Duloxetine Hydrochloride Capsule, Delayed Release Pellets
NDC Package 73476-747-00

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 pellets delivery system. Marketed by Towa Pharmaceutical Europe, S.l., this product is identified by NDC 73476-747.

Identification & Billing

NDC Package Code
73476-747-00
Package Description
100000 CAPSULE, DELAYED RELEASE PELLETS in 1 DRUM
Product Code
73476-747
11-Digit Billing Format
73476074700

Clinical Specifications

Proprietary Name
Duloxetine Hydrochloride
Non-Proprietary Name
Duloxetine Hydrochloride
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.
Active Ingredient(s)
DULOXETINE HYDROCHLORIDE 30 mg/1

Regulatory & Marketing

Labeler Name
Towa Pharmaceutical Europe, S.l.
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
01-29-2016
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 73476-747-00 identifies a specific commercial package of 100000 capsule, delayed release pellets in 1 drum of Duloxetine Hydrochloride (UNFINISHED drug), drug for further processing labeled by Towa Pharmaceutical Europe, S.l.. This capsule, delayed release pellets 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 Towa Pharmaceutical Europe, S.l. on January 29, 2016. The current certification is valid through December 31, 2026.

How is this Towa Pharmaceutical Europe, S.l. product billed for insurance claims?

For medical billing and reimbursement, this package follows the 11-digit CMS format: 73476074700. 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)
73476-747-00
11-Digit CMS (5-4-2)
73476-0747-00

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