Duloxetine Capsule, Delayed Release
NDC Package 31722-170-01

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 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 adults Additional 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 Camber Pharmaceuticals, Inc., this product is identified by NDC 31722-170 and is authorized under FDA application ANDA204343.

Identification & Billing

NDC Package Code
31722-170-01
Package Description
100 CAPSULE, DELAYED RELEASE in 1 BOTTLE
Product Code
31722-170
11-Digit Billing Format
31722017001
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
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: • 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 adults Additional 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
Camber Pharmaceuticals, Inc.
Product Type
Human Prescription Drug
FDA Application #
ANDA204343
Marketing Category
ANDA - A product marketed under an approved Abbreviated New Drug Application.
Start Marketing Date
12-30-2020
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 (31722-170). Click a package code to view its specific billing and regulatory data.

31722-170-10
1000 CAPSULE, DELAYED RELEASE in 1 BOTTLE
31722-170-30
30 CAPSULE, DELAYED RELEASE in 1 BOTTLE
31722-170-31
7 CAPSULE, DELAYED RELEASE in 1 BLISTER PACK
31722-170-90
90 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 31722-170-01 identifies a specific commercial package of 100 capsule, delayed release in 1 bottle of Duloxetine, a human prescription drug labeled by Camber Pharmaceuticals, Inc.. 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 Camber Pharmaceuticals, Inc. on December 30, 2020. The current certification is valid through December 31, 2026.

How is this Camber Pharmaceuticals, Inc. product billed for insurance claims?

For medical billing and reimbursement, this package follows the 11-digit CMS format: 31722017001. 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)
31722-170-01
11-Digit CMS (5-4-2)
31722-0170-01

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