Clindamycin Hydrochloride
NDC Package 50090-2502-2

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 A-s Medication Solutions, this product is identified by NDC 50090-2502 and is authorized under FDA application ANDA065243.

Identification & Billing

NDC Package Code
50090-2502-2
Package Description
16 CAPSULE in 1 BOTTLE
Product Code
50090-2502
11-Digit Billing Format
50090250202
Billing Unit
EA - Billing unit of "each" is used when the product is dispensed in discreet units.
Units Per Package
16 EA
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 HCl and other antibacterial drugs, clindamycin HCl capsules, USP 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
A-s Medication Solutions
FDA Application #
ANDA065243
Marketing Category
ANDA - A product marketed under an approved Abbreviated New Drug Application.
Start Marketing Date
08-12-2005
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 (50090-2502). Click a package code to view its specific billing and regulatory data.

50090-2502-0
30 CAPSULE in 1 BOTTLE
50090-2502-1
45 CAPSULE in 1 BOTTLE, PLASTIC
50090-2502-3
40 CAPSULE in 1 BOTTLE
50090-2502-4
20 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 50090-2502-2 identifies a specific commercial package of 16 capsule in 1 bottle of Clindamycin Hydrochloride, labeled by A-s Medication Solutions. This product is billed for "EA" each discreet unit and contains an estimated amount of 16 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 A-s Medication Solutions on August 12, 2005. The current certification is valid through December 31, 2022.

How is this A-s Medication Solutions product billed for insurance claims?

For medical billing and reimbursement, this package follows the 11-digit CMS format: 50090250202. Quantities are measured in per "each", products billed on a per each basis are usually products dispensed in discreet units.. There are 16 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)
50090-2502-2
11-Digit CMS (5-4-2)
50090-2502-02

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