Caffeine Citrate Solution
NDC Package 25021-601-03

View Billable Units, 11-Digit Conversion Format, and RxNorm mappings
Table of Contents
    1. Package Information
    2. 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 Sagent Pharmaceuticals, this product is identified by NDC 25021-601 and is authorized under FDA application ANDA090827.

Identification & Billing

NDC Package Code
25021-601-03
Package Description
1 VIAL in 1 CARTON / 3 mL in 1 VIAL
Product Code
25021-601
11-Digit Billing Format
25021060103
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
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
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
Sagent Pharmaceuticals
Product Type
Human Prescription Drug
FDA Application #
ANDA090827
Marketing Category
ANDA - A product marketed under an approved Abbreviated New Drug Application.
Start Marketing Date
09-15-2012
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 25021-601-03 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 Sagent Pharmaceuticals. This solution 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 Sagent Pharmaceuticals on September 15, 2012. 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 Sagent Pharmaceuticals product billed for insurance claims?

For medical billing and reimbursement, this package follows the 11-digit CMS format: 25021060103. 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 (5-3-2)
25021-601-03
11-Digit CMS (5-4-2)
25021-0601-03

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