Isagel
NDC Package 11701-032-37
Package Information
Isagel is a . Marketed by Coloplast Manufacturing Us, Llc, this product is identified by NDC 11701-032 and is authorized under FDA application part333E.
Identification & Billing
Clinical Specifications
Regulatory & Marketing
Hierarchy Structure
- 11701 - Coloplast Manufacturing Us, Llc
- 11701-032 - Isagel
- 11701-032-37 - 2.5 mL in 1 PACKET
- 11701-032 - Isagel
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 11701-032-37 identifies a specific commercial package of 2.5 ml in 1 packet of Isagel, labeled by Coloplast Manufacturing Us, Llc. 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 Coloplast Manufacturing Us, Llc on June 15, 2009. The current certification is valid through August 31, 2013.
How is this Coloplast Manufacturing Us, Llc product billed for insurance claims?
For medical billing and reimbursement, this package follows the 11-digit CMS format: 11701003237. 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.