Cobenfy Capsule, Coated Pellets
NDC Package 0003-0125-98

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

Cobenfy (xanomeline and trospium chloride) capsules is cOBENFY is indicated for the treatment of schizophrenia in adults. This formulation utilizes a capsule, coated pellets delivery system. Marketed by E.r. Squibb & Sons, L.l.c., this product is identified by NDC 0003-0125 and is authorized under FDA application NDA216158.

Identification & Billing

NDC Package Code
0003-0125-98
Package Description
10 BLISTER PACK in 1 CARTON / 10 CAPSULE, COATED PELLETS in 1 BLISTER PACK
Product Code
0003-0125
11-Digit Billing Format
00003012598
RxNorm Crosswalk
  • RxCUI: 2694843 - xanomeline 50 MG / trospium chloride 20 MG Oral Capsule
  • RxCUI: 2694843 - trospium chloride 20 MG / xanomeline 50 MG Oral Capsule
  • RxCUI: 2694843 - xanomeline 50 MG (equivalent to xanomeline tartrate 76.7 MG) / trospium chloride 20 MG (trospium 18.3 MG) Oral Capsule
  • RxCUI: 2694850 - COBENFY 50 MG / 20 MG Oral Capsule
  • RxCUI: 2694850 - trospium chloride 20 MG / xanomeline 50 MG Oral Capsule [Cobenfy]

Clinical Specifications

Proprietary Name
Cobenfy
Non-Proprietary Name
Xanomeline And Trospium Chloride
Substance Name
Trospium Chloride; Xanomeline
Dosage Form
Capsule, Coated Pellets - A solid dosage form in which the drug is enclosed within either a hard or soft soluble container or "shell" made from a suitable form of gelatin; the drug itself is in the form of granules to which varying amounts of coating have been applied.
Administration Route
Oral - Administration to or by way of the mouth.
Active Ingredient(s)
Pharmacologic Class
Usage Information
COBENFY is indicated for the treatment of schizophrenia in adults.

Regulatory & Marketing

Labeler Name
E.r. Squibb & Sons, L.l.c.
Product Type
Human Prescription Drug
FDA Application #
NDA216158
Marketing Category
NDA - A product marketed under an approved New Drug Application.
Start Marketing Date
09-27-2024
Listing Expiration
12-31-2027
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 (0003-0125). Click a package code to view its specific billing and regulatory data.

0003-0125-14
14 CAPSULE, COATED PELLETS in 1 BLISTER PACK
0003-0125-60
60 CAPSULE, COATED PELLETS 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 0003-0125-98 identifies a specific commercial package of 10 blister pack in 1 carton / 10 capsule, coated pellets in 1 blister pack of Cobenfy, a human prescription drug labeled by E.r. Squibb & Sons, L.l.c.. This capsule, coated pellets is formulated for oral use and contains trospium chloride; xanomeline 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 E.r. Squibb & Sons, L.l.c. on September 27, 2024. The current certification is valid through December 31, 2027.

How is this E.r. Squibb & Sons, L.l.c. product billed for insurance claims?

For medical billing and reimbursement, this package follows the 11-digit CMS format: 00003012598. 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)
0003-0125-98
11-Digit CMS (5-4-2)
00003-0125-98

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