Cefadroxil Capsule
NDC Package 67296-2199-1

11-digit billing NDC: 67296219901

Package Information

Cefadroxil capsules are indicated for the treatment of patients with infection caused by susceptible strains of the designated organisms in the following diseases:Urinary tract infections caused by E. This formulation utilizes a capsule delivery system. Marketed by Redpharm Drug, this product is identified by NDC 67296-2199 and is authorized under FDA application ANDA065282.

Identification & Billing

NDC Package Code
67296-2199-1
Package Description
14 CAPSULE in 1 BOTTLE
Product Code
11-Digit Billing Format
67296219901
RxNorm Crosswalk

Clinical Specifications

Proprietary Name
Cefadroxil
Non-Proprietary Name
Cefadroxil
Substance Name
Cefadroxil
Dosage Form
Capsule - A solid oral dosage form consisting of a shell and a filling. The shell is composed of a single sealed enclosure, or two halves that fit together and which are sometimes sealed with a band. Capsule shells may be made from gelatin, starch, or cellulose, or other suitable materials, may be soft or hard, and are filled with solid or liquid ingredients that can be poured or squeezed.
Administration Route
Oral - Administration to or by way of the mouth.
Active Ingredient(s)
Usage Information
Cefadroxil capsules are indicated for the treatment of patients with infection caused by susceptible strains of the designated organisms in the following diseases:Urinary tract infections caused by E. coli, P. mirabilis, and Klebsiellaspecies. Skin and skin structure infections caused by staphylococci and/or streptococci.Pharyngitis and/or tonsillitis caused by Streptococcus pyogenes(Group A beta-hemolytic streptococci). Note:Only penicillin by the intramuscular route of administration has been shown to be effective in the prophylaxis of rheumatic fever. Cefadroxil is generally effective in the eradication of streptococci from the oropharynx. However, data establishing the efficacy of cefadroxil for the prophylaxis of subsequent rheumatic fever are not available. 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 cefadroxil capsules and other antibacterial drugs, cefadroxil capsules 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
Redpharm Drug
Product Type
Human Prescription Drug
FDA Application #
ANDA065282
Marketing Category
ANDA - A product marketed under an approved Abbreviated New Drug Application.
Start Marketing Date
01-31-2007
Listing Expiration
12-31-2026
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 67296-2199-1 identifies a specific commercial package of 14 capsule in 1 bottle of Cefadroxil, a human prescription drug labeled by Redpharm Drug. This capsule is formulated for oral use and contains cefadroxil 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 Redpharm Drug on January 31, 2007. The current certification is valid through December 31, 2026.

How is this Redpharm Drug product billed for insurance claims?

For medical billing and reimbursement, this package follows the 11-digit CMS format: 67296219901. 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)
67296-2199-1
11-Digit CMS (5-4-2)
67296-2199-01

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