Duloxetine Hydrochloride Capsule, Delayed Release Pellets
NDC Package 50771-201-01

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

Package Information

Duloxetine Hydrochloride capsules is duloxetine delayed-release capsules, USP are indicated for the treatment of:• Major Depressive Disorder [see Clinical Studies ( 14.1)] • Generalized Anxiety Disorder [see Clinical Studies ( 14.2)] • Diabetic Peripheral Neuropathy [see Clinical Studies( 14.3)] • Chronic Musculoskeletal Pain [see Clinical Studies ( 14.5)]. This formulation utilizes a capsule, delayed release pellets delivery system. Marketed by Yaopharma Co., Ltd., this product is identified by NDC 50771-201 and is authorized under FDA application ANDA207219.

Identification & Billing

NDC Package Code
50771-201-01
Package Description
60 CAPSULE, DELAYED RELEASE PELLETS in 1 BOTTLE, PLASTIC
Product Code
50771-201
11-Digit Billing Format
50771020101
RxNorm Crosswalk
  • RxCUI: 596926 - DULoxetine 20 MG Delayed Release Oral Capsule
  • RxCUI: 596926 - duloxetine 20 MG Delayed Release Oral Capsule
  • RxCUI: 596926 - duloxetine 20 MG (as duloxetine HCl 22.4 MG) Delayed Release Oral Capsule
  • RxCUI: 596930 - DULoxetine 30 MG Delayed Release Oral Capsule
  • RxCUI: 596930 - duloxetine 30 MG Delayed Release Oral Capsule

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.
Administration Route
Oral - Administration to or by way of the mouth.
Active Ingredient(s)
DULOXETINE HYDROCHLORIDE 20 mg/1
Pharmacologic Class
Usage Information
Duloxetine delayed-release capsules, USP are indicated for the treatment of:• Major Depressive Disorder [see Clinical Studies ( 14.1)] • Generalized Anxiety Disorder [see Clinical Studies ( 14.2)] • Diabetic Peripheral Neuropathy [see Clinical Studies( 14.3)] • Chronic Musculoskeletal Pain [see Clinical Studies ( 14.5)]

Regulatory & Marketing

Labeler Name
Yaopharma Co., Ltd.
Product Type
Human Prescription Drug
FDA Application #
ANDA207219
Marketing Category
ANDA - A product marketed under an approved Abbreviated New Drug Application.
Start Marketing Date
01-01-2024
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.

Frequently Asked Questions

What is the distribution configuration for this product package?

The code 50771-201-01 identifies a specific commercial package of 60 capsule, delayed release pellets in 1 bottle, plastic of Duloxetine Hydrochloride, a human prescription drug labeled by Yaopharma Co., Ltd.. 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 Yaopharma Co., Ltd. on January 01, 2024. The current certification is valid through December 31, 2026.

How is this Yaopharma Co., Ltd. product billed for insurance claims?

For medical billing and reimbursement, this package follows the 11-digit CMS format: 50771020101. 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)
50771-201-01
11-Digit CMS (5-4-2)
50771-0201-01

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