Cleocin Phosphate (0009-6582) (standalone)
NDC Package 0009-6582-01

View Billable Units, 11-Digit Conversion Format, and RxNorm mappings
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 discontinued by the firm.

Cleocin Phosphate (0009-6582) (standalone) is cLEOCIN PHOSPHATE products are indicated in the treatment of serious infections caused by susceptible anaerobic bacteria.CLEOCIN PHOSPHATE products are also indicated in the treatment of serious infections due to susceptible strains of streptococci, pneumococci, and staphylococci. Marketed by Pharmacia & Upjohn Company Llc, this product is identified by NDC 0009-6582 and is authorized under FDA application ANDA062803.

Identification & Billing

NDC Package Code
0009-6582-01
Package Description
25 VIAL in 1 CARTON / 2 mL in 1 VIAL (0009-6582-02)
Product Code
0009-6582
11-Digit Billing Format
00009658201
RxNorm Crosswalk

Clinical Specifications

Proprietary Name
Cleocin Phosphate (0009-6582) (standalone)
Dosage Form
-
Usage Information
CLEOCIN PHOSPHATE products are indicated in the treatment of serious infections caused by susceptible anaerobic bacteria.CLEOCIN PHOSPHATE products are 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 BOXED WARNING, 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.CLEOCIN PHOSPHATE 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 CLEOCIN PHOSPHATE and other antibacterial drugs, CLEOCIN PHOSPHATE 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
Pharmacia & Upjohn Company Llc
FDA Application #
ANDA062803
Marketing Category
ANDA - A product marketed under an approved Abbreviated New Drug Application.
Start Marketing Date
10-16-1987
End Marketing Date
09-30-2019
Listing Expiration
09-30-2019
Exclude Flag
D
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 0009-6582-01 identifies a specific commercial package of 25 vial in 1 carton / 2 ml in 1 vial (0009-6582-02) of Cleocin Phosphate (0009-6582) (standalone), labeled by Pharmacia & Upjohn Company Llc. 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 Pharmacia & Upjohn Company Llc on October 16, 1987. The current certification is valid through September 30, 2019.

How is this Pharmacia & Upjohn Company Llc product billed for insurance claims?

For medical billing and reimbursement, this package follows the 11-digit CMS format: 00009658201. 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 (4-4-2)
0009-6582-01
11-Digit CMS (5-4-2)
00009-6582-01

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