Carbamazepine Tablet, Extended Release
NDC Package 72516-021-01

11-digit billing NDC: 72516002101 · Billing unit: EA · 100 EA per package
Table of Contents
    1. Package Information
    2. Frequently Asked Questions

Package Information

Carbamazepine tablets is carbamazepine should not be used in patients with a history of previous bone marrow depression, hypersensitivity to the drug, or known sensitivity to any of the tricyclic compounds, such as amitriptyline, desipramine, imipramine, protriptyline, nortriptyline, etc. This formulation utilizes a tablet, extended release delivery system. Marketed by Oryza Pharmaceuticals Inc., this product is identified by NDC 72516-021 and is authorized under FDA application ANDA212948.

Identification & Billing

NDC Package Code
72516-021-01
Package Description
100 TABLET, EXTENDED RELEASE in 1 BOTTLE
Product Code
72516-021
11-Digit Billing Format
72516002101
Billing Unit
EA - Billing unit of "each" is used when the product is dispensed in discreet units.
Units Per Package
100 EA
RxNorm Crosswalk
  • RxCUI: 402505 - carBAMazepine 200 MG 12HR Extended Release Oral Tablet
  • RxCUI: 402505 - 12 HR carbamazepine 200 MG Extended Release Oral Tablet
  • RxCUI: 402505 - carbamazepine 200 MG 12 HR Extended Release Oral Tablet
  • RxCUI: 402506 - carBAMazepine 400 MG 12HR Extended Release Oral Tablet
  • RxCUI: 402506 - 12 HR carbamazepine 400 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 should not be used in patients with a history of previous bone marrow depression, hypersensitivity to the drug, or known sensitivity to any of the tricyclic compounds, such as amitriptyline, desipramine, imipramine, protriptyline, nortriptyline, etc. Likewise, on theoretical grounds its use with monoamine oxidase (MAO) inhibitors is not recommended. Before administration of carbamazepine, MAO inhibitors should be discontinued for a minimum of 14 days, or longer if the clinical situation permits.Coadministration of carbamazepine and nefazodone may result in insufficient plasma concentrations of nefazodone and its active metabolite to achieve a therapeutic effect. Coadministration of carbamazepine with nefazodone is contraindicated.

Regulatory & Marketing

Labeler Name
Oryza Pharmaceuticals Inc.
Product Type
Human Prescription Drug
FDA Application #
ANDA212948
Marketing Category
ANDA - A product marketed under an approved Abbreviated New Drug Application.
Start Marketing Date
05-18-2026
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 72516-021-01 identifies a specific commercial package of 100 tablet, extended release in 1 bottle of Carbamazepine ER, a human prescription drug labeled by Oryza Pharmaceuticals Inc.. 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 Oryza Pharmaceuticals Inc. on May 18, 2026. The current certification is valid through December 31, 2027.

How is this Oryza Pharmaceuticals Inc. product billed for insurance claims?

For medical billing and reimbursement, this package follows the 11-digit CMS format: 72516002101. Quantities are measured in per "each", products billed on a per each basis are usually products dispensed in discreet units.. There are 100 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)
72516-021-01
11-Digit CMS (5-4-2)
72516-0021-01

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