Duloxetine Hydrochloride
NDC Package 50436-2995-2

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

Package Information

This product is EXCLUDED from the official NDC directory because the listing data was discontinued by the firm.

Duloxetine Hydrochloride is duloxetine delayed-release capsules are indicated for the treatment of:Major Depressive Disorder [see Clinical Studies (14.1)] Generalized Anxiety Disorder [see Clinical Studies (14.2)]Diabetic Peripheral Neuropathy [see Clinical Studies (14.3)] Chronic Musculoskeletal Pain [see Clinical Studies (14.5)]. Marketed by Unit Dose Services, this product is identified by NDC 50436-2995 and is authorized under FDA application ANDA202045.

Identification & Billing

NDC Package Code
50436-2995-2
Package Description
60 CAPSULE, DELAYED RELEASE in 1 BOTTLE
Product Code
50436-2995
11-Digit Billing Format
50436299502
RxNorm Crosswalk
  • RxCUI: 596926 - DULoxetine 20 MG Delayed Release Oral Capsule
  • RxCUI: 596926 - duloxetine 20 MG Delayed Release Oral Capsule
  • RxCUI: 596926 - duloxetine 20 MG (as duloxetine HCl 22.4 MG) Delayed Release Oral Capsule
  • RxCUI: 596930 - DULoxetine 30 MG Delayed Release Oral Capsule
  • RxCUI: 596930 - duloxetine 30 MG Delayed Release Oral Capsule

Clinical Specifications

Proprietary Name
Duloxetine Hydrochloride
Dosage Form
-
Usage Information
Duloxetine delayed-release capsules are indicated for the treatment of:Major Depressive Disorder [see Clinical Studies (14.1)] Generalized Anxiety Disorder [see Clinical Studies (14.2)]Diabetic Peripheral Neuropathy [see Clinical Studies (14.3)] Chronic Musculoskeletal Pain [see Clinical Studies (14.5)]

Regulatory & Marketing

Labeler Name
Unit Dose Services
FDA Application #
ANDA202045
Marketing Category
ANDA - A product marketed under an approved Abbreviated New Drug Application.
Start Marketing Date
06-13-2014
End Marketing Date
12-31-2017
Listing Expiration
12-31-2017
Exclude Flag
D
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 50436-2995-2 identifies a specific commercial package of 60 capsule, delayed release in 1 bottle of Duloxetine Hydrochloride, labeled by Unit Dose Services. 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 Unit Dose Services on June 13, 2014. The current certification is valid through December 31, 2017.

How is this Unit Dose Services product billed for insurance claims?

For medical billing and reimbursement, this package follows the 11-digit CMS format: 50436299502. 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)
50436-2995-2
11-Digit CMS (5-4-2)
50436-2995-02

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