Clindamycin Palmitate Hydrochloride Powder, For Solution
NDC Package 53746-468-19

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

Package Information

Clindamycin Palmitate Hydrochloride powders is clindamycin palmitate hydrochloride for oral solution is indicated in the treatment of serious infections caused by susceptible anaerobic bacteria. This formulation utilizes a powder, for solution delivery system. Marketed by Amneal Pharmaceuticals Of New York Llc, this product is identified by NDC 53746-468 and is authorized under FDA application ANDA203513.

Identification & Billing

NDC Package Code
53746-468-19
Package Description
1 BOTTLE in 1 CARTON / 100 mL in 1 BOTTLE
Product Code
53746-468
11-Digit Billing Format
53746046819
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 (pediatric)
Non-Proprietary Name
Clindamycin Palmitate Hydrochloride
Substance Name
Clindamycin Palmitate Hydrochloride
Dosage Form
Powder, For Solution - An intimate mixture of dry, finely divided drugs and/or chemicals, which, upon the addition of suitable vehicles, yields a solution.
Administration Route
Oral - Administration to or by way of the mouth.
Active Ingredient(s)
CLINDAMYCIN PALMITATE HYDROCHLORIDE 75 mg/5mL
Pharmacologic Class
Usage Information
Clindamycin palmitate hydrochloride for oral solution 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 palmitate hydrochloride for oral solution and other antibacterial drugs, clindamycin palmitate hydrochloride for oral solution 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
Amneal Pharmaceuticals Of New York Llc
Product Type
Human Prescription Drug
FDA Application #
ANDA203513
Marketing Category
ANDA - A product marketed under an approved Abbreviated New Drug Application.
Start Marketing Date
04-01-2024
Listing Expiration
12-31-2026
Exclude Flag
N
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 53746-468-19 identifies a specific commercial package of 1 bottle in 1 carton / 100 ml in 1 bottle of Clindamycin Palmitate Hydrochloride (pediatric), a human prescription drug labeled by Amneal Pharmaceuticals Of New York Llc. This powder, for solution is formulated for oral use and contains clindamycin palmitate hydrochloride as the active substance.

Is this product currently listed with the FDA?

Yes, this product is active and verified within the NDC Directory. It was introduced to the market by Amneal Pharmaceuticals Of New York Llc on April 01, 2024. The current certification is valid through December 31, 2026.

How is this Amneal Pharmaceuticals Of New York Llc product billed for insurance claims?

For medical billing and reimbursement, this package follows the 11-digit CMS format: 53746046819. 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)
53746-468-19
11-Digit CMS (5-4-2)
53746-0468-19

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