Caffeine Citrate
NDC Package 0517-0020-10
Package Information
Caffeine Citrate is a medication used for the short-term treatment of a breathing problem (apnea) in premature infants. Marketed by American Regent, Inc., this product is identified by NDC 0517-0020 and is authorized under FDA application ANDA077906.
Identification & Billing
Clinical Specifications
Regulatory & Marketing
Hierarchy Structure
- 0517 - American Regent, Inc.
- 0517-0020 - Caffeine Citrate
- 0517-0020-10 - 10 VIAL, SINGLE-DOSE in 1 BOX / 3 mL in 1 VIAL, SINGLE-DOSE
- 0517-0020 - Caffeine Citrate
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.
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Billing & HCPCS Mapping
To facilitate insurance claims and reimbursement, this drug package is mapped to specific HCPCS administrative codes. This crosswalk aligns clinical data with the billing standards used in ASP (Average Sales Price), AWP, and OPPS payment systems. Use the cards below to identify the correct billable units for provider claims.
Note for Medical Coders: These mappings are synthesized from various CMS datasets including OPPS, PrEP, and DAC (Data Analysis and Coding) contractors. Always confirm unit conversions against the current quarter's pricing files before final submission.
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Other Available Packages
The following commercial packages are registered under the same Product NDC (0517-0020). Click a package code to view its specific billing and regulatory data.
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Frequently Asked Questions
What is the distribution configuration for this product package?
The code 0517-0020-10 identifies a specific commercial package of 10 vial, single-dose in 1 box / 3 ml in 1 vial, single-dose of Caffeine Citrate, labeled by American Regent, Inc.. This is formulated for use and contains as the active substance.
Is this product currently listed with the FDA?
This product code is currently listed as inactive or excluded from the primary directory. It was introduced to the market by American Regent, Inc. on September 10, 2007. The current certification is valid through December 31, 2020.
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 American Regent, Inc. product billed for insurance claims?
For medical billing and reimbursement, this package follows the 11-digit CMS format: 00517002010. 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:
Note: The zero is added to the Labeler segment to maintain the 5-4-2 structure.