Carbamazepine Er Tablet, Extended Release
NDC Package 35561-357-99

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

Carbamazepine Er (carbamazepine) tablets is carbamazepine is used to prevent and control seizures. This formulation utilizes a tablet, extended release delivery system. Marketed by Bostal Llc, this product is identified by NDC 35561-357 and is authorized under FDA application ANDA215591.

Identification & Billing

NDC Package Code
35561-357-99
Package Description
33051 TABLET, EXTENDED RELEASE in 1 DRUM
Product Code
35561-357
11-Digit Billing Format
35561035799
RxNorm Crosswalk
  • RxCUI: 199378 - carBAMazepine 100 MG 12HR Extended Release Oral Tablet
  • RxCUI: 199378 - 12 HR carbamazepine 100 MG Extended Release Oral Tablet
  • RxCUI: 199378 - carbamazepine 100 MG 12 HR Extended Release Oral Tablet
  • RxCUI: 402505 - carBAMazepine 200 MG 12HR Extended Release Oral Tablet
  • RxCUI: 402505 - 12 HR carbamazepine 200 MG Extended Release Oral Tablet

Clinical Specifications

Proprietary Name
Carbamazepine Er
Non-Proprietary Name
Carbamazepine
Substance Name
Carbamazepine
Dosage Form
Tablet, Extended Release - A solid dosage form containing a drug which allows at least a reduction in dosing frequency as compared to that drug presented in conventional dosage form.
Administration Route
Oral - Administration to or by way of the mouth.
Active Ingredient(s)
CARBAMAZEPINE 400 mg/1
Pharmacologic Class
Usage Information
Carbamazepine is used to prevent and control seizures. This medication is known as an anticonvulsant or anti-epileptic drug. It is also used to relieve certain types of nerve pain (such as trigeminal neuralgia). This medication works by reducing the spread of seizure activity in the brain and restoring the normal balance of nerve activity. Some forms of this medication are also used to treat bipolar disorder. Carbamazepine can help to decrease extreme changes in mood and help you feel less agitated.

Regulatory & Marketing

Labeler Name
Bostal Llc
Product Type
Human Prescription Drug
FDA Application #
ANDA215591
Marketing Category
ANDA - A product marketed under an approved Abbreviated New Drug Application.
Start Marketing Date
03-31-2022
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 (35561-357). Click a package code to view its specific billing and regulatory data.

35561-357-12
100 TABLET, EXTENDED RELEASE in 1 BOTTLE
35561-357-13
500 TABLET, EXTENDED RELEASE 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 35561-357-99 identifies a specific commercial package of 33051 tablet, extended release in 1 drum of Carbamazepine Er, a human prescription drug labeled by Bostal Llc. This tablet, extended release is formulated for oral use and contains carbamazepine 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 Bostal Llc on March 31, 2022. The current certification is valid through December 31, 2027.

What are the primary indications for this medication?

Carbamazepine is used to prevent and control seizures. This medication is known as an anticonvulsant or anti-epileptic drug. It is also used to relieve certain types of nerve pain (such as trigeminal neuralgia). This medication works by reducing the spread of seizure activity in the brain and restoring the normal balance of nerve activity. Some forms of this medication are also used to treat bipolar disorder. Carbamazepine can help to decrease extreme changes in mood and help you feel less agitated.

How is this Bostal Llc product billed for insurance claims?

For medical billing and reimbursement, this package follows the 11-digit CMS format: 35561035799. 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)
35561-357-99
11-Digit CMS (5-4-2)
35561-0357-99

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