epc]

Normalized Code Variants

Searchable formats for this product NDC code

Digits Only 01210678
Hyphenated Format 0121-0678

Supplemental Identifiers

RxCUI
312036
UNII
00FN6IH15D

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 nortriptyline hydrochloride (source: ndc)
Generic Name nortriptyline hydrochloride (source: ndc)
Application Number ANDA075606 (source: ndc)
Routes
ORAL
source: ndc

Resolved Composition

Strengths
  • 10 mg/5mL
source: ndc
Packaging
  • 473 mL in 1 BOTTLE (0121-0678-16)
source: ndc

Packages (1)

0121-0678-16 473 mL in 1 BOTTLE (0121-0678-16)

Ingredients (1)

nortriptyline hydrochloride (10 mg/5mL)

Linked Drug Pages (1)

Nortriptyline Hydrochloride ndc-match (0.9)

Raw FDA Data

View complete raw FDA NDC JSON payload 
{"route": ["ORAL"], "spl_id": "49445e55-d381-44c5-9e91-392f530d6dfc", "openfda": {"unii": ["00FN6IH15D"], "rxcui": ["312036"], "spl_set_id": ["3fcabf90-357a-4a06-b680-9572dc28bcfe"], "manufacturer_name": ["PAI Holdings, LLC dba PAI Pharma"], "is_original_packager": [true]}, "finished": true, "packaging": [{"sample": false, "description": "473 mL in 1 BOTTLE (0121-0678-16)", "package_ndc": "0121-0678-16", "marketing_start_date": "20000823"}], "brand_name": "Nortriptyline Hydrochloride", "product_id": "0121-0678_49445e55-d381-44c5-9e91-392f530d6dfc", "dosage_form": "SOLUTION", "pharm_class": ["Tricyclic Antidepressant [EPC]"], "product_ndc": "0121-0678", "generic_name": "Nortriptyline Hydrochloride", "labeler_name": "PAI Holdings, LLC dba PAI Pharma", "product_type": "HUMAN PRESCRIPTION DRUG", "brand_name_base": "Nortriptyline Hydrochloride", "active_ingredients": [{"name": "NORTRIPTYLINE HYDROCHLORIDE", "strength": "10 mg/5mL"}], "application_number": "ANDA075606", "marketing_category": "ANDA", "marketing_start_date": "20000823", "listing_expiration_date": "20271231"}