Carglumic Acid Tablet, For Suspension
NDC Package 35573-459-60

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

Package Information

Carglumic Acid tablets is classified as a

administered via oral route. This formulation utilizes a tablet, for suspension delivery system. Marketed by Burel Pharmaceuticals, Llc, this product is identified by NDC 35573-459 and is authorized under FDA application ANDA213395.

Identification & Billing

NDC Package Code
35573-459-60
Package Description
60 TABLET, FOR SUSPENSION in 1 BOTTLE
Product Code
35573-459
11-Digit Billing Format
35573045960
Billing Unit
EA - Billing unit of "each" is used when the product is dispensed in discreet units.
Units Per Package
60 EA
RxNorm Crosswalk
  • RxCUI: 905390 - carglumic acid 200 MG Tablet for Oral Suspension
  • RxCUI: 905390 - carglumic acid 200 MG Dispersible Tablet for Oral Suspension

Clinical Specifications

Proprietary Name
Carglumic Acid
Non-Proprietary Name
Carglumic Acid
Substance Name
Carglumic Acid
Dosage Form
Tablet, For Suspension - A tablet that forms a suspension when placed in a liquid (formerly referred to as a ‘dispersible tablet’).
Administration Route
Oral - Administration to or by way of the mouth.
Active Ingredient(s)
CARGLUMIC ACID 200 mg/1
Pharmacologic Class

Regulatory & Marketing

Labeler Name
Burel Pharmaceuticals, Llc
Product Type
Human Prescription Drug
FDA Application #
ANDA213395
Marketing Category
ANDA - A product marketed under an approved Abbreviated New Drug Application.
Start Marketing Date
12-19-2022
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 35573-459-60 identifies a specific commercial package of 60 tablet, for suspension in 1 bottle of Carglumic Acid, a human prescription drug labeled by Burel Pharmaceuticals, Llc. This product is billed for "EA" each discreet unit and contains an estimated amount of 60 billable units per package. This tablet, for suspension is formulated for oral use and contains carglumic acid 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 Burel Pharmaceuticals, Llc on December 19, 2022. The current certification is valid through December 31, 2026.

How is this Burel Pharmaceuticals, Llc product billed for insurance claims?

For medical billing and reimbursement, this package follows the 11-digit CMS format: 35573045960. Quantities are measured in per "each", products billed on a per each basis are usually products dispensed in discreet units.. There are 60 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)
35573-459-60
11-Digit CMS (5-4-2)
35573-0459-60

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