Cephalexin
NDC Package 33261-485-01

11-digit billing NDC: 33261048501 · Billing unit: ML · 100 ML 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.

Cephalexin is indicated for the treatment of the following infections when caused by susceptible strains of the designated microorganisms:Respiratory tract infections caused by S. Marketed by Aidarex Pharmaceuticals Llc, this product is identified by NDC 33261-485 and is authorized under FDA application ANDA065234.

Identification & Billing

NDC Package Code
33261-485-01
Package Description
100 mL in 1 BOTTLE
Product Code
33261-485
11-Digit Billing Format
33261048501
Billing Unit
ML - Billing unit of "milliliter" is used when a product is measured by its liquid volume.
Units Per Package
100 ML
RxNorm Crosswalk

Clinical Specifications

Proprietary Name
Cephalexin
Dosage Form
-
Usage Information
Cephalexin is indicated for the treatment of the following infections when caused by susceptible strains of the designated microorganisms:Respiratory tract infections caused by S. pneumoniae and S. pyogenes. (Penicillin is the usual drug of choice in the treatment and prevention of streptococcal infections, including the prophylaxis of rheumatic fever. Cephalexin is generally effective in the eradication of streptococci from the nasopharynx; however, substantial data establishing the efficacy of cephalexin in the subsequent prevention of rheumatic fever are not available at present.)Otitis media due to S. pneumoniae, H. influenzae, staphylococci, streptococci, and M. catarrhalis.Skin and skin structure infections caused by staphylococci and/or streptococci.Bone infections caused by staphylococci and/or P. mirabilis.Genitourinary tract infections, including acute prostatitis, caused by E. coli, P. mirabilis, and K. pneumoniae.Note – Culture and susceptibility tests should be initiated prior to and during therapy. Renal function studies should be performed when indicated.To reduce the development of drug-resistant bacteria and maintain the effectiveness of cephalexin for oral suspension and other antibacterial drugs, cephalexin for oral suspension should be used only to treat or prevent infections that are proven or strongly suspected to be caused by susceptible bacteria. When culture and susceptibility information are available, they should be considered in selecting or modifying antibacterial therapy. In the absence of such data, local epidemiology and susceptibility patterns may contribute to the empiric selection of therapy.

Regulatory & Marketing

Labeler Name
Aidarex Pharmaceuticals Llc
FDA Application #
ANDA065234
Marketing Category
ANDA - A product marketed under an approved Abbreviated New Drug Application.
Start Marketing Date
01-11-2006
Listing Expiration
12-31-2019
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.

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Frequently Asked Questions

What is the distribution configuration for this product package?

The code 33261-485-01 identifies a specific commercial package of 100 ml in 1 bottle of Cephalexin, labeled by Aidarex Pharmaceuticals Llc. This product is billed per "ML" milliliter and contains an estimated amount of 100 billable units per package. 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 Aidarex Pharmaceuticals Llc on January 11, 2006. The current certification is valid through December 31, 2019.

How is this Aidarex Pharmaceuticals Llc product billed for insurance claims?

For medical billing and reimbursement, this package follows the 11-digit CMS format: 33261048501. Quantities are measured in per "ml or milliliter", products billed per milliliter are usually products measured by liquid volume.. 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)
33261-485-01
11-Digit CMS (5-4-2)
33261-0485-01

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