Duloxetine D/r Capsule, Delayed Release
NDC Package 72189-608-90

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 D/r 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 and pediatric patients 13 years of age and older Chronic musculoskeletal pain in adults. This formulation utilizes a capsule, delayed release delivery system. Marketed by Direct_rx, this product is identified by NDC 72189-608 and is authorized under FDA application ANDA090694.

Identification & Billing

NDC Package Code
72189-608-90
Package Description
90 CAPSULE, DELAYED RELEASE in 1 BOTTLE
Product Code
72189-608
11-Digit Billing Format
72189060890
Billing Unit
EA - Billing unit of "each" is used when the product is dispensed in discreet units.
Units Per Package
90 EA
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 D/r
Non-Proprietary Name
Duloxetine D/r
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: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 and pediatric patients 13 years of age and older Chronic musculoskeletal pain in adults

Regulatory & Marketing

Labeler Name
Direct_rx
Product Type
Human Prescription Drug
FDA Application #
ANDA090694
Marketing Category
ANDA - A product marketed under an approved Abbreviated New Drug Application.
Start Marketing Date
01-16-2025
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 (72189-608). Click a package code to view its specific billing and regulatory data.

72189-608-30
30 CAPSULE, DELAYED RELEASE in 1 BOTTLE
72189-608-60
60 CAPSULE, DELAYED RELEASE 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 72189-608-90 identifies a specific commercial package of 90 capsule, delayed release in 1 bottle of Duloxetine D/r, a human prescription drug labeled by Direct_rx. This product is billed for "EA" each discreet unit and contains an estimated amount of 90 billable units per package. 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 Direct_rx on January 16, 2025. The current certification is valid through December 31, 2026.

How is this Direct_rx product billed for insurance claims?

For medical billing and reimbursement, this package follows the 11-digit CMS format: 72189060890. Quantities are measured in per "each", products billed on a per each basis are usually products dispensed in discreet units.. There are 90 total billable units per package. 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)
72189-608-90
11-Digit CMS (5-4-2)
72189-0608-90

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