Chloramphenicol Sodium Succinate Injection, Powder, Lyophilized, For Solution
NDC Package 63323-011-15

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

Package Information

Chloramphenicol Sodium Succinate injection is 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. This formulation utilizes a injection, powder, lyophilized, for solution delivery system. Marketed by Fresenius Kabi Usa, Llc, this product is identified by NDC 63323-011 and is authorized under FDA application ANDA062365.

Identification & Billing

NDC Package Code
63323-011-15
Package Description
10 VIAL in 1 TRAY / 10 mL in 1 VIAL
Product Code
63323-011
11-Digit Billing Format
63323001115
Billing Unit
EA - Billing unit of "each" is used when the product is dispensed in discreet units.
Units Per Package
1 EA
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

Clinical Specifications

Proprietary Name
Chloramphenicol Sodium Succinate
Non-Proprietary Name
Chloramphenicol Sodium Succinate
Substance Name
Chloramphenicol Sodium Succinate
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
Intravenous - Administration within or into a vein or veins.
Active Ingredient(s)
CHLORAMPHENICOL SODIUM SUCCINATE 1 g/10mL
Pharmacologic Class
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.

Regulatory & Marketing

Labeler Name
Fresenius Kabi Usa, Llc
Product Type
Human Prescription Drug
FDA Application #
ANDA062365
Marketing Category
ANDA - A product marketed under an approved Abbreviated New Drug Application.
Start Marketing Date
01-12-2001
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.

Billing & HCPCS Mapping

To facilitate insurance claims and reimbursement, this drug package is mapped to specific HCPCS administrative codes. This crosswalk aligns clinical data with the billing standards used in ASP (Average Sales Price), AWP, and OPPS payment systems. Use the cards below to identify the correct billable units for provider claims.

J0720
Source: PDAC
INJECTION, CHLORAMPHENICOL SODIUM SUCCINATE, UP TO 1 GM
HCPCS Dosage 1 GM
Units / Pkg

Note for Medical Coders: These mappings are synthesized from various CMS datasets including OPPS, PrEP, and DAC (Data Analysis and Coding) contractors. Always confirm unit conversions against the current quarter's pricing files before final submission.

* 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 63323-011-15 identifies a specific commercial 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. This product is billed for "EA" each discreet unit and contains an estimated amount of 1 billable units per package. This injection, powder, lyophilized, for solution is formulated for intravenous use and contains chloramphenicol sodium succinate 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 Fresenius Kabi Usa, Llc on January 12, 2001. The current certification is valid through December 31, 2026.

How is this Fresenius Kabi Usa, Llc product billed for insurance claims?

For medical billing and reimbursement, this package follows the 11-digit CMS format: 63323001115. Quantities are measured in per "each", products billed on a per each basis are usually products dispensed in discreet units.. There are 1 total billable units per package. 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)
63323-011-15
11-Digit CMS (5-4-2)
63323-0011-15

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