Caffeine Citrate Solution
NDC Package 42571-346-69

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 Micro Labs Limited, this product is identified by NDC 42571-346 and is authorized under FDA application ANDA213202.

Identification & Billing

NDC Package Code
42571-346-69
Package Description
10 VIAL in 1 BOX / 3 mL in 1 VIAL
Product Code
42571-346
11-Digit Billing Format
42571034669
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 60 mg/3mL
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
Micro Labs Limited
Product Type
Human Prescription Drug
FDA Application #
ANDA213202
Marketing Category
ANDA - A product marketed under an approved Abbreviated New Drug Application.
Start Marketing Date
02-01-2020
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 42571-346-69 identifies a specific commercial package of 10 vial in 1 box / 3 ml in 1 vial of Caffeine Citrate, a human prescription drug labeled by Micro Labs Limited. 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 Micro Labs Limited on February 01, 2020. 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 Micro Labs Limited product billed for insurance claims?

For medical billing and reimbursement, this package follows the 11-digit CMS format: 42571034669. 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)
42571-346-69
11-Digit CMS (5-4-2)
42571-0346-69

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