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  5. NDC Package Code: 0003-0125-60 Cobenfy

NDC Package 0003-0125-60 Cobenfy

Xanomeline And Trospium Chloride Capsule, Coated Pellets Oral - View Billable Units, 11-Digit Format, RxNorm

Table of Contents

    1. Package Information
    2. Other Packages
    3. Frequently Asked Questions

Package Information

Find all the important details about this NDC Package code, including the 11-Digit NDC Billing number, billing units, wholesale price, RxNorm crosswalk, active ingredients, pharmacologic clasess, etc.

NDC Package Code:
0003-0125-60
Package Description:
60 CAPSULE, COATED PELLETS in 1 BOTTLE
Product Code:
0003-0125
Proprietary Name:
Cobenfy
Non-Proprietary Name:
Xanomeline And Trospium Chloride
Substance Name:
Trospium Chloride; Xanomeline
Usage Information:
COBENFY is indicated for the treatment of schizophrenia in adults.
11-Digit NDC Billing Format:
00003012560
Billing Unit:
EA - Billing unit of "each" is used when the product is dispensed in discreet units.
NDC to RxNorm Crosswalk:
60 EA
NDC to 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]
Product Type:
Human Prescription Drug
Labeler Name:
E.r. Squibb & Sons, L.l.c.
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(s):
Oral - Administration to or by way of the mouth.
Active Ingredient(s):
Pharmacologic Class(es):
Sample Package:
No
FDA Application Number:
NDA216158
Marketing Category:
NDA - A product marketed under an approved New Drug Application.
Start Marketing Date:
09-27-2024
Listing Expiration Date:
12-31-2025
Exclude Flag:
N
Code Structure:

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 disclaimer below.

Other Product Packages

The following packages are also available for this product:

NDC Package CodePackage Description
0003-0125-1414 CAPSULE, COATED PELLETS in 1 BLISTER PACK

* Please review the disclaimer below.

Frequently Asked Questions

What is NDC 0003-0125-60?

The NDC Packaged Code 0003-0125-60 is assigned to a package of 60 capsule, coated pellets in 1 bottle of Cobenfy, a human prescription drug labeled by E.r. Squibb & Sons, L.l.c.. The product's dosage form is capsule, coated pellets and is administered via oral form.

Is NDC 0003-0125 included in the NDC Directory?

Yes, Cobenfy with product code 0003-0125 is active and included in the NDC Directory. The product was first marketed by E.r. Squibb & Sons, L.l.c. on September 27, 2024 and its listing in the NDC Directory is set to expire on December 31, 2025 if the product is not updated or renewed by the manufacturer.

What is the NDC billing unit for package 0003-0125-60?

The contents of this package are billed per "each", products billed on a per each basis are usually products dispensed in discreet units. The calculated billable units for this package is 60.

What is the 11-digit format for NDC 0003-0125-60?

The 11-digit format is 00003012560. The 11-digit billing format might be required by the Centers for Medicare & Medicaid Services (CMS) and other payers in billing claim forms.

This package code is originally configured in a 4-4-2 segment 10-digit format and by adding a zero within the original NDC package code we can obtain the converted 11-digit format in a 5-4-2 segment configuration. The table below shows the 11-digit code conversion:

10-Digit Format10-Digit Original Code11-Digit Format11-Digit Code
4-4-20003-0125-605-4-200003-0125-60