Bafiertam Capsule
NDC Package 69387-001-01

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

Package Information

Bafiertam (monomethyl fumarate) capsules is bAFIERTAM is indicated for the treatment of relapsing forms of multiple sclerosis (MS), to include clinically isolated syndrome, relapsing-remitting disease, and active secondary progressive disease, in adults. This formulation utilizes a capsule delivery system. Marketed by Banner Life Sciences Llc, this product is identified by NDC 69387-001 and is authorized under FDA application NDA210296.

Identification & Billing

NDC Package Code
69387-001-01
Package Description
120 CAPSULE in 1 BOTTLE
Product Code
69387-001
11-Digit Billing Format
69387000101
Billing Unit
EA - Billing unit of "each" is used when the product is dispensed in discreet units.
Units Per Package
120 EA

Clinical Specifications

Proprietary Name
Bafiertam
Non-Proprietary Name
Monomethyl Fumarate
Substance Name
Monomethyl Fumarate
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)
MONOMETHYL FUMARATE 95 mg/1
Usage Information
BAFIERTAM is indicated for the treatment of relapsing forms of multiple sclerosis (MS), to include clinically isolated syndrome, relapsing-remitting disease, and active secondary progressive disease, in adults.

Regulatory & Marketing

Labeler Name
Banner Life Sciences Llc
Product Type
Human Prescription Drug
FDA Application #
NDA210296
Marketing Category
NDA - A product marketed under an approved New Drug Application.
Start Marketing Date
04-28-2020
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.

Frequently Asked Questions

What is the distribution configuration for this product package?

The code 69387-001-01 identifies a specific commercial package of 120 capsule in 1 bottle of Bafiertam, a human prescription drug labeled by Banner Life Sciences Llc. This product is billed for "EA" each discreet unit and contains an estimated amount of 120 billable units per package. This capsule is formulated for oral use and contains monomethyl fumarate 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 Banner Life Sciences Llc on April 28, 2020. The current certification is valid through December 31, 2027.

How is this Banner Life Sciences Llc product billed for insurance claims?

For medical billing and reimbursement, this package follows the 11-digit CMS format: 69387000101. Quantities are measured in per "each", products billed on a per each basis are usually products dispensed in discreet units.. There are 120 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)
69387-001-01
11-Digit CMS (5-4-2)
69387-0001-01

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