Anubis Barcelona Regul Oil Cream
NDC Package 83021-300-01

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

Package Information

Anubis Barcelona Regul Oil (propylene glycol, glyceryl stearate se, humulus lupulus (hops) cone extract) cream is classified as a

administered via topical route. This formulation utilizes a cream delivery system. Marketed by Anubis Cosmetics Sl, this product is identified by NDC 83021-300 and is authorized under FDA application M006.

Identification & Billing

NDC Package Code
83021-300-01
Package Description
200 mL in 1 TUBE
Product Code
83021-300
11-Digit Billing Format
83021030001

Clinical Specifications

Proprietary Name
Anubis Barcelona Regul Oil
Non-Proprietary Name
Propylene Glycol, Glyceryl Stearate Se, Humulus Lupulus (hops) Cone Extract
Substance Name
Alcohol; Arctium Lappa Root; C13-14 Isoparaffin; Cetearyl Ethylhexanoate; Cetostearyl Alcohol; Ethylhexylglycerin; Fd&c Yellow No. 5; Fragrance 13576; Glycerin; Glyceryl Stearate Se; Hops; Imidurea; Laureth-7; Limonene, (+)-; Methylchloroisothiazolinone; Methylisothiazolinone; Methylparaben; Mineral Oil; Niacinamide; Panthenol; Peg/ppg-20/6 Dimethicone; Pentaerythritol Tetrakis(3-(3,5-di-tert-butyl-4-hydroxyphenyl)propionate); Phenoxyethanol; Polyacrylamide (crosslinked; 0.01-0.2 Mole Percent Bisacrylamide); Propylene Glycol; Propylparaben; Riboflavin; Tioxolone; Triisopropanolamine; Water; Yeast, Unspecified
Dosage Form
Cream - An emulsion, semisolid3 dosage form, usually containing > 20% water and volatiles5 and/or < 50% hydrocarbons, waxes, or polyols as the vehicle. This dosage form is generally for external application to the skin or mucous membranes.
Administration Route
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)
Pharmacologic Class

Regulatory & Marketing

Labeler Name
Anubis Cosmetics Sl
Product Type
Human Otc Drug
FDA Application #
M006
Marketing Category
OTC MONOGRAPH FINAL - A product marketed pursuant to a final Over-the-Counter (OTC) Drug Monograph.
Start Marketing Date
10-20-2022
End Marketing Date
02-03-2028
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 83021-300-01 identifies a specific commercial package of 200 ml in 1 tube of Anubis Barcelona Regul Oil, a human over the counter drug labeled by Anubis Cosmetics Sl. This cream is formulated for topical use and contains alcohol; arctium lappa root; c13-14 isoparaffin; cetearyl ethylhexanoate; cetostearyl alcohol; ethylhexylglycerin; fd&c yellow no. 5; fragrance 13576; glycerin; glyceryl stearate se; hops; imidurea; laureth-7; limonene, (+)-; methylchloroisothiazolinone; methylisothiazolinone; methylparaben; mineral oil; niacinamide; panthenol; peg/ppg-20/6 dimethicone; pentaerythritol tetrakis(3-(3,5-di-tert-butyl-4-hydroxyphenyl)propionate); phenoxyethanol; polyacrylamide (crosslinked; 0.01-0.2 mole percent bisacrylamide); propylene glycol; propylparaben; riboflavin; tioxolone; triisopropanolamine; water; yeast, unspecified 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 Anubis Cosmetics Sl on October 20, 2022.

How is this Anubis Cosmetics Sl product billed for insurance claims?

For medical billing and reimbursement, this package follows the 11-digit CMS format: 83021030001. 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)
83021-300-01
11-Digit CMS (5-4-2)
83021-0300-01

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