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  5. NDC Package Code: 80425-0086-2 Duloxetine Hcl DR

NDC Package 80425-0086-2 Duloxetine Hcl DR

Capsule, Delayed Release Pellets Oral - View Billable Units, 11-Digit Format, RxNorm

Table of Contents

    1. Package Information
    2. Other Packages
    3. 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:
80425-0086-2
Package Description:
60 CAPSULE, DELAYED RELEASE PELLETS in 1 BOTTLE
Product Code:
80425-0086
Proprietary Name:
Duloxetine Hcl DR
Non-Proprietary Name:
Duloxetine Hcl
Substance Name:
Duloxetine Hydrochloride
Usage Information:
Duloxetine is used to treat depression and anxiety. In addition, duloxetine is used to help relieve nerve pain (peripheral neuropathy) in people with diabetes or ongoing pain due to medical conditions such as arthritis, chronic back pain, or fibromyalgia (a condition that causes widespread pain). Duloxetine may improve your mood, sleep, appetite, and energy level, and decrease nervousness. It can also decrease pain due to certain medical conditions. Duloxetine is known as a serotonin-norepinephrine reuptake inhibitor (SNRI). This medication works by helping to restore the balance of certain natural substances (serotonin and norepinephrine) in the brain.
11-Digit NDC Billing Format:
80425008602
Billing Unit:
EA - Billing unit of "each" is used when the product is dispensed in discreet units.
NDC to RxNorm Crosswalk:
60 EA
NDC to RxNorm Crosswalk:
  • RxCUI: 596930 - DULoxetine 30 MG Delayed Release Oral Capsule
  • RxCUI: 596930 - duloxetine 30 MG Delayed Release Oral Capsule
  • RxCUI: 596930 - duloxetine 30 MG (as duloxetine HCl 33.7 MG) Delayed Release Oral Capsule
    • Product Type:
    Human Prescription Drug
    Labeler Name:
    Advanced Rx Pharmacy Of Tennessee, Llc
    Dosage Form:
    Capsule, Delayed Release Pellets - A solid dosage form in which the drug is enclosed within either a hard or soft soluble container or "shell" made from a suitable form of gelatin; the drug itself is in the form of granules to which enteric coating has been applied, thus delaying release of the drug until its passage into the intestines.
    Administration Route(s):
  • Oral - Administration to or by way of the mouth.
    • Active Ingredient(s):
  • DULOXETINE HYDROCHLORIDE 30 mg/1
    • Pharmacologic Class(es):
  • Norepinephrine Uptake Inhibitors - [MoA] (Mechanism of Action)
  • Serotonin Uptake Inhibitors - [MoA] (Mechanism of Action)
  • Serotonin and Norepinephrine Reuptake Inhibitor - [EPC] (Established Pharmacologic Class)
    • Sample Package:
    No
    FDA Application Number:
    ANDA090776
    Marketing Category:
    ANDA - A product marketed under an approved Abbreviated New Drug Application.
    Start Marketing Date:
    12-17-2013
    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.

    Other Product Packages

    The following packages are also available for this product:

    NDC Package CodePackage Description
    80425-0086-130 CAPSULE, DELAYED RELEASE PELLETS in 1 BOTTLE

    * Please review the disclaimer below.

    Frequently Asked Questions

    What is NDC 80425-0086-2?

    The NDC Packaged Code 80425-0086-2 is assigned to a package of 60 capsule, delayed release pellets in 1 bottle of Duloxetine Hcl DR, a human prescription drug labeled by Advanced Rx Pharmacy Of Tennessee, Llc. The product's dosage form is capsule, delayed release pellets and is administered via oral form.This product is billed for "EA" each discreet unit and contains an estimated amount of 60 billable units per package.

    Is NDC 80425-0086 included in the NDC Directory?

    Yes, Duloxetine Hcl DR with product code 80425-0086 is active and included in the NDC Directory. The product was first marketed by Advanced Rx Pharmacy Of Tennessee, Llc on December 17, 2013 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 80425-0086-2?

    The contents of this package are billed per "each", products billed on a per each basis are usually products dispensed in discreet units. The calculated billable units for this package is 60.

    What is the 11-digit format for NDC 80425-0086-2?

    The 11-digit format is 80425008602. 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 5-4-1 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
    5-4-180425-0086-25-4-280425-0086-02