Neurolite Kit
NDC Package 87333-006-05

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

Package Information

Neurolite (bicisate dihydrochloride) kits is nEUROLITE® single photon emission computerized tomography (SPECT) is indicated as an adjunct to conventional CT or MRI imaging in the localization of stroke in patients in whom stroke has already been diagnosed.NEUROLITE® is not indicated for assessment of functional viability of brain tissue. This formulation utilizes a kit delivery system. Marketed by Shine Spect Usa, Llc, this product is identified by NDC 87333-006 and is authorized under FDA application NDA020256.

Identification & Billing

NDC Package Code
87333-006-05
Package Description
5 KIT in 1 PACKAGE, COMBINATION / 1 KIT in 1 KIT * 1 INJECTION in 1 VIAL (87333-002-01) * 1 mL in 1 VIAL (87333-004-01)
Product Code
87333-006
11-Digit Billing Format
87333000605

Clinical Specifications

Proprietary Name
Neurolite
Non-Proprietary Name
Bicisate Dihydrochloride
Dosage Form
Kit - A packaged collection of related material.
Usage Information
NEUROLITE® single photon emission computerized tomography (SPECT) is indicated as an adjunct to conventional CT or MRI imaging in the localization of stroke in patients in whom stroke has already been diagnosed.NEUROLITE® is not indicated for assessment of functional viability of brain tissue. Also, NEUROLITE® is not indicated for distinguishing between stroke and other brain lesions.

Regulatory & Marketing

Labeler Name
Shine Spect Usa, Llc
Product Type
Human Prescription Drug
FDA Application #
NDA020256
Marketing Category
NDA - A product marketed under an approved New Drug Application.
Start Marketing Date
09-10-2026
Listing Expiration
12-31-2027
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.

Other Available Packages

The following commercial packages are registered under the same Product NDC (87333-006). Click a package code to view its specific billing and regulatory data.

87333-006-02
2 KIT in 1 PACKAGE, COMBINATION / 1 KIT in 1 KIT * 1 INJECTION in 1 VIAL (87333-002-01) * 1 mL in 1 VIAL (87333-004-01)

* 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 87333-006-05 identifies a specific commercial package of 5 kit in 1 package, combination / 1 kit in 1 kit * 1 injection in 1 vial (87333-002-01) * 1 ml in 1 vial (87333-004-01) of Neurolite, a human prescription drug labeled by Shine Spect Usa, Llc. This kit is formulated for use and contains 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 Shine Spect Usa, Llc on September 10, 2026. The current certification is valid through December 31, 2027.

How is this Shine Spect Usa, Llc product billed for insurance claims?

For medical billing and reimbursement, this package follows the 11-digit CMS format: 87333000605. 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)
87333-006-05
11-Digit CMS (5-4-2)
87333-0006-05

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