Isosulfan Blue Injection, Solution
NDC Package 70069-221-06

View Billable Units, 11-Digit Conversion Format, and RxNorm mappings
Table of Contents
    1. Package Information
    2. Frequently Asked Questions

Package Information

Isosulfan Blue injection is 1% upon subcutaneous administration, delineates lymphatic vessels draining the region of injection. This formulation utilizes a injection, solution delivery system. Marketed by Somerset Therapeutics, Llc, this product is identified by NDC 70069-221 and is authorized under FDA application ANDA210558.

Identification & Billing

NDC Package Code
70069-221-06
Package Description
6 VIAL in 1 CARTON / 5 mL in 1 VIAL (70069-221-01)
Product Code
70069-221
11-Digit Billing Format
70069022106

Clinical Specifications

Proprietary Name
Isosulfan Blue
Non-Proprietary Name
Isosulfan Blue
Substance Name
Isosulfan Blue
Dosage Form
Injection, Solution - A liquid preparation containing one or more drug substances dissolved in a suitable solvent or mixture of mutually miscible solvents that is suitable for injection.
Administration Route
Subcutaneous - Administration beneath the skin; hypodermic. Synonymous with the term SUBDERMAL.
Active Ingredient(s)
ISOSULFAN BLUE 10 mg/mL
Usage Information
Isosulfan blue injection 1% upon subcutaneous administration, delineates lymphatic vessels draining the region of injection. It is an adjunct to lymphography in: primary and secondary lymphedema of the extremities; chyluria, chylous ascites or chylothorax; lymph node involvement by primary or secondary neoplasm; and lymph node response to therapeutic modalities.

Regulatory & Marketing

Labeler Name
Somerset Therapeutics, Llc
Product Type
Human Prescription Drug
FDA Application #
ANDA210558
Marketing Category
ANDA - A product marketed under an approved Abbreviated New Drug Application.
Start Marketing Date
07-23-2019
Listing Expiration
12-31-2026
Exclude Flag
N
Sample Package
No

Hierarchy Structure

Code Lineage

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.

Frequently Asked Questions

What is the distribution configuration for this product package?

The code 70069-221-06 identifies a specific commercial package of 6 vial in 1 carton / 5 ml in 1 vial (70069-221-01) of Isosulfan Blue, a human prescription drug labeled by Somerset Therapeutics, Llc. This injection, solution is formulated for subcutaneous use and contains isosulfan blue 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 Somerset Therapeutics, Llc on July 23, 2019. The current certification is valid through December 31, 2026.

How is this Somerset Therapeutics, Llc product billed for insurance claims?

For medical billing and reimbursement, this package follows the 11-digit CMS format: 70069022106. 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:

10-Digit Format (5-3-2)
70069-221-06
11-Digit CMS (5-4-2)
70069-0221-06

Note: The zero is added to the Product segment to maintain the 5-4-2 structure.