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  5. NDC Package Code: 65862-185-01 Clindamycin Hydrochloride

NDC Package 65862-185-01 Clindamycin Hydrochloride

Capsule 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:
65862-185-01
Package Description:
100 CAPSULE in 1 BOTTLE
Product Code:
65862-185
Proprietary Name:
Clindamycin Hydrochloride
Non-Proprietary Name:
Clindamycin Hydrochloride
Substance Name:
Clindamycin Hydrochloride
Usage Information:
Clindamycin hydrochloride capsules are indicated in the treatment of serious infections caused by susceptible anaerobic bacteria.Clindamycin hydrochloride capsules are 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 hydrochloride and other antibacterial drugs, clindamycin hydrochloride 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:
65862018501
Billing Unit:
EA - Billing unit of "each" is used when the product is dispensed in discreet units.
NDC to RxNorm Crosswalk:
100 EA
NDC to RxNorm Crosswalk:
  • RxCUI: 197518 - clindamycin HCl 150 MG Oral Capsule
  • RxCUI: 197518 - clindamycin 150 MG Oral Capsule
  • RxCUI: 197518 - clindamycin (as clindamycin HCl) 150 MG Oral Capsule
  • RxCUI: 284215 - clindamycin HCl 300 MG Oral Capsule
  • RxCUI: 284215 - clindamycin 300 MG Oral Capsule
    • Product Type:
    Human Prescription Drug
    Labeler Name:
    Aurobindo Pharma Limited
    Dosage Form:
    Capsule - A solid oral dosage form consisting of a shell and a filling. The shell is composed of a single sealed enclosure, or two halves that fit together and which are sometimes sealed with a band. Capsule shells may be made from gelatin, starch, or cellulose, or other suitable materials, may be soft or hard, and are filled with solid or liquid ingredients that can be poured or squeezed.
    Administration Route(s):
  • Oral - Administration to or by way of the mouth.
    • Active Ingredient(s):
  • CLINDAMYCIN HYDROCHLORIDE 150 mg/1
  • CLINDAMYCIN HYDROCHLORIDE 150 mg/1
    • 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:
    ANDA065442
    Marketing Category:
    ANDA - A product marketed under an approved Abbreviated New Drug Application.
    Start Marketing Date:
    08-26-2009
    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.

    Other Product Packages

    The following packages are also available for this product:

    NDC Package CodePackage Description
    65862-185-05500 CAPSULE in 1 BOTTLE
    65862-185-222000 CAPSULE in 1 BAG

    * Please review the disclaimer below.

    Frequently Asked Questions

    What is NDC 65862-185-01?

    The NDC Packaged Code 65862-185-01 is assigned to a package of 100 capsule in 1 bottle of Clindamycin Hydrochloride, a human prescription drug labeled by Aurobindo Pharma Limited. The product's dosage form is capsule and is administered via oral form.

    Is NDC 65862-185 included in the NDC Directory?

    Yes, Clindamycin Hydrochloride with product code 65862-185 is active and included in the NDC Directory. The product was first marketed by Aurobindo Pharma Limited on August 26, 2009 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 65862-185-01?

    The contents of this package are billed per "each", products billed on a per each basis are usually products dispensed in discreet units. The calculated billable units for this package is 100.

    What is the 11-digit format for NDC 65862-185-01?

    The 11-digit format is 65862018501. 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
    5-3-265862-185-015-4-265862-0185-01