NDC Package 78518-008-01 Cream

View Billable Units, 11-Digit Format, RxNorm

Package Information

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

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:
78518-008-01
Package Description:
1 TUBE in 1 CARTON / 35 mg in 1 TUBE
Product Code:
Proprietary Name:
Cream
Usage Information:
UsesHelps prevent sunburnIf used as directed with other sun protection measures (see Directions), decreases the risk of skin cancer and early skin aging caused by the sun.
11-Digit NDC Billing Format:
78518000801
Labeler Name:
Monat Global Corp
Sample Package:
No
FDA Application Number:
M020
Marketing Category:
OTC MONOGRAPH FINAL - A product marketed pursuant to a final Over-the-Counter (OTC) Drug Monograph.
Start Marketing Date:
09-12-2022
Listing Expiration Date:
12-31-2024
Exclude Flag:
I
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.

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Frequently Asked Questions

What is NDC 78518-008-01?

The NDC Packaged Code 78518-008-01 is assigned to a package of 1 tube in 1 carton / 35 mg in 1 tube of Cream, labeled by Monat Global Corp. The product's dosage form is and is administered via form.

Is NDC 78518-008 included in the NDC Directory?

No, Cream with product code 78518-008 is excluded from the NDC Directory because it's listing has been INACTIVATED by FDA. The product was first marketed by Monat Global Corp on September 12, 2022 and its listing in the NDC Directory is set to expire on December 31, 2024 if the product is not updated or renewed by the manufacturer.

What is the 11-digit format for NDC 78518-008-01?

The 11-digit format is 78518000801. 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 5-3-2 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
5-3-278518-008-015-4-278518-0008-01