Clindamycin Phosphate
NDC Package 54868-3695-0

11-digit billing NDC: 54868369500 · Billing unit: ML · 50 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.

Clindamycin Phosphate is clindamycin Injection, USP is indicated in the treatment of serious infections caused by susceptible anaerobic bacteria.Clindamycin Injection, USP is also indicated in the treatment of serious infections due to susceptible strains of streptococci, pneumococci, and staphylococci. Marketed by Physicians Total Care, Inc., this product is identified by NDC 54868-3695 and is authorized under FDA application ANDA062801.

Identification & Billing

NDC Package Code
54868-3695-0
Package Description
1 TRAY in 1 CASE / 25 VIAL, SINGLE-DOSE in 1 TRAY / 2 mL in 1 VIAL, SINGLE-DOSE
Product Code
54868-3695
11-Digit Billing Format
54868369500
Billing Unit
ML - Billing unit of "milliliter" is used when a product is measured by its liquid volume.
Units Per Package
50 ML
RxNorm Crosswalk

Clinical Specifications

Proprietary Name
Clindamycin Phosphate
Dosage Form
-
Usage Information
Clindamycin Injection, USP is indicated in the treatment of serious infections caused by susceptible anaerobic bacteria.Clindamycin Injection, USP is also indicated in the treatment of serious infections due to susceptible strains of streptococci, pneumococci, and staphylococci. Its use should be reserved for penicillin-allergic patients or other patients for whom, in the judgment of the physician, a penicillin is inappropriate. Because of the risk of antibiotic-associated pseudomembranous colitis, as described in the WARNING box, before selecting clindamycin the physician should consider the nature of the infection and the suitability of less toxic alternatives (e.g., erythromycin).Bacteriologic studies should be performed to determine the causative organisms and their susceptibility to clindamycin.Indicated surgical procedures should be performed in conjunction with antibiotic therapy.Clindamycin Injection, USP is indicated in the treatment of serious infections caused by susceptible strains of the designated organisms in the conditions listed below:Lower respiratory tract infections including pneumonia, empyema, and lung abscess caused by anaerobes, Streptococcus pneumoniae, other streptococci (except E. faecalis), and Staphylococcus aureus.Skin and skin structure infections caused by Streptococcus pyogenes, Staphylococcus aureus, and anaerobes.Gynecological infections including endometritis, nongonococcal tubo-ovarian abscess, pelvic cellulitis, and postsurgical vaginal cuff infection caused by susceptible anaerobes.Intra-abdominal infections including peritonitis and intra-abdominal abscess caused by susceptible anaerobic organisms.Septicemia caused by Staphylococcus aureus, streptococci (except Enterococcus faecalis), and susceptible anaerobes.Bone and joint infections including acute hematogenous osteomyelitis caused by Staphylococcus aureus and as adjunctive therapy in the surgical treatment of chronic bone and joint infections due to susceptible organisms. To reduce the development of drug-resistant bacteria and maintain the effectiveness of clindamycin and other antibacterial drugs, clindamycin 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
Physicians Total Care, Inc.
FDA Application #
ANDA062801
Marketing Category
ANDA - A product marketed under an approved Abbreviated New Drug Application.
Start Marketing Date
02-27-1997
Listing Expiration
12-31-2017
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 54868-3695-0 identifies a specific commercial package of 1 tray in 1 case / 25 vial, single-dose in 1 tray / 2 ml in 1 vial, single-dose of Clindamycin Phosphate, labeled by Physicians Total Care, Inc.. This product is billed per "ML" milliliter and contains an estimated amount of 50 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 Physicians Total Care, Inc. on February 27, 1997. The current certification is valid through December 31, 2017.

How is this Physicians Total Care, Inc. product billed for insurance claims?

For medical billing and reimbursement, this package follows the 11-digit CMS format: 54868369500. Quantities are measured in per "ml or milliliter", products billed per milliliter are usually products measured by liquid volume.. There are 50 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)
54868-3695-0
11-Digit CMS (5-4-2)
54868-3695-00

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