Duloxetine
NDC Package 50090-2844-0

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 inactivated by the FDA.

Duloxetine is 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 A-s Medication Solutions, this product is identified by NDC 50090-2844 and is authorized under FDA application ANDA090778.

Identification & Billing

NDC Package Code
50090-2844-0
Package Description
29 BLISTER PACK in 1 BOX, UNIT-DOSE / 1 CAPSULE, DELAYED RELEASE in 1 BLISTER PACK
Product Code
50090-2844
11-Digit Billing Format
50090284400
Billing Unit
EA - Billing unit of "each" is used when the product is dispensed in discreet units.
Units Per Package
29 EA
RxNorm Crosswalk
  • RxCUI: 596934 - DULoxetine 60 MG Delayed Release Oral Capsule
  • RxCUI: 596934 - duloxetine 60 MG Delayed Release Oral Capsule
  • RxCUI: 596934 - duloxetine 60 MG (as duloxetine HCl 67.3 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 [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
A-s Medication Solutions
FDA Application #
ANDA090778
Marketing Category
ANDA - A product marketed under an approved Abbreviated New Drug Application.
Start Marketing Date
12-11-2013
Listing Expiration
12-31-2022
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.

Frequently Asked Questions

What is the distribution configuration for this product package?

The code 50090-2844-0 identifies a specific commercial package of 29 blister pack in 1 box, unit-dose / 1 capsule, delayed release in 1 blister pack of Duloxetine, labeled by A-s Medication Solutions. This product is billed for "EA" each discreet unit and contains an estimated amount of 29 billable units per package. 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 A-s Medication Solutions on December 11, 2013. The current certification is valid through December 31, 2022.

How is this A-s Medication Solutions product billed for insurance claims?

For medical billing and reimbursement, this package follows the 11-digit CMS format: 50090284400. Quantities are measured in per "each", products billed on a per each basis are usually products dispensed in discreet units.. There are 29 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)
50090-2844-0
11-Digit CMS (5-4-2)
50090-2844-00

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