Caffeine Citrate Injection
NDC Package 51754-0500-1

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

Package Information

Caffeine Citrate injection is a medication used for the short-term treatment of a breathing problem (apnea) in premature infants. This formulation utilizes a injection delivery system. Marketed by Exela Pharma Sciences, Llc, this product is identified by NDC 51754-0500 and is authorized under FDA application ANDA077233.

Identification & Billing

NDC Package Code
51754-0500-1
Package Description
1 VIAL in 1 CARTON / 3 mL in 1 VIAL
Product Code
51754-0500
11-Digit Billing Format
51754050001
Billing Unit
ML - Billing unit of "milliliter" is used when a product is measured by its liquid volume.
RxNorm Crosswalk

Clinical Specifications

Proprietary Name
Caffeine Citrate
Non-Proprietary Name
Caffeine Citrate
Substance Name
Caffeine Citrate
Dosage Form
Injection - A sterile preparation intended for parenteral use; five distinct classes of injections exist as defined by the USP.
Administration Route
Intravenous - Administration within or into a vein or veins.
Active Ingredient(s)
CAFFEINE CITRATE 20 mg/mL
Pharmacologic Class
Usage Information
This medication is used for the short-term treatment of a breathing problem (apnea) in premature infants. Caffeine blocks certain proteins (adenosine receptors) which lead to improved breathing in these infants.

Regulatory & Marketing

Labeler Name
Exela Pharma Sciences, Llc
Product Type
Human Prescription Drug
FDA Application #
ANDA077233
Marketing Category
ANDA - A product marketed under an approved Abbreviated New Drug Application.
Start Marketing Date
03-30-2015
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.

Frequently Asked Questions

What is the distribution configuration for this product package?

The code 51754-0500-1 identifies a specific commercial package of 1 vial in 1 carton / 3 ml in 1 vial of Caffeine Citrate, a human prescription drug labeled by Exela Pharma Sciences, Llc. This injection is formulated for intravenous use and contains caffeine citrate 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 Exela Pharma Sciences, Llc on March 30, 2015. The current certification is valid through December 31, 2026.

What are the primary indications for this medication?

This medication is used for the short-term treatment of a breathing problem (apnea) in premature infants. Caffeine blocks certain proteins (adenosine receptors) which lead to improved breathing in these infants.

How is this Exela Pharma Sciences, Llc product billed for insurance claims?

For medical billing and reimbursement, this package follows the 11-digit CMS format: 51754050001. Quantities are measured in per "ml or milliliter", products billed per milliliter are usually products measured by liquid volume.. 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 (5-4-1)
51754-0500-1
11-Digit CMS (5-4-2)
51754-0500-01

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