Nortriptyline Hydrochloride Solution
NDC Package 0121-0678-16

View Billable Units, 11-Digit Conversion Format, and RxNorm mappings
Table of Contents
    1. Package Information
    2. Frequently Asked Questions

Package Information

Nortriptyline Hydrochloride solution is nortriptyline hydrochloride oral solution USP is indicated for the relief of symptoms of depression. This formulation utilizes a solution delivery system. Marketed by Pai Holdings, Llc Dba Pai Pharma, this product is identified by NDC 0121-0678 and is authorized under FDA application ANDA075606.

Identification & Billing

NDC Package Code
0121-0678-16
Package Description
473 mL in 1 BOTTLE
Product Code
0121-0678
11-Digit Billing Format
00121067816
Billing Unit
ML - Billing unit of "milliliter" is used when a product is measured by its liquid volume.
Units Per Package
473 ML
RxNorm Crosswalk
  • RxCUI: 312036 - nortriptyline HCl 10 MG in 5 mL Oral Solution
  • RxCUI: 312036 - nortriptyline 2 MG/ML Oral Solution
  • RxCUI: 312036 - nortriptyline (as nortriptyline hydrochloride) 10 MG per 5 ML Oral Solution
  • RxCUI: 312036 - nortriptyline HCl 10 MG per 5 ML Oral Solution
  • RxCUI: 312036 - nortriptyline HCl 20 MG per 10 ML Oral Solution

Clinical Specifications

Proprietary Name
Nortriptyline Hydrochloride
Non-Proprietary Name
Nortriptyline Hydrochloride
Substance Name
Nortriptyline Hydrochloride
Dosage Form
Solution - A clear, homogeneous liquid1 dosage form that contains one or more chemical substances dissolved in a solvent or mixture of mutually miscible solvents.
Administration Route
Oral - Administration to or by way of the mouth.
Active Ingredient(s)
NORTRIPTYLINE HYDROCHLORIDE 10 mg/5mL
Pharmacologic Class
Tricyclic Antidepressant - [EPC] (Established Pharmacologic Class)
Usage Information
Nortriptyline hydrochloride oral solution USP is indicated for the relief of symptoms of depression. Endogenous depressions are more likely to be alleviated than are other depressive states.

Regulatory & Marketing

Labeler Name
Pai Holdings, Llc Dba Pai Pharma
Product Type
Human Prescription Drug
FDA Application #
ANDA075606
Marketing Category
ANDA - A product marketed under an approved Abbreviated New Drug Application.
Start Marketing Date
08-23-2000
Listing Expiration
12-31-2027
Exclude Flag
N
Sample Package
No

Hierarchy Structure

Code Lineage

The NDC Directory contains ONLY information on final marketed drugs submitted to FDA electronically by labelers. A labeler might be a manufacturer, re-packager or re-labeler. The product information included in the NDC directory does not indicate that FDA has verified the information provided by the product labeler. Assigned NDC numbers are not in any way an indication of FDA approval of the product.

* Please review the full disclaimer at the bottom of this page.

Frequently Asked Questions

What is the distribution configuration for this product package?

The code 0121-0678-16 identifies a specific commercial package of 473 ml in 1 bottle of Nortriptyline Hydrochloride, a human prescription drug labeled by Pai Holdings, Llc Dba Pai Pharma. This solution is formulated for oral use and contains nortriptyline hydrochloride as the active substance.

Is this product currently listed with the FDA?

Yes, this product is active and verified within the NDC Directory. It was introduced to the market by Pai Holdings, Llc Dba Pai Pharma on August 23, 2000. The current certification is valid through December 31, 2027.

How is this Pai Holdings, Llc Dba Pai Pharma product billed for insurance claims?

For medical billing and reimbursement, this package follows the 11-digit CMS format: 00121067816. Quantities are measured in per "ml or milliliter", products billed per milliliter are usually products measured by liquid volume.. There are 473 total billable units per package. The table below illustrates the segment conversion from the 10-digit labeler code to the 11-digit provider format.

11-Digit Code Conversion

Billing payers usually require a 5-4-2 segment configuration. Below is the conversion from the 10-digit package format to the 11-digit billing format:

10-Digit Format (4-4-2)
0121-0678-16
11-Digit CMS (5-4-2)
00121-0678-16

Note: The zero is added to the Labeler segment to maintain the 5-4-2 structure.