Miacalcin Injection, Solution
NDC Package 72078-039-02
Package Information
Miacalcin (calcitonin salmon) injection is a medication used to treat certain bone problems (e.g., Paget's disease, postmenopausal osteoporosis) and to reduce high blood levels of calcium. This formulation utilizes a injection, solution delivery system. Marketed by Mylan Institutional Llc, this product is identified by NDC 72078-039 and is authorized under FDA application NDA017808.
Identification & Billing
Clinical Specifications
- Intramuscular - Administration within a muscle.
- Subcutaneous - Administration beneath the skin; hypodermic. Synonymous with the term SUBDERMAL.
Regulatory & Marketing
Hierarchy Structure
- 72078 - Mylan Institutional Llc
- 72078-039 - Miacalcin
- 72078-039-02 - 1 VIAL, MULTI-DOSE in 1 CARTON / 2 mL in 1 VIAL, MULTI-DOSE
- 72078-039 - Miacalcin
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 72078-039-02 identifies a specific commercial package of 1 vial, multi-dose in 1 carton / 2 ml in 1 vial, multi-dose of Miacalcin, a human prescription drug labeled by Mylan Institutional Llc. This injection, solution is formulated for intramuscular; subcutaneous use and contains calcitonin salmon 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 Mylan Institutional Llc on July 18, 2022. The current certification is valid through December 31, 2027.
What are the primary indications for this medication?
This medication is used to treat certain bone problems (e.g., Paget's disease, postmenopausal osteoporosis) and to reduce high blood levels of calcium. Calcitonin is a man-made hormone that works by slowing bone loss and maintaining normal calcium levels in the blood. It may also help to reduce bone pain in people who have Paget's disease.
How is this Mylan Institutional Llc product billed for insurance claims?
For medical billing and reimbursement, this package follows the 11-digit CMS format: 72078003902. 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 Product segment to maintain the 5-4-2 structure.
