Ruconest
NDC Package 68012-350-02
Package Information
Ruconest is a medication used to treat the swelling problems caused by a certain immune disease passed down through families (hereditary angioedema-HAE). Marketed by Santarus, Inc., this product is identified by NDC 68012-350 and is authorized under FDA application BLA125495.
Identification & Billing
Clinical Specifications
Regulatory & Marketing
Hierarchy Structure
- 68012 - Santarus, Inc.
- 68012-350 - Ruconest
- 68012-350-02 - 1 VIAL, SINGLE-USE in 1 CARTON / 1 INJECTION, POWDER, FOR SOLUTION in 1 VIAL, SINGLE-USE (68012-350-01)
- 68012-350 - Ruconest
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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Frequently Asked Questions
What is the distribution configuration for this product package?
The code 68012-350-02 identifies a specific commercial package of 1 vial, single-use in 1 carton / 1 injection, powder, for solution in 1 vial, single-use (68012-350-01) of Ruconest, labeled by Santarus, Inc.. 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 Santarus, Inc. on September 22, 2014. The current certification is valid through January 18, 2022.
What are the primary indications for this medication?
This medication is used to treat the swelling problems caused by a certain immune disease passed down through families (hereditary angioedema-HAE). HAE is caused by low levels or improper function of a natural substance produced by the body (C1-esterase inhibitor). Symptoms such as rapid swelling of the hands, feet, limbs, face, tongue, or throat can occur. Swelling of the intestinal tract may cause symptoms such as abdominal cramps, diarrhea, or vomiting. Attacks of swelling may occur without reason. However, anxiety, stress, sickness, and surgery may trigger attacks in some people. This medication works by increasing the level of C1-esterase inhibitor to help treat attacks of sudden swelling due to hereditary angioedema.
How is this Santarus, Inc. product billed for insurance claims?
For medical billing and reimbursement, this package follows the 11-digit CMS format: 68012035002. 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.