Clindamycin Hydrochloride
NDC Package 53002-0621-4

View Billable Units, 11-Digit Conversion Format, and RxNorm mappings
Table of Contents
    1. Package Information
    2. Other Packages
    3. Frequently Asked Questions

Package Information

This product is EXCLUDED from the official NDC directory because the listing data was inactivated by the FDA.

Clindamycin Hydrochloride is clindamycin is indicated in the treatment of serious infections caused by susceptible anaerobic bacteria.Clindamycin is also indicated in the treatment of serious infections due to susceptible strains of streptococci, pneumococci, and staphylococci. Marketed by Rpk Pharmaceuticals, Inc., this product is identified by NDC 53002-0621 and is authorized under FDA application ANDA063083.

Identification & Billing

NDC Package Code
53002-0621-4
Package Description
28 CAPSULE in 1 BOTTLE
Product Code
53002-0621
11-Digit Billing Format
53002062104
RxNorm Crosswalk

Clinical Specifications

Proprietary Name
Clindamycin Hydrochloride
Dosage Form
-
Usage Information
Clindamycin is indicated in the treatment of serious infections caused by susceptible anaerobic bacteria.Clindamycin 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 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).Anaerobes: Serious respiratory tract infections such as empyema, anaerobic pneumonitis, and lung abscess; serious skin and soft tissue infections; septicemia; intra-abdominal infections such as peritonitis and intra-abdominal abscess (typically resulting from anaerobic organisms resident in the normal gastrointestinal tract); infections of the female pelvis and genital tract such as endometritis, nongonococcal tubo-ovarian abscess, pelvic cellulitis, and postsurgical vaginal cuff infection.Streptococci: Serious respiratory tract infections; serious skin and soft tissue infections.Staphylococci: Serious respiratory tract infections; serious skin and soft tissue infections.Pneumococci: Serious respiratory tract infections. Bacteriologic studies should be performed to determine the causative organisms and their susceptibility to clindamycin.To reduce the development of drug-resistant bacteria and maintain the effectiveness of clindamycin hydrochloride and other antibacterial drugs, clindamycin hydrochloride 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
Rpk Pharmaceuticals, Inc.
FDA Application #
ANDA063083
Marketing Category
ANDA - A product marketed under an approved Abbreviated New Drug Application.
Start Marketing Date
09-09-2014
Listing Expiration
12-31-2022
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.

Other Available Packages

The following commercial packages are registered under the same Product NDC (53002-0621). Click a package code to view its specific billing and regulatory data.

53002-0621-1
10 CAPSULE in 1 BOTTLE
53002-0621-2
15 CAPSULE in 1 BOTTLE
53002-0621-3
20 CAPSULE in 1 BOTTLE
53002-0621-5
30 CAPSULE in 1 BOTTLE
53002-0621-6
40 CAPSULE 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 53002-0621-4 identifies a specific commercial package of 28 capsule in 1 bottle of Clindamycin Hydrochloride, labeled by Rpk Pharmaceuticals, Inc.. 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 Rpk Pharmaceuticals, Inc. on September 09, 2014. The current certification is valid through December 31, 2022.

How is this Rpk Pharmaceuticals, Inc. product billed for insurance claims?

For medical billing and reimbursement, this package follows the 11-digit CMS format: 53002062104. 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)
53002-0621-4
11-Digit CMS (5-4-2)
53002-0621-04

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