Minoxidil
NDC Package 54868-3781-1

11-digit billing NDC: 54868378101
Table of Contents
    1. Package Information
    2. Other Packages
    3. Frequently Asked Questions

Package Information

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

Minoxidil is part your hair and apply one mL 2 times a day directly onto the scalp in the area of hair thinning/lossusing more or more often will not improve resultscontinued use is necessary to increase and keep your hair regrowth, or hair loss will begin againOther informationsee hair loss pictures on side of this cartonbefore use, read all information on carton and enclosed leafletkeep this carton.  It contains important information.in clinical studies of mostly white men aged 18-49 years with moderate degrees of hair loss, the following response to minoxidil topical solution 2% for men was reported: 26% of men reported moderate to dense hair regrowth after using minoxidil topical solution 2% for men for 4 months (26% had moderate to dense regrowth; 33% had minimal regrowth). Marketed by Physicians Total Care, Inc., this product is identified by NDC 54868-3781 and is authorized under FDA application ANDA074588.

Identification & Billing

NDC Package Code
54868-3781-1
Package Description
1 BOTTLE in 1 CARTON / 60 mL in 1 BOTTLE
Product Code
54868-3781
11-Digit Billing Format
54868378101
RxNorm Crosswalk

Clinical Specifications

Proprietary Name
Minoxidil
Dosage Form
-
Usage Information
Part your hair and apply one mL 2 times a day directly onto the scalp in the area of hair thinning/lossusing more or more often will not improve resultscontinued use is necessary to increase and keep your hair regrowth, or hair loss will begin againOther informationsee hair loss pictures on side of this cartonbefore use, read all information on carton and enclosed leafletkeep this carton.  It contains important information.in clinical studies of mostly white men aged 18-49 years with moderate degrees of hair loss, the following response to minoxidil topical solution 2% for men was reported: 26% of men reported moderate to dense hair regrowth after using minoxidil topical solution 2% for men for 4 months (26% had moderate to dense regrowth; 33% had minimal regrowth). This compares with 11% of men reporting hair regrowth after using the placebo, the liquid without minoxidil in it, for 4 months (11% had moderate to dense regrowth; 31% had minimal regrowth).store at controlled room temperature 20° to 25°C (68° to 77°F). Keep tightly closed.

Regulatory & Marketing

Labeler Name
Physicians Total Care, Inc.
FDA Application #
ANDA074588
Marketing Category
ANDA - A product marketed under an approved Abbreviated New Drug Application.
Start Marketing Date
06-04-1996
Listing Expiration
12-31-2017
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.

Other Available Packages

The following commercial packages are registered under the same Product NDC (54868-3781). Click a package code to view its specific billing and regulatory data.

54868-3781-0
2 BOTTLE in 1 CARTON / 60 mL in 1 BOTTLE

* 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 54868-3781-1 identifies a specific commercial package of 1 bottle in 1 carton / 60 ml in 1 bottle of Minoxidil, labeled by Physicians Total Care, Inc.. 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 Physicians Total Care, Inc. on June 04, 1996. The current certification is valid through December 31, 2017.

How is this Physicians Total Care, Inc. product billed for insurance claims?

For medical billing and reimbursement, this package follows the 11-digit CMS format: 54868378101. 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 (5-4-1)
54868-3781-1
11-Digit CMS (5-4-2)
54868-3781-01

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