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  5. NDC Package Code: 16714-483-02 Clindamycin Palmitate Hydrochloride (pediatric)

NDC Package 16714-483-02 Clindamycin Palmitate Hydrochloride (pediatric)

Solution Oral - View Billable Units, 11-Digit Format, RxNorm

Table of Contents

    1. Package Information
    2. Other Packages
    3. Frequently Asked Questions

Package Information

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:
16714-483-02
Package Description:
1 BOTTLE, PLASTIC in 1 CARTON / 100 mL in 1 BOTTLE, PLASTIC
Product Code:
16714-483
Proprietary Name:
Clindamycin Palmitate Hydrochloride (pediatric)
Non-Proprietary Name:
Clindamycin Palmitate Hydrochloride (pediatric)
Substance Name:
Clindamycin Palmitate Hydrochloride
Usage Information:
Clindamycin palmitate hydrochloride for oral solution (Pediatric) 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 (Pediatric) and other antibacterial drugs, clindamycin palmitate hydrochloride for oral solution (Pediatric) 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.
11-Digit NDC Billing Format:
16714048302
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
    • Product Type:
    Human Prescription Drug
    Labeler Name:
    Northstar Rx Llc
    Dosage Form:
    Solution - A clear, homogeneous liquid1 dosage form that contains one or more chemical substances dissolved in a solvent or mixture of mutually miscible solvents.
    Administration Route(s):
  • Oral - Administration to or by way of the mouth.
    • Active Ingredient(s):
  • CLINDAMYCIN PALMITATE HYDROCHLORIDE 75 mg/5mL
    • Pharmacologic Class(es):
  • Decreased Sebaceous Gland Activity - [PE] (Physiologic Effect)
  • Lincosamide Antibacterial - [EPC] (Established Pharmacologic Class)
  • Lincosamides - [CS]
  • Neuromuscular Blockade - [PE] (Physiologic Effect)
    • Sample Package:
    No
    FDA Application Number:
    ANDA202409
    Marketing Category:
    ANDA - A product marketed under an approved Abbreviated New Drug Application.
    Start Marketing Date:
    04-30-2013
    Listing Expiration Date:
    12-31-2025
    Exclude Flag:
    N
    Code Structure:

    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.

    Other Product Packages

    The following packages are also available for this product:

    NDC Package CodePackage Description
    16714-483-011 BOTTLE in 1 CARTON / 100 mL in 1 BOTTLE

    * Please review the disclaimer below.

    Frequently Asked Questions

    What is NDC 16714-483-02?

    The NDC Packaged Code 16714-483-02 is assigned to a package of 1 bottle, plastic in 1 carton / 100 ml in 1 bottle, plastic of Clindamycin Palmitate Hydrochloride (pediatric), a human prescription drug labeled by Northstar Rx Llc. The product's dosage form is solution and is administered via oral form.

    Is NDC 16714-483 included in the NDC Directory?

    Yes, Clindamycin Palmitate Hydrochloride (pediatric) with product code 16714-483 is active and included in the NDC Directory. The product was first marketed by Northstar Rx Llc on April 30, 2013 and its listing in the NDC Directory is set to expire on December 31, 2025 if the product is not updated or renewed by the manufacturer.

    What is the NDC billing unit for package 16714-483-02?

    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 16714-483-02?

    The 11-digit format is 16714048302. 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 Format10-Digit Original Code11-Digit Format11-Digit Code
    5-3-216714-483-025-4-216714-0483-02