Alvimopan Capsule
NDC Package 0591-2312-00

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

Alvimopan capsules are indicated to accelerate the time to upper and lower gastrointestinal recovery following surgeries that include partial bowel resection with primary anastomosis. This formulation utilizes a capsule delivery system. Marketed by Actavis Pharma, Inc., this product is identified by NDC 0591-2312 and is authorized under FDA application ANDA208295.

Identification & Billing

NDC Package Code
0591-2312-00
Package Description
20000 CAPSULE in 1 BOX
Product Code
0591-2312
11-Digit Billing Format
00591231200
RxNorm Crosswalk
RxCUI: 799835 - alvimopan 12 MG Oral Capsule

Clinical Specifications

Proprietary Name
Alvimopan
Non-Proprietary Name
Alvimopan
Substance Name
Alvimopan
Dosage Form
Capsule - A solid oral dosage form consisting of a shell and a filling. The shell is composed of a single sealed enclosure, or two halves that fit together and which are sometimes sealed with a band. Capsule shells may be made from gelatin, starch, or cellulose, or other suitable materials, may be soft or hard, and are filled with solid or liquid ingredients that can be poured or squeezed.
Administration Route
Oral - Administration to or by way of the mouth.
Active Ingredient(s)
Pharmacologic Class
Usage Information
Alvimopan capsules are indicated to accelerate the time to upper and lower gastrointestinal recovery following surgeries that include partial bowel resection with primary anastomosis.

Regulatory & Marketing

Labeler Name
Actavis Pharma, Inc.
Product Type
Human Prescription Drug
FDA Application #
ANDA208295
Marketing Category
ANDA - A product marketed under an approved Abbreviated New Drug Application.
Start Marketing Date
12-01-2020
Listing Expiration
12-31-2026
Exclude Flag
N
Sample Package
N/A

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 (0591-2312). Click a package code to view its specific billing and regulatory data.

0591-2312-15
30 BLISTER PACK in 1 CARTON / 1 CAPSULE in 1 BLISTER PACK (0591-2312-45)

* 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 0591-2312-00 identifies a specific commercial package of 20000 capsule in 1 box of Alvimopan, a human prescription drug labeled by Actavis Pharma, Inc.. This capsule is formulated for oral use and contains alvimopan 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 Actavis Pharma, Inc. on December 01, 2020. The current certification is valid through December 31, 2026.

How is this Actavis Pharma, Inc. product billed for insurance claims?

For medical billing and reimbursement, this package follows the 11-digit CMS format: 00591231200. 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 (4-4-2)
0591-2312-00
11-Digit CMS (5-4-2)
00591-2312-00

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