Citric Buffered Normal Saline Injection, Solution
NDC Package 71288-040-65

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

Package Information

Citric Buffered Normal Saline (anhydrous citric acid) injection is xENLETA is indicated for the treatment of adults with community-acquired bacterial pneumonia (CABP) caused by the following susceptible microorganisms: Streptococcus pneumoniae, Staphylococcus aureus (methicillin-susceptible isolates), Haemophilus influenzae, Legionella pneumophila, Mycoplasma pneumoniae, and Chlamydophila pneumoniae. This formulation utilizes a injection, solution delivery system. Marketed by Meitheal Pharmaceuticals Inc., this product is identified by NDC 71288-040 and is authorized under FDA application NDA211673.

Identification & Billing

NDC Package Code
71288-040-65
Package Description
6 BAG in 1 CARTON / 270 mL in 1 BAG (71288-040-64)
Product Code
71288-040
11-Digit Billing Format
71288004065

Clinical Specifications

Proprietary Name
Citric Buffered Normal Saline
Non-Proprietary Name
Anhydrous Citric Acid
Substance Name
Anhydrous Citric Acid
Dosage Form
Injection, Solution - A liquid preparation containing one or more drug substances dissolved in a suitable solvent or mixture of mutually miscible solvents that is suitable for injection.
Administration Route
Intravenous - Administration within or into a vein or veins.
Active Ingredient(s)
ANHYDROUS CITRIC ACID 166 mg/270mL
Pharmacologic Class
Usage Information
XENLETA is indicated for the treatment of adults with community-acquired bacterial pneumonia (CABP) caused by the following susceptible microorganisms: Streptococcus pneumoniae, Staphylococcus aureus (methicillin-susceptible isolates), Haemophilus influenzae, Legionella pneumophila, Mycoplasma pneumoniae, and Chlamydophila pneumoniae.

Regulatory & Marketing

Labeler Name
Meitheal Pharmaceuticals Inc.
Product Type
Human Prescription Drug
FDA Application #
NDA211673
Marketing Category
NDA - A product marketed under an approved New Drug Application.
Start Marketing Date
09-09-2019
Listing Expiration
12-31-2027
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.

Frequently Asked Questions

What is the distribution configuration for this product package?

The code 71288-040-65 identifies a specific commercial package of 6 bag in 1 carton / 270 ml in 1 bag (71288-040-64) of Citric Buffered Normal Saline, a human prescription drug labeled by Meitheal Pharmaceuticals Inc.. This injection, solution is formulated for intravenous use and contains anhydrous citric acid 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 Meitheal Pharmaceuticals Inc. on September 09, 2019. The current certification is valid through December 31, 2027.

How is this Meitheal Pharmaceuticals Inc. product billed for insurance claims?

For medical billing and reimbursement, this package follows the 11-digit CMS format: 71288004065. 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)
71288-040-65
11-Digit CMS (5-4-2)
71288-0040-65

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