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  5. NDC Package Code: 50436-0747-3 Duloxetine Delayed-release

NDC Package 50436-0747-3 Duloxetine Delayed-release

View Billable Units, 11-Digit Format, RxNorm

Table of Contents

    1. Package Information
    2. Other Packages
    3. Frequently Asked Questions

Package Information

This product is EXCLUDED from the official NDC directory because the listing data was inactivated by the FDA.

Find all the important details about this NDC Package code, including the 11-Digit NDC Billing number, billing units, wholesale price, RxNorm crosswalk, active ingredients, pharmacologic clasess, etc.

NDC Package Code:
50436-0747-3
Package Description:
90 CAPSULE, DELAYED RELEASE PELLETS in 1 BOTTLE
Product Code:
50436-0747
Proprietary Name:
Duloxetine Delayed-release
Usage Information:
Duloxetine delayed-release capsules are indicated for the treatment of:Major depressive disorder in adultsGeneralized anxiety disorder in adults and pediatric patients 7 years of age and olderDiabetic peripheral neuropathic pain in adultsFibromyalgia in adultsChronic musculoskeletal pain in adultsAdditional pediatric use information is approved for Eli Lilly and Company, Inc.'s CYMBALTA (duloxetine) delayed-release capsules. However, due to Eli Lilly and Company Inc.'s marketing exclusivity rights, this drug product is not labeled with that pediatric information.
11-Digit NDC Billing Format:
50436074703
NDC to RxNorm Crosswalk:
  • RxCUI: 596930 - DULoxetine 30 MG Delayed Release Oral Capsule
  • RxCUI: 596930 - duloxetine 30 MG Delayed Release Oral Capsule
  • RxCUI: 596930 - duloxetine 30 MG (as duloxetine HCl 33.7 MG) Delayed Release Oral Capsule
  • RxCUI: 596934 - DULoxetine 60 MG Delayed Release Oral Capsule
  • RxCUI: 596934 - duloxetine 60 MG Delayed Release Oral Capsule
Labeler Name:
Unit Dose Services
Sample Package:
No
FDA Application Number:
ANDA203088
Marketing Category:
ANDA - A product marketed under an approved Abbreviated New Drug Application.
Start Marketing Date:
06-11-2014
Listing Expiration Date:
12-31-2022
Exclude Flag:
I
Code Structure:

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 disclaimer below.

Other Product Packages

The following packages are also available for this product:

NDC Package CodePackage Description
50436-0747-130 CAPSULE, DELAYED RELEASE PELLETS in 1 BOTTLE
50436-0747-260 CAPSULE, DELAYED RELEASE PELLETS in 1 BOTTLE

* Please review the disclaimer below.

Frequently Asked Questions

What is NDC 50436-0747-3?

The NDC Packaged Code 50436-0747-3 is assigned to a package of 90 capsule, delayed release pellets in 1 bottle of Duloxetine Delayed-release, labeled by Unit Dose Services. The product's dosage form is and is administered via form.

Is NDC 50436-0747 included in the NDC Directory?

No, Duloxetine Delayed-release with product code 50436-0747 is excluded from the NDC Directory because it's listing has been INACTIVATED by FDA. The product was first marketed by Unit Dose Services on June 11, 2014 and its listing in the NDC Directory is set to expire on December 31, 2022 if the product is not updated or renewed by the manufacturer.

What is the 11-digit format for NDC 50436-0747-3?

The 11-digit format is 50436074703. The 11-digit billing format might be required by the Centers for Medicare & Medicaid Services (CMS) and other payers in billing claim forms.

This package code is originally configured in a 5-4-1 segment 10-digit format and by adding a zero within the original NDC package code we can obtain the converted 11-digit format in a 5-4-2 segment configuration. The table below shows the 11-digit code conversion:

10-Digit Format10-Digit Original Code11-Digit Format11-Digit Code
5-4-150436-0747-35-4-250436-0747-03