Duloxetine Capsule, Delayed Release
NDC Package 51655-237-25

View Billable Units, 11-Digit Conversion Format, and RxNorm mappings
Table of Contents
    1. Package Information
    2. Frequently Asked Questions

Package Information

Duloxetine capsules is duloxetine delayed-release capsules are indicated for the treatment of: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 adults in Chronic musculoskeletal pain in adultsAdditional pediatric use information is approved for Eli Lilly and Company, Inc.’s CYMBALTA (duloxetine) delayed-release capsules. This formulation utilizes a capsule, delayed release delivery system. Marketed by Northwind Health Company, Llc, this product is identified by NDC 51655-237 and is authorized under FDA application ANDA208706.

Identification & Billing

NDC Package Code
51655-237-25
Package Description
60 CAPSULE, DELAYED RELEASE in 1 BOTTLE, PLASTIC
Product Code
51655-237
11-Digit Billing Format
51655023725
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
Non-Proprietary Name
Duloxetine
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.
Administration Route
Oral - Administration to or by way of the mouth.
Active Ingredient(s)
DULOXETINE HYDROCHLORIDE 60 mg/1
Pharmacologic Class
Usage Information
Duloxetine delayed-release capsules are indicated for the treatment of: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 adults in Chronic 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.

Regulatory & Marketing

Labeler Name
Northwind Health Company, Llc
Product Type
Human Prescription Drug
FDA Application #
ANDA208706
Marketing Category
ANDA - A product marketed under an approved Abbreviated New Drug Application.
Start Marketing Date
04-23-2021
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.

Frequently Asked Questions

What is the distribution configuration for this product package?

The code 51655-237-25 identifies a specific commercial package of 60 capsule, delayed release in 1 bottle, plastic of Duloxetine, a human prescription drug labeled by Northwind Health Company, Llc. This capsule, delayed release 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 Northwind Health Company, Llc on April 23, 2021. The current certification is valid through December 31, 2027.

How is this Northwind Health Company, Llc product billed for insurance claims?

For medical billing and reimbursement, this package follows the 11-digit CMS format: 51655023725. 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)
51655-237-25
11-Digit CMS (5-4-2)
51655-0237-25

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