Micafungin
NDC Package 16714-301-10
Package Information
Micafungin is for injection is indicated for:Treatment of Candidemia, Acute Disseminated Candidiasis, Candida Peritonitis and Abscesses in adult and pediatric patients 4 months of age and older [see Clinical Studies (14.1) and Use in Specific Populations (8.4)].Treatment of Esophageal Candidiasis in adult and pediatric patients 4 months of age and older [see Clinical Studies (14.2)].Prophylaxis of Candida Infections in adult and pediatric patients 4 months of age and older undergoing hematopoietic stem cell transplantation [see Clinical Studies (14.3)].Limitations of UseMicafungin has not been adequately studied in patients with endocarditis, osteomyelitis and meningoencephalitis due to Candida.The efficacy of micafungin against infections caused by fungi other than Candida has not been established.Additional pediatric use information is approved for ASTELLAS PHARMA US INC's MYCAMINE (Micafungin for injection). Marketed by Northstar Rx Llc., this product is identified by NDC 16714-301 and is authorized under FDA application ANDA215241.
Identification & Billing
Clinical Specifications
Regulatory & Marketing
Hierarchy Structure
- 16714 - Northstar Rx Llc.
- 16714-301 - Micafungin
- 16714-301-10 - 10 VIAL in 1 CARTON / 5 mL in 1 VIAL (16714-301-01)
- 16714-301 - Micafungin
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.
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.
* 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 16714-301-10 identifies a specific commercial package of 10 vial in 1 carton / 5 ml in 1 vial (16714-301-01) of Micafungin, labeled by Northstar Rx Llc.. This product is billed for "EA" each discreet unit and contains an estimated amount of 1 billable units per package. 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 Northstar Rx Llc. on November 01, 2022. The current certification is valid through April 30, 2026.
How is this Northstar Rx Llc. product billed for insurance claims?
For medical billing and reimbursement, this package follows the 11-digit CMS format: 16714030110. Quantities are measured in per "each", products billed on a per each basis are usually products dispensed in discreet units.. There are 1 total billable units per package. 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 Product segment to maintain the 5-4-2 structure.
