Duloxetine Capsule, Delayed Release Pellets
NDC Package 0228-2891-03

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 capsules 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)]Fibromyalgia [see Clinical Studies (14.4)]Chronic Musculoskeletal Pain [see Clinical Studies (14.5)]. This formulation utilizes a capsule, delayed release pellets delivery system. Marketed by Actavis Pharma, Inc., this product is identified by NDC 0228-2891 and is authorized under FDA application ANDA090776.

Identification & Billing

NDC Package Code
0228-2891-03
Package Description
30 CAPSULE, DELAYED RELEASE PELLETS in 1 BOTTLE
Product Code
0228-2891
11-Digit Billing Format
00228289103
Billing Unit
EA - Billing unit of "each" is used when the product is dispensed in discreet units.
Units Per Package
30 EA
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
Non-Proprietary Name
Duloxetine
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)
Pharmacologic Class
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)]Fibromyalgia [see Clinical Studies (14.4)]Chronic Musculoskeletal Pain [see Clinical Studies (14.5)]

Regulatory & Marketing

Labeler Name
Actavis Pharma, Inc.
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
12-31-2027
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 (0228-2891). Click a package code to view its specific billing and regulatory data.

0228-2891-00
18613 CAPSULE, DELAYED RELEASE PELLETS in 1 CONTAINER
0228-2891-50
500 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 0228-2891-03 identifies a specific commercial package of 30 capsule, delayed release pellets in 1 bottle of Duloxetine, a human prescription drug labeled by Actavis Pharma, Inc.. 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 Actavis Pharma, Inc. on December 17, 2013. The current certification is valid through December 31, 2027.

How is this Actavis Pharma, Inc. product billed for insurance claims?

For medical billing and reimbursement, this package follows the 11-digit CMS format: 00228289103. Quantities are measured in per "each", products billed on a per each basis are usually products dispensed in discreet units.. There are 30 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 (4-4-2)
0228-2891-03
11-Digit CMS (5-4-2)
00228-2891-03

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