Datscan Injection, Solution
NDC Package 17156-210-01

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

Package Information

Datscan (ioflupane i-123) injection is daTscan is a radiopharmaceutical indicated for striatal dopamine transporter visualization using single photon emission computed tomography (SPECT) brain imaging to assist in the evaluation of adult patients with suspected Parkinsonian syndromes (PS). This formulation utilizes a injection, solution delivery system. Marketed by Medi-physics Inc. Dba Ge Healthcare., this product is identified by NDC 17156-210 and is authorized under FDA application NDA022454.

Identification & Billing

NDC Package Code
17156-210-01
Package Description
1 VIAL, GLASS in 1 CONTAINER / 2.5 mL in 1 VIAL, GLASS
Product Code
17156-210
11-Digit Billing Format
17156021001
Billing Unit
EA - Billing unit of "each" is used when the product is dispensed in discreet units.
Units Per Package
1 EA

Clinical Specifications

Proprietary Name
Datscan
Non-Proprietary Name
Ioflupane I-123
Substance Name
Ioflupane I-123
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
Intravenous - Administration within or into a vein or veins.
Active Ingredient(s)
IOFLUPANE I-123 2 mCi/mL
Pharmacologic Class
Usage Information
DaTscan is a radiopharmaceutical indicated for striatal dopamine transporter visualization using single photon emission computed tomography (SPECT) brain imaging to assist in the evaluation of adult patients with suspected Parkinsonian syndromes (PS). In these patients, DaTscan may be used to help differentiate essential tremor from tremor due to PS (idiopathic Parkinson's disease, multiple system atrophy and progressive supranuclear palsy). DaTscan is an adjunct to other diagnostic evaluations.

Regulatory & Marketing

Labeler Name
Medi-physics Inc. Dba Ge Healthcare.
Product Type
Human Prescription Drug
FDA Application #
NDA022454
Marketing Category
NDA - A product marketed under an approved New Drug Application.
Start Marketing Date
03-01-2011
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.

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.

A9584
Source: OPPS
Iodine i-123 ioflupane
HCPCS Dosage Per Study Dose, up to 5 millicuries
Units / Pkg 1

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 17156-210-01 identifies a specific commercial package of 1 vial, glass in 1 container / 2.5 ml in 1 vial, glass of Datscan, a human prescription drug labeled by Medi-physics Inc. Dba Ge Healthcare.. This product is billed for "EA" each discreet unit and contains an estimated amount of 1 billable units per package. This injection, solution is formulated for intravenous use and contains ioflupane i-123 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 Medi-physics Inc. Dba Ge Healthcare. on March 01, 2011. The current certification is valid through December 31, 2027.

How is this Medi-physics Inc. Dba Ge Healthcare. product billed for insurance claims?

For medical billing and reimbursement, this package follows the 11-digit CMS format: 17156021001. 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:

10-Digit Format (5-3-2)
17156-210-01
11-Digit CMS (5-4-2)
17156-0210-01

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