Mycapssa Capsule, Delayed Release
NDC Package 10122-550-28

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

Package Information

Mycapssa (octreotide) capsules is mYCAPSSA is indicated for long-term maintenance treatment in acromegaly patients who have responded to and tolerated treatment with octreotide or lanreotide. This formulation utilizes a capsule, delayed release delivery system. Marketed by Chiesi Usa, Inc., this product is identified by NDC 10122-550 and is authorized under FDA application NDA208232.

Identification & Billing

NDC Package Code
10122-550-28
Package Description
4 BLISTER PACK in 1 DOSE PACK / 7 CAPSULE, DELAYED RELEASE in 1 BLISTER PACK
Product Code
10122-550
11-Digit Billing Format
10122055028
Billing Unit
EA - Billing unit of "each" is used when the product is dispensed in discreet units.
Units Per Package
4 EA
RxNorm Crosswalk
  • RxCUI: 2380611 - octreotide 20 MG Delayed Release Oral Capsule
  • RxCUI: 2380611 - octreotide (as octreotide acetate) 20 MG Delayed Release Oral Capsule
  • RxCUI: 2380617 - Mycapssa 20 MG Delayed Release Oral Capsule
  • RxCUI: 2380617 - octreotide 20 MG Delayed Release Oral Capsule [Mycapssa]

Clinical Specifications

Proprietary Name
Mycapssa
Non-Proprietary Name
Octreotide
Substance Name
Octreotide
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)
OCTREOTIDE 20 mg/1
Pharmacologic Class
Usage Information
MYCAPSSA is indicated for long-term maintenance treatment in acromegaly patients who have responded to and tolerated treatment with octreotide or lanreotide.

Regulatory & Marketing

Labeler Name
Chiesi Usa, Inc.
Product Type
Human Prescription Drug
FDA Application #
NDA208232
Marketing Category
NDA - A product marketed under an approved New Drug Application.
Start Marketing Date
07-06-2020
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.

Frequently Asked Questions

What is the distribution configuration for this product package?

The code 10122-550-28 identifies a specific commercial package of 4 blister pack in 1 dose pack / 7 capsule, delayed release in 1 blister pack of Mycapssa, a human prescription drug labeled by Chiesi Usa, Inc.. This product is billed for "EA" each discreet unit and contains an estimated amount of 4 billable units per package. This capsule, delayed release is formulated for oral use and contains octreotide 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 Chiesi Usa, Inc. on July 06, 2020. The current certification is valid through December 31, 2026.

How is this Chiesi Usa, Inc. product billed for insurance claims?

For medical billing and reimbursement, this package follows the 11-digit CMS format: 10122055028. Quantities are measured in per "each", products billed on a per each basis are usually products dispensed in discreet units.. There are 4 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)
10122-550-28
11-Digit CMS (5-4-2)
10122-0550-28

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