Clindamycin Palmitate Hydrochloride
NDC Package 10135-569-19

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 inactivated by the FDA.

Clindamycin Palmitate Hydrochloride is clindamycin palmitate HCl for oral solution, USP (pediatric) is indicated in the treatment of serious infections cause by susceptible anaerobic bacteria. Marketed by Marlex Pharmaceuticals Inc, this product is identified by NDC 10135-569 and is authorized under FDA application ANDA203513.

Identification & Billing

NDC Package Code
10135-569-19
Package Description
1 BOTTLE in 1 BOX / 100 mL in 1 BOTTLE
Product Code
10135-569
11-Digit Billing Format
10135056919
Billing Unit
ML - Billing unit of "milliliter" is used when a product is measured by its liquid volume.
RxNorm Crosswalk
  • RxCUI: 562266 - clindamycin palmitate HCl 75 MG in 5 mL Oral Solution
  • RxCUI: 562266 - clindamycin 15 MG/ML Oral Solution
  • RxCUI: 562266 - clindamycin (as clindamycin palmitate HCl) 15 MG/ML Oral Solution
  • RxCUI: 562266 - clindamycin 75 MG per 5 ML Powder for Oral Solution

Clinical Specifications

Proprietary Name
Clindamycin Palmitate Hydrochloride
Dosage Form
-
Usage Information
Clindamycin palmitate HCl for oral solution, USP (pediatric) is indicated in the treatment of serious infections cause 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 WARNING box, 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.

Regulatory & Marketing

Labeler Name
Marlex Pharmaceuticals Inc
FDA Application #
ANDA203513
Marketing Category
ANDA - A product marketed under an approved Abbreviated New Drug Application.
Start Marketing Date
08-01-2015
Listing Expiration
12-31-2020
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 10135-569-19 identifies a specific commercial package of 1 bottle in 1 box / 100 ml in 1 bottle of Clindamycin Palmitate Hydrochloride, labeled by Marlex 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 Marlex Pharmaceuticals Inc on August 01, 2015. The current certification is valid through December 31, 2020.

How is this Marlex Pharmaceuticals Inc product billed for insurance claims?

For medical billing and reimbursement, this package follows the 11-digit CMS format: 10135056919. Quantities are measured in per "ml or milliliter", products billed per milliliter are usually products measured by liquid volume.. 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 (5-3-2)
10135-569-19
11-Digit CMS (5-4-2)
10135-0569-19

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