Duloxetine Hydrochloride Capsule, Delayed Release
NDC Package 33342-161-07

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 Hydrochloride capsules is duloxetine delayed-release capsules 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 delivery system. Marketed by Macleods Pharmaceuticals Limited, this product is identified by NDC 33342-161 and is authorized under FDA application ANDA204815.

Identification & Billing

NDC Package Code
33342-161-07
Package Description
30 CAPSULE, DELAYED RELEASE in 1 BOTTLE
Product Code
33342-161
11-Digit Billing Format
33342016107
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 - 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 30 mg/1
Pharmacologic Class
Usage Information
Duloxetine delayed-release capsules 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
Macleods Pharmaceuticals Limited
Product Type
Human Prescription Drug
FDA Application #
ANDA204815
Marketing Category
ANDA - A product marketed under an approved Abbreviated New Drug Application.
Start Marketing Date
03-24-2017
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 (33342-161). Click a package code to view its specific billing and regulatory data.

33342-161-10
90 CAPSULE, DELAYED RELEASE in 1 BOTTLE
33342-161-12
10 BLISTER PACK in 1 CARTON / 10 CAPSULE, DELAYED RELEASE in 1 BLISTER PACK
33342-161-44
1000 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 33342-161-07 identifies a specific commercial package of 30 capsule, delayed release in 1 bottle of Duloxetine Hydrochloride, a human prescription drug labeled by Macleods Pharmaceuticals Limited. 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 Macleods Pharmaceuticals Limited on March 24, 2017. The current certification is valid through December 31, 2026.

How is this Macleods Pharmaceuticals Limited product billed for insurance claims?

For medical billing and reimbursement, this package follows the 11-digit CMS format: 33342016107. 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)
33342-161-07
11-Digit CMS (5-4-2)
33342-0161-07

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