NDC Package 0781-3223-95 Cefepime Hydrochloride

View Billable Units, 11-Digit Format, RxNorm

Package Information
Frequently Asked Questions

Package Information

This product is EXCLUDED from the official NDC directory because the listing data was inactivated by the FDA.

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:

0781-3223-95

Package Description:

10 VIAL, SINGLE-DOSE in 1 CARTON / 1 INJECTION, POWDER, FOR SOLUTION in 1 VIAL, SINGLE-DOSE (0781-3223-91)

Product Code:

0781-3223

Proprietary Name:

Cefepime Hydrochloride

Usage Information:

Cefepime for injection, USP is indicated in the treatment of the following infections caused by susceptible strains of the designated microorganisms (see also PRECAUTIONS: Pediatric Use and DOSAGE AND ADMINISTRATION):Pneumonia (moderate to severe) caused by Streptococcus pneumoniae, including cases associated with concurrent bacteremia, Pseudomonas aeruginosa, Klebsiellapneumoniae, or Enterobacter species.Empiric Therapy for Febrile Neutropenic Patients. Cefepime as monotherapy is indicated for empiric treatment of febrile neutropenic patients. In patients at high risk for severe infection (including patients with a history of recent bone marrow transplantation, with hypotension at presentation, with an underlying hematologic malignancy, or with severe or prolonged neutropenia), antimicrobial monotherapy may not be appropriate. Insufficient data exist to support the efficacy of cefepime monotherapy in such patients. (See CLINICAL STUDIES.)Uncomplicated and Complicated Urinary Tract Infections (including pyelonephritis) caused by Escherichia coli or Klebsiellapneumoniae, when the infection is severe, or caused by Escherichia coli, Klebsiellapneumoniae, or Proteus mirabilis, when the infection is mild to moderate, including cases associated with concurrent bacteremia with these microorganisms.Uncomplicated Skin and Skin Structure Infections caused by Staphylococcus aureus (methicillin-susceptible isolates only) or Streptococcus pyogenes.Complicated Intra-abdominal Infections (used in combination with metronidazole) caused by Escherichia coli, viridans group streptococci, Pseudomonas aeruginosa, Klebsiellapneumoniae, Enterobacterspecies, or Bacteroidesfragilis. (See CLINICAL STUDIES.)To reduce the development of drug-resistant bacteria and maintain the effectiveness of cefepime for injection, USP and other antibacterial drugs, cefepime for injection, USP 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:

00781322395

Billing Unit:

EA - Billing unit of "each" is used when the product is dispensed in discreet units.

NDC to RxNorm Crosswalk:

10 EA

NDC to RxNorm Crosswalk:

RxCUI: 1665088 - cefepime 2 GM Injection

RxCUI: 1665088 - cefepime 2000 MG Injection

RxCUI: 1665088 - cefepime 2 GM (as cefepime HCl) Injection

RxCUI: 1665093 - cefepime 1 GM Injection

RxCUI: 1665093 - cefepime 1000 MG Injection

Labeler Name:

Sandoz Inc

Sample Package:

Start Marketing Date:

05-01-2008

Listing Expiration Date:

12-31-2019

Exclude Flag:

Code Structure:

0781 - Sandoz Inc
- 0781-3223 - Cefepime Hydrochloride
  - 0781-3223-95 - 10 VIAL, SINGLE-DOSE in 1 CARTON / 1 INJECTION, POWDER, FOR SOLUTION in 1 VIAL, SINGLE-DOSE (0781-3223-91)

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 0781-3223-95?

The NDC Packaged Code 0781-3223-95 is assigned to a package of 10 vial, single-dose in 1 carton / 1 injection, powder, for solution in 1 vial, single-dose (0781-3223-91) of Cefepime Hydrochloride, labeled by Sandoz Inc. The product's dosage form is and is administered via form.This product is billed for "EA" each discreet unit and contains an estimated amount of 10 billable units per package.

Is NDC 0781-3223 included in the NDC Directory?

No, Cefepime Hydrochloride with product code 0781-3223 is excluded from the NDC Directory because it's listing has been INACTIVATED by FDA. The product was first marketed by Sandoz Inc on May 01, 2008 and its listing in the NDC Directory is set to expire on December 31, 2019 if the product is not updated or renewed by the manufacturer.

What is the NDC billing unit for package 0781-3223-95?

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 10.

What is the 11-digit format for NDC 0781-3223-95?

The 11-digit format is 00781322395. 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 Format	10-Digit Original Code	11-Digit Format	11-Digit Code
4-4-2	0781-3223-95	5-4-2	00781-3223-95

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