1. Home
  2. Labeler Index
  3. Tagrid Llc
  4. 85384-0001
  5. NDC Package Code: 85384-0001-1 1% Ketoconazole

NDC Package 85384-0001-1 1% Ketoconazole

Ketoconazole Shampoo Topical - View Billable Units, 11-Digit Format, RxNorm

Table of Contents

    1. Package Information
    2. Frequently Asked Questions

Package Information

Find all the important details about this NDC Package code, including the 11-Digit NDC Billing number, billing units, wholesale price, RxNorm crosswalk, active ingredients, pharmacologic clasess, etc.

NDC Package Code:
85384-0001-1
Package Description:
250 mL in 1 BOTTLE
Product Code:
85384-0001
Proprietary Name:
1% Ketoconazole
Non-Proprietary Name:
Ketoconazole
Substance Name:
Ketoconazole
Usage Information:
This medication is used to control dandruff. Use of this medication may help to relieve the flaking, scaling and itching associated with dandruff. Ketoconazole is an azole antifungal that works by preventing the growth of fungus. Ketoconazole 2% shampoo is also used to treat a skin condition known as pityriasis (tinea versicolor), a fungal infection that causes a lightening or darkening of the skin of the neck, chest, arms, or legs.
11-Digit NDC Billing Format:
85384000101
NDC to RxNorm Crosswalk:
Product Type:
Human Otc Drug
Labeler Name:
Tagrid Llc
Dosage Form:
Shampoo - A liquid soap or detergent used to clean the hair and scalp and is often used as a vehicle for dermatologic agents.
Administration Route(s):
Topical - Administration to a particular spot on the outer surface of the body. The E2B term TRANSMAMMARY is a subset of the term TOPICAL.
Active Ingredient(s):
KETOCONAZOLE 10 mg/mL
Pharmacologic Class(es):
Sample Package:
No
FDA Application Number:
M005
Marketing Category:
OTC MONOGRAPH DRUG -
Start Marketing Date:
03-31-2025
Listing Expiration Date:
12-31-2026
Exclude Flag:
N
Code Structure:

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 disclaimer below.

Frequently Asked Questions

What is NDC 85384-0001-1?

The NDC Packaged Code 85384-0001-1 is assigned to a package of 250 ml in 1 bottle of 1% Ketoconazole, a human over the counter drug labeled by Tagrid Llc. The product's dosage form is shampoo and is administered via topical form.

Is NDC 85384-0001 included in the NDC Directory?

Yes, 1% Ketoconazole with product code 85384-0001 is active and included in the NDC Directory. The product was first marketed by Tagrid Llc on March 31, 2025 and its listing in the NDC Directory is set to expire on December 31, 2026 if the product is not updated or renewed by the manufacturer.

What is the 11-digit format for NDC 85384-0001-1?

The 11-digit format is 85384000101. The 11-digit billing format might be required by the Centers for Medicare & Medicaid Services (CMS) and other payers in billing claim forms.

This package code is originally configured in a 5-4-1 segment 10-digit format and by adding a zero within the original NDC package code we can obtain the converted 11-digit format in a 5-4-2 segment configuration. The table below shows the 11-digit code conversion:

10-Digit Format10-Digit Original Code11-Digit Format11-Digit Code
5-4-185384-0001-15-4-285384-0001-01