Carbamazepine
NDC Package 29033-019-12

11-digit billing NDC: 29033001912 · Billing unit: EA · 120 EA per package
Table of Contents
    1. Package Information
    2. Frequently Asked Questions

Package Information

This product is EXCLUDED from the official NDC directory because the listing data was inactivated by the FDA.

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 and nortriptyline. Marketed by Nostrum Laboratories, Inc., this product is identified by NDC 29033-019 and is authorized under FDA application ANDA076697.

Identification & Billing

NDC Package Code
29033-019-12
Package Description
120 CAPSULE, EXTENDED RELEASE in 1 BOTTLE
Product Code
29033-019
11-Digit Billing Format
29033001912
Billing Unit
EA - Billing unit of "each" is used when the product is dispensed in discreet units.
Units Per Package
120 EA
RxNorm Crosswalk
  • RxCUI: 200131 - carBAMazepine 300 MG 12HR Extended Release Oral Capsule
  • RxCUI: 200131 - 12 HR carbamazepine 300 MG Extended Release Oral Capsule
  • RxCUI: 200131 - carbamazepine 300 MG 12 HR Extended Release Oral Capsule
  • RxCUI: 200133 - carBAMazepine 200 MG 12HR Extended Release Oral Capsule
  • RxCUI: 200133 - 12 HR carbamazepine 200 MG Extended Release Oral Capsule

Clinical Specifications

Proprietary Name
Carbamazepine
Dosage Form
-
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 and nortriptyline. Likewise, on theoretical grounds its use with monoamine oxidase 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.Coadministration of carbamazepine extended-release capsules are contraindicated with delavirdine due to the potential for loss of virologic response and possible resistance to delavirdine or to the class of non-nucleoside reverse transcriptase inhibitors.

Regulatory & Marketing

Labeler Name
Nostrum Laboratories, Inc.
FDA Application #
ANDA076697
Marketing Category
ANDA - A product marketed under an approved Abbreviated New Drug Application.
Start Marketing Date
02-17-2020
Listing Expiration
12-31-2025
Exclude Flag
I
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 29033-019-12 identifies a specific commercial package of 120 capsule, extended release in 1 bottle of Carbamazepine, labeled by Nostrum Laboratories, Inc.. This is formulated for use and contains as the active substance.

Is this product currently listed with the FDA?

This product code is currently listed as inactive or excluded from the primary directory. It was introduced to the market by Nostrum Laboratories, Inc. on February 17, 2020. The current certification is valid through December 31, 2025.

How is this Nostrum Laboratories, Inc. product billed for insurance claims?

For medical billing and reimbursement, this package follows the 11-digit CMS format: 29033001912. 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)
29033-019-12
11-Digit CMS (5-4-2)
29033-0019-12

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