1. Labeler Index
  2. Fresenius Kabi Usa, Llc
  3. 63323-011
  4. NDC Package Code: 63323-011-15 Chloramphenicol Sodium Succinate

NDC Package 63323-011-15 Chloramphenicol Sodium Succinate

Injection, Powder, Lyophilized, For Solution Intravenous - View Billable Units, 11-Digit Format, RxNorm

Table of Contents

    1. Package Information
    2. NDC HCPCS Crosswalk
    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:
63323-011-15
Package Description:
10 VIAL in 1 TRAY / 10 mL in 1 VIAL
Product Code:
63323-011
Proprietary Name:
Chloramphenicol Sodium Succinate
Non-Proprietary Name:
Chloramphenicol Sodium Succinate
Substance Name:
Chloramphenicol Sodium Succinate
Usage Information:
In accord with the concepts in the Warning Box and this INDICATIONS AND USAGE section, chloramphenicol must be used only in those serious infections for which less potentially dangerous drugs are ineffective or contraindicated.  However, chloramphenicol may be chosen to initiate antibiotic therapy on the clinical impression that one of the conditions below is believed to be present; in vitro sensitivity tests should be performed concurrently so that the drug may be discontinued as soon as possible if less potentially dangerous agents are indicated by such tests.  The decision to continue use of chloramphenicol rather than another antibiotic when both are suggested by in vitro studies to be effective against a specific pathogen should be based upon severity of the infection, susceptibility of the pathogen to the various antimicrobial drugs, efficacy of the various drugs in the infection, and the important additional concepts contained in the Warning Box above.•  Acute infections caused by Salmonella typhi*    It is not recommended for the routine treatment of the typhoid carrier state.•  Serious infections caused by susceptible strains in accordance with the concepts expressed above:   a) Salmonella species   b) H. influenzae, specially meningeal infections   c) Rickettsia   d) Lymphogranuloma-psittacosis group    e) Various gram-negative bacteria causing bacteremia, meningitis or other serious gram-negative infections.   f)  Other susceptible organisms which have been demonstrated to be resistant to all other appropriate antimicrobial agents.•   Cystic fibrosis regimens*In treatment of typhoid fever some authorities recommend that chloramphenicol be administered at therapeutic levels for 8 to 10 days after the patient has become afebrile to lessen the possibility of relapse.
11-Digit NDC Billing Format:
63323001115
Billing Unit:
EA - Billing unit of "each" is used when the product is dispensed in discreet units.
NDC to RxNorm Crosswalk:
1 EA
NDC to RxNorm Crosswalk:
  • RxCUI: 239200 - chloramphenicol 100 MG/ML Injectable Solution
  • RxCUI: 239200 - chloramphenicol (as chloramphenicol sodium succinate) 1 GM per 10 ML Powder for Injectable Solution
    • Product Type:
    Human Prescription Drug
    Labeler Name:
    Fresenius Kabi Usa, Llc
    Dosage Form:
    Injection, Powder, Lyophilized, For Solution - A dosage form intended for the solution prepared by lyophilization ("freeze drying"), a process which involves the removal of water from products in the frozen state at extremely low pressures; this is intended for subsequent addition of liquid to create a solution that conforms in all respects to the requirements for Injections.
    Administration Route(s):
  • Intravenous - Administration within or into a vein or veins.
    • Active Ingredient(s):
  • CHLORAMPHENICOL SODIUM SUCCINATE 1 g/10mL
    • Pharmacologic Class(es):
  • Amphenicol-class Antibacterial - [EPC] (Established Pharmacologic Class)
  • Amphenicols - [EXT]
    • Sample Package:
    No
    FDA Application Number:
    ANDA062365
    Marketing Category:
    ANDA - A product marketed under an approved Abbreviated New Drug Application.
    Start Marketing Date:
    01-12-2001
    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.

    NDC HCPCS Crosswalk

    This crosswalk is intended to help the public understand which drug products (identified by NDCs) are assigned to which HCPCS billing codes.

    NDC 63323-011-15 HCPCS crosswalk information with package details and bill units information.

    NDC Billing CodeHCPCS CodeHCPCS Code Desc.DosagePackage SizePackage QuantityBillable UnitsBillable Units / Pkg
    63323001115J0720Chloramphenicol sodium injec1 GM110110

    * Please review the disclaimer below.

    Frequently Asked Questions

    What is NDC 63323-011-15?

    The NDC Packaged Code 63323-011-15 is assigned to a package of 10 vial in 1 tray / 10 ml in 1 vial of Chloramphenicol Sodium Succinate, a human prescription drug labeled by Fresenius Kabi Usa, Llc. The product's dosage form is injection, powder, lyophilized, for solution and is administered via intravenous form.This product is billed for "EA" each discreet unit and contains an estimated amount of 1 billable units per package.

    Is NDC 63323-011 included in the NDC Directory?

    Yes, Chloramphenicol Sodium Succinate with product code 63323-011 is active and included in the NDC Directory. The product was first marketed by Fresenius Kabi Usa, Llc on January 12, 2001 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 63323-011-15?

    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 1.

    What is the 11-digit format for NDC 63323-011-15?

    The 11-digit format is 63323001115. 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
    5-3-263323-011-155-4-263323-0011-15