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  5. NDC Package Code: 70954-319-10 Paroxetine

NDC Package 70954-319-10 Paroxetine

Suspension Oral - View Billable Units, 11-Digit Format, RxNorm

Table of Contents

    1. Package Information
    2. Frequently Asked Questions

Package Information

Find all the important details about this NDC Package code, including the 11-Digit NDC Billing number, billing units, wholesale price, RxNorm crosswalk, active ingredients, pharmacologic clasess, etc.

NDC Package Code:
70954-319-10
Package Description:
250 mL in 1 BOTTLE
Product Code:
70954-319
Proprietary Name:
Paroxetine
Non-Proprietary Name:
Paroxetine
Substance Name:
Paroxetine Hydrochloride Hemihydrate
Usage Information:
Paroxetine is indicated in adults for the treatment of:Major depressive disorder (MDD)Obsessive compulsive disorder (OCD)Panic disorder (PD)Social anxiety disorder (SAD)Generalized anxiety disorder (GAD)Posttraumatic stress disorder (PTSD)
11-Digit NDC Billing Format:
70954031910
Billing Unit:
ML - Billing unit of "milliliter" is used when a product is measured by its liquid volume.
NDC to RxNorm Crosswalk:
250 ML
NDC to RxNorm Crosswalk:
  • RxCUI: 312242 - PARoxetine HCl 10 MG in 5 mL Oral Suspension
  • RxCUI: 312242 - paroxetine hydrochloride 2 MG/ML Oral Suspension
  • RxCUI: 312242 - paroxetine (as paroxetine hydrochloride) 10 MG per 5 ML Oral Suspension
    • Product Type:
    Human Prescription Drug
    Labeler Name:
    Ani Pharmaceuticals, Inc.
    Dosage Form:
    Suspension - A liquid1 dosage form that contains solid particles dispersed in a liquid vehicle.
    Administration Route(s):
  • Oral - Administration to or by way of the mouth.
    • Active Ingredient(s):
  • PAROXETINE HYDROCHLORIDE HEMIHYDRATE 10 mg/5mL
    • Pharmacologic Class(es):
  • Serotonin Reuptake Inhibitor - [EPC] (Established Pharmacologic Class)
  • Serotonin Uptake Inhibitors - [MoA] (Mechanism of Action)
    • Sample Package:
    No
    FDA Application Number:
    ANDA215003
    Marketing Category:
    ANDA - A product marketed under an approved Abbreviated New Drug Application.
    Start Marketing Date:
    09-03-2021
    Listing Expiration Date:
    12-31-2024
    Exclude Flag:
    N
    Code Structure:

    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 disclaimer below.

    Frequently Asked Questions

    What is NDC 70954-319-10?

    The NDC Packaged Code 70954-319-10 is assigned to a package of 250 ml in 1 bottle of Paroxetine, a human prescription drug labeled by Ani Pharmaceuticals, Inc.. The product's dosage form is suspension and is administered via oral form.This product is billed per "ML" milliliter and contains an estimated amount of 250 billable units per package.

    Is NDC 70954-319 included in the NDC Directory?

    Yes, Paroxetine with product code 70954-319 is active and included in the NDC Directory. The product was first marketed by Ani Pharmaceuticals, Inc. on September 03, 2021 and its listing in the NDC Directory is set to expire on December 31, 2024 if the product is not updated or renewed by the manufacturer.

    What is the NDC billing unit for package 70954-319-10?

    The contents of this package are billed per "ml or milliliter", products billed per milliliter are usually products measured by liquid volume. The calculated billable units for this package is 250.

    What is the 11-digit format for NDC 70954-319-10?

    The 11-digit format is 70954031910. The 11-digit billing format might be required by the Centers for Medicare & Medicaid Services (CMS) and other payers in billing claim forms.

    This package code is originally configured in a 5-3-2 segment 10-digit format and by adding a zero within the original NDC package code we can obtain the converted 11-digit format in a 5-4-2 segment configuration. The table below shows the 11-digit code conversion:

    10-Digit Format10-Digit Original Code11-Digit Format11-Digit Code
    5-3-270954-319-105-4-270954-0319-10