Caffeine Citrate Solution
NDC Package 51754-0501-2

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

Package Information

Caffeine Citrate solution is a medication used for the short-term treatment of a breathing problem (apnea) in premature infants. This formulation utilizes a solution delivery system. Marketed by Exela Pharma Sciences, Llc, this product is identified by NDC 51754-0501 and is authorized under FDA application ANDA077304.

Identification & Billing

NDC Package Code
51754-0501-2
Package Description
5 VIAL in 1 CARTON / 3 mL in 1 VIAL
Product Code
51754-0501
11-Digit Billing Format
51754050102
RxNorm Crosswalk

Clinical Specifications

Proprietary Name
Caffeine Citrate
Non-Proprietary Name
Caffeine Citrate
Substance Name
Caffeine Citrate
Dosage Form
Solution - A clear, homogeneous liquid1 dosage form that contains one or more chemical substances dissolved in a solvent or mixture of mutually miscible solvents.
Administration Route
Oral - Administration to or by way of the mouth.
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 #
ANDA077304
Marketing Category
ANDA - A product marketed under an approved Abbreviated New Drug Application.
Start Marketing Date
09-21-2006
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.

Other Available Packages

The following commercial packages are registered under the same Product NDC (51754-0501). Click a package code to view its specific billing and regulatory data.

51754-0501-3
10 VIAL in 1 CARTON / 3 mL in 1 VIAL

* 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 51754-0501-2 identifies a specific commercial package of 5 vial in 1 carton / 3 ml in 1 vial of Caffeine Citrate, a human prescription drug labeled by Exela Pharma Sciences, Llc. This solution is formulated for oral 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 September 21, 2006. 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: 51754050102. 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)
51754-0501-2
11-Digit CMS (5-4-2)
51754-0501-02

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