Rootly Extra Strength Hair Regrowth Treatment For Men
NDC Package 70150-005-01

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

Package Information

This product is EXCLUDED from the official NDC directory because the listing data was inactivated by the FDA.

Rootly Extra Strength Hair Regrowth Treatment For Men is • apply one mL with dropper 2 times a day directly onto the scalp in the hair loss area• using more or more often will not improve results• continued use is necessary to increase and keep your hair regrowth, or hair loss will begin again. Marketed by Ttem, Llc, this product is identified by NDC 70150-005 and is authorized under FDA application ANDA076239.

Identification & Billing

NDC Package Code
70150-005-01
Package Description
1 BOTTLE in 1 BOX / 60 mL in 1 BOTTLE
Product Code
70150-005
11-Digit Billing Format
70150000501
RxNorm Crosswalk

Clinical Specifications

Proprietary Name
Rootly Extra Strength Hair Regrowth Treatment For Men
Dosage Form
-
Usage Information
• apply one mL with dropper 2 times a day directly onto the scalp in the hair loss area• using more or more often will not improve results• continued use is necessary to increase and keep your hair regrowth, or hair loss will begin again

Regulatory & Marketing

Labeler Name
Ttem, Llc
FDA Application #
ANDA076239
Marketing Category
ANDA - A product marketed under an approved Abbreviated New Drug Application.
Start Marketing Date
08-24-2021
Listing Expiration
12-31-2024
Exclude Flag
I
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 70150-005-01 identifies a specific commercial package of 1 bottle in 1 box / 60 ml in 1 bottle of Rootly Extra Strength Hair Regrowth Treatment For Men, labeled by Ttem, 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 Ttem, Llc on August 24, 2021. The current certification is valid through December 31, 2024.

How is this Ttem, Llc product billed for insurance claims?

For medical billing and reimbursement, this package follows the 11-digit CMS format: 70150000501. 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)
70150-005-01
11-Digit CMS (5-4-2)
70150-0005-01

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