Duloxetine Capsule, Delayed Release Pellets
NDC Package 82804-024-60

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 (duloxetine hydrochloride) capsules is duloxetine delayed-release capsules are indicated for the treatment of:•Major depressive disorder in adults•Generalized anxiety disorder in adults and pediatric patients 7 years of age and older•Diabetic peripheral neuropathic pain in adults•Fibromyalgia in adults•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 pellets delivery system. Marketed by Proficient Rx Lp, this product is identified by NDC 82804-024 and is authorized under FDA application ANDA203088.

Identification & Billing

NDC Package Code
82804-024-60
Package Description
60 CAPSULE, DELAYED RELEASE PELLETS in 1 BOTTLE
Product Code
82804-024
11-Digit Billing Format
82804002460
RxNorm Crosswalk
  • RxCUI: 616402 - DULoxetine 40 MG Delayed Release Oral Capsule
  • RxCUI: 616402 - duloxetine 40 MG Delayed Release Oral Capsule
  • RxCUI: 616402 - duloxetine 40 MG (as duloxetine HCl 44.9 MG) Delayed Release Oral Capsule

Clinical Specifications

Proprietary Name
Duloxetine Delayed-release
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.
Administration Route
Oral - Administration to or by way of the mouth.
Active Ingredient(s)
DULOXETINE HYDROCHLORIDE 40 mg/1
Pharmacologic Class
Usage Information
Duloxetine delayed-release capsules are indicated for the treatment of:•Major depressive disorder in adults•Generalized anxiety disorder in adults and pediatric patients 7 years of age and older•Diabetic peripheral neuropathic pain in adults•Fibromyalgia in adults•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
Proficient Rx Lp
Product Type
Human Prescription Drug
FDA Application #
ANDA203088
Marketing Category
ANDA - A product marketed under an approved Abbreviated New Drug Application.
Start Marketing Date
05-21-2018
Listing Expiration
12-31-2026
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 (82804-024). Click a package code to view its specific billing and regulatory data.

82804-024-30
30 CAPSULE, DELAYED RELEASE PELLETS in 1 BOTTLE
82804-024-90
90 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 82804-024-60 identifies a specific commercial package of 60 capsule, delayed release pellets in 1 bottle of Duloxetine Delayed-release, a human prescription drug labeled by Proficient Rx Lp. 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 Proficient Rx Lp on May 21, 2018. The current certification is valid through December 31, 2026.

How is this Proficient Rx Lp product billed for insurance claims?

For medical billing and reimbursement, this package follows the 11-digit CMS format: 82804002460. 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)
82804-024-60
11-Digit CMS (5-4-2)
82804-0024-60

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