Carbamazepine Suspension
NDC Package 51672-4047-4

11-digit billing NDC: 51672404704 · Billing unit: ML · 450 ML per package
Table of Contents
    1. Package Information
    2. Other Packages
    3. Frequently Asked Questions

Package Information

Carbamazepine suspension 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 suspension delivery system. Marketed by Sun Pharmaceutical Industries, Inc., this product is identified by NDC 51672-4047 and is authorized under FDA application ANDA076729.

Identification & Billing

NDC Package Code
51672-4047-4
Package Description
1 BOTTLE in 1 CARTON / 450 mL in 1 BOTTLE
Product Code
51672-4047
11-Digit Billing Format
51672404704
Billing Unit
ML - Billing unit of "milliliter" is used when a product is measured by its liquid volume.
Units Per Package
450 ML
RxNorm Crosswalk

Clinical Specifications

Proprietary Name
Carbamazepine
Non-Proprietary Name
Carbamazepine
Substance Name
Carbamazepine
Dosage Form
Suspension - A liquid1 dosage form that contains solid particles dispersed in a liquid vehicle.
Administration Route
Oral - Administration to or by way of the mouth.
Active Ingredient(s)
CARBAMAZEPINE 100 mg/5mL
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
Sun Pharmaceutical Industries, Inc.
Product Type
Human Prescription Drug
FDA Application #
ANDA076729
Marketing Category
ANDA - A product marketed under an approved Abbreviated New Drug Application.
Start Marketing Date
09-20-2004
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 (51672-4047). Click a package code to view its specific billing and regulatory data.

51672-4047-9
450 mL 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 51672-4047-4 identifies a specific commercial package of 1 bottle in 1 carton / 450 ml in 1 bottle of Carbamazepine, a human prescription drug labeled by Sun Pharmaceutical Industries, Inc.. This suspension 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 Sun Pharmaceutical Industries, Inc. on September 20, 2004. The current certification is valid through December 31, 2027.

How is this Sun Pharmaceutical Industries, Inc. product billed for insurance claims?

For medical billing and reimbursement, this package follows the 11-digit CMS format: 51672404704. Quantities are measured in per "ml or milliliter", products billed per milliliter are usually products measured by liquid volume.. There are 450 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 (5-4-1)
51672-4047-4
11-Digit CMS (5-4-2)
51672-4047-04

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