NDC Package 10135-569-19 Clindamycin Palmitate Hydrochloride

View Billable Units, 11-Digit Format, RxNorm

Package Information
Frequently Asked Questions

Package Information

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

Find all the important details about this NDC Package code, including the 11-Digit NDC Billing number, billing units, wholesale price, RxNorm crosswalk, active ingredients, pharmacologic clasess, etc.

NDC Package Code:

10135-569-19

Package Description:

1 BOTTLE in 1 BOX / 100 mL in 1 BOTTLE

Product Code:

10135-569

Proprietary Name:

Clindamycin Palmitate Hydrochloride

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.

11-Digit NDC Billing Format:

10135056919

Billing Unit:

ML - Billing unit of "milliliter" is used when a product is measured by its liquid volume.

NDC to 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

Labeler Name:

Marlex Pharmaceuticals Inc

Sample Package:

Start Marketing Date:

08-01-2015

Listing Expiration Date:

12-31-2020

Exclude Flag:

Code Structure:

10135 - Marlex Pharmaceuticals Inc
- 10135-569 - Clindamycin Palmitate Hydrochloride
  - 10135-569-19 - 1 BOTTLE in 1 BOX / 100 mL in 1 BOTTLE

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 disclaimer below.

Frequently Asked Questions

What is NDC 10135-569-19?

The NDC Packaged Code 10135-569-19 is assigned to a package of 1 bottle in 1 box / 100 ml in 1 bottle of Clindamycin Palmitate Hydrochloride, labeled by Marlex Pharmaceuticals Inc. The product's dosage form is and is administered via form.

Is NDC 10135-569 included in the NDC Directory?

No, Clindamycin Palmitate Hydrochloride with product code 10135-569 is excluded from the NDC Directory because it's listing has been INACTIVATED by FDA. The product was first marketed by Marlex Pharmaceuticals Inc on August 01, 2015 and its listing in the NDC Directory is set to expire on December 31, 2020 if the product is not updated or renewed by the manufacturer.

What is the NDC billing unit for package 10135-569-19?

The contents of this package are billed per "ml or milliliter", products billed per milliliter are usually products measured by liquid volume.

What is the 11-digit format for NDC 10135-569-19?

The 11-digit format is 10135056919. The 11-digit billing format might be required by the Centers for Medicare & Medicaid Services (CMS) and other payers in billing claim forms.

This package code is originally configured in a 5-3-2 segment 10-digit format and by adding a zero within the original NDC package code we can obtain the converted 11-digit format in a 5-4-2 segment configuration. The table below shows the 11-digit code conversion:

10-Digit Format	10-Digit Original Code	11-Digit Format	11-Digit Code
5-3-2	10135-569-19	5-4-2	10135-0569-19

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