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  5. NDC Package Code: 0009-0760-04 Cleocin Pediatric

NDC Package 0009-0760-04 Cleocin Pediatric

Clindamycin Palmitate Hydrochloride Granule, For Solution Oral - View Billable Units, 11-Digit Format, RxNorm

Table of Contents

    1. Package Information
    2. 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:
0009-0760-04
Package Description:
1 BOTTLE in 1 CARTON / 100 mL in 1 BOTTLE
Product Code:
0009-0760
Proprietary Name:
Cleocin Pediatric
Non-Proprietary Name:
Clindamycin Palmitate Hydrochloride
Substance Name:
Clindamycin Palmitate Hydrochloride
Usage Information:
CLEOCIN PEDIATRIC (clindamycin palmitate HCl) 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 CLEOCIN PEDIATRIC and other antibacterial drugs, CLEOCIN 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:
00009076004
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
  • RxCUI: 748743 - Cleocin 75 MG in 5 mL Oral Solution
    • Product Type:
    Human Prescription Drug
    Labeler Name:
    Pharmacia & Upjohn Company Llc
    Dosage Form:
    Granule, For Solution - A small medicinal particle or grain made available in its more stable dry form, to be reconstituted with solvent just before dispensing; the granules are so prepared to contain not only the medicinal agent, but the colorants, flavorants, and any other desired pharmaceutic ingredient.
    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:
    ANDA062644
    Marketing Category:
    ANDA - A product marketed under an approved Abbreviated New Drug Application.
    Start Marketing Date:
    04-17-1986
    Listing Expiration Date:
    12-31-2024
    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.

    Frequently Asked Questions

    What is NDC 0009-0760-04?

    The NDC Packaged Code 0009-0760-04 is assigned to a package of 1 bottle in 1 carton / 100 ml in 1 bottle of Cleocin Pediatric, a human prescription drug labeled by Pharmacia & Upjohn Company Llc. The product's dosage form is granule, for solution and is administered via oral form.

    Is NDC 0009-0760 included in the NDC Directory?

    Yes, Cleocin Pediatric with product code 0009-0760 is active and included in the NDC Directory. The product was first marketed by Pharmacia & Upjohn Company Llc on April 17, 1986 and its listing in the NDC Directory is set to expire on December 31, 2024 if the product is not updated or renewed by the manufacturer.

    What is the NDC billing unit for package 0009-0760-04?

    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 0009-0760-04?

    The 11-digit format is 00009076004. 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 4-4-2 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
    4-4-20009-0760-045-4-200009-0760-04