Duloxetine Hydrochloride Capsule, Delayed Release
NDC Package 0110-9544-15

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 an UNFINISHED DRUG part of the official NDC directory. Unfinished drugs include products like active ingredients some of which are used in bulk for further processing or compounding. The FDA requires a list of these drugs manufactured in a U.S. commercial distribution facility.

Duloxetine Hydrochloride capsules is a drug for further processing. This formulation utilizes a capsule, delayed release delivery system. Marketed by Lilly Del Caribe, Inc., this product is identified by NDC 0110-9544.

Identification & Billing

NDC Package Code
0110-9544-15
Package Description
300000 CAPSULE, DELAYED RELEASE in 1 DRUM
Product Code
0110-9544
11-Digit Billing Format
00110954415

Clinical Specifications

Proprietary Name
Duloxetine Hydrochloride
Non-Proprietary Name
Duloxetine Hydrochloride
Substance Name
Duloxetine Hydrochloride
Dosage Form
Capsule, Delayed Release - A solid dosage form in which the drug is enclosed within either a hard or soft soluble container made from a suitable form of gelatin, and which releases a drug (or drugs) at a time other than promptly after administration. Enteric-coated articles are delayed release dosage forms.
Active Ingredient(s)
DULOXETINE HYDROCHLORIDE 20 mg/1

Regulatory & Marketing

Labeler Name
Lilly Del Caribe, Inc.
Product Type
Drug For Further Processing
Marketing Category
DRUG FOR FURTHER PROCESSING - A drug (other than the bulk ingredient API) that is in an interim stage of manufacture, processing, preparation, or packaging, and not ready for human or animal use.
Start Marketing Date
12-17-2004
Listing Expiration
12-31-2026
Exclude Flag
N
Unfinished Product
Yes
Sample Package
N/A

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 0110-9544-15 identifies a specific commercial package of 300000 capsule, delayed release in 1 drum of Duloxetine Hydrochloride (UNFINISHED drug), drug for further processing labeled by Lilly Del Caribe, Inc.. This capsule, delayed release is formulated for 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 Lilly Del Caribe, Inc. on December 17, 2004. The current certification is valid through December 31, 2026.

How is this Lilly Del Caribe, Inc. product billed for insurance claims?

For medical billing and reimbursement, this package follows the 11-digit CMS format: 00110954415. 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)
0110-9544-15
11-Digit CMS (5-4-2)
00110-9544-15

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