Duloxetine
NDC Package 45865-813-30

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

This product is EXCLUDED from the official NDC directory because the listing data was inactivated by the FDA.

Duloxetine is delayed-release capsules are indicated for the treatment of major depressive disorder (MDD). Marketed by Medsource Pharmaceuticals, this product is identified by NDC 45865-813 and is authorized under FDA application ANDA090723.

Identification & Billing

NDC Package Code
45865-813-30
Package Description
30 CAPSULE, DELAYED RELEASE PELLETS in 1 BOTTLE
Product Code
45865-813
11-Digit Billing Format
45865081330
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
  • RxCUI: 596934 - DULoxetine 60 MG Delayed Release Oral Capsule
  • RxCUI: 596934 - duloxetine 60 MG Delayed Release Oral Capsule

Clinical Specifications

Proprietary Name
Duloxetine
Dosage Form
-
Usage Information
Duloxetine delayed-release capsules are indicated for the treatment of major depressive disorder (MDD). The efficacy of duloxetine was established in four short term and one maintenance trial in adults [see CLINICAL STUDIES (14.1)]. A major depressive episode (DSM-IV) implies a prominent and relatively persistent (nearly every day for at least 2 weeks) depressed or dysphoric mood that usually interferes with daily functioning, and includes at least 5 of the following 9 symptoms: depressed mood, loss of interest in usual activities, significant change in weight and/or appetite, insomnia or hypersomnia, psychomotor agitation or retardation, increased fatigue, feelings of guilt or worthlessness, slowed thinking or impaired concentration, or a suicide attempt or suicidal ideation.

Regulatory & Marketing

Labeler Name
Medsource Pharmaceuticals
FDA Application #
ANDA090723
Marketing Category
ANDA - A product marketed under an approved Abbreviated New Drug Application.
Start Marketing Date
06-18-2014
Listing Expiration
12-31-2024
Exclude Flag
I
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 (45865-813). Click a package code to view its specific billing and regulatory data.

45865-813-60
60 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 45865-813-30 identifies a specific commercial package of 30 capsule, delayed release pellets in 1 bottle of Duloxetine, labeled by Medsource Pharmaceuticals. This is formulated for use and contains as the active substance.

Is this product currently listed with the FDA?

This product code is currently listed as inactive or excluded from the primary directory. It was introduced to the market by Medsource Pharmaceuticals on June 18, 2014. The current certification is valid through December 31, 2024.

How is this Medsource Pharmaceuticals product billed for insurance claims?

For medical billing and reimbursement, this package follows the 11-digit CMS format: 45865081330. 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 (5-3-2)
45865-813-30
11-Digit CMS (5-4-2)
45865-0813-30

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