Duloxetine Hcl Capsule, Delayed Release Pellets
NDC Package 80425-0086-2

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

Package Information

Duloxetine Hcl capsules is duloxetine is used to treat depression and anxiety. This formulation utilizes a capsule, delayed release pellets delivery system. Marketed by Advanced Rx Of Tennessee, Llc, this product is identified by NDC 80425-0086 and is authorized under FDA application ANDA090776.

Identification & Billing

NDC Package Code
80425-0086-2
Package Description
60 CAPSULE, DELAYED RELEASE PELLETS in 1 BOTTLE
Product Code
80425-0086
11-Digit Billing Format
80425008602
Billing Unit
EA - Billing unit of "each" is used when the product is dispensed in discreet units.
Units Per Package
60 EA
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

Clinical Specifications

Proprietary Name
Duloxetine Hcl DR
Non-Proprietary Name
Duloxetine Hcl
Substance Name
Duloxetine Hydrochloride
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
Oral - Administration to or by way of the mouth.
Active Ingredient(s)
DULOXETINE HYDROCHLORIDE 30 mg/1
Pharmacologic Class
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.

Regulatory & Marketing

Labeler Name
Advanced Rx Of Tennessee, Llc
Product Type
Human Prescription Drug
FDA Application #
ANDA090776
Marketing Category
ANDA - A product marketed under an approved Abbreviated New Drug Application.
Start Marketing Date
12-17-2013
Listing Expiration
12-31-2026
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.

Other Available Packages

The following commercial packages are registered under the same Product NDC (80425-0086). Click a package code to view its specific billing and regulatory data.

80425-0086-1
30 CAPSULE, DELAYED RELEASE PELLETS in 1 BOTTLE

* 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 80425-0086-2 identifies a specific commercial package of 60 capsule, delayed release pellets in 1 bottle of Duloxetine Hcl DR, a human prescription drug labeled by Advanced Rx Of Tennessee, Llc. This product is billed for "EA" each discreet unit and contains an estimated amount of 60 billable units per package. This capsule, delayed release pellets is formulated for oral use and contains duloxetine 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 Advanced Rx Of Tennessee, Llc on December 17, 2013. The current certification is valid through December 31, 2026.

What are the primary indications for this medication?

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.

How is this Advanced Rx Of Tennessee, Llc product billed for insurance claims?

For medical billing and reimbursement, this package follows the 11-digit CMS format: 80425008602. Quantities are measured in per "each", products billed on a per each basis are usually products dispensed in discreet units.. There are 60 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 (5-4-1)
80425-0086-2
11-Digit CMS (5-4-2)
80425-0086-02

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