Steritalc Powder
NDC Package 62327-333-43

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

Package Information

Steritalc (talc) powders is a human prescription drug administered via intrapleural route. This formulation utilizes a powder delivery system. Marketed by Novatech Sa, this product is identified by NDC 62327-333 and is authorized under FDA application NDA205555.

Identification & Billing

NDC Package Code
62327-333-43
Package Description
4 VIAL, GLASS in 1 BOX / 10 mL in 1 VIAL, GLASS (62327-333-03)
Product Code
62327-333
11-Digit Billing Format
62327033343
Billing Unit
EA - Billing unit of "each" is used when the product is dispensed in discreet units.
Units Per Package
1 EA
RxNorm Crosswalk

Clinical Specifications

Proprietary Name
Steritalc 3g
Non-Proprietary Name
Talc
Substance Name
Talc
Dosage Form
Powder - An intimate mixture of dry, finely divided drugs and/or chemicals that may be intended for internal or external use.
Administration Route
Intrapleural - Administration within the pleura.
Active Ingredient(s)
TALC 3 g/10mL

Regulatory & Marketing

Labeler Name
Novatech Sa
Product Type
Human Prescription Drug
FDA Application #
NDA205555
Marketing Category
NDA - A product marketed under an approved New Drug Application.
Start Marketing Date
11-01-2017
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 62327-333-43 identifies a specific commercial package of 4 vial, glass in 1 box / 10 ml in 1 vial, glass (62327-333-03) of Steritalc 3g, a human prescription drug labeled by Novatech Sa. This product is billed for "EA" each discreet unit and contains an estimated amount of 1 billable units per package. This powder is formulated for intrapleural use and contains talc 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 Novatech Sa on November 01, 2017. The current certification is valid through December 31, 2026.

How is this Novatech Sa product billed for insurance claims?

For medical billing and reimbursement, this package follows the 11-digit CMS format: 62327033343. 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)
62327-333-43
11-Digit CMS (5-4-2)
62327-0333-43

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