Cefotetan Injection, Powder, For Solution
NDC Package 63323-385-10

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

Cefotetan (cefotetan disodium) injection is cefotetan is an antibiotic used to treat a wide variety of bacterial infections. This formulation utilizes a injection, powder, for solution delivery system. Marketed by Fresenius Kabi Usa, Llc, this product is identified by NDC 63323-385 and is authorized under FDA application ANDA065374.

Identification & Billing

NDC Package Code
63323-385-10
Package Description
10 VIAL in 1 CARTON / 10 mL in 1 VIAL (63323-385-01)
Product Code
63323-385
11-Digit Billing Format
63323038510
Billing Unit
EA - Billing unit of "each" is used when the product is dispensed in discreet units.
Units Per Package
1 EA
RxNorm Crosswalk

Clinical Specifications

Proprietary Name
Cefotetan
Non-Proprietary Name
Cefotetan Disodium
Substance Name
Cefotetan Disodium
Dosage Form
Injection, Powder, For Solution - A sterile preparation intended for reconstitution to form a solution for parenteral use.
Administration Route
  • Intramuscular - Administration within a muscle.
  • Intravenous - Administration within or into a vein or veins.
Active Ingredient(s)
CEFOTETAN DISODIUM 1 g/10mL
Pharmacologic Class
Usage Information
Cefotetan is an antibiotic used to treat a wide variety of bacterial infections. It may also be used before and during certain surgeries to help prevent infection. This medication is known as a cephalosporin antibiotic. It works by stopping the growth of bacteria. This antibiotic treats only bacterial infections. It will not work for virus infections (such as common cold, flu). Using any antibiotic when it is not needed can cause it to not work for future infections.

Regulatory & Marketing

Labeler Name
Fresenius Kabi Usa, Llc
Product Type
Human Prescription Drug
FDA Application #
ANDA065374
Marketing Category
ANDA - A product marketed under an approved Abbreviated New Drug Application.
Start Marketing Date
11-18-2009
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.

J0525
Source: PDAC
INJECTION, CEFOTETAN DISODIUM, 10 MG
HCPCS Dosage 10 MG
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 63323-385-10 identifies a specific commercial package of 10 vial in 1 carton / 10 ml in 1 vial (63323-385-01) of Cefotetan, 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, for solution is formulated for intramuscular; intravenous use and contains cefotetan disodium 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 November 18, 2009. The current certification is valid through December 31, 2026.

What are the primary indications for this medication?

Cefotetan is an antibiotic used to treat a wide variety of bacterial infections. It may also be used before and during certain surgeries to help prevent infection. This medication is known as a cephalosporin antibiotic. It works by stopping the growth of bacteria. This antibiotic treats only bacterial infections. It will not work for virus infections (such as common cold, flu). Using any antibiotic when it is not needed can cause it to not work for future infections.

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: 63323038510. 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)
63323-385-10
11-Digit CMS (5-4-2)
63323-0385-10

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